Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

PubMed

Borba, Helena Hiemisch Lobo; Wiens, Astrid; de Souza, Thais Teles; Correr, Cassyano Januário; Pontarolo, Roberto

2014-04-01

The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and tolerability data were observed between the belimumab and placebo groups. No differences were observed between the rituximab and placebo groups for the efficacy outcomes or safety parameters. Extracted data from the 13 studies were pooled, allowing assessment of the safety of biologic drugs. The meta-analysis revealed a satisfactory safety profile of these agents when used for SLE treatment, as there were no significant differences between the two evaluated groups (biologic agents and placebo) for all outcomes analyzed. Belimumab exhibited a satisfactory profile regarding efficacy, safety, and tolerability. Rituximab showed no superiority over placebo in terms of efficacy, despite its suitable safety profile. Biologic agents exhibited a good safety profile for SLE treatment, indicating that these agents are promising therapies and should be further investigated.

Safety, tolerability, and risks associated with first- and second-generation antipsychotics: a state-of-the-art clinical review

PubMed Central

Solmi, Marco; Murru, Andrea; Pacchiarotti, Isabella; Undurraga, Juan; Veronese, Nicola; Fornaro, Michele; Stubbs, Brendon; Monaco, Francesco; Vieta, Eduard; Seeman, Mary V; Correll, Christoph U; Carvalho, André F

2017-01-01

Since the discovery of chlorpromazine (CPZ) in 1952, first-generation antipsychotics (FGAs) have revolutionized psychiatric care in terms of facilitating discharge from hospital and enabling large numbers of patients with severe mental illness (SMI) to be treated in the community. Second-generation antipsychotics (SGAs) ushered in a progressive shift from the paternalistic management of SMI symptoms to a patient-centered approach, which emphasized targets important to patients – psychosocial functioning, quality of life, and recovery. These drugs are no longer limited to specific Diagnostic and Statistical Manual of Mental Disorders (DSM) categories. Evidence indicates that SGAs show an improved safety and tolerability profile compared with FGAs. The incidence of treatment-emergent extrapyramidal side effects is lower, and there is less impairment of cognitive function and treatment-related negative symptoms. However, treatment with SGAs has been associated with a wide range of untoward effects, among which treatment-emergent weight gain and metabolic abnormalities are of notable concern. The present clinical review aims to summarize the safety and tolerability profile of selected FGAs and SGAs and to link treatment-related adverse effects to the pharmacodynamic profile of each drug. Evidence, predominantly derived from systematic reviews, meta-analyses, and clinical trials of the drugs amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, sertindole, ziprasidone, CPZ, haloperidol, loxapine, and perphenazine, is summarized. In addition, the safety and tolerability profiles of antipsychotics are discussed in the context of the “behavioral toxicity” conceptual framework, which considers the longitudinal course and the clinical and therapeutic consequences of treatment-emergent side effects. In SMI, SGAs with safer metabolic profiles should ideally be prescribed first. However, alongside with safety, efficacy should also be considered on a patient-tailored basis. PMID:28721057

Microbiological performance of a food safety management system in a food service operation.

PubMed

Lahou, E; Jacxsens, L; Daelman, J; Van Landeghem, F; Uyttendaele, M

2012-04-01

The microbiological performance of a food safety management system in a food service operation was measured using a microbiological assessment scheme as a vertical sampling plan throughout the production process, from raw materials to final product. The assessment scheme can give insight into the microbiological contamination and the variability of a production process and pinpoint bottlenecks in the food safety management system. Three production processes were evaluated: a high-risk sandwich production process (involving raw meat preparation), a medium-risk hot meal production process (starting from undercooked raw materials), and a low-risk hot meal production process (reheating in a bag). Microbial quality parameters, hygiene indicators, and relevant pathogens (Listeria monocytogenes, Salmonella, Bacillus cereus, and Escherichia coli O157) were in accordance with legal criteria and/or microbiological guidelines, suggesting that the food safety management system was effective. High levels of total aerobic bacteria (>3.9 log CFU/50 cm(2)) were noted occasionally on gloves of food handlers and on food contact surfaces, especially in high contamination areas (e.g., during handling of raw material, preparation room). Core control activities such as hand hygiene of personnel and cleaning and disinfection (especially in highly contaminated areas) were considered points of attention. The present sampling plan was used to produce an overall microbiological profile (snapshot) to validate the food safety management system in place.

Safety profile of methotrexate in inflammatory bowel disease.

PubMed

Gabbani, Tommaso; Deiana, Simona; Lunardi, Sarah; Manetti, Natalia; Annese, Vito

2016-10-01

Methotrexate, which was initially developed in 1948 for the treatment of leukemia, is known to be an immunomodulatory and anti-inflammatory drug. It has been widely used for over 60 years as both a low and high-dose therapy in chronic inflammatory diseases. The aim of this review was to analyze and summarize the available data specifically on the safety of this drug in the management of inflammatory bowel diseases. A structured search of articles was conducted using the PubMed database up to April 2016. All articles in English with isolated or combined keywords were included according to their relevance to the aims of this study. Numerous of studies have established the efficacy of parenteral methotrexate in the management of steroid-dependent and steroid-resistant Crohn's disease, either for inducing or maintaining remission. However, its efficacy in ulcerative colitis has not been properly investigated. Additionally, methotrexate has been shown to reduce the effect of immunization with anti-TNF agents when combined. The drug has potential advantages over thiopurines such as its weekly administration, a possible shorter time of action, low cost, decreased risk for malignancy and overall a comparable safety profile.

THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.

PubMed

Fernández, Óscar

2016-01-01

From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects. A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported. The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THC:CBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 sprays/day. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THC:CBD oromucosal spray. The findings aligned closely with the UK/German/Swiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 sprays/day) and safety profile, including no evidence of addiction, abuse or misuse. The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice. © 2016 S. Karger AG, Basel.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

Chronic non-cancer pain: Focus on once-daily tramadol formulations

PubMed Central

Coluzzi, Flaminia; Mattia, Consalvo

2007-01-01

Despite progress in pain management, chronic non-cancer pain (CNCP) represents still a clinical challenge. The efficacy and safety profile of tramadol make it suitable as a long-term treatment in a variety of CNCP conditions. New once-daily (OD) formulations of tramadol have been marketed in various countries, in order to offer the advantage of a reduced dosing regimen and to improve patients’ compliance. This review focuses on the technology, pharmacology, clinical efficacy, and safety of different once-daily tramadol formulations. Hydrophilic vs hydrophobic matrix systems and newer technologies used in once-daily formulations to control drug delivery are discussed. Three randomized controlled trials (RCTs) established OD tramadol analgesic efficacy to be superior to that of placebo for pain management and functional improvement in patients with osteoarthritis. Three RCTs demonstrated similar rates of efficacy between OD tramadol and immediate-release (IR) or sustained-release (SR) formulations, with a better adverse events profile. An open trial on long term tolerability showed that OD tramadol is generally safe in rheumatological pain treatment. PMID:18473006

Adverse outcomes in maternity care for women with a low risk profile in The Netherlands: a case series analysis

PubMed Central

2013-01-01

Background This study aimed to perform a structural analysis of determinants of risk of critical incidents in care for women with a low risk profile at the start of pregnancy with a view on improving patient safety. Methods We included 71 critical incidents in primary midwifery care and subsequent hospital care in case of referral after 36 weeks of pregnancy that were related to substandard care and for that reason were reported to the Health Care Inspectorate in The Netherlands in 36 months (n = 357). We performed a case-by-case analysis, using a previously validated instrument which covered five broad domains: healthcare organization, communication between healthcare providers, patient risk factors, clinical management, and clinical outcomes. Results Determinants that were associated with risk concerned healthcare organization (n = 20 incidents), communication about treatment procedures (n = 39), referral processes (n = 19), risk assessment by telephone triage (n = 10), and clinical management in an out of hours setting (n = 19). The 71 critical incidents included three cases of maternal death, eight cases of severe maternal morbidity, 42 perinatal deaths and 12 critical incidents with severe morbidity for the child. Suboptimal prenatal risk assessment, a delay in availability of health care providers in urgent situations, miscommunication about treatment between care providers, and miscommunication with patients in situations with a language barrier were associated with safety risks. Conclusions Systematic analysis of critical incidents improves insight in determinants of safety risk. The wide variety of determinants of risk of critical incidents implies that there is no single intervention to improve patient safety in the care for pregnant women with initially a low risk profile. PMID:24286376

An evaluation of a new instrument to measure organisational safety culture values and practices.

PubMed

Díaz-Cabrera, D; Hernández-Fernaud, E; Isla-Díaz, R

2007-11-01

The main aim of this research is to evaluate a safety culture measuring instrument centred upon relevant organisational values and practices related to the safety management system. Seven dimensions that reflect underlying safety meanings are proposed. A second objective is to explore the four cultural orientations in the field of safety arising from the competing values framework. The study sample consisted of 299 participants from five companies in different sectors. The results show six dimensions of organisational values and practices and different company profiles in the organisations studied. The four cultural orientations proposed by the competing values framework are not confirmed. Nevertheless, a coexistence of diverse cultural orientations or paradoxes in the companies is observed.

Laser safety at high profile projects

NASA Astrophysics Data System (ADS)

Barat, K.

2011-03-01

Laser Safety at high profile laser facilities tends to be more controlled than in the standard laser lab found at a research institution. The reason for this is the potential consequences for such facilities from incidents. This ranges from construction accidents, to equipment damage to personnel injuries. No laser user wants to sustain a laser eye injury. Unfortunately, many laser users, most commonly experienced researchers and inexperienced graduate students, do receive laser eye injuries during their careers. . More unforgiveable is the general acceptance of this scenario, as part of the research & development experience. How do senior researchers, safety personnel and management stop this trend? The answer lies in a cultural change that involves institutional training, user mentoring, hazard awareness by users and administrative controls. None of these would inhibit research activities. As a matter of fact, proper implementation of these controls would increase research productivity. This presentation will review and explain the steps needed to steer an institution, research division, group or individual lab towards a culture that should nearly eliminate laser accidents. As well as how high profile facilities try to avoid laser injuries. Using the definition of high profile facility as one who's funding in the million to billions of dollars or Euros and derives form government funding.

Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis.

PubMed

Lancaster, Lisa H; de Andrade, Joao A; Zibrak, Joseph D; Padilla, Maria L; Albera, Carlo; Nathan, Steven D; Wijsenbeek, Marlies S; Stauffer, John L; Kirchgaessler, Klaus-Uwe; Costabel, Ulrich

2017-12-31

Pirfenidone is one of two approved therapies for the treatment of idiopathic pulmonary fibrosis (IPF). Randomised controlled clinical trials and subsequent post hoc analyses have demonstrated that pirfenidone reduces lung function decline, decreases mortality and improves progression-free survival. Long-term extension trials, registries and real-world studies have also shown similar treatment effects with pirfenidone. However, for patients with IPF to obtain the maximum benefits of pirfenidone treatment, the potential adverse events (AEs) associated with pirfenidone need to be managed. This review highlights the well-known and established safety profile of pirfenidone based on randomised controlled clinical trials and real-world data. Key strategies for preventing and managing the most common pirfenidone-related AEs are described, with the goal of maximising adherence to pirfenidone with minimal AEs. Copyright ©ERS 2017.

Drafting Fundamentals. Drafting Module 1. Instructor's Guide.

ERIC Educational Resources Information Center

Missouri Univ., Columbia. Instructional Materials Lab.

This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. The guide contains a cross-reference table of instructional materials. Ten units cover drafting fundamentals: (1) introduction to drafting; (2) general safety;…

12 CFR Appendix A to Part 570 - Interagency Guidelines Establishing Standards for Safety and Soundness

Code of Federal Regulations, 2010 CFR

2010-01-01

... risk assessment; 3. Timely and accurate financial, operational and regulatory reports; 4. Adequate... asset concentrations; and 6. Provide periodic asset reports with adequate information for management and... profile of the institution's assets and operations; 3. Assess the source, volatility, and sustainability...

12 CFR Appendix A to Part 30 - Interagency Guidelines Establishing Standards for Safety and Soundness

Code of Federal Regulations, 2010 CFR

2010-01-01

... risk assessment; 3. Timely and accurate financial, operational and regulatory reports; 4. Adequate... asset concentrations; and 6. Provide periodic asset reports with adequate information for management and... profile of the institution's assets and operations; 3. Assess the source, volatility, and sustainability...

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

PubMed

Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

2018-01-01

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria.

PubMed

Sologuren, Ander; Vinas, Rosa; Cordon, Esther; Riesgo, Susana E; Del Mar Fores, Maria; Senan, Maria Rosa; Fernandez, Sonia; Labeaga, Luis; Ruiz-Mijan, Manuel

2018-03-20

Bilastine is an H1-antihistamine approved for symptomatic treatment of patients with allergic rhinoconjunctivitis or urticaria. The safety profile of bilastine in clinical trials of allergic rhinoconjunctivitis or urticaria, assessed by type and frequency of adverse events (AE), was similar to that of placebo. As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed. A prospective, multicenter, observational, open-label, 3-month follow-up study was performed to assess the safetyprofile of bilastine 20 mg in patients aged greater than or equal to 65 years with allergic rhinoconjunctivitis and/or urticaria. A total of 74 of 146 patients (50.7%) reported 129 treatment-emergent AEs (TEAE) during the study period. Theincidence of TEAEs was low, with monthly and quarterly rates of 0.29 (95% confidence intervals [CI], 0.229-0.367) and 0.88(95% CI, 0.688 -1.100), respectively. Monthly and quarterly incidence rates were 0.04 (95% CI, 0.016-0.082) and 0.12 (95%CI, 0.048-0.246), respectively, for related TEAEs (eight TEAEs in seven patients) and were 0.02 (95% CI, 0.003- 0.048) and0.05 (95% CI, 0.010-0.143), respectively, for serious TEAEs (five TEAES in three patients). All serious TEAEs were considered to be unrelated to bilastine. Bilastine 20 mg showed a favorable safety profile with a low incidence of TEAEs in patients aged greater than or equal to 65 years.The results were in accordance with the known safety profile of bilastine 20 mg and incidence of AEs reported in previous studies and described in the approved summary of product characteristics.

Clinician perceptions of personal safety and confidence to manage inpatient aggression in a forensic psychiatric setting.

PubMed

Martin, T; Daffern, M

2006-02-01

Inpatient mental health clinicians need to feel safe in the workplace. They also require confidence in their ability to work with aggressive patients, allowing the provision of therapeutic care while protecting themselves and other patients from psychological and physical harm. The authors initiated this study with the predetermined belief that a comprehensive and integrated organizational approach to inpatient aggression was required to support clinicians and that this approach increased confidence and staff perceptions of personal safety. To assess perceptions of personal safety and confidence, clinicians in a forensic psychiatric hospital were surveyed using an adapted version of the Confidence in Coping With Patient Aggression Instrument. In this study clinicians reported the hospital as safe. They reported confidence in their work with aggressive patients. The factors that most impacted on clinicians' confidence to manage aggression were colleagues' knowledge, experience and skill, management of aggression training, use of prevention and intervention strategies, teamwork and the staff profile. These results are considered with reference to an expanding literature on inpatient aggression. It is concluded that organizational resources, policies and frameworks support clinician perceptions of safety and confidence to manage inpatient aggression. However, how these are valued by clinicians and translated into practice at unit level needs ongoing attention.

Oral medications regarding their safety and efficacy in the management of patent ductus arteriosus

PubMed Central

Oncel, Mehmet Yekta; Erdeve, Omer

2016-01-01

Patent ductus arteriosus (PDA) is a common clinical condition in preterm infants which is inversely related to birth weight and gestational age. Cyclooxygenase inhibitors such as indomethacin and ibuprofen which block the prostaglandin conversion from arachidonic acid are the most commonly used drugs for ductal closure. This review focuses on the safety and efficacy oral medications in the management of PDA in preterm infants. Ibuprofen seems to be the first choice due to its higher safety profile, as it is associated with fewer gastrointestinal and renal side effects when compared to indomethacin. PDA closure rates are better with oral than with intravenous ibuprofen probably due to the pharmacokinetic of the drug. However, these medications were reported to be associated with several adverse including transient renal failure, gastrointestinal bleeding and perforation, hyperbilirubinemia and platelet dysfunction. Paracetamol seems be an alternative to PDA therapy with lower adverse events and side effects. PMID:26862505

American Council on Consumer Interests Annual Conference (44th, Washington, D.C., March 25-28, 1998).

ERIC Educational Resources Information Center

Leech, Irene E., Ed.

1998-01-01

Among the 25 refereed papers, 14 refereed poster sessions, 17 invited papers, and 14 panel/workshop sessions are the following: "Forces Driving Change in Food Safety" (Foreman); "Are Two Incomes Needed to Get Ahead Today?" (Walden); "Financial Manager Profile Scale" (Lytton, Grable); "Real World Financial…

Microbial profiling, neural network and semantic web: an integrated information system for human pathogen risk management, prevention and surveillance in food safety

USDA-ARS?s Scientific Manuscript database

It is estimated that food-borne pathogens cause approximately 76 million cases of gastrointestinal illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States annually. Genomic, proteomic, and metabolomic studies, particularly, genome sequencing projects are providing valuable inform...

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.

PubMed

Moreau, Philippe; Dimopoulos, Meletios A; Richardson, Paul G; Siegel, David S; Cavo, Michele; Corradini, Paolo; Weisel, Katja; Delforge, Michel; O'Gorman, Peter; Song, Kevin; Chen, Christine; Bahlis, Nizar; Oriol, Albert; Hansson, Markus; Kaiser, Martin; Anttila, Pekka; Raymakers, Reinier; Joao, Cristina; Cook, Gordon; Sternas, Lars; Biyukov, Tsvetan; Slaughter, Ana; Hong, Kevin; Herring, Jennifer; Yu, Xin; Zaki, Mohamed; San-Miguel, Jesus

2017-09-01

Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management. This analysis included 1088 patients who received ≥ 2 prior therapies, including lenalidomide and bortezomib, and progressed ≤ 60 days of last therapy. Patients received 28-day cycles of pomalidomide 4 mg/day on days 1-21 and low-dose dexamethasone 40 mg (20 mg if aged > 75 years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. The most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care. Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

PubMed

Lu, Zhengwu

2009-01-01

Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

An overview of the novel H1-antihistamine bilastine in allergic rhinitis and urticaria.

PubMed

Jáuregui, Ignacio; García-Lirio, Eduardo; Soriano, Ana María; Gamboa, Pedro M; Antépara, Ignacio

2012-01-01

Currently available second-generation H1-antihistamines include a wide group of drugs with a better therapeutic index (or risk-benefit ratio) than the classic antihistamines, although their properties and safety profiles may differ. Bilastine is a newly registered H1-antihistamine for the oral treatment of allergic rhinitis and urticaria, with established antihistaminic and antiallergic properties. Clinical studies in allergic rhinitis and chronic urticaria show that once-daily treatment with bilastine 20 mg is effective in managing symptoms and improving patient's quality of life, with at least comparable efficacy to other nonsedative H1-antihistamines. As far as studies in healthy volunteers, clinical assays and clinical experience can establish, bilastine's safety profile is satisfactory, since it lacks anticholinergic effects, does not impair psychomotor performance or actual driving, and appears to be entirely free from cardiovascular effects.

[Abatacept].

PubMed

Iwamoto, Naoki; Kawakami, Atsushi

2016-06-01

Abatacept (ABT) is a recombinant fusion protein comprising the extracellular domain of human CTLA4, which inhibits the activation of T cells. Several clinical trials have provided evidence of efficacy and safety of ABT in the patients with rheumatoid athritis (RA) with various clinical characteristics such as MTX inadequate responders (IR), TNF inhibitor-IR. Moreover, indirect comparison of ABT to other biologics reported in Cochrane review revealed that ABT has better safety profile in serious adverse events and serious infection Thus the features of ABT in the treatment of RA have gradually become apparent and knowledge of these features is helpful for better use of biologics. In this review we will discuss the efficacy and safety of ABT in the management of RA.

What to Do with 15 Years of Injury Data from a College Guide Training Diploma Program?

ERIC Educational Resources Information Center

Jackson, Jeff S.

2017-01-01

The outdoor leadership field is maturing in its understanding of activity safety and objective measures of risk exposure. Patterns of injury, relative exposure between related activities, and risk profiles per user group are only just beginning to accumulate academic findings from which a collective understanding of managing adventure-based risk…

Advanced Range Safety System for High Energy Vehicles

NASA Technical Reports Server (NTRS)

Claxton, Jeffrey S.; Linton, Donald F.

2002-01-01

The advanced range safety system project is a collaboration between the National Aeronautics and Space Administration and the United States Air Force to develop systems that would reduce costs and schedule for safety approval for new classes of unmanned high-energy vehicles. The mission-planning feature for this system would yield flight profiles that satisfy the mission requirements for the user while providing an increased quality of risk assessment, enhancing public safety. By improving the speed and accuracy of predicting risks to the public, mission planners would be able to expand flight envelopes significantly. Once in place, this system is expected to offer the flexibility of handling real-time risk management for the high-energy capabilities of hypersonic vehicles including autonomous return-from-orbit vehicles and extended flight profiles over land. Users of this system would include mission planners of Space Launch Initiative vehicles, space planes, and other high-energy vehicles. The real-time features of the system could make extended flight of a malfunctioning vehicle possible, in lieu of an immediate terminate decision. With this improved capability, the user would have more time for anomaly resolution and potential recovery of a malfunctioning vehicle.

The Role of Mifepristone in Meningiomas Management: A Systematic Review of the Literature.

PubMed

Cossu, Giulia; Levivier, Marc; Daniel, Roy Thomas; Messerer, Mahmoud

2015-01-01

We performed a systematic literature review to analyze the clinical application and the safety of mifepristone, a prominent antiprogesterone agent, in meningioma patients. A systematic search was performed through Medline, Cochrane, and clinicaltrials.gov databases from 1960 to 2014. Study Selection. Studies were selected through a PICO approach. Population was meningioma patients, meningioma cells cultures, and animal models. Intervention was mifepristone administration. Control was placebo administration or any other drug tested. Outcomes were clinical and radiological responsiveness, safety profile, and cell growth inhibition. A total of 7 preclinical and 6 clinical studies and one abstract were included. Encouraging results were found in preclinical studies. Concerning clinical studies, the response rate to mifepristone in terms of radiological regression and symptomatic improvement/stability in patients with inoperable meningioma was low. In meningiomatosis, favorable preliminary results were recorded. The safety profile was good. Limitations were as follows. The tumoral expression of progesterone receptors was not analyzed systematically in every study considered. No clear evidence exists to recommend mifepristone in inoperable meningiomas. Preliminary encouraging results were found in diffuse meningiomatosis. Mifepristone is a well-tolerated treatment. Patients' selection and hormonal profile analysis in meningiomas are fundamental for a better understanding of its benefit. Multicenter placebo-controlled trials are required.

A nationwide hospital survey on patient safety culture in Belgian hospitals: setting priorities at the launch of a 5-year patient safety plan.

PubMed

Vlayen, Annemie; Hellings, Johan; Claes, Neree; Peleman, Hilde; Schrooten, Ward

2012-09-01

To measure patient safety culture in Belgian hospitals and to examine the homogeneous grouping of underlying safety culture dimensions. The Hospital Survey on Patient Safety Culture was distributed organisation-wide in 180 Belgian hospitals participating in the federal program on quality and safety between 2007 and 2009. Participating hospitals were invited to submit their data to a comparative database. Homogeneous groups of underlying safety culture dimensions were sought by hierarchical cluster analysis. 90 acute, 42 psychiatric and 11 long-term care hospitals submitted their data for comparison to other hospitals. The benchmark database included 55 225 completed questionnaires (53.7% response rate). Overall dimensional scores were low, although scores were found to be higher for psychiatric and long-term care hospitals than for acute hospitals. The overall perception of patient safety was lower in French-speaking hospitals. Hierarchical clustering of dimensions resulted in two distinct clusters. Cluster I grouped supervisor/manager expectations and actions promoting safety, organisational learning-continuous improvement, teamwork within units and communication openness, while Cluster II included feedback and communication about error, overall perceptions of patient safety, non-punitive response to error, frequency of events reported, teamwork across units, handoffs and transitions, staffing and management support for patient safety. The nationwide safety culture assessment confirms the need for a long-term national initiative to improve patient safety culture and provides each hospital with a baseline patient safety culture profile to direct an intervention plan. The identification of clusters of safety culture dimensions indicates the need for a different approach and context towards the implementation of interventions aimed at improving the safety culture. Certain clusters require unit level improvements, whereas others demand a hospital-wide policy.

A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Simulation of Flood Profiles for Fivemile Creek at Tarrant, Alabama, 2006

USGS Publications Warehouse

Lee, K.G.; Hedgecock, T.S.

2007-01-01

A one-dimensional step-backwater model was used to simulate flooding conditions for Fivemile Creek at Tarrant, Alabama. The 100-year flood stage published in the current flood insurance study for Tarrant by the Federal Emergency Management Agency was significantly exceeded by the March 2000 and May 2003 floods in this area. A peak flow of 14,100 cubic feet per second was computed by the U.S. Geological Survey for the May 2003 flood in the vicinity of Lawson Road. Using this estimated peak flow, flood-plain surveys with associated roughness coefficients, and the surveyed high-water profile for the May 2003 flood, a flow model was calibrated to closely match this known event. The calibrated model was then used to simulate flooding for the 10-, 50-, 100-, and 500-year recurrence interval floods. The results indicate that for the 100-year recurrence interval, the flood profile is about 2.5 feet higher, on average, than the profile published by the Federal Emergency Management Agency. The absolute maximum and minimum difference is 6.80 feet and 0.67 foot, respectively. All water-surface elevations computed for the 100-year flood are higher than those published by the Federal Emergency Management Agency, except for cross section H. The results of this study provide the community with flood-profile information that can be used for existing flood-plain mitigation, future development, and safety plans for the city.

Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus.

PubMed

Cappuzzo, Federico; Moro-Sibilot, Denis; Gautschi, Oliver; Boleti, Ekaterini; Felip, Enriqueta; Groen, Harry J M; Germonpré, Paul; Meldgaard, Peter; Arriola, Edurne; Steele, Nicola; Fox, Jesme; Schnell, Patrick; Engelsberg, Arne; Wolf, Jürgen

2015-02-01

Within 4 years of the discovery of anaplastic lymphoma kinase (ALK) rearrangements in non-small cell lung cancer (NSCLC), the ALK inhibitor crizotinib gained US and European approval for the treatment of advanced ALK-positive NSCLC. This was due to the striking response data observed with crizotinib in phase I and II trials in patients with ALK-positive NSCLC, as well as the favorable tolerability and safety profile observed. Recently published phase III data established crizotinib as a new standard of care for this NSCLC molecular subset. A consequence of such rapid approval, however, is the limited clinical experience and relative paucity of information concerning optimal therapy management. In this review, we discuss the development of crizotinib and the clinical relevance of its safety profile, examining crizotinib-associated adverse events in detail and making specific management recommendations. Crizotinib-associated adverse events were mostly mild to moderate in severity in clinical studies, and appropriate monitoring and supportive therapies are considered effective in avoiding the need for dose interruption or reduction in most cases. Therapy management of patients following disease progression on crizotinib is also discussed. Based on available clinical data, it is evident that patients may have prolonged benefit from crizotinib after Response Evaluation Criteria in Solid Tumors-defined disease progression, and crizotinib should be continued for as long as the patient derives benefit. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com; Nolte, Marc W.; Solomon, Cristina

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii)more » the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated, with no adverse events. • Overall, human fibrinogen concentrate demonstrated a good safety profile. • This data adds to the safety information available to date on this hemostatic agent.« less

Avelumab: a new standard for treating metastatic Merkel cell carcinoma.

PubMed

Baker, Mairead; Cordes, Lisa; Brownell, Isaac

2018-04-01

Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer. Although MCC is chemosensitive, responses to traditional chemotherapeutic agents are not durable. Avelumab, a novel anti-PD-L1 immune checkpoint inhibitor, recently became the first FDA-approved agent for the treatment of metastatic MCC and represents a new option to improve patient survival. Areas covered: This article presents an overview of MCC and summarizes the development of avelumab in the treatment of metastatic MCC. Preclinical studies, phase 1 and phase 2 clinical trials, and the safety profile of avelumab are reviewed. Future perspectives and ongoing studies are also discussed. Expert commentary: Avelumab demonstrated rapid and durable responses and a manageable safety profile in the treatment of metastatic MCC. Patient outcomes are favorable when compared to historical responses to standard chemotherapy. Ongoing clinical trials will continue to characterize avelumab and its optimal use in MCC therapy.

Development of a Quality and Safety Competency Curriculum for Radiation Oncology Residency: An International Delphi Study.

PubMed

Adleman, Jenna; Gillan, Caitlin; Caissie, Amanda; Davis, Carol-Anne; Liszewski, Brian; McNiven, Andrea; Giuliani, Meredith

2017-06-01

To develop an entry-to-practice quality and safety competency profile for radiation oncology residency. A comprehensive list of potential quality and safety competency items was generated from public and professional resources and interprofessional focus groups. Redundant or out-of-scope items were eliminated through investigator consensus. Remaining items were subjected to an international 2-round modified Delphi process involving experts in radiation oncology, radiation therapy, and medical physics. During Round 1, each item was scored independently on a 9-point Likert scale indicating appropriateness for inclusion in the competency profile. Items indistinctly ranked for inclusion or exclusion were re-evaluated through web conference discussion and reranked in Round 2. An initial 1211 items were compiled from 32 international sources and distilled to 105 unique potential quality and safety competency items. Fifteen of the 50 invited experts participated in round 1: 10 radiation oncologists, 4 radiation therapists, and 1 medical physicist from 13 centers in 5 countries. Round 1 rankings resulted in 80 items included, 1 item excluded, and 24 items indeterminate. Two areas emerged more prominently within the latter group: change management and human factors. Web conference with 5 participants resulted in 9 of these 24 items edited for content or clarity. In Round 2, 12 participants rescored all indeterminate items resulting in 10 items ranked for inclusion. The final 90 enabling competency items were organized into thematic groups consisting of 18 key competencies under headings adapted from Deming's System of Profound Knowledge. This quality and safety competency profile may inform minimum training standards for radiation oncology residency programs. Copyright © 2017 Elsevier Inc. All rights reserved.

Development of a Quality and Safety Competency Curriculum for Radiation Oncology Residency: An International Delphi Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Adleman, Jenna; Gillan, Caitlin; Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario

Purpose: To develop an entry-to-practice quality and safety competency profile for radiation oncology residency. Methods and Materials: A comprehensive list of potential quality and safety competency items was generated from public and professional resources and interprofessional focus groups. Redundant or out-of-scope items were eliminated through investigator consensus. Remaining items were subjected to an international 2-round modified Delphi process involving experts in radiation oncology, radiation therapy, and medical physics. During Round 1, each item was scored independently on a 9-point Likert scale indicating appropriateness for inclusion in the competency profile. Items indistinctly ranked for inclusion or exclusion were re-evaluated through webmore » conference discussion and reranked in Round 2. Results: An initial 1211 items were compiled from 32 international sources and distilled to 105 unique potential quality and safety competency items. Fifteen of the 50 invited experts participated in round 1: 10 radiation oncologists, 4 radiation therapists, and 1 medical physicist from 13 centers in 5 countries. Round 1 rankings resulted in 80 items included, 1 item excluded, and 24 items indeterminate. Two areas emerged more prominently within the latter group: change management and human factors. Web conference with 5 participants resulted in 9 of these 24 items edited for content or clarity. In Round 2, 12 participants rescored all indeterminate items resulting in 10 items ranked for inclusion. The final 90 enabling competency items were organized into thematic groups consisting of 18 key competencies under headings adapted from Deming's System of Profound Knowledge. Conclusions: This quality and safety competency profile may inform minimum training standards for radiation oncology residency programs.« less

Long-term tolerability of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study.

PubMed

Klipping, Christine; Duijkers, Ingrid; Fortier, Michel P; Marr, Joachim; Trummer, Dietmar; Elliesen, Jörg

2012-04-01

This study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens. In this Phase III, multicentre, open-label study, women (aged 18-35 years) were randomised to EE/DRSP in the following regimens: flexible(MIB) (24-120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexible(MIB) regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres. Results were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexible(MIB), conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens. EE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives.

System Risk Balancing Profiles: Software Component

NASA Technical Reports Server (NTRS)

Kelly, John C.; Sigal, Burton C.; Gindorf, Tom

2000-01-01

The Software QA / V&V guide will be reviewed and updated based on feedback from NASA organizations and others with a vested interest in this area. Hardware, EEE Parts, Reliability, and Systems Safety are a sample of the future guides that will be developed. Cost Estimates, Lessons Learned, Probability of Failure and PACTS (Prevention, Avoidance, Control or Test) are needed to provide a more complete risk management strategy. This approach to risk management is designed to help balance the resources and program content for risk reduction for NASA's changing environment.

Considerations on long-term immuno-intervention in the treatment of multiple sclerosis: an expert opinion.

PubMed

Grigoriadis, Nikolaos; Linnebank, Michael; Alexandri, Nektaria; Muehl, Sarah; Hofbauer, Günther F L

2016-10-01

As management of multiple sclerosis (MS) requires life-long treatment with disease-modifying agents, any risks associated with long-term use should be considered when evaluating therapeutic options. Immune cells of the innate and adaptive immune systems play various roles in the pathogenesis of MS. MS therapies affect the immune system, each with a unique mode of action, and consequently possess different long-term safety profiles. Rare, but serious safety concerns, including an increased risk of infection and cancer, have been associated with immunosuppressant use. The risks associated with newer immunosuppressive agents, which target specific elements of MS disease pathophysiology, are not yet fully established as the duration of clinical trials is relatively short and post-marketing experience is limited. Non-immunosuppressants used to treat MS have well-defined safety profiles established over a large number of patient-years demonstrating them to be well-tolerated long-term treatment options. When considering the long-term use of disease-modifying agents for treating MS, classification as immunosuppressants or non-immunosuppressants can be useful when evaluating potential risks associated with chronic use. A successful therapeutic strategy for any serious, chronic disease such as MS should weigh effectiveness versus long-term safety of available treatments.

Recommendations by the Spanish Society of Rheumatology for the management of patients diagnosed with rheumatoid arthritis who cannot be treated with methotrexate.

PubMed

García-Vicuña, Rosario; Martín-Martínez, María Auxiliadora; Gonzalez-Crespo, María Rosa; Tornero-Molina, Jesús; Fernández-Nebro, Antonio; Blanco-García, Francisco Javier; Blanco-Alonso, Ricardo; Marsal-Barril, Sara

To establish a set of recommendations for the management of patients diagnosed with rheumatoid arthritis (RA) who cannot be treated with methotrexate (MTX) due to contraindications, drug toxicity or lack of adherence, and to establish therapeutic strategies more effective and safer in these RA patients. A qualitative analysis of the scientific evidence available to June 2015. The 2-round Delphi technique of consensus was used to collect and establish expert opinion based on the participants' clinical experience when only low quality evidence was available. A total of eighteen recommendations were developed for the management of this patient profile. Fourteen of these recommendations were related to drug safety aspects. Recommendations on contraindication and toxicity of MTX have been updated. The experts recommend the use of biological monotherapy, a preferred treatment option, in patients whose profiles reveal a contraindication, intolerance or circumstances that prevent us against the use of MTX. There is some high-quality scientific evidence that supports contraindication and establishes certain conditions of MTX use in RA patients with specific clinical profiles. Copyright © 2016. Publicado por Elsevier España, S.L.U.

Efficacy and tolerability of lumiracoxib, a highly selective cyclo-oxygenase-2 (COX2) inhibitor, in the management of pain and osteoarthritis

PubMed Central

Geusens, Piet; Lems, Willem

2008-01-01

Lumiracoxib is a COX2 inhibitor that is highly selective, is more effective than placebo on pain in osteoarthritis (OA), with similar analgesic and anti-inflammatory effects as non-selective NSAIDs and the selective COX2 inhibitor celecoxib, has a lower incidence of upper gastrointestinal (GI) side effects in patients not taking aspirin, and a similar incidence of cardiovascular (CV) side effects compared to naproxen or ibuprofen. In the context of earlier guidelines and taking into account the GI and CV safety results of the TARGET study, lumiracoxib had secured European Medicines Agency (EMEA) approval with as indication symptomatic treatment of OA as well as short-term management of acute pain associated with primary dysmenorrhea and following orthopedic or dental surgery. In the complex clinical context of efficiency and safety of selective and non-selective COX inhibitors, its prescription and use should be based on the risk and safety profile of the patient. In addition, there is further need for long-term GI and CV safety studies and general post-marketing safety on its use in daily practice. Meanwhile, at the time of submission of this manuscript, the EMEA has withdrawn lumiracoxib throughout Europe because of the risk of serious side effects affecting the liver. PMID:18728796

Flupyradifurone: a brief profile of a new butenolide insecticide

PubMed Central

Nauen, Ralf; Jeschke, Peter; Velten, Robert; Beck, Michael E; Ebbinghaus-Kintscher, Ulrich; Thielert, Wolfgang; Wölfel, Katharina; Haas, Matthias; Kunz, Klaus; Raupach, Georg

2015-01-01

BACKGROUND The development and commercialisation of new chemical classes of insecticides for efficient crop protection measures against destructive invertebrate pests is of utmost importance to overcome resistance issues and to secure sustainable crop yields. Flupyradifurone introduced here is the first representative of the novel butenolide class of insecticides active against various sucking pests and showing an excellent safety profile. RESULTS The discovery of flupyradifurone was inspired by the butenolide scaffold in naturally occurring stemofoline. Flupyradifurone acts reversibly as an agonist on insect nicotinic acetylcholine receptors but is structurally different from known agonists, as shown by chemical similarity analysis. It shows a fast action on a broad range of sucking pests, as demonstrated in laboratory bioassays, and exhibits excellent field efficacy on a number of crops with different application methods, including foliar, soil, seed treatment and drip irrigation. It is readily taken up by plants and translocated in the xylem, as demonstrated by phosphor imaging analysis. Flupyradifurone is active on resistant pests, including cotton whiteflies, and is not metabolised by recombinantly expressed CYP6CM1, a cytochrome P450 conferring metabolic resistance to neonicotinoids and pymetrozine. CONCLUSION The novel butenolide insecticide flupyradifurone shows unique properties and will become a new tool for integrated pest management around the globe, as demonstrated by its insecticidal, ecotoxicological and safety profile. © 2014 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. PMID:25351824

[Management of new oral anticoagulants in gastrointestinal bleeding and endoscopy].

PubMed

del Molino, Fátima; Gonzalez, Isabel; Saperas, Esteve

2015-10-01

New oral direct anticoagulants agents are alternatives to warfarin for long-term anticoagulation in a growing number of patients that require long-term anticoagulation for atrial fibrillation, deep venous thrombosis and pulmonary embolism. These new agents with predictable pharmacokinetic and pharmacodynamics profiles offer a favorable global safety profile, but increased gastrointestinal bleeding compared to the vitamin K antagonists. Many gastroenterologists are unfamiliar and may be wary of these newer drugs, since Clinical experience is limited and no specific antidote is available to reverse their anticoagulant effect. In this article the risk of these new agents and, how to manage these agents in both the presence of acute gastrointestinal bleeding and in patients undergoing endoscopic procedures is reviewed. Copyright © 2014 Elsevier España, S.L.U. and AEEH y AEG. All rights reserved.

Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
.

PubMed

Brumbaugh Paradis, Heather; Alter, Debbie; Llerandi, Diane

2017-10-01

Venetoclax (Venclexta™) is a potent, selective, orally available, small-molecule B-cell lymphoma 2 inhibitor that achieves response rates of about 80% and has an acceptable safety profile for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
. The aim was to describe treatment management considerations when caring for patients using venetoclax.
. A review was done of safety and management considerations based on current clinical practice and 240 patients with CLL who received venetoclax monotherapy on clinical trials from 2011-2016.
. Common adverse events were neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue. Because of rapid tumor reduction with venetoclax, nurses should be aware of the potential for tumor lysis syndrome (TLS) and the need to educate patients on steps to minimize risks, including gradual dose ramp-up, adequate hydration, and use of prophylactic antihyperuricemia agents. Following implementation of these risk-reducing measures, no clinical TLS events were reported in ongoing trials.

Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian Health-Care System.

PubMed

Piwko, Charles; Prady, Catherine; Yunger, Simon; Pollex, Erika; Moser, Aurelie

2015-08-01

Trastuzumab emtansine (T-DM1, KADCYLA(®)) is an antibody-drug conjugate comprised of the cytotoxic agent DM1 and trastuzumab (HERCEPTIN(®)). The safety profile of T-DM1 in human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane was investigated in the phase III EMILIA trial. The trial demonstrated clinically and statistically meaningful differences in the safety profile between T-DM1 and capecitabine plus lapatinib (CAP + LAP). The objective of this study was to estimate the costs of managing treatment-related grade ≥ 3 adverse events (AEs) that occurred in ≥ 2% of patients and grade 2 AEs that occurred in ≥ 5% of patients taking T-DM1 compared with patients taking CAP + LAP based on the EMILIA trial, from the perspective of Canadian public payers. An Excel-based model was utilized to estimate the relevant costs. Clinical data were obtained from the EMILIA trial. Cost information was obtained from the literature, clinical experts, and standard cost sources. The analysis was conducted from the Canadian public-payer perspective and reported in 2014 Canadian dollars (CAD). The management of included treatment-related AEs resulted in higher estimated per-patient costs of CAD6901 for CAP + LAP versus CAD3380 for T-DM1, resulting in savings of CAD3521. From a Canadian perspective, this analysis demonstrated that utilizing T-DM1 for the management of HER2-positive metastatic breast cancer results in substantial savings to the public health-care system when considering the costs of treatment-related AEs, due to fewer amount of toxicities compared with CAP + LAP. Results of various sensitivity analyses investigating changes in number and costs of AEs confirmed the findings; however, the magnitude of cost savings varied. Further analyses are necessary to determine whether these cost savings would occur in other countries and health-care systems.

A risk microbiological profile of the Australian red meat industry: risk ratings of hazard-product pairings.

PubMed

Sumner, John; Ross, Tom; Jenson, Ian; Pointon, Andrew

2005-11-25

A risk profile of microbial hazards across the supply continuum for the beef, sheep and goat meat industries was developed using both a qualitative tool and a semi-quantitative, spreadsheet tool, Risk Ranger. The latter is useful for highlighting factors contributing to food safety risk and for ranking the risk of various product/pathogen combinations. In the present profile the qualitative tool was used as a preliminary screen for a wide range of hazard-product pairings while Risk Ranger was used to rank in order of population health risk pairings for which quantitative data were available and for assessing the effect of hypothetical scenarios. 'High' risk hazard-product pairings identified were meals contaminated with Clostridium perfringens provided by caterers which have not implemented HACCP; kebabs cross-contaminated by Salmonella present in drip trays or served undercooked; meals served in the home cross-contaminated with Salmonella. 'Medium' risk hazard-product pairings identified were ready-to-eat meats contaminated with Listeria monocytogenes and which have extended shelf life; Uncooked Comminuted Fermented Meat (UCFM)/Salami contaminated with Enterohaemorrhagic E. coli (EHEC) and Salmonella; undercooked hamburgers contaminated with EHEC; kebabs contaminated by Salmonella under normal production or following final "flash" heating. Identified 'low' risk hazard-product pairings included cooked, ready-to-eat sausages contaminated with Salmonella; UCFM/Salami contaminated with L. monocytogenes; well-cooked hamburgers contaminated with EHEC. The risk profile provides information of value to Australia's risk managers in the regulatory, processing and R&D sectors of the meat and meat processing industry for the purposes of identifying food safety risks in the industry and for prioritising risk management actions.

Evaluation of the in-service safety performance of safety-shape and vertical concrete barriers.

DOT National Transportation Integrated Search

2011-12-16

Roadside concrete barriers have been widely used to protect errant motorists from hitting : roadside hazards or obstacles. Two concrete barrier profiles, vertical and safety-shape, have been used : for this purpose. The safety-shape profile has been ...

Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI).

PubMed

Kuzman, Ilija; Bezlepko, Alexandr; Kondova Topuzovska, Irena; Rókusz, László; Iudina, Liudmyla; Marschall, Hans-Peter; Petri, Thomas

2014-06-30

Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions. CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score. 2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n=1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n=2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from "moderate" or "severe" in 91.8% of patients at baseline to "no infection" or "mild" in 95.5% at last visit. In the safety population (n=2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin. The efficacy and safety profiles of moxifloxacin at the recommended dose of 400 mg daily are characterized in this large observational study of hospitalized CAP patients from Eastern and Central Europe and the Middle East. The high response rate in this study, which included patients with a range of disease severities, suggests that treatment with broader-spectrum drugs such as moxifloxacin is appropriate for patients with CAP who are managed in hospital. ClinicalTrials.gov identifier: NCT00987792.

[Safety and efficacy of ketamine for pain relief].

PubMed

Niesters, Marieke; Dahan, Albert; van Kleef, Maarten

2016-01-01

Intravenous ketamine treatment is frequently used for the management of chronic pain, especially in those patients who do not benefit from other therapies. In this commentary we discuss the efficacy of ketamine for relief of chronic pain and ketamine's safety profile. A review of the literature indicates that only a few studies show that intravenous ketamine has analgesic effects that persist beyond the infusion period, an effect that occurs in about two-thirds of patients. Ketamine has multiple safety issues, ranging from psychotomimetic and schizotypal symptoms, sympathetic stimulation, tachycardia and hypertension, and damage to the liver and the urogenital tract. Damage to the urogenital tract seems to be restricted to individuals who chronically abuse ketamine. We indicate the need for large randomized trials in which ketamine is compared with an 'active' placebo.

Safe use of vaccines and vaccine compliance with food safety requirements.

PubMed

Grein, K; Papadopoulos, O; Tollis, M

2007-08-01

Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

Clinical governance breakdown: Australian cases of wilful blindness and whistleblowing.

PubMed

Cleary, Sonja; Duke, Maxine

2017-01-01

After their attempts to have patient safety concerns addressed internally were ignored by wilfully blind managers, nurses from Bundaberg Base Hospital and Macarthur Health Service felt compelled to 'blow the whistle'. Wilful blindness is the human desire to prefer ignorance to knowledge; the responsibility to be informed is shirked. To provide an account of instances of wilful blindness identified in two high-profile cases of nurse whistleblowing in Australia. Critical case study methodology using Fay's Critical Social Theory to examine, analyse and interpret existing data generated by the Commissions of Inquiry held into Bundaberg Base Hospital and Macarthur Health Service patient safety breaches. All data was publicly available and assessed according to the requirements of unobtrusive research methods and secondary data analysis. Ethical considerations: Data collection for the case studies relied entirely on publicly available documentary sources recounting and detailing past events. Data from both cases reveal managers demonstrating wilful blindness towards patient safety concerns. Concerns were unaddressed; nurses, instead, experienced retaliatory responses leading to a 'social crisis' in the organisation and to whistleblowing. Managers tasked with clinical governance must be aware of mechanisms with the potential to blind them. The human tendency to favour positive news and avoid conflict is powerful. Understanding wilful blindness can assist managers' awareness of the competing emotions occurring in response to ethical challenges, such as whistleblowing.

Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases.

PubMed

Egbring, Marco; Kullak-Ublick, Gerd A; Russmann, Stefan

2010-01-01

To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.

An update on the safety of nutraceuticals and effects on lipid parameters.

PubMed

Cicero, Arrigo F G; Colletti, Alessandro

2018-03-01

Cardiovascular diseases (CVDs) are the leading cause of mortality and disability in developed countries, whereas a large portion of patients in primary prevention have uncontrolled level of CVD risk factors. Dietary supplementation with bioactive natural compounds with demonstrated lipid-lowering effects is currently supported by the international guidelines for CVD prevention and some international expert panels. Areas covered: This review provides insights on issues concerning the tolerability and safety of the most commonly used nutraceuticals with demonstrated lipid-lowering effect in humans. They will be then divided into three main categories according to their mechanism of action (cholesterol synthesis inhibitors, intestinal cholesterol absorption inhibitors, and LDL-C excretion stimulants) and their pharmacological profile will be discussed. Expert opinion: A growing body of preclinical, epidemiological and clinical evidence has defined the tolerability and safety profile of the most commonly used lipid-lowering nutraceuticals. In the most part of cases, the side effects are mild and reversible. However, detailed knowledge of specific health risks and pharmacological interactions for each individual compound is needed for the management of frail patients, such as children, elderly, patients with liver or renal failure, and patients consuming numerous drugs.

From ontology selection and semantic web to an integrated information system for food-borne diseases and food safety.

PubMed

Yan, Xianghe; Peng, Yun; Meng, Jianghong; Ruzante, Juliana; Fratamico, Pina M; Huang, Lihan; Juneja, Vijay; Needleman, David S

2011-01-01

Several factors have hindered effective use of information and resources related to food safety due to inconsistency among semantically heterogeneous data resources, lack of knowledge on profiling of food-borne pathogens, and knowledge gaps among research communities, government risk assessors/managers, and end-users of the information. This paper discusses technical aspects in the establishment of a comprehensive food safety information system consisting of the following steps: (a) computational collection and compiling publicly available information, including published pathogen genomic, proteomic, and metabolomic data; (b) development of ontology libraries on food-borne pathogens and design automatic algorithms with formal inference and fuzzy and probabilistic reasoning to address the consistency and accuracy of distributed information resources (e.g., PulseNet, FoodNet, OutbreakNet, PubMed, NCBI, EMBL, and other online genetic databases and information); (c) integration of collected pathogen profiling data, Foodrisk.org ( http://www.foodrisk.org ), PMP, Combase, and other relevant information into a user-friendly, searchable, "homogeneous" information system available to scientists in academia, the food industry, and government agencies; and (d) development of a computational model in semantic web for greater adaptability and robustness.

Career Profile: Flight Operations Engineer (Airborne Science) Robert Rivera

NASA Image and Video Library

2015-05-14

Operations engineers at NASA's Armstrong Flight Research Center help to advance science, technology, aeronautics, and space exploration by managing operational aspects of a flight research project. They serve as the governing authority on airworthiness related to the modification, operation, or maintenance of specialized research or support aircraft so those aircraft can be flown safely without jeopardizing the pilots, persons on the ground or the flight test project. With extensive aircraft modifications often required to support new research and technology development efforts, operations engineers are key leaders from technical concept to flight to ensure flight safety and mission success. Other responsibilities of an operations engineer include configuration management, performing systems design and integration, system safety analysis, coordinating flight readiness activities, and providing real-time flight support. This video highlights the responsibilities and daily activities of NASA Armstrong operations engineer Robert Rivera during the preparation and execution of the Global Hawk airborne missions under NASA's Science Mission Directorate.

Avelumab for the treatment of urothelial cancer.

PubMed

Rodriguez-Vida, Alejo; Bellmunt, Joaquim

2018-05-01

Metastatic urothelial carcinoma (UC) remains an aggressive disease associated with limited treatment options and a reduced survival. In spite of this, the first-line treatment based on platinum-based combinations has remained virtually unchanged for the last 20-30 years. Similarly, before the advent of the immune checkpoint inhibitors, there were no FDA-approved drugs for second-line therapy. In the last few years, impressive signs of anti-tumor activity have been reported with several immunotherapy agents targeting the programmed cell death-1 (PD-1) pathway. Avelumab, a PD-1 ligand (PD-L1) inhibitor, is currently being investigated for the treatment of UC. Areas covered: This article will review the pharmacological characteristics of avelumab, the efficacy studies which led to its approval, its safety profile, as well as its place within the management of urothelial carcinoma with immunotherapy. For that matter, we undertook a literature review of all the studies assessing the pharmacology of avelumab and its efficacy within clinical trials. Expert commentary: Avelumab has shown promising antitumor activity and a manageable safety profile in patients with UC. Its dual mechanism of action, blocking the interaction between PD-L1 and PD-1 and promoting antibody-dependent cell-mediated cytotoxicity could potentially be of great interest since it could produce synergistic clinical efficacy.

Training survey -- educational profile for Hanford HANDI 2000 project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wilson, D.

Fluor Daniel Hanford, Inc. (FDH) is currently adopting streamlined business processes through integrated software solutions. Replacing the legacy software (current/replacement systems, attached) also avoids significant maintenance required to resolve Year 2000 issues. This initiative is being referred to as `HANDI 2000`. The software being implemented in the first phase of this project includes Indus International`s PASSPORT Software, Peoplesoft and Primavera P3 Software. The project, which encompasses all the system replacements that will occur, has been named `HANDI 2000.` The PASSPORT applications being implemented are Inventory Management, Purchasing, Contract Management, Accounts Payable, and MSDS (Material Safety Data Sheets).

Device-identified atrial fibrillation at pacing clinics. Should it guide anticoagulation?

PubMed

Merinopoulos, Ioannis; Raphael, Claire E; Yardley, Alaina; Goonewardene, Manoj; Vassiliou, Vassilios S

2016-03-15

In recent years, there has been a significant increase in the number of devices implanted following improvement in their safety profile, extension of indications and reduction in cost. Although the reason remains largely the beneficial effect on heart rhythm stabilisation, implanted devices might also have additional advantages, notably identification of silent arrhythmia. Should clinicians therefore act on device-identified atrial fibrillation (AF) and should such identification be used to guide anticoagulation management? This review evaluates the current evidence on the management of device-identified asymptomatic AF. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

Buprenorphine – an attractive opioid with underutilized potential in treatment of chronic pain

PubMed Central

Khanna, Ish K; Pillarisetti, Sivaram

2015-01-01

Despite proven clinical utility, buprenorphine has not been used widely for the treatment of chronic pain. Questions about “ceiling effect” or bell-shaped curve observed for analgesia in preclinical studies and potential withdrawal issues on combining with marketed μ-agonists continue to hinder progress in expanding full potential of buprenorphine in the treatment of cancer and noncancer pain. Mounting evidence from clinical studies and conclusions drawn by a panel of experts strongly support superior safety and efficacy profile of buprenorphine vs marketed opioids. No ceiling on analgesic effect has been reported in clinical studies. The receptor pharmacology and pharmacokinetics profile of buprenorphine is complex but unique and contributes to its distinct safety and efficacy. The buprenorphine pharmacology also allows it to be combined with other μ-receptor opioids for additivity in efficacy. Transdermal delivery products of buprenorphine have been preferred choices for the management of pain but new delivery options are under investigation for the treatment of both opioid dependence and chronic pain. PMID:26672499

Topical capsaicin for pain in osteoarthritis: A literature review.

PubMed

Guedes, Vânia; Castro, João Paulo; Brito, Iva

Osteoarthritis is the most common joint disorder worldwide. The predominant symptom, pain, is usually treated with acetaminophen or oral non-steroidal anti-inflammatory drugs, although they are associated with a significant risk of side effects. Topical capsaicin may represent an effective and safe alternative. The aim of this review is to examine the evidence for the efficacy and safety profile of topical capsaicin in the management of pain caused by osteoarthritis. Databases were searched for articles published between 2004 and 2016, in Portuguese, English or Spanish, using the search terms "capsaicin" and "osteoarthritis". When compared to placebo, it was found that topical capsaicin has a good safety profile and efficacy in reducing osteoarthritis pain of the hand, knee, hip or shoulder. However, the studies have significant limitations, the most important the difficulty of blinding. It is attributed to this review the strength of recommendation B. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Intravenous non-opioid analgesia for peri- and postoperative pain management: a scientific review of intravenous acetaminophen and ibuprofen

PubMed Central

Koh, Wonuk; Nguyen, Kimngan Pham

2015-01-01

Pain is a predictable consequence following operations, but the management of postoperative pain is another challenge for anesthesiologists and inappropriately controlled pain may lead to unwanted outcomes in the postoperative period. Opioids are indeed still at the mainstream of postoperative pain control, but solely using only opioids for postoperative pain management may be connected with risks of complications and adverse effects. As a consequence, the concept of multimodal analgesia has been proposed and is recommended whenever possible. Acetaminophen is one of the most commonly used analgesic and antipyretic drug for its good tolerance and high safety profiles. The introduction of intravenous form of acetaminophen has led to a wider flexibility of its use during peri- and postoperative periods, allowing the early initiation of multimodal analgesia. Many studies have revealed the efficacy, safety and opioid sparing effects of intravenous acetaminophen. Intravenous ibuprofen has also shown to be well tolerated and demonstrated to have significant opioid sparing effects during the postoperative period. However, the number of randomized controlled trials confirming the efficacy and safety is small and should be used in caution in certain group of patients. Intravenous acetaminophen and ibuprofen are important options for multimodal postoperative analgesia, improving pain and patient satisfaction. PMID:25664148

Intravenous non-opioid analgesia for peri- and postoperative pain management: a scientific review of intravenous acetaminophen and ibuprofen.

PubMed

Koh, Wonuk; Nguyen, Kimngan Pham; Jahr, Jonathan S

2015-02-01

Pain is a predictable consequence following operations, but the management of postoperative pain is another challenge for anesthesiologists and inappropriately controlled pain may lead to unwanted outcomes in the postoperative period. Opioids are indeed still at the mainstream of postoperative pain control, but solely using only opioids for postoperative pain management may be connected with risks of complications and adverse effects. As a consequence, the concept of multimodal analgesia has been proposed and is recommended whenever possible. Acetaminophen is one of the most commonly used analgesic and antipyretic drug for its good tolerance and high safety profiles. The introduction of intravenous form of acetaminophen has led to a wider flexibility of its use during peri- and postoperative periods, allowing the early initiation of multimodal analgesia. Many studies have revealed the efficacy, safety and opioid sparing effects of intravenous acetaminophen. Intravenous ibuprofen has also shown to be well tolerated and demonstrated to have significant opioid sparing effects during the postoperative period. However, the number of randomized controlled trials confirming the efficacy and safety is small and should be used in caution in certain group of patients. Intravenous acetaminophen and ibuprofen are important options for multimodal postoperative analgesia, improving pain and patient satisfaction.

Review of extended-release formulations of Tramadol for the management of chronic non-cancer pain: focus on marketed formulations

PubMed Central

Kizilbash, Arshi; Ngô-Minh, Cường

2014-01-01

Patients with chronic non-malignant pain report impairments of physical, social, and psychological well-being. The goal of pain management should include reducing pain and improving quality of life. Patients with chronic pain require medications that are able to provide adequate pain relief, have minimum dosing intervals to maintain efficacy, and avoid breakthrough pain. Tramadol has proven efficacy and a favourable safety profile. The positive efficacy and safety profile has been demonstrated historically in numerous published clinical studies as well as from post-marketing experience. It is a World Health Organization “Step 2” opioid analgesic that has been shown to be effective, well-tolerated, and valuable, where treatment with strong opioids is not required. A number of extended release formulations of Tramadol are available in Canada and the United States. An optimal extended release Tramadol formulation would be expected to provide consistent pain control with once daily dosing, few sleep interruptions, flexible dosing schedules, and no limitation on taking with meals. Appropriate treatment options should be based on the above proposed attributes. A comparative review of available extended release Tramadol formulations shows that these medications are not equivalent in their pharmacokinetic profile and this may have implications for selecting the optimal therapy for patients with pain syndromes where Tramadol is an appropriate analgesic agent. Differences in pharmacokinetics amongst the formulations may also translate into varied clinical responses in patients. Selection of the appropriate formulation by the health care provider should therefore be based on the patient’s chronic pain condition, needs, and lifestyle. PMID:24711710

Liposomal bupivacaine for regional anesthesia.

PubMed

Uskova, Anna; O'Connor, Jessica E

2015-10-01

Using a regional block in a multimodal approach to postoperative analgesia management involves addressing, which local anesthetic and how much should be used to ensure adequate pain relief to reduce related morbidity and mortality. This article will review literature surrounding the recently approved formulation of slow release liposomal bupivacaine, define its proven benefits, and identify ongoing studies to further examine the utility of this novel formulation by various routes. Recent Phase II and III clinical trials have demonstrated the ability of liposomal bupivacaine to provide prolonged analgesia, maintain a high safety profile in therapeutic doses, and decrease opioid requirements when compared with placebo in local infiltration applications for up to 24 h. Between 24 and 72 h after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity. Conventional bupivacaine or ropivacaine groups (current standard practice in many hospitals in the USA) were not compared. In addition, the analgesic efficacy, cost-effectiveness, and safety profile of liposomal bupivacaine has not thoroughly been studied in various standard clinical settings such as perineural, intrathecal, and epidural administration. Current published data do not provide superior clinical results for EXPAREL over conventional bupivacaine based upon the lack of adequately powered multicentered clinical trials with comparison groups. Further investigation is necessary to identify the analgesic efficacy and safety profile of liposomal bupivacaine versus standard local anesthetics and to define the optimal clinical indication for liposomal bupivacaine administration in regional anesthesia.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Long-term safety concerns with proton pump inhibitors.

PubMed

Ali, Tauseef; Roberts, David Neil; Tierney, William M

2009-10-01

Proton pump inhibitors (PPIs) are among the most widely prescribed medications worldwide. Their use has resulted in dramatic improvements in treatment of peptic ulcer disease and gastroesophageal reflux disease. Despite an acceptable safety profile, mounting data demonstrate concerns about the long-term use of PPIs. To provide a comprehensive review regarding the concerns of long-term PPI use, a literature search was performed to identify pertinent original and review articles. Despite study shortcomings, the collective body of information overwhelmingly suggests an increased risk of infectious complications and nutritional deficiencies. Data regarding any increased risk in gastric or colon malignancy are less convincing. PPIs have revolutionized the management and complications of acid-related disorders with a high margin of safety; however, with the data available, efforts to reduce the dosing of or discontinue the use of PPIs must be reassessed frequently.

Visualizing variations in organizational safety culture across an inter-hospital multifaceted workforce.

PubMed

Kobuse, Hiroe; Morishima, Toshitaka; Tanaka, Masayuki; Murakami, Genki; Hirose, Masahiro; Imanaka, Yuichi

2014-06-01

To develop a reliable and valid questionnaire that can distinguish features of organizational culture for patient safety across subgroups such as hospitals, professions, management/non-management positions and units/wards. We developed a Hospital Organizational Culture Questionnaire based on a conceptual framework incorporating items from a review of existing literature. The questionnaire was administered to hospital staff including doctors, nurses, allied health personnel, and administrative staff at six public hospitals in Japan. Reliability and validity were assessed through exploratory factor analysis, multitrait scaling analysis, Cronbach's alpha coefficient and multiple regression analysis using staff-perceived achievement of safety as the response variable. Discriminative power across subgroups was assessed with radar chart profiling. Of the 3304 hospital staff surveyed, 2924 (88.5%) responded. After exploratory factor analysis and multitrait analysis, the finalized questionnaire was composed of 24 items in the following eight dimensions: improvement orientation, passion for mission, professional growth, resource allocation prioritization, inter-sectional collaboration, responsibility and authority, teamwork, and information sharing. Construct validity and internal consistency of dimensions were confirmed with multitrait analysis and Cronbach's alpha coefficients, respectively. Multiple regression analysis showed that improvement orientation, passion for mission, resource allocation prioritization and information sharing were significantly associated with higher achievement in safety practices. Our questionnaire tool was able to distinguish features of safety culture among different subgroups. Our questionnaire demonstrated excellent validity and reliability, and revealed distinct cultural patterns among different subgroups. Quantitative assessment of organizational safety culture with this tool may further the understanding of associated characteristics of each subgroup and provide insight into organizational readiness for patient safety improvement. © 2014 John Wiley & Sons, Ltd.

Seizures as a Potential Complication of Treatment With Simeprevir and Sofosbuvir.

PubMed

Syal, Gaurav; Heldenbrand, Seth D; Duarte-Rojo, Andres

2016-01-01

Newer direct-acting antiviral agents have revolutionized the medical management of chronic hepatitis C. In addition to being extremely efficacious, they report very mild adverse drug reactions from experience in clinical trials. However, because they are relatively new on the horizon, postmarketing surveillance studies refining the safety profile are not yet available. We present a case of seizures as a potential side effect of antiviral therapy with sofosbuvir and simeprevir.

Long-term tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study

PubMed Central

Klipping, Christine; Duijkers, Ingrid; Fortier, Michel P; Marr, Joachim; Trummer, Dietmar; Elliesen, Jörg

2012-01-01

Background This study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens. Study design In this Phase III, multicentre, open-label study, women (aged 18–35 years) were randomised to EE/DRSP in the following regimens: flexibleMIB (24–120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexibleMIB regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres. Results Results were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexibleMIB, conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens. Conclusions EE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives. PMID:22454004

Fludarabine plus alemtuzumab (FA) front-line treatment in young patients with chronic lymphocytic leukemia (CLL) and an adverse biologic profile.

PubMed

Mauro, Francesca R; Molica, Stefano; Laurenti, Luca; Cortelezzi, Agostino; Carella, Angelo M; Zaja, Francesco; Chiarenza, Annalisa; Angrilli, Francesco; Nobile, Francesco; Marasca, Roberto; Musolino, Caterina; Brugiatelli, Maura; Piciocchi, Alfonso; Vignetti, Marco; Fazi, Paola; Gentile, Giuseppe; De Propris, Maria S; Della Starza, Irene; Marinelli, Marilisa; Chiaretti, Sabina; Del Giudice, Ilaria; Nanni, Mauro; Albano, Francesco; Cuneo, Antonio; Guarini, Anna; Foà, Robin

2014-02-01

In 45, ≤ 60 years old patients with CLL and an adverse biologic profile, a front-line treatment with Fludarabine and Campath (Alemtuzumab(®)) was given. The overall response rate was 75.5%, the complete response rate (CR) 24.4% with the lowest CR rates, 16.7% and 8.3%, in 11q and 17p deleted cases. The 3-year progression-free survival (PFS) and overall survival were 42.5% and 79.9%, respectively. PFS was significantly influenced by CLL duration, beta2-microglobulin, and improved by post-remissional stem cell transplantation. Front-line fludarabine and alemtuzumab showed a manageable safety profile and evidence of a benefit in a small series of CLL patients with adverse biologic features. Copyright © 2013 Elsevier Ltd. All rights reserved.

[The workplace injury trends in the petrochemical industry: from data analysis to risk management].

PubMed

Campo, Giuseppe; Martini, Benedetta

2013-01-01

The most recent INAIL data show that, in 2009-2011, the accident frequency rate and the severity rate of workplace injuries in the chemical industry are lower than for the total non-agricultural workforce. The chemical industry, primarily because of the complex and hazardous work processes, requires an appropriate system for assessing and monitoring specific risks.The implementation of Responsible Care, a risk management system specific for the chemical industry, in 1984, has represented a historical step in the process of critical awareness of risk management by the chemical companies. Responsible Care is a risk management system specifically designed on the risk profiles of this type of enterprise, which integrates safety, health and environment. A risk management system, suitable for the needs of a chemical company, should extend its coverage area, beyond the responsible management of products throughout the entire production cycle, to the issues of corporate responsibility.

Understanding the positive benefit:risk profile of alemtuzumab in relapsing multiple sclerosis: perspectives from the Alemtuzumab Clinical Development Program.

PubMed

Havrdova, Eva; Cohen, Jeffrey A; Horakova, Dana; Kovarova, Ivana; Meluzinova, Eva

2017-01-01

The introduction of high-efficacy therapies for relapsing-remitting multiple sclerosis has driven re-evaluation of treatment goals and benefit:risk considerations in treatment choice. In the alemtuzumab Phase II and III clinical trials, patients treated with alemtuzumab 12 mg versus subcutaneous interferon beta-1a demonstrated significantly reduced annualized relapse rates and improved magnetic resonance imaging outcomes, and were significantly more likely to achieve no evidence of disease activity and reduction in brain volume loss. In two of the studies, alemtuzumab-treated patients had a significantly reduced risk of 6-month confirmed disease worsening, compared with subcutaneous interferon beta-1a. Benefits were maintained throughout 5 years, with a majority of patients receiving no alemtuzumab retreatment or other disease-modifying therapy. Trial results support alemtuzumab's manageable, consistent safety profile in relapsing-remitting multiple sclerosis. Infusion-associated reactions, the most frequent adverse events (AEs), can be minimized by corticosteroid pretreatment, monitoring, and symptomatic management. Other AEs include infections and autoimmune events. Oral anti-herpes prophylaxis should be initiated on the first day of each alemtuzumab treatment course and continued according to local guidelines. Overall cancer risk was lower in the alemtuzumab clinical trials than in a reference population; however, continuing surveillance will determine if alemtuzumab may be associated with certain malignancies such as thyroid papillary carcinoma and melanoma, which are currently identified as potential risks. The post-approval risk management strategy includes a safety monitoring program. Autoimmune AEs (thyroid events, immune thrombocytopenia, nephropathies) can be detected in a timely manner with the monitoring program, which includes physician and patient education about the signs and symptoms, monthly renal and hematologic monitoring, and quarterly thyroid function monitoring for 48 months after the last alemtuzumab course. Education, vigilance by physicians and patients, and monthly laboratory monitoring are recommended to maintain alemtuzumab's positive benefit:risk profile.

Multidimensional Characterization of Sexual Minority Adolescents’ Sexual Safety Strategies

PubMed Central

Masters, N. Tatiana; Beadnell, Blair; Morrison, Diane M.; Hoppe, Marilyn J.; Wells, Elizabeth A.

2013-01-01

Young adults have high rates of sexually transmitted infections (STIs). Sexual minority youths’ risk for STIs, including HIV, is as high as or higher than sexual majority peers’. Sexual safety, while often treated as a single behavior such as condom use, can be best conceptualized as the result of multiple factors. We used latent class analysis to identify profiles based on ever-used sexual safety strategies and lifetime number of partners among 425 self-identified LGBTQ youth aged 14-19. Data collection took place anonymously online. We identified four specific subgroup profiles for males and three for females, with each subgroup representing a different level and type of sexual safety. Profiles differed from each other in terms of age and outness for males, and in outness, personal homonegativity, and amount of education received about sexual/romantic relationships for females. Youths’ sexual safety profiles have practice implications for sexuality educators, health care professionals, and parents. PMID:24011111

COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD.

PubMed

Kessler, Romain; Casan-Clara, Pere; Koehler, Dieter; Tognella, Silvia; Viejo, Jose Luis; Dal Negro, Roberto W; Díaz-Lobato, Salvador; Reissig, Karina; Rodríguez González-Moro, José Miguel; Devouassoux, Gilles; Chavaillon, Jean-Michel; Botrus, Pierre; Arnal, Jean-Michel; Ancochea, Julio; Bergeron-Lafaurie, Anne; De Abajo, Carlos; Randerath, Winfried J; Bastian, Andreas; Cornelissen, Christian G; Nilius, Georg; Texereau, Joëlle B; Bourbeau, Jean

2018-01-01

The COPD Patient Management European Trial (COMET) investigated the efficacy and safety of a home-based COPD disease management intervention for severe COPD patients.The study was an international open-design clinical trial in COPD patients (forced expiratory volume in 1 s <50% of predicted value) randomised 1:1 to the disease management intervention or to the usual management practices at the study centre. The disease management intervention included a self-management programme, home telemonitoring, care coordination and medical management. The primary end-point was the number of unplanned all-cause hospitalisation days in the intention-to-treat (ITT) population. Secondary end-points included acute care hospitalisation days, BODE (body mass index, airflow obstruction, dyspnoea and exercise) index and exacerbations. Safety end-points included adverse events and deaths.For the 157 (disease management) and 162 (usual management) patients eligible for ITT analyses, all-cause hospitalisation days per year (mean±sd) were 17.4±35.4 and 22.6±41.8, respectively (mean difference -5.3, 95% CI -13.7 to -3.1; p=0.16). The disease management group had fewer per-protocol acute care hospitalisation days per year (p=0.047), a lower BODE index (p=0.01) and a lower mortality rate (1.9% versus 14.2%; p<0.001), with no difference in exacerbation frequency. Patient profiles and hospitalisation practices varied substantially across countries.The COMET disease management intervention did not significantly reduce unplanned all-cause hospitalisation days, but reduced acute care hospitalisation days and mortality in severe COPD patients. Copyright ©ERS 2018.

New life to an old treatment: pegylated Interferon beta 1a in the management of multiple sclerosis.

PubMed

Ortiz, Miguel Angel; Espino-Paisan, Laura; Nunez, Concepcion; Alvarez-Lafuente, Roberto; Urcelay, Elena

2018-02-25

In the 1990s, the betainterferons and glatiramer acetate were introduced for treating relapsing-remitting multiple sclerosis. These medications have a demonstrated record of efficacy and safety, although they require frequent administration via injection and are only partially effective. The optimization of treatment in patients who do not respond adequately to this first-line therapy is essential for attaining the best long-term outcomes. Switching to the recently approved emergent therapies is a strategy to consider for treatment of patients with a suboptimal response. This review summarizes the mechanisms of action, clinical benefits, and safety profiles of current multiple sclerosis disease-modifying therapies, including highly efficacious monoclonal antibodies or convenient oral therapies. Although the first-line interferon beta exhibits a favorable benefit-to-risk profile, treatment compliance is compromised potentially due to its known adverse events and frequent injectable administration. Less frequent dosing and improved pharmacological properties have been achieved by reaction of interferon beta with chemically activated polyethylene glycol. Provided that none of the available therapies shows better effectiveness for all outcomes and their safety in clinical practice is a fundamental concern, the pegylated form of interferon beta seems to keep its place as a competitive therapeutic option. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A review of the efficacy and safety of oral antidiabetic drugs

PubMed Central

Stein, Stephanie Aleskow; Lamos, Elizabeth Mary; Davis, Stephen N

2014-01-01

Introduction Additional oral antidiabetic agents to metformin, sulfonylureas (SU) and thiazolidinediones (TZD) are approved for the treatment of type 2 diabetes. Areas covered The efficacy and safety of metformin, SUs, TZDs, dipeptidyl peptidase-IV (DPP-4) inhibitors, meglitinide analogs, α-glucosidase inhibitors (AGIs), bile-acid sequestrants (BAS) and bromocriptine will be reviewed. Expert opinion Several new oral agents have been approved for type 2 diabetes management in recent years. It is important to understand the efficacy and safety of these medications in addition to the older agents to best maximize oral drug therapy for diabetes. Of the recently introduced oral hypoglycemic/antihyperglycemic agents, the DPP-4 inhibitors are moderately efficacious compared with mainstay treatment with metformin with a low side-effect profile and have good efficacy in combination with other oral agents and insulin. They are a recommended alternative when metformin use is limited by gastrointestinal (GI) side effects or when SU treatment results in significant hypoglycemia or weight gain. Meglitinide analogs are limited by their frequent dosing, expense and hypoglycemia (repaglinide > nateglinide), while AGIs are also limited by their dosing schedule and GI side-effect profile. BAS and bromocriptine have the lowest efficacy with regard to HbA1c reduction, also are plagued by GI adverse reactions, but have a low risk of hypoglycemia. PMID:23241069

Chitosan-tailored lipidic nanoconstructs of Fusidic acid as promising vehicle for wound infections: An explorative study.

PubMed

Thakur, Kanika; Sharma, Gajanand; Singh, Bhupinder; Chhibber, Sanjay; Patil, A B; Katare, Om Prakash

2018-08-01

The current research study intends to explore the combined potential of lipid nanoparticles and chitosan as an optimum therapy for the management of wound infections. Fusidic acid (FA), a steroidal antibiotic employed for treatment of primary and secondary topical infections was encapsulated within the nanoengineered lipid-polymer hybrid nanoparticles (FA-LPHNs). A number of variables like lipid/polymer ratio, lipid, surfactant and chitosan concentration, stirring speed were optimized to get the desired particle size and % entrapment efficiency. The developed carriers were further characterized for particle size, antibacterial activity, cytotoxicity studies in HaCat cell lines, ex vivo permeation studies and skin safety profile. The developed LPHNs offered nanometric size (284.67 ± 5.67 nm), sustained drug release (79.31 ± 0.45%) and enhanced drug permeation (72.09 ± 1.26%). The changes in viability of HaCat cells were insignificant indicating the safety profile of LPHNs. The administration of FA-LPHNs resulted in 5-times and 4-times decrease in its inhibitory concentration against MRSA 33591 and MSSA 25921 respectively, along with antibacterial activity for a longer duration. Further, hydrogel incorporated nanoparticles were found to be topically applicable and compatible with mice skin. The studies indicated the superiority of FA-LPHNs for better management of wounds and associated infections over the conventional marketed product. Copyright © 2018. Published by Elsevier B.V.

Simulation of Flood Profiles for Catoma Creek near Montgomery, Alabama, 2008

USGS Publications Warehouse

Lee, K.G.; Hedgecock, T.S.

2008-01-01

A one-dimensional step-backwater model was used to simulate flooding conditions for Catoma Creek near Montgomery, Alabama. A peak flow of 50,000 cubic feet per second was computed by the U.S. Geological Survey for the March 1990 flood at the Norman Bridge Road gaging station. Using this estimated peak flow, flood-plain surveys with associated roughness coefficients, and surveyed high-water marks for the March 1990 flood, a flow model was calibrated to closely match the known event. The calibrated model then was used to simulate flooding for the 10-, 50-, 100-, and 500-year recurrence-interval floods. The 100-year flood stage for the Alabama River also was computed in the vicinity of the Catoma Creek confluence using observed high-water profiles from the 1979 and 1990 floods and gaging-station data. The results indicate that the 100-year flood profile for Catoma Creek within the 15-mile study reach is about 2.5 feet higher, on average, than the profile published by the Federal Emergency Management Agency. The maximum and minimum differences are 6.0 feet and 0.8 foot, respectively. All water-surface elevations computed for the 100-year flood are higher than those published by the Federal Emergency Management Agency. The 100-year flood stage computed for the Alabama River in the vicinity of the Catoma Creek confluence was about 4.5 feet lower than the elevation published by the Federal Emergency Management Agency. The results of this study provide the community with flood-profile information that can be used for flood-plain mitigation, future development, and safety plans for the city.

Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

PubMed Central

Devabhakthuni, Sandeep

2013-01-01

The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects. PMID:24665213

[Guidelines in RA treatment: concepts on safety and recommendations using anti-TNF-alpha inhibitors. Grupo de Estudio de Nuevas Terapias de Enfermedades reumáticas (GENTE)].

PubMed

Díaz-Jouanen, Efraín; Abud-Mendoza, Carlos; Garza-Elizondo, Mario Alberto; Medrano-Ramírez, Gabriel; Burgos-Vargas, Rubén; Orozco-Alcalá, José Javier; Pacheco-Tena, César Francisco; Pineda, Carlos; Pozos-Espíndola, Juan Carlos; Ramos-Niembro, Francisco; Robles-San-Román, Manuel; Santana-Sahagún, Jesús Ernesto

2009-01-01

Recommendations for the use of Disease-Modifying Antirheumatic Drugs (DMARD) with both conventional and biological agents in Rheumatoid Arthritis (RA) must be based on their safety profile, adverse effects, risks, and advantages. With the purpose of presenting the most updated information about the safety of tumor necrosis factor alpha (TNFalpha) antagonists, in this article we summarize the literature published during the last three years about this sort of biological agents in specific clinical situations, such as risk of developing infections, cancer, cardiovascular diseases, and autoimmunity; as well as their administration to patients who will undergo surgical procedures, pregnant and/or breast-feeding women, and patients who need immunizations. Likewise, in this analysis we offer specific recommendations, based on evidence, for the best anti-TNF-alfa management.

Ketorolac as an analgesic agent for infants and children after cardiac surgery: safety profile and appropriate patient selection.

PubMed

Jalkut, Meredith K

2014-01-01

Ketorolac has been used safely as an analgesic agent for children following cardiac surgery in selected populations. Controversy exists among institutions about the risks involved with this medication in this patient group. This article reviews the current literature regarding the safety of ketorolac for postoperative pain management in children after cardiac surgery. Specifically, concerns about renal dysfunction and increased bleeding risk are addressed. Additionally, the article details pharmacokinetics and potential benefits of ketorolac, such as its opioid-sparing effect. The literature reflects that the use of this medication is not well studied in certain pediatric cardiac patients such as neonates and those with single-ventricle physiology, and the safety of this medication in regards to these special populations is reviewed. In conclusion, ketorolac can be used in specific pediatric patients after cardiac surgery with minimal risk of bleeding or renal dysfunction with appropriate dosing and duration of use.

Bazedoxifene/conjugated estrogens for managing the burden of estrogen deficiency symptoms.

PubMed

Mirkin, Sebastian; Ryan, Kelly A; Chandran, Arthi B; Komm, Barry S

2014-01-01

The bothersome vasomotor and vaginal symptoms and bone loss that accompany the menopausal transition are associated with significant direct costs due to physician visits and medication, as well as indirect costs from reduced health-related quality of life (HRQoL) and work productivity. With life expectancies increasing, the number of postmenopausal women is also increasing, and more women are remaining in the workforce. These factors have led to an increased burden of menopausal symptoms on healthcare systems. Hormone therapy (HT) has been shown to effectively reduce menopausal symptoms and significantly increase quality-adjusted life years in postmenopausal women, particularly in women experiencing severe symptoms. However, many women discontinue use of HT before their symptoms have dissipated due to safety and tolerability concerns. The tissue selective estrogen complex (TSEC) that pairs bazedoxifene (BZA) with conjugated estrogens (CE) has been developed to provide relief of menopausal symptoms and prevent bone loss without stimulating the breast or endometrium, and to have improved tolerability compared with HT. In this context, BZA 20mg/CE 0.45 and 0.625 mg were shown to prevent bone loss and effectively treat menopausal symptoms in postmenopausal women with an intact uterus, while also demonstrating a favorable safety/tolerability profile. BZA 20mg/CE 0.45 and 0.625 mg were further associated with clinically significant improvements in HRQoL, sleep, and treatment satisfaction. Taken together, the reduction in menopausal symptoms, improvement in HRQoL, and favorable safety/tolerability profile associated with BZA/CE suggest that it is a cost-effective alternative to HT for managing the burden of menopausal symptoms. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Insulin glargine 300 units/mL: A new basal insulin product for diabetes mellitus.

PubMed

Clements, Jennifer N; Bello, Larkin

2016-03-15

The pharmacokinetics, efficacy, and safety of U-300 insulin glargine for the management of diabetes are reviewed. U-300 (300 units/mL) insulin glargine is a long-acting basal insulin with low within-day variability, high day-to-day reproducibility, longer duration, and constant pharmacokinetic profile compared with U-100 (100 units/mL) insulin glargine. U-300 was evaluated in six randomized, active-comparator, open-label, Phase III clinical studies (EDITION trials) among patients with type 1 or 2 diabetes. The primary endpoint for all EDITION studies was the reduction in glycosylated hemoglobin from baseline to six months. Safety endpoints included confirmed or nocturnal hypoglycemia between week 9 and month 6 and the change in weight from baseline. For hypoglycemic episodes, U-300 insulin glargine was superior to U-100 insulin glargine when comparing the risk of hypoglycemia. U-300 insulin glargine is supplied in a prefilled device (for safety purposes) and packaged in boxes of three or five pens. It is still early to determine the role of U-300 insulin glargine in diabetes management. When compared with U-100 insulin glargine, U-300 insulin glargine appeared to be associated with a lower risk of hypoglycemia and nocturnal hypoglycemia, most likely due to its pharmacokinetics. The wholesale average cost of U-300 insulin glargine is $335.48 per box of three pens. The efficacy outcomes of U-300 insulin glargine were similar to those of U-100 insulin glargine, but the constant pharmacokinetic profile and longer duration of action of U-300 insulin glargine may help certain patients with type 1 or type 2 diabetes achieve better glycemic control. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Azilsartan medoxomil in the management of hypertension: an evidence-based review of its place in therapy

PubMed Central

Angeloni, Emiliano

2016-01-01

Background Azilsartan (AZI) is a relatively new angiotensin receptor blocker available for the treatment of any stage of hypertension, which was eventually given in combination with chlorthalidone (CLT). Objective To review pharmacology and clinical role of AZI monotherapy and AZI/CLT or AZI/amlodipine combination therapies for hypertension management. Methods PubMed, Embase, and Cochrane Library were searched using search terms “ azilsartan”, “chlorthalidone,” “pharmacology,” “pharmacokinetics,” “pharmacodynamics,” “pharmacoeconomics,” and “cost-effectiveness.” To obtain other relevant information, US Food and Drug Association as well as manufacturer prescribing information were also reviewed. Results Randomized controlled trials demonstrated AZI to be superior to other sartans, such as valsartan, olmesartan, and candesartan, in terms of 24-hour ambulatory blood pressure monitoring (ABPM) reduction with respect. That beneficial effect of azilsartan was also associated with similar safety profiles. When compared to other antihypertensive drugs, azilsartan was found to be superior to any angiotensin-converting enzyme inhibitor, including ramipril, in terms of ABPM results, and noninferior to amlodipine in terms of sleep-BP control. The association of AZI and CLT was then found to be superior to other sartans + thiazide combination therapies in terms of both BP lowering and goal achievement. The combination of AZI and amlodipine has also been tested in clinical trials, but compared only with placebo, demonstrating its superiority in terms of efficacy and similarity in terms of safety. Conclusion Azilsartan is a safe and effective treatment option for every stage of hypertension, both alone or in fixed-dose combination tablets with chlorthalidone or amlodipine. Beneficial effects of AZI were also noted in patients with any degree of renal impairment. In addition, safety profiles of AZI were similar to that of the placebo. PMID:27103882

Azilsartan medoxomil in the management of hypertension: an evidence-based review of its place in therapy.

PubMed

Angeloni, Emiliano

2016-01-01

Azilsartan (AZI) is a relatively new angiotensin receptor blocker available for the treatment of any stage of hypertension, which was eventually given in combination with chlorthalidone (CLT). To review pharmacology and clinical role of AZI monotherapy and AZI/CLT or AZI/amlodipine combination therapies for hypertension management. PubMed, Embase, and Cochrane Library were searched using search terms " azilsartan", "chlorthalidone," "pharmacology," "pharmacokinetics," "pharmacodynamics," "pharmacoeconomics," and "cost-effectiveness." To obtain other relevant information, US Food and Drug Association as well as manufacturer prescribing information were also reviewed. Randomized controlled trials demonstrated AZI to be superior to other sartans, such as valsartan, olmesartan, and candesartan, in terms of 24-hour ambulatory blood pressure monitoring (ABPM) reduction with respect. That beneficial effect of azilsartan was also associated with similar safety profiles. When compared to other antihypertensive drugs, azilsartan was found to be superior to any angiotensin-converting enzyme inhibitor, including ramipril, in terms of ABPM results, and noninferior to amlodipine in terms of sleep-BP control. The association of AZI and CLT was then found to be superior to other sartans + thiazide combination therapies in terms of both BP lowering and goal achievement. The combination of AZI and amlodipine has also been tested in clinical trials, but compared only with placebo, demonstrating its superiority in terms of efficacy and similarity in terms of safety. Azilsartan is a safe and effective treatment option for every stage of hypertension, both alone or in fixed-dose combination tablets with chlorthalidone or amlodipine. Beneficial effects of AZI were also noted in patients with any degree of renal impairment. In addition, safety profiles of AZI were similar to that of the placebo.

Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.

PubMed

Gavin, Paul D; Simon, Lee S; Schlagheck, Thomas; Smith, Alisha J; Shakib, Sepehr

2017-07-01

To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM). Eleven healthy subjects received a single application of three TPM/oxycodone patches applied to the torso for 72 h. Oxycodone was detected 8.0 ± 2.7-h postpatch administration, reaching a mean maximum plasma concentration of 3.41 ± 1.34 ng/ml at 49.3 ± 21.2 h. The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone. No treatment-limiting skin irritation was observed. A 3-day application of the TPM/oxycodone patch demonstrated an acceptable safety profile and was well tolerated by healthy subjects, with limited dermal irritation following application.

Career Profile: Flight Operations Engineer (Airborne Science) Matthew Berry

NASA Image and Video Library

2014-11-05

Operations engineers at NASA's Armstrong Flight Research Center help to advance science, technology, aeronautics, and space exploration by managing operational aspects of a flight research project. They serve as the governing authority on airworthiness related to the modification, operation, or maintenance of specialized research or support aircraft so those aircraft can be flown safely without jeopardizing the pilots, persons on the ground or the flight test project. With extensive aircraft modifications often required to support new research and technology development efforts, operations engineers are key leaders from technical concept to flight to ensure flight safety and mission success. Other responsibilities of an operations engineer include configuration management, performing systems design and integration, system safety analysis, coordinating flight readiness activities, and providing real-time flight support. This video highlights the responsibilities and daily activities of NASA Armstrong operations engineer Matthew Berry during the preparation and execution of flight tests in support of aeronautics research. http://www.nasa.gov/centers/armstrong/home/ http://www.nasa.gov/

Career Profile: Flight Operations Engineer (Aeronautics) Brian Griffin

NASA Image and Video Library

2014-10-17

Operations engineers at NASA's Armstrong Flight Research Center help to advance science, technology, aeronautics, and space exploration by managing operational aspects of a flight research project. They serve as the governing authority on airworthiness related to the modification, operation, or maintenance of specialized research or support aircraft so those aircraft can be flown safely without jeopardizing the pilots, persons on the ground or the flight test project. With extensive aircraft modifications often required to support new research and technology development efforts, operations engineers are key leaders from technical concept to flight to ensure flight safety and mission success. Other responsibilities of an operations engineer include configuration management, performing systems design and integration, system safety analysis, coordinating flight readiness activities, and providing real-time flight support. This video highlights the responsibilities and daily activities of NASA Armstrong operations engineer Brian Griffin during the preparation and execution of flight tests in support of aeronautics research. http://www.nasa.gov/centers/armstrong/home/ http://www.nasa.gov/

Role of dihydropyridinic calcium channel blockers in the management of hypertension.

PubMed

Coca, Antonio; Mazón, Pilar; Aranda, Pedro; Redón, Josep; Divisón, Juan Antonio; Martínez, Javier; Calvo, Carlos; Galcerán, Josep María; Barrios, Vivencio; Roca-Cusachs I Coll, Alexandre

2013-01-01

Dihydropyridinic calcium channel blockers are a subclass of antihypertensive drugs with growing significance in the therapeutic armamentarium. Early studies in the 1990s had aroused certain fears with regard to the safety of the first drugs from this class, since they had a fast onset of action and a short half-life, and thus they were associated with reflex adrenergic activation. New molecules with long half-lives and high lipophilia have shown safety and efficacy in the control of blood pressure, as well as in the reduction of several end points related to hypertension. Moreover, these new molecules, which block special subtypes of calcium channel receptors, provide drugs not only with an action profile that goes beyond the antihypertensive effect, but also with a lower rate of side effects. Therefore, in the light of new studies that include calcium channel blockers alone or in combination, these agents will probably be used even more extensively for the management of hypertension in the following years.

A review on adverse event profiles of epidermal growth factor receptor-tyrosine kinase inhibitors in nonsmall cell lung cancer patients.

PubMed

Biswas, B; Ghadyalpatil, N; Krishna, M V; Deshmukh, J

2017-12-01

The epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of EGFR-mutant nonsmall cell lung cancer (NSCLC). These EGFR TKIs demonstrate a different adverse event (AE) profile as compared to conventional chemotherapy agents. They are more commonly associated with cutaneous AEs and diarrhea while hematological AEs occurred commonly with chemotherapy agents. These AEs are the extension of pharmacological effect and occur as a result of blockade of EGFR-regulated pathways in the skin and gastrointestinal tract. This review article sheds light on the safety profile of first-, second-, and third-generation EGFR TKIs based on data obtained from several clinical trials conducted in NSCLC patients and highlights trials comparing these agents with the conventional chemotherapy agents. The strategies to manage EGFR TKI-related AEs are also reviewed.

Expert opinion on a flexible extended regimen of drospirenone/ethinyl estradiol contraceptive.

PubMed

Han, Leo; Jensen, Jeffrey T

2014-10-01

Oral contraceptives are often prescribed in extended or continuous forms in order to manage menstrual bleeding and menstrual-related side effects. However, with extended regimens, unscheduled intracycle bleeding can become problematic. Flexible extended dosing of a contraceptive containing drospirenone (DRSP) and ethinyl estradiol (EE) was designed to improve bleeding profiles during extended cycles through active management of bleeding symptoms. We examine the rationale for flexible extended dosing as well as review the dosing regimen. We will focus on the findings of the two most important clinical trials regarding flexible extended DRSP/EE (3 mg/20 μg), including the bleeding profiles of women in those trials. Pharmacology, mechanisms of action, efficacy as well as safety of DRSP containing pills will also be reviewed. Flexible extended dosing of DRSP/EE (3 mg/20 μg) has similar pharmacokinetics and contraceptive efficacy of both conventional and fixed extended regimens. However, it has the added benefit of fewer days of bleeding/spotting compared to conventional and fixed extended regimens.

Narrative writing: Effective ways and best practices

PubMed Central

Ledade, Samir D.; Jain, Shishir N.; Darji, Ankit A.; Gupta, Vinodkumar H.

2017-01-01

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement. PMID:28447014

Narrative writing: Effective ways and best practices.

PubMed

Ledade, Samir D; Jain, Shishir N; Darji, Ankit A; Gupta, Vinodkumar H

2017-01-01

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement.

Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3)

PubMed Central

Bartlett, Cynthia Huang; Schnell, Patrick; DeMichele, Angela M.; Loi, Sherene; Ro, Jungsil; Colleoni, Marco; Iwata, Hiroji; Harbeck, Nadia; Cristofanilli, Massimo; Zhang, Ke; Thiele, Alexandra; Turner, Nicholas C.; Rugo, Hope S.

2016-01-01

Background. Palbociclib enhances endocrine therapy and improves clinical outcomes in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Because this is a new target, it is clinically important to understand palbociclib’s safety profile to effectively manage toxicity and optimize clinical benefit. Materials and Methods. Patients with endocrine-resistant, HR-positive/HER2-negative MBC (n = 521) were randomly assigned 2:1 to receive fulvestrant (500 mg intramuscular injection) with or without goserelin with oral palbociclib (125 mg daily; 3 weeks on/1 week off) or placebo. Safety assessments at baseline and day 1 of each cycle included blood counts on day 15 for the first 2 cycles. Hematologic toxicity was assessed by using laboratory data. Results. A total of 517 patients were treated (palbociclib, n = 345; placebo, n = 172); median follow-up was 8.9 months. With palbociclib, neutropenia was the most common grade 3 (55%) and 4 (10%) adverse event; median times to onset and duration of grade ≥3 episodes were 16 and 7 days, respectively. Asian ethnicity and below-median neutrophil counts at baseline were significantly associated with an increased chance of developing grade 3–4 neutropenia with palbociclib. Dose modifications for grade 3–4 neutropenia had no adverse effect on progression-free survival. In the palbociclib arm, febrile neutropenia occurred in 3 (<1%) patients. The percentage of grade 1–2 infections was higher than in the placebo arm. Grade 1 stomatitis occurred in 8% of patients. Conclusion. Palbociclib plus fulvestrant treatment was well-tolerated, and the primary toxicity of asymptomatic neutropenia was effectively managed by dose modification without apparent loss of efficacy. This study appears at ClinicalTrials.gov, NCT01942135. Implications for Practice: Treatment with palbociclib in combination with fulvestrant was generally safe and well-tolerated in patients with hormone receptor (HR)-positive metastatic breast cancer. Consistent with the drug's proposed mechanism of action, palbociclib-related neutropenia differs in its clinical time course, patterns, and consequences from those seen with chemotherapy. Neutropenia can be effectively managed by a dose reduction, interruption, or cycle delay without compromising efficacy. A significant efficacy gain and a favorable safety profile support the consideration of incorporating palbociclib into the routine management of HR-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. PMID:27368881

Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3).

PubMed

Verma, Sunil; Bartlett, Cynthia Huang; Schnell, Patrick; DeMichele, Angela M; Loi, Sherene; Ro, Jungsil; Colleoni, Marco; Iwata, Hiroji; Harbeck, Nadia; Cristofanilli, Massimo; Zhang, Ke; Thiele, Alexandra; Turner, Nicholas C; Rugo, Hope S

2016-10-01

Palbociclib enhances endocrine therapy and improves clinical outcomes in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Because this is a new target, it is clinically important to understand palbociclib's safety profile to effectively manage toxicity and optimize clinical benefit. Patients with endocrine-resistant, HR-positive/HER2-negative MBC (n = 521) were randomly assigned 2:1 to receive fulvestrant (500 mg intramuscular injection) with or without goserelin with oral palbociclib (125 mg daily; 3 weeks on/1 week off) or placebo. Safety assessments at baseline and day 1 of each cycle included blood counts on day 15 for the first 2 cycles. Hematologic toxicity was assessed by using laboratory data. A total of 517 patients were treated (palbociclib, n = 345; placebo, n = 172); median follow-up was 8.9 months. With palbociclib, neutropenia was the most common grade 3 (55%) and 4 (10%) adverse event; median times to onset and duration of grade ≥3 episodes were 16 and 7 days, respectively. Asian ethnicity and below-median neutrophil counts at baseline were significantly associated with an increased chance of developing grade 3-4 neutropenia with palbociclib. Dose modifications for grade 3-4 neutropenia had no adverse effect on progression-free survival. In the palbociclib arm, febrile neutropenia occurred in 3 (<1%) patients. The percentage of grade 1-2 infections was higher than in the placebo arm. Grade 1 stomatitis occurred in 8% of patients. Palbociclib plus fulvestrant treatment was well-tolerated, and the primary toxicity of asymptomatic neutropenia was effectively managed by dose modification without apparent loss of efficacy. This study appears at ClinicalTrials.gov, NCT01942135. Treatment with palbociclib in combination with fulvestrant was generally safe and well-tolerated in patients with hormone receptor (HR)-positive metastatic breast cancer. Consistent with the drug's proposed mechanism of action, palbociclib-related neutropenia differs in its clinical time course, patterns, and consequences from those seen with chemotherapy. Neutropenia can be effectively managed by a dose reduction, interruption, or cycle delay without compromising efficacy. A significant efficacy gain and a favorable safety profile support the consideration of incorporating palbociclib into the routine management of HR-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. ©AlphaMed Press.

33 CFR 96.220 - What makes up a safety management system?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.220 What makes up a safety management system? (a) The safety management system must document the responsible person's— (1) Safety and pollution prevention...

Dike Strength Analysis on a Regional Scale Based On a Stochastic Subsoil Model

NASA Astrophysics Data System (ADS)

Koelewijn, A. R.; Vastenburg, E. W.

2013-12-01

About two-third of the Netherlands is protected against flooding by dikes and levees. The subsoil can be characterized by fluvial and marine sediments. Maintaining the safety of these dikes and levees is of vital importance. Insufficient safety is not permissible, but excessive safety would imply a waste of money and other resources. Therefore safety assessments are carried out on a regular basis. Over the past decades, a practice has grown to calculate a limited number of cross-sections, roughly one every 500 to 1000 meters. For this purpose, a representative cross-section is selected as an estimate of the most vulnerable surface geometry and the subsoil conditions determined from boreholes and cone penetration tests, for which slope stability and piping analyses are carried out. This is a time-consuming procedure which is not only expensive, but also neglects geological knowledge. A method to incorporate geological knowledge of an area, including updating on the basis of additional investigations, has been described in Koelewijn et al. [2011]. In addition, various groups have worked to incorporate geotechnical stability models and detailed Lidar-measurements of the surface into a more efficient and rational calculation process [Knoeff et al. 2011, Lam et al. 2013, van den Ham & Mastbergen, 2013]. Combining this experience with the 3D subsoil model opens possibilities for cost-effective additional soil investigations for those locations where ruling out unfavorable conditions really influences the decisions to be made regarding rejection and improvement, see the figure for examples of different subsoil profiles along a dike. The resulting system has been applied for semi-automated calculations of dikes in various parts of the Netherlands, totalling over 4000 km by now, and a part of the Mississippi levee system. [van den Ham & Mastbergen, 2013] G.A. van den Ham & D.R. Mastbergen, A semi-probabilistic assessment method for flow slides. AGU Fall meeting, 2013 [Knoeff et al. 2011] J.G. Knoeff, E.W. Vastenburg, G.A. van den Ham & J. Lopez de la Cruz, Automated levee flood risk management, 5th Int. Conf. on Flood Management, Tokyo, 2011 [Koelewijn et al. 2011] A.R. Koelewijn, G.A.M. Kruse & J. Pruiksma, Stochastic subsoil modelling - first set-up of the model and reliability analyses, report 12042000-002-HYE-0001, Deltares, Delft, 2011 [In Dutch] [Lam et al. 2013] K.S. Lam, P.W. Gill & L.W.A. Zwang, Implementation of new levee strength modules for continuous safety assessments, Comprehensive Flood Risk Managment, Taylor & Francis, London, 2013, 317-326. Dike sections with stochastic subsoil profiles.

The role of tramadol in pain management in Latin America: a report by the Change Pain Latin America Advisory Panel.

PubMed

Santos Garcia, Joäo Batista; Lech, Osvandré; Campos Kraychete, Durval; Rico, María Antonieta; Hernández-Castro, John Jairo; Colimon, Frantz; Guerrero, Carlos; Sempértegui Gallegos, Manuel; Lara-Solares, Argelia; Flores Cantisani, José Alberto; Amescua-Garcia, César; Guillén Núñez, María Del Rocío; Berenguel Cook, María Del Rosario; Jreige Iskandar, Aziza; Bonilla Sierra, Patricia

2017-09-01

Change Pain Latin America (CPLA) was created to enhance chronic pain understanding and develop pain management improving strategies in this region. During its seventh meeting (August 2016), the main objective was to discuss tramadol's role in treating pain in Latin America. Furthermore, potential pain management consequences were considered, if tramadol was to become more stringently controlled. Key topics discussed were: main indications for prescribing tramadol, its pharmacological characteristics, safety and tolerability, effects of restrictions on its availability and use, and consequent impact on pain care quality. The experts agreed that tramadol is used to treat a wide spectrum of non-oncological pain conditions (e.g. post-surgical, musculoskeletal, post-traumatic, neuropathic, fibromyalgia), as well as cancer pain. Its relevance when treating special patient groups (e.g. the elderly) is recognized. The main reasons for tramadol's high significance as a treatment option are: its broad efficacy, an inconspicuous safety profile and its availability, considering that access to strong analgesics - mainly controlled drugs (classical opioids) - is highly restricted in some countries. The CPLA also agreed that tramadol is well tolerated, without the safety issues associated with long-term nonsteroidal anti-inflammatory drug (NSAID) use, with fewer opioid-like side effects than classical opioids and lower abuse risk. In Latin America, tramadol is a valuable and frequently used medication for treating moderate to severe pain. More stringent regulations would have significant impact on its availability, especially for outpatients. This could cause regression to older and frequently inadequate pain management methods, resulting in unnecessary suffering for many Latin American patients.

Cold chain management in meat storage, distribution and retail: A review

NASA Astrophysics Data System (ADS)

Nastasijević, I.; Lakićević, B.; Petrović, Z.

2017-09-01

Meat is a perishable product with a short shelf life and therefore short selling times. Therefore, cold chain management in meat supply is of utmost importance for the maintenance of quality and safety of meat/meat products. Raw meat/meat products are likely to support the growth of pathogenic microorganisms and/or spoilage bacteria, and should be kept at temperatures that do not result in a risk to health. The cold chain should not be interrupted at all times along the meat distribution chain. The complexity of global meat supply chain, with frequently long distribution chains associated with transportation of the product within one country, from one to another country and from one to another continent, makes the solutions for the chilling and freezing regimes, as well as monitoring of time-temperature profiles, very important for the overall success in delivery of product which will be accepted by consumer for its freshness and safety levels. From recently, there are several available options for control and management of the cold chain, such as chilled and frozen storage combinations, superchilling, ionizing radiation, biopreservation, high hydrostatic pressure (HHP), active packaging, wireless sensors, supported with the software-based cold chain database (CCD).

From the traditional concept of safety management to safety integrated with quality.

PubMed

García Herrero, Susana; Mariscal Saldaña, Miguel Angel; Manzanedo del Campo, Miguel Angel; Ritzel, Dale O

2002-01-01

This editorial reviews the evolution of the concepts of safety and quality that have been used in the traditional workplace. The traditional programs of safety are explored showing strengths and weaknesses. The concept of quality management is also viewed. Safety management and quality management principles, stages, and measurement are highlighted. The concepts of quality and safety guarantee are assessed. Total Quality Management concepts are reviewed and applied to safety quality. Total safety management principles are discussed. Finally, an analysis of the relationship between quality and safety from data collected from a company in Spain is presented.

Can Civility Norms Boost Positive Effects of Management Commitment to Safety?

PubMed

McGonagle, Alyssa K; Childress, Niambi M; Walsh, Benjamin M; Bauerle, Timothy J

2016-07-03

We proposed that civility norms would strengthen relationships between management commitment to safety and workers' safety motivation, safety behaviors, and injuries. Survey data were obtained from working adults in hazardous jobs-those for which physical labor is required and/or a realistic possibility of physical injury is present (N = 290). Results showed that management commitment positively related to workers' safety motivation, safety participation, and safety compliance, and negatively related to minor injuries. Furthermore, management commitment to safety displayed a stronger positive relationship with safety motivation and safety participation, and a stronger negative relationship with minor worker injuries when civility norms were high (versus low). The results confirm existing known relationships between management commitment to safety and worker safety motivation and behavior; furthermore, civility norms facilitate the relationships between management commitment to safety and various outcomes important to worker safety. In order to promote an optimally safe working environment, managers should demonstrate a commitment to worker safety and promote positive norms for interpersonal treatment between workers in their units.

Selecting optimal second-generation antihistamines for allergic rhinitis and urticaria in Asia.

PubMed

Recto, Marysia Tiongco; Gabriel, Ma Teresita; Kulthanan, Kanokvalai; Tantilipikorn, Pongsakorn; Aw, Derrick Chen-Wee; Lee, Tak Hong; Chwen, Ch'ng Chin; Mutusamy, Somasundran; Hao, Nguyen Trong; Quang, Vo Thanh; Canonica, Giorgio Walter

2017-01-01

Allergic diseases are on the rise in many parts of the world, including the Asia-Pacific (APAC) region. Second-generation antihistamines are the first-line treatment option in the management of allergic rhinitis and urticaria. International guidelines describe the management of these conditions; however, clinicians perceive the additional need to tailor treatment according to patient profiles. This study serves as a consensus of experts from several countries in APAC (Hong Kong, Malaysia, the Philippines, Singapore, Thailand, Vietnam), which aims to describe the unmet needs, practical considerations, challenges, and key decision factors when determining optimal second-generation antihistamines for patients with allergic rhinitis and/or urticaria. Specialists from allergology, dermatology, and otorhinolaryngology were surveyed on practical considerations and key decision points when treating patients with allergic rhinitis and/or urticaria. Clinicians felt the need for additional tools for diagnosis of these diseases and a single drug with all preferred features of an antihistamine. Challenges in treatment include lack of clinician and patient awareness and compliance, financial constraints, and treatment for special patient populations such as those with concomitant disease. Selection of optimal second-generation antihistamines depends on many factors, particularly drug safety and efficacy, impact on psychomotor abilities, and sedation. Country-specific considerations include drug availability and cost-effectiveness. Survey results reveal bilastine as a preferred choice due to its high efficacy and safety, suitability for special patient populations, and the lack of sedative effects. Compliance to the international guidelines is present among allergists, dermatologists and otorhinolaryngologists; however, this is lower amongst general practitioners (GPs). To increase awareness, allergy education programs targeted at GPs and patients may be beneficial. Updates to the existing international guidelines are suggested in APAC to reflect appropriate management for different patient profiles and varying symptoms of allergic rhinitis and urticaria.

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single Enantiomer (+)-Mefloquine Compared with Racemic Mefloquine in Healthy Persons

PubMed Central

Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg

2010-01-01

Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (−) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (−)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted. PMID:21118921

Industrial Hygiene Issues

NASA Technical Reports Server (NTRS)

Brisbin, Steven G.

1999-01-01

This breakout session is a traditional conference instrument used by the NASA industrial hygiene personnel as a method to convene personnel across the Agency with common interests. This particular session focused on two key topics, training systems and automation of industrial hygiene data. During the FY 98 NASA Occupational Health Benchmarking study, the training system under development by the U.S. Environmental Protection Agency (EPA) was deemed to represent a "best business practice." The EPA has invested extensively in the development of computer based training covering a broad range of safety, health and environmental topics. Currently, five compact disks have been developed covering the topics listed: Safety, Health and Environmental Management Training for Field Inspection Activities; EPA Basic Radiation Training Safety Course; The OSHA 600 Collateral Duty Safety and Health Course; and Key program topics in environmental compliance, health and safety. Mr. Chris Johnson presented an overview of the EPA compact disk-based training system and answered questions on its deployment and use across the EPA. This training system has also recently been broadly distributed across other Federal Agencies. The EPA training system is considered "public domain" and, as such, is available to NASA at no cost in its current form. Copies of the five CD set of training programs were distributed to each NASA Center represented in the breakout session. Mr. Brisbin requested that each NASA Center review the training materials and determine whether there is interest in using the materials as it is or requesting that EPA tailor the training modules to suit NASA's training program needs. The Safety, Health and Medical Services organization at Ames Research Center has completed automation of several key program areas. Mr. Patrick Hogan, Safety Program Manager for Ames Research Center, presented a demonstration of the automated systems, which are described by the following: (1) Safety, Health and Environmental Training. This system includes an assessment of training needs for every NASA Center organization, course descriptions, schedules and automated course scheduling, and presentation of training program metrics; (2) Safety and Health Inspection Information. This system documents the findings from each facility inspection, tracks abatement status on those findings and presents metrics on each department for senior management review; (3) Safety Performance Evaluation Profile. The survey system used by NASA to evaluate employee and supervisory perceptions of safety programs is automated in this system; and (4) Documentation Tracking System. Electronic archive and retrieval of all correspondence and technical reports generated by the Safety, Health and Medical Services Office are provided by this system.

Hypnosis: Adjunct Therapy for Cancer Pain Management

PubMed Central

Kravits, Kathy

2013-01-01

Pain is a symptom associated with prolonged recovery from illness and procedures, decreased quality of life, and increased health-care costs. While there have been advances in the management of cancer pain, there is a need for therapeutic strategies that complement pharmaceutical management without significantly contributing to the side-effect profile of these agents. Hypnosis provides a safe and efficacious supplement to pharmaceutical management of cancer pain. One barrier to the regular use of hypnosis is health-care providers’ lack of current knowledge of the efficacy and safety of hypnosis. Advanced practitioners who are well-informed about hypnosis have an opportunity to increase the treatment options for patients who are suffering with cancer pain by suggesting to the health-care team that hypnosis be incorporated into the plan of care. Integration of hypnosis into the standard of care will benefit patients, caregivers, and survivors by reducing pain and the suffering associated with it. PMID:25031986

Efficient Management of Fruit Pests by Pheromone Nanogels

PubMed Central

Bhagat, Deepa; Samanta, Suman K.; Bhattacharya, Santanu

2013-01-01

Environment-friendly management of fruit flies involving pheromones is useful in reducing the undesirable pest populations responsible for decreasing the yield and the crop quality. A nanogel has been prepared from a pheromone, methyl eugenol (ME) using a low-molecular mass gelator. This was very stable at open ambient conditions and slowed down the evaporation of pheromone significantly. This enabled its easy handling and transportation without refrigeration, and reduction in the frequency of pheromone recharging in the orchard. Notably the involvement of the nano-gelled pheromone brought about an effective management of Bactrocera dorsalis, a prevalent harmful pest for a number of fruits including guava. Thus a simple, practical and low cost green chemical approach is developed that has a significant potential for crop protection, long lasting residual activity, excellent efficacy and favorable safety profiles. This makes the present invention well-suited for pest management in a variety of crops. PMID:23416455

[Identification and management of violence in psychiatry: Nurse and patient perceptions of safety and dangerousness].

PubMed

Perron, Amélie; Jacob, Jean Daniel; Beauvais, Louise; Corbeil, Danielle; Bérubé, David

2015-03-01

This paper reports the results of a study on the identification and management of violence on a psychiatric ward and in the psychiatric emergency of a Quebec hospital. The purpose of this exploratory and descriptive study was to examine patients' and nurses' perceptions and strategies for identifying and managing patient aggression and violence. Results show that the type of setting influences the way aggressive behaviour issues are perceived and managed. The types of behaviours deemed aggressive or risky also vary between the two units. Moreover, patients and nurses are similarly described by all participants as susceptible to being violent and to being a victim of violence. Prevention of aggression and violence remains a significant challenge in psychiatric nursing, where administrative and environmental constraints, the growing complexity of clinical profiles, divergent interprofessional approaches to care, and collective feelings of apprehension and vulnerability interact.

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

PubMed

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Safety management vs. picking leaves.

PubMed

Wright, D

1991-09-01

A safety program will generally have as its base a comprehensive written document made available for everyone in the organization. The document should indicate a positive commitment to safety by management. It should not be a "how to" guide, but rather a broad outline to establish responsibilities, goals, and methods. The safety manager is appointed in writing and answers to the highest level of management. As opposed to a "doer," the safety manager acts as a director and administrator of the safety program. This is accomplished through the advisory capacity of the safety program for solicited and unsolicited problems. The focus of the safety manager is on the system and how it contributes to safety problems, rather than individual problems. Management has the ultimate responsibility for safety. Their efforts should reflect a proactive attitude to correct problems in the system. In order to identify areas of interest, technically competent input from the safety manager should be required. The support of the safety program by top management determines the success of the program. Without a clear and firm commitment by the organization, safety will receive no more than lip service from the employees. The benefits of a proactive approach will be realized in the organization's ability to manage safety issues, rather than reacting to them.

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

A system of safety management practices and worker engagement for reducing and preventing accidents: an empirical and theoretical investigation.

PubMed

Wachter, Jan K; Yorio, Patrick L

2014-07-01

The overall research objective was to theoretically and empirically develop the ideas around a system of safety management practices (ten practices were elaborated), to test their relationship with objective safety statistics (such as accident rates), and to explore how these practices work to achieve positive safety results (accident prevention) through worker engagement. Data were collected using safety manager, supervisor and employee surveys designed to assess and link safety management system practices, employee perceptions resulting from existing practices, and safety performance outcomes. Results indicate the following: there is a significant negative relationship between the presence of ten individual safety management practices, as well as the composite of these practices, with accident rates; there is a significant negative relationship between the level of safety-focused worker emotional and cognitive engagement with accident rates; safety management systems and worker engagement levels can be used individually to predict accident rates; safety management systems can be used to predict worker engagement levels; and worker engagement levels act as mediators between the safety management system and safety performance outcomes (such as accident rates). Even though the presence of safety management system practices is linked with incident reduction and may represent a necessary first-step in accident prevention, safety performance may also depend on mediation by safety-focused cognitive and emotional engagement by workers. Thus, when organizations invest in a safety management system approach to reducing/preventing accidents and improving safety performance, they should also be concerned about winning over the minds and hearts of their workers through human performance-based safety management systems designed to promote and enhance worker engagement. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

The discovery and development of aclidinium bromide for the treatment of chronic obstructive pulmonary disease.

PubMed

Malerba, Mario; Radaeli, Alessandro; Santini, Giuseppe; Morjaria, Jaymin; Mores, Nadia; Mondino, Chiara; Macis, Giuseppe; Montuschi, Paolo

2018-06-01

Bronchodilators, including long-acting muscarinic receptor antagonists (LAMAs), are a mainstay of the pharmacological treatment of chronic obstructive pulmonary disease (COPD). LAMAs act as bronchodilators principally by antagonizing airway smooth muscle cells M 3 muscarinic receptors. Aclidinium bromide is a twice-daily LAMA which was developed to improve on the efficacy and/or safety of previous LAMAs. Area covered: Herein, the authors present the pharmacotherapeutic role of aclidinium in COPD and point out unmet need in this research area. The following aspects are covered: a) the discovery and medicinal chemistry of aclidinium bromide; b) an overview of the market; c) its mechanism of action; d) its pharmacokinetic/pharmacodynamic profile derived from pre-clinical studies; e) the clinical studies which led to its licensing; f) the evidence from meta-analyses; g) the aclidinium/formoterol fixed dose combination for COPD and h) priorities in this area of research. Expert opinion: Aclidinium bromide has the pharmacological properties, safety and efficacy profile and inhaler characteristics which makes it a valuable therapeutic option for pharmacological management of patients with COPD. Due to its rapid biotransformation into inactive metabolites, aclidinium is potentially one of the safest LAMAs. Further head-to-head randomized clinical trials are required to define efficacy and safety of aclidinium when compared to once-daily LAMAs. The clinical relevance of airway anti-remodeling effects of aclidinium has to be defined.

Dose-dependent acute liver injury with hypersensitivity features in humans due to a novel microsomal prostaglandin E synthase 1 inhibitor.

PubMed

Jin, Yan; Regev, Arie; Kam, Jeanelle; Phipps, Krista; Smith, Claire; Henck, Judith; Campanale, Kristina; Hu, Leijun; Hall, D Greg; Yang, Xiao Yan; Nakano, Masako; McNearney, Terry Ann; Uetrecht, Jack; Landschulz, William

2018-01-01

LY3031207, a novel microsomal prostaglandin E synthase 1 inhibitor, was evaluated in a multiple ascending dose study after nonclinical toxicology studies and a single ascending dose study demonstrated an acceptable toxicity, safety and tolerability profile. Healthy subjects were randomized to receive LY3031207 (25, 75 and 275 mg), placebo or celecoxib (400 mg) once daily for 28 days. The safety, tolerability and pharmacokinetic and pharmacodynamic profiles of LY3031207 were evaluated. The study was terminated when two subjects experienced drug-induced liver injury (DILI) after they had received 225 mg LY3031207 for 19 days. Liver biopsy from these subjects revealed acute liver injury with eosinophilic infiltration. Four additional DILI cases were identified after LY3031207 dosing had been stopped. All six DILI cases shared unique presentations of hepatocellular injury with hypersensitivity features and demonstrated a steep dose-dependent trend. Prompt discontinuation of the study drug and supportive medical care resulted in full recovery. Metabolites from metabolic activation of the imidazole ring were observed in plasma and urine samples from all subjects randomized to LY3031207 dosing. This study emphasized the importance of careful safety monitoring and serious adverse events management in phase I trials. Metabolic activation of the imidazole ring may be involved in the development of hepatotoxicity of LY3031207. © 2017 The British Pharmacological Society.

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

PubMed Central

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. PMID:28740389

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity.

PubMed

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD.

Safety assessment of FDA-approved (orlistat and lorcaserin) anti-obesity medications.

PubMed

Halpern, Bruno; Halpern, Alfredo

2015-02-01

Options for treating obesity remain limited despite it being a chronic, recurrent and morbid condition. New drugs that are proposed for its treatment encounter strong reluctance by regulatory agencies and many doctors. This review will focus on the safety of an older drug, orlistat (the only one still approved in the European Union) and a newer recently FDA-approved one, lorcaserin. Both are approved as long-term monotherapy for obesity in the United States of America and they have demonstrated median weight loss of nearly 3% over placebo. Research, development and approval of new anti-obesity drugs are necessary for improved management of this chronic condition. Orlistat and lorcaserin are two FDA-approved drugs with limited overall efficacy. Nevertheless they are useful weapons for at least some obese individuals. Orlistat has a long and solid safety profile, whereas the safety of lorcaserin is still a matter of debate, mainly due to a lack of long-term data. However, lorcaserin's selective agonism on 5HT2c serotonin receptors diminishes concerns about valvulopathy associated with other serotonin agonists, such as fenfluramine.

TAK-264 (MLN0264) in Previously Treated Asian Patients with Advanced Gastrointestinal Carcinoma Expressing Guanylyl Cyclase C: Results from an Open-Label, Non-randomized Phase 1 Study

PubMed Central

Bang, Yung-Jue; Takano, Toshimi; Lin, Chia-Chi; Fasanmade, Adedigbo; Yang, Huyuan; Danaee, Hadi; Asato, Takayuki; Kalebic, Thea; Wang, Hui; Doi, Toshihiko

2018-01-01

Purpose This phase 1 dose-escalation portion of the study evaluated the safety, pharmacokinetics (PK), and antitumor activity of TAK-264 in Asian patients with advanced gastrointestinal (GI) carcinoma or metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma expressing guanylyl cyclase C (GCC). Materials and Methods Adult patients with advanced GI malignancies expressing GCC (H-score ≥ 10) received TAK-264 on day 1 of 3-week cycles as 30-minute intravenous infusions for up to 1 year or until disease progression or unacceptable toxicity. The primary objectives were to evaluate the safety profile including dose-limiting toxicities (DLTs) during cycle 1, determine the maximum tolerated dose (MTD), and characterize the PK profile of TAK-264. Results Twelve patients were enrolled and treated with 1.2 mg/kg (n=3), 1.5 mg/kg (n=3), or 1.8 mg/kg TAK-264 (n=6). Median number of treatment cycles received was two (range, 1 to 10). None of the patients experienced a DLT and the MTD was not determined. Ten patients (83%) experienced adverse events (AEs). The most common were neutropenia, anorexia, and nausea (each reported by four patients). Five patients (42%) experienced grade ≥ 3 AEs consisting of tumor hemorrhage and hypertension, ascites, adrenal insufficiency, neutropenia and asthenia. Serum exposure to TAK-264 increased proportionally with the dose and the median half-life was approximately 5.5-6.6 days. No patients experienced an objective response. Conclusion TAK-264 demonstrated a manageable safety profile with limited antitumor activity consistent with studies conducted in Western patients with advanced GI malignancies. TAK-264 exposure increased proportionally with the dose. PMID:28494535

The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

PubMed

Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

2014-04-01

The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

'High profile health facilities can add to your trouble': Women, stigma and un/safe abortion in Kenya.

PubMed

Izugbara, Chimaraoke O; Egesa, Carolyne; Okelo, Rispah

2015-09-01

Public health discourses on safe abortion assume the term to be unambiguous. However, qualitative evidence elicited from Kenyan women treated for complications of unsafe abortion contrasted sharply with public health views of abortion safety. For these women, safe abortion implied pregnancy termination procedures and services that concealed their abortions, shielded them from the law, were cheap and identified through dependable social networks. Participants contested the notion that poor quality abortion procedures and providers are inherently dangerous, asserting them as key to women's preservation of a good self, management of stigma, and protection of their reputation, respect, social relationships, and livelihoods. Greater public health attention to the social dimensions of abortion safety is urgent. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Cutaneous lichen planus: A systematic review of treatments.

PubMed

Fazel, Nasim

2015-06-01

Various treatment modalities are available for cutaneous lichen planus. Pubmed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database were searched for all the systematic reviews and randomized controlled trials related to cutaneous lichen planus. Two systematic reviews and nine relevant randomized controlled trials were identified. Acitretin, griseofulvin, hydroxychloroquine and narrow band ultraviolet B are demonstrated to be effective in the treatment of cutaneous lichen planus. Sulfasalazine is effective, but has an unfavorable safety profile. KH1060, a vitamin D analogue, is not beneficial in the management of cutaneous lichen planus. Evidence from large scale randomized trials demonstrating the safety and efficacy for many other treatment modalities used to treat cutaneous lichen planus is simply not available.

Crisaborole and its potential role in treating atopic dermatitis: overview of early clinical studies.

PubMed

Zane, L T; Chanda, S; Jarnagin, K; Nelson, D B; Spelman, L; Gold, Lf Stein

2016-07-01

Atopic dermatitis (AD), a chronic, relapsing, inflammatory skin disease that is characterized by intense pruritus and eczematous lesions with up to 90% of patients presenting with mild to moderate disease. Current topical treatments for AD have not changed in over 15 years and are associated with safety concerns. In AD, overactivity of phosphodiesterase 4 (PDE4), leads to inflammation and disease exacerbation. Crisaborole Topical Ointment, 2%, is a novel, nonsteroidal, topical anti-inflammatory PDE4 inhibitor currently being investigated for the treatment of mild to moderate AD. Preliminary studies in children and adults demonstrated favorable efficacy and safety profiles. Crisaborole may represent an anti-inflammatory option that safely minimizes the symptoms and severity of AD and that can be used for both acute and long-term management.

Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use

PubMed Central

Cicchetti, Americo; Berrino, Alexandra; Casini, Marina; Codella, Paola; Facco, Giuseppina; Fiore, Alessandra; Marano, Giuseppe; Marchetti, Marco; Midolo, Emanuela; Minacori, Roberta; Refolo, Pietro; Romano, Federica; Ruggeri, Matteo; Sacchini, Dario; Spagnolo, Antonio G.; Urbina, Irene; Vaglio, Stefania; Grazzini, Giuliano; Liumbruno, Giancarlo M.

2016-01-01

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains. Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed. PMID:27403740

Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective.

PubMed

Lewis, James H

2010-02-01

Irritable bowel syndrome affects 5-10% of North Americans, with an estimated one-third having a diarrhea-predominant form. Alosetron hydrochloride (Lotronex) is a serotonin receptor type 3 antagonist approved in early 2000 for use in women with diarrhea-predominant irritable bowel syndrome (IBS-D). Initial use was widespread, but infrequent serious adverse events of ischemic colitis and severe constipation-related complications prompted alosetron's voluntary withdrawal from the US market in November 2000. Unprecedented public request prompted its reintroduction in 2002 under a Risk Management Plan, including a more restricted indication and a Prescribing Program for Lotronex. Despite these measures, the use of alosetron has been very limited since its reintroduction. Possible deterrents to its use include concerns over safety and the possible medical-legal implications raised by the Risk Management Plan. It is also possible that changes in the natural history and/or diagnosis of IBS-D have reduced the target population. Given the unique regulatory history of alosetron, these issues continue to engender controversy. This article profiles these concerns and reviews the pharmacology, clinical efficacy and safety, and post-marketing experience with alosetron. Myths and misconceptions related to alosetron use, or lack thereof, are addressed to provide the reader with the evidence needed to make informed treatment decisions for their female patients with severe IBS-D.

Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada.

PubMed

Reid, Robert L; Fortier, Michel P; Smith, Lynne; Mirkin, Sebastian; Grubb, Gary S; Constantine, Ginger D

2010-12-01

The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg. Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events. Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively. Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting. Copyright © 2010 Elsevier Inc. All rights reserved.

33 CFR 96.220 - What makes up a safety management system?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false What makes up a safety management... SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.220 What makes up a safety management system? (a) The...

Non-Vitamin K Oral Anticoagulants (NOACs) A Review of Clinical Management and Laboratory Issues.

PubMed

Blann, Andrew

2016-01-01

The non-vitamin K oral anticoagulants (NOACs) are set to replace vitamin K antagonists (principally warfarin), unfractionated heparin and low molecular weight heparin as the leading antithrombotic prophylaxis in several medical and surgical settings. As a group, NOACs have a better safety profile and at least an equivalent (and sometimes superior) efficacy profile than their comparator. The objective of this review is to provide the practitioner with a comprehensive, balanced and contemporary view of these drugs and their applications. More specifically, it focuses on the evidence base for their licences, use in clinical practice (such as in renal dysfunction, orthopaedic surgery, atrial fibrillation, and venous thromboembolism, and the effects of co-medications), responses to actual or perceived haemorrhage, and the role of the laboratory.

Failure mode and effects analysis based risk profile assessment for stereotactic radiosurgery programs at three cancer centers in Brazil.

PubMed

Teixeira, Flavia C; de Almeida, Carlos E; Saiful Huq, M

2016-01-01

The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.

Restaurant manager and worker food safety certification and knowledge.

PubMed

Brown, Laura G; Le, Brenda; Wong, Melissa R; Reimann, David; Nicholas, David; Faw, Brenda; Davis, Ernestine; Selman, Carol A

2014-11-01

Over half of foodborne illness outbreaks occur in restaurants. To combat these outbreaks, many public health agencies require food safety certification for restaurant managers, and sometimes workers. Certification entails passing a food safety knowledge examination, which is typically preceded by food safety training. Current certification efforts are based on the assumption that certification leads to greater food safety knowledge. The Centers for Disease Control and Prevention conducted this study to examine the relationship between food safety knowledge and certification. We also examined the relationships between food safety knowledge and restaurant, manager, and worker characteristics. We interviewed managers (N=387) and workers (N=365) about their characteristics and assessed their food safety knowledge. Analyses showed that certified managers and workers had greater food safety knowledge than noncertified managers and workers. Additionally, managers and workers whose primary language was English had greater food safety knowledge than those whose primary language was not English. Other factors associated with greater food safety knowledge included working in a chain restaurant, working in a larger restaurant, having more experience, and having more duties. These findings indicate that certification improves food safety knowledge, and that complex relationships exist among restaurant, manager, and worker characteristics and food safety knowledge.

Restaurant Manager and Worker Food Safety Certification and Knowledge

PubMed Central

Brown, Laura G.; Le, Brenda; Wong, Melissa R.; Reimann, David; Nicholas, David; Faw, Brenda; Davis, Ernestine; Selman, Carol A.

2017-01-01

Over half of foodborne illness outbreaks occur in restaurants. To combat these outbreaks, many public health agencies require food safety certification for restaurant managers, and sometimes workers. Certification entails passing a food safety knowledge examination, which is typically preceded by food safety training. Current certification efforts are based on the assumption that certification leads to greater food safety knowledge. The Centers for Disease Control and Prevention conducted this study to examine the relationship between food safety knowledge and certification. We also examined the relationships between food safety knowledge and restaurant, manager, and worker characteristics. We interviewed managers (N = 387) and workers (N = 365) about their characteristics and assessed their food safety knowledge. Analyses showed that certified managers and workers had greater food safety knowledge than noncertified managers and workers. Additionally, managers and workers whose primary language was English had greater food safety knowledge than those whose primary language was not English. Other factors associated with greater food safety knowledge included working in a chain restaurant, working in a larger restaurant, having more experience, and having more duties. These findings indicate that certification improves food safety knowledge, and that complex relationships exist among restaurant, manager, and worker characteristics and food safety knowledge. PMID:25361386

41 CFR 102-80.10 - What are the basic safety and environmental management policies for real property?

Code of Federal Regulations, 2010 CFR

2010-07-01

... safety and environmental management policies for real property? 102-80.10 Section 102-80.10 Public... MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT General Provisions § 102-80.10 What are the basic safety and environmental management policies for real property? The basic safety and...

33 CFR 96.320 - What is involved to complete a safety management audit and when is it required to be completed?

Code of Federal Regulations, 2011 CFR

2011-07-01

... certificate or a Safety Management Certificate; (3) Periodic audits including— (i) An annual verification... safety management audit and when is it required to be completed? 96.320 Section 96.320 Navigation and... SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems Be...

Hypertension: management perspectives.

PubMed

Borghi, Claudio; Cicero, Arrigo F G

2012-10-01

The increasing worldwide prevalence of hypertension and the related increase in cost due to diagnosis, management and negative outcomes forces public health institutions and clinical researchers to find new strategies to improve blood pressure (BP) control. So what are the possible future perspectives for high BP management? Three main points are briefly discussed in this article: individualized therapy, the known genetic contribution to hypertension development and control, and the improvement of disease management, including perspectives on new antihypertensive drug development. It is likely that the integration of the best available current knowledge with recent diagnostic and therapeutic achievements for the management of hypertension prevention and treatment will lead to the early detection of at-risk conditions, early diagnosis, and individualized and efficacious treatment. The most promising antihypertensive drugs currently in development are innovative renin-angiotensin-aldosterone system modulators. Further drugs have potentially interesting mechanisms of action, but renalase analogs are in the very early phases of development, and available endothelin antagonists have a poor safety profile.

The Coast Guard Proceedings of the Marine Safety and Security Council: Spring 2016

DTIC Science & Technology

2016-04-01

PROCEEDINGS Spring 2016 Vol. 73, Number 1 Safety Management System Objectives 6 Safety Management Facilitates Safe Vessel Operation Vessel systems...crew, and operations. by LCDR Aaron W. Demo 9 Safety Management Systems to Prevent Pollution from Ships Standard procedures protect the environment...by LCDR Michael Lendvay 11 Dead Reckoning by Safety Management ? Check your course. by LCDR Corydon F. Heard IV Safety Management Systems and the Outer

An Airborne Millimeter-Wave FM-CW Radar for Thickness Profiling of Freshwater Ice

DTIC Science & Technology

1992-11-01

commercial and recreational application, including safety and trafficability surveys. A proto- type broadband millimeter wave (26.5 to 40 GHz) Frequency...and utility for ice safety and traffica- appropriate antenna for transmission. Morey (1974) bility studies. Other important applications include...resolution and a 2.7- which can provide reliable safety survey profiling for GHz center frequency, that is capable of airborne pro- the entire practical

Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

PubMed Central

Scavone, Cristina; Sportiello, Liberata; Sullo, Maria G.; Ferrajolo, Carmen; Ruggiero, Rosanna; Sessa, Maurizio; Berrino, Pasquale M.; di Mauro, Gabriella; Berrino, Liberato; Rossi, Francesco; Rafaniello, Concetta; Capuano, Annalisa; Valentini, G.

2017-01-01

Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design: A prospective observational study. Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13–3.84). Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline. Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91–180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred. Conclusions: The results of our study demonstrated that the majority of AEs were not serious and expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies. PMID:28932193

Operating room data management: improving efficiency and safety in a surgical block.

PubMed

Agnoletti, Vanni; Buccioli, Matteo; Padovani, Emanuele; Corso, Ruggero M; Perger, Peter; Piraccini, Emanuele; Orelli, Rebecca Levy; Maitan, Stefano; Dell'amore, Davide; Garcea, Domenico; Vicini, Claudio; Montella, Teresa Maria; Gambale, Giorgio

2013-03-11

European Healthcare Systems are facing a difficult period characterized by increasing costs and spending cuts due to economic problems. There is the urgent need for new tools which sustain Hospitals decision makers work. This project aimed to develop a data recording system of the surgical process of every patient within the operating theatre. The primary goal was to create a practical and easy data processing tool to give hospital managers, anesthesiologists and surgeons the information basis to increase operating theaters efficiency and patient safety. The developed data analysis tool is embedded in an Oracle Business Intelligence Environment, which processes data to simple and understandable performance tachometers and tables. The underlying data analysis is based on scientific literature and the projects teams experience with tracked data. The system login is layered and different users have access to different data outputs depending on their professional needs. The system is divided in the tree profile types Manager, Anesthesiologist and Surgeon. Every profile includes subcategories where operators can access more detailed data analyses. The first data output screen shows general information and guides the user towards more detailed data analysis. The data recording system enabled the registration of 14.675 surgical operations performed from 2009 to 2011. Raw utilization increased from 44% in 2009 to 52% in 2011. The number of high complexity surgical procedures (≥120 minutes) has increased in certain units while decreased in others. The number of unscheduled procedures performed has been reduced (from 25% in 2009 to 14% in 2011) while maintaining the same percentage of surgical procedures. The number of overtime events decreased in 2010 (23%) and in 2011 (21%) compared to 2009 (28%) and the delays expressed in minutes are almost the same (mean 78 min). The direct link found between the complexity of surgical procedures, the number of unscheduled procedures and overtime show a positive impact of the project on OR management. Despite a consistency in the complexity of procedures (19% in 2009 and 21% in 2011), surgical groups have been successful in reducing the number of unscheduled procedures (from 25% in 2009 to 14% in 2011) and overtime (from 28% in 2009 to 21% in 2011). The developed project gives healthcare managers, anesthesiologists and surgeons useful information to increase surgical theaters efficiency and patient safety. In difficult economic times is possible to develop something that is of some value to the patient and healthcare system too.

Operating room data management: improving efficiency and safety in a surgical block

PubMed Central

2013-01-01

Background European Healthcare Systems are facing a difficult period characterized by increasing costs and spending cuts due to economic problems. There is the urgent need for new tools which sustain Hospitals decision makers work. This project aimed to develop a data recording system of the surgical process of every patient within the operating theatre. The primary goal was to create a practical and easy data processing tool to give hospital managers, anesthesiologists and surgeons the information basis to increase operating theaters efficiency and patient safety. Methods The developed data analysis tool is embedded in an Oracle Business Intelligence Environment, which processes data to simple and understandable performance tachometers and tables. The underlying data analysis is based on scientific literature and the projects teams experience with tracked data. The system login is layered and different users have access to different data outputs depending on their professional needs. The system is divided in the tree profile types Manager, Anesthesiologist and Surgeon. Every profile includes subcategories where operators can access more detailed data analyses. The first data output screen shows general information and guides the user towards more detailed data analysis. The data recording system enabled the registration of 14.675 surgical operations performed from 2009 to 2011. Results Raw utilization increased from 44% in 2009 to 52% in 2011. The number of high complexity surgical procedures (≥120 minutes) has increased in certain units while decreased in others. The number of unscheduled procedures performed has been reduced (from 25% in 2009 to 14% in 2011) while maintaining the same percentage of surgical procedures. The number of overtime events decreased in 2010 (23%) and in 2011 (21%) compared to 2009 (28%) and the delays expressed in minutes are almost the same (mean 78 min). The direct link found between the complexity of surgical procedures, the number of unscheduled procedures and overtime show a positive impact of the project on OR management. Despite a consistency in the complexity of procedures (19% in 2009 and 21% in 2011), surgical groups have been successful in reducing the number of unscheduled procedures (from 25% in 2009 to 14% in 2011) and overtime (from 28% in 2009 to 21% in 2011). Conclusions The developed project gives healthcare managers, anesthesiologists and surgeons useful information to increase surgical theaters efficiency and patient safety. In difficult economic times is possible to develop something that is of some value to the patient and healthcare system too. PMID:23496977

Tranexamic acid in epistaxis: a systematic review.

PubMed

Kamhieh, Y; Fox, H

2016-12-01

The role of tranexamic acid in the management of epistaxis remains unclear. There is uncertainty about its safety and about the contraindications for its use. We performed a systematic review of the use of systemic and topical tranexamic acid in epistaxis and a comparative review of its use in other specialties. This review assesses and summarises the existing evidence for the efficacy and safety of tranexamic acid in the management of epistaxis. Systematic review. MEDLINE and EMBASE were searched for 'epistaxis' and equivalent MESH terms, combined with the Boolean operator 'OR' and 'tranexamic acid'. The Cochrane library and society guidelines were reviewed for evidence regarding the use of tranexamic acid in other specialties. All five relevant RCTs were included in the review and were evaluated according to the recommendations of the Cochrane Handbook for Systematic Reviews. Three RCTS pertained to spontaneous epistaxis; of these, one trial found no benefit of oral tranexamic acid in acute epistaxis, one trial found no significant benefit of topical tranexamic acid, but the largest of the trials showed significant benefit of topical tranexamic acid in acute epistaxis management. Two RCTs examined oral tranexamic acid for prophylaxis of recurrent epistaxes in patients with hereditary haemorrhagic telangiectasia; both showed significant reduction in severity and frequency. Tranexamic acid, as a WHO 'essential medicine', is a powerful, readily available tool, the use of which in epistaxis has been limited by uncertainty over its efficacy and its safety profile. This systematic review summarises the existing evidence and extrapolates from the wealth of data for other specialties to address the clinical question - does TXA have a role in epistaxis management? © 2016 John Wiley & Sons Ltd.

Omacetaxine Mepesuccinate for Chronic Myeloid Leukemia.

PubMed

Rosshandler, Yasmin; Shen, Ann Q; Cortes, Jorge; Khoury, Hanna Jean

2016-05-01

Omacetaxine mepesuccinate is approved by the Food and Drug Administration in the United States for the treatment of chronic myeloid leukemia in chronic or accelerated phase resistant to two or more tyrosine kinase inhibitors. This review summarizes the mode of action, pharmacokinetics, efficacy and safety of omacetaxine mepesuccinate. Omacetaxine mepesuccinate has activity in chronic myeloid leukemia, especially in the chronic phase, regardless of the presence of ABL1 kinase domain mutations. Omacetaxine mepesuccinate has distinct but manageable adverse events profile. Omacetaxine mepesuccinate is a treatment option for a subset of patients with refractory chronic myeloid leukemia.

21 CFR 601.35 - Evaluation of safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... established, low-risk profile). Upon reviewing the relevant product characteristics and safety information..., carrier, or ligand; (3) The risks of an incorrect diagnostic determination; (4) The adverse reaction profile of the drug; (5) Results of human experience with the radiopharmaceutical for other uses; and (6...

Efficacy and safety of metformin in the management of type 2 diabetes mellitus in older adults: a systematic review for the development of recommendations to reduce potentially inappropriate prescribing.

PubMed

Schlender, Lisa; Martinez, Yolanda V; Adeniji, Charles; Reeves, David; Faller, Barbara; Sommerauer, Christina; Al Qur'an, Thekraiat; Woodham, Adrine; Kunnamo, Ilkka; Sönnichsen, Andreas; Renom-Guiteras, Anna

2017-10-16

Metformin is usually prescribed as first line therapy for type 2 diabetes mellitus (DM2). However, the benefits and risks of metformin may be different for older people. This systematic review examined the available evidence on the safety and efficacy of metformin in the management of DM2 in older adults. The findings were used to develop recommendations for the electronic decision support tool of the European project PRIMA-eDS. The systematic review followed a staged approach, initially searching for systematic reviews and meta-analyses first, and then individual studies when prior searches were inconclusive. The target population was older people (≥65 years old) with DM2. Studies were included if they reported safety or efficacy outcomes with metformin (alone or in combination) for the management of DM2 compared to placebo, usual or no treatment, or other antidiabetics. Using the evidence identified, recommendations were developed using GRADE methodology. Fifteen studies were included (4 intervention and 11 observational studies). In ten studies at least 80% of participants were 65 years or older and 5 studies reported subgroup analyses by age. Comorbidities were reported by 9 studies, cognitive status was reported by 4 studies and functional status by 1 study. In general, metformin showed similar or better safety and efficacy than other specific or non-specific active treatments. However, these findings were mainly based on retrospective observational studies. Four recommendations were developed suggesting to discontinue the use of metformin for the management of DM2 in older adults with risk factors such as age > 80, gastrointestinal complaints during the last year and/or GFR ≤60 ml/min. On the evidence available, the safety and efficacy profiles of metformin appear to be better, and certainly no worse, than other treatments for the management of DM2 in older adults. However, the quality and quantity of the evidence is low, with scarce data on adverse events such as gastrointestinal complaints or renal failure. Further studies are needed to more reliably assess the benefits and risks of metformin in very old (>80), cognitively and functionally impaired older people.

Study on development and application of platform with students' safety based on SOA

NASA Astrophysics Data System (ADS)

Jiang, Derong

2011-10-01

Students' safety management is a very important work, which is responsible for the entire school student security problems, student safety primarily prevent, only advance predict various of the imminent problems, to better protect their safety. The system mainly used on the development request the student safety management, safety evaluation, safety education, and etc, which are for daily management work completed for students in the security digital management. Development of the system can reduce the safety management for department working pressure, meanwhile, can reduce the labor force to use, accelerate query speed, strengthens the management, as well as the national various departments about the information step, making each management standardized. Therefore, developing a set of suitability and the populace, compatibly good system is very necessary.

Drugs for youth via Internet and the example of mephedrone.

PubMed

Vardakou, I; Pistos, C; Spiliopoulou, Ch

2011-03-25

Recently a new class of "designer drugs" has emerged on the drugs abuse market, known as "legal highs". Such drugs are legal to use and possess, and legal to supply. Mephedrone, a central nervous system stimulant, is the most widely experienced "legal high". This review presents any available information about psychoactive properties, safety profile, clinical data, and legislation of the new "legal high" and emphasizes the role of Internet with mephedrone's expansion. Available data were collected by various literature search engines and World Wide Web. All valuable information about psychoactive properties, safety profile and clinical data for mephedrone and its use as "legal high" were managed to spot and summarise. Internet plays a significant role for the distribution of "legal highs", becoming one of the major "drug market". Adolescents and young adults who are curious about drugs may search on the Internet and thereby become exposed to thousands of sites that expound upon the positive effects of drugs and downplay or deny any negative effects. Use of mephedrone is mainly a youth phenomenon. The hazardous side-effects are strong desire to re-dose, uncomfortable changes in body temperature and heart rate, hallucinations and psychosis. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

BIlateral juxtapapillary retinal capillary haemangioma: Usefulness of aflibercept in the management of its complications.

PubMed

Campos Polo, R; Rubio Sánchez, C; García Guisado, D M; Díaz Luque, M J

2017-10-01

A 45 year-old man with a history of adrenal phaeochromocytoma presented with a subretinal juxtapapillary haemorrhage on his left eye and a small asymptomatic vascular tumour in the contralateral eye. With the mentioned findings, the patient was diagnosed with bilateral retinal capillary haemangioma in the context of a von Hippel Lindau disease. Intravitreal aflibercept was prescribed, with a good outcome of the disease. Many treatments have been proposed for the management of juxtapapillary retinal capillary haemangioma with variable results. Intravitreal aflibercept can be a useful treatment with a good safety profile. Copyright © 2017 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab.

PubMed

Vegh, Zsuzsanna; Kurti, Zsuzsanna; Lakatos, Peter L

2017-01-01

Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts. © 2017 S. Karger AG, Basel.

Exploitation of molecular profiling techniques for GM food safety assessment.

PubMed

Kuiper, Harry A; Kok, Esther J; Engel, Karl-Heinz

2003-04-01

Several strategies have been developed to identify unintended alterations in the composition of genetically modified (GM) food crops that may occur as a result of the genetic modification process. These include comparative chemical analysis of single compounds in GM food crops and their conventional non-GM counterparts, and profiling methods such as DNA/RNA microarray technologies, proteomics and metabolite profiling. The potential of profiling methods is obvious, but further exploration of specificity, sensitivity and validation is needed. Moreover, the successful application of profiling techniques to the safety evaluation of GM foods will require linked databases to be built that contain information on variations in profiles associated with differences in developmental stages and environmental conditions.

Safety management by walking around (SMBWA): a safety intervention program based on both peer and manager participation.

PubMed

Luria, Gil; Morag, Ido

2012-03-01

"Management by walking around" (MBWA) is a practice that has aroused much interest in management science and practice. The purpose of this study is to demonstrate adaptation of this practice to safety management. We describe a three-year long case study that collected empirical data in which a modified MBWA was practiced in order to improve safety in a semiconductor fabrication facility. The main modification involved integrating an information system with the MBWA in order to create a practice that would generate safety leadership development and an organizational safety learning mechanism, while promoting employee safety participation. The results of the case study demonstrate that the SMBWA practice facilitated thousands of tours in which safety leadership behaviors were practiced by managers and by employees (employees performed five times as many tours as managers). The information system collected information about safety behaviors and safety conditions that could not otherwise be obtained. Thus, this study presents a new organizational safety practice SMBWA, and demonstrates the ways in which SMBWA may improve safety in organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Study of Internal Dump Stability of Dudhichua Open Cast Project, Northern Coalfields Limited, India

NASA Astrophysics Data System (ADS)

Sengupta, S.; Roy, I.

2015-04-01

Dudhichua Open Cast Project is one of the prestigious projects of Northern Coalfields Limited, India; with total mineable coal reserves of approximately 400 million tonnes and corresponding 1,700 million m3 volume of waste rock i.e. overburden material. Accommodating this waste dump masses in the limited space of the de-coaled portion of the quarry is considered as one of the major challenges to the mine operators. It has been reported that this mine is facing frequent slope failures of waste rock dumps which is of great concern to the mine management in view of unsafe working condition. To tackle the above problem, a detailed investigation was carried out to propose a stable dump profile which will cater to the land economics and safety aspects of the mine. A detailed investigation along with recommendation of optimum design for dragline dump profile along with shovel-dumper-dump profile is presented in this paper.

Spent Nuclear Fuel (SNF) project Integrated Safety Management System phase I and II Verification Review Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

CARTER, R.P.

1999-11-19

The U.S. Department of Energy (DOE) commits to accomplishing its mission safely. To ensure this objective is met, DOE issued DOE P 450.4, Safety Management System Policy, and incorporated safety management into the DOE Acquisition Regulations ([DEAR] 48 CFR 970.5204-2 and 90.5204-78). Integrated Safety Management (ISM) requires contractors to integrate safety into management and work practices at all levels so that missions are achieved while protecting the public, the worker, and the environment. The contractor is required to describe the Integrated Safety Management System (ISMS) to be used to implement the safety performance objective.

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

Novel Use of Pharmacogenetic Testing in the Identification of CYP2C9 Polymorphisms Related to NSAID-Induced Gastropathy.

PubMed

Gupta, Anita; Zheng, Lu; Ramanujam, Vendhan; Gallagher, John

2015-05-01

To illustrate the potential value of pharmacogenetic testing to identify patients at risk for nonsteroidal anti-inflammatory drug-induced gastropathy. Case report. We report a case encountered in an outpatient setting for pain management. We present a case of a patient treated with celecoxib who developed severe nonsteroidal anti-inflammatory drug-induced gastropathy. Suspecting a relation between this adverse event and altered drug metabolism, pharmacogenetic testing was performed to assess the role of the cytochrome P450 (CP450) enzyme profile. Pharmacogenetic testing revealed a relation between this adverse event and an allelic variant of cytochrome P450, CYP2C9, subsequently leading to discontinuation of the drug along with counseling to caution the patient to avoid the use of celecoxib and other drugs metabolized by the same enzyme. Although pharmacogenetic testing is not routinely used in clinical decision making, pain physicians must be aware of the potential benefits of this testing for managing patients with pain, and to improve drug efficacy and safety profile. Wiley Periodicals, Inc.

Differences in Hospital Managers', Unit Managers', and Health Care Workers' Perceptions of the Safety Climate for Respiratory Protection.

PubMed

Peterson, Kristina; Rogers, Bonnie M E; Brosseau, Lisa M; Payne, Julianne; Cooney, Jennifer; Joe, Lauren; Novak, Debra

2016-07-01

This article compares hospital managers' (HM), unit managers' (UM), and health care workers' (HCW) perceptions of respiratory protection safety climate in acute care hospitals. The article is based on survey responses from 215 HMs, 245 UMs, and 1,105 HCWs employed by 98 acute care hospitals in six states. Ten survey questions assessed five of the key dimensions of safety climate commonly identified in the literature: managerial commitment to safety, management feedback on safety procedures, coworkers' safety norms, worker involvement, and worker safety training. Clinically and statistically significant differences were found across the three respondent types. HCWs had less positive perceptions of management commitment, worker involvement, and safety training aspects of safety climate than HMs and UMs. UMs had more positive perceptions of management's supervision of HCWs' respiratory protection practices. Implications for practice improvements indicate the need for frontline HCWs' inclusion in efforts to reduce safety climate barriers and better support effective respiratory protection programs and daily health protection practices. © 2016 The Author(s).

75 FR 68224 - Safety Management Systems for Part 121 Certificate Holders

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... the general framework for an organization-wide safety management approach to air carrier operations... System? An SMS is an organization-wide approach to managing safety risk and assuring the effectiveness of... under 14 CFR part 121 to develop and implement a safety management system (SMS) to improve the safety of...

Selective estrogen receptor modulators in clinical practice: a safety overview.

PubMed

Ellis, Amanda J; Hendrick, Vicky M; Williams, Robert; Komm, Barry S

2015-06-01

Selective estrogen receptor (ER) modulators (SERMs) are a class of nonsteroidal compounds that interact with ERs, each with a distinct tissue-specific profile. Depending upon the degree of ER agonism/antagonism at the target tissue, SERMs show efficacy for various indications including osteoporosis, dyspareunia, and breast cancer, and are associated with safety risks. This review describes the safety profile of SERMs (tamoxifen, raloxifene, toremifene, bazedoxifene, lasofoxifene, and ospemifene) and fulvestrant (a pure ER antagonist) from Phase III trials, long-term extension studies, and active comparator studies. Tamoxifen, a first-generation SERM, is indicated for breast cancer prevention and treatment but is associated with serious safety concerns including endometrial cancer, venous thromboembolic events (VTE), and stroke. Toremifene, raloxifene, bazedoxifene, lasofoxifene, and ospemifene present generally improved, though distinctly different, safety profiles compared with tamoxifen, especially with endometrial cancer and stroke. However, the risk of VTE remains a concern for most SERMs. Each SERM presents a unique risk/benefit profile based on varying indications and tissue-specific ER agonist and antagonist effects, making careful patient selection and ongoing patient monitoring crucial aspects of treatment. Future research may focus on identifying new SERMs for endocrine-resistant and endocrine-responsive cancers and post-menopausal symptoms.

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2014 CFR

2014-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

Berkeley Lab - Materials Sciences Division

Science.gov Websites

? Click Here! Resources for MSD Safety MSD Safety MSD's Integrated Safety Management Plan [PDF] Safety culture and policies at MSD MSD0010: Integrated Safety Management: Principles and Case Studies Calendar for MSD classes on Integrated Safety Management MSD0015 Handout - Waste Briefing Document [PDF] Waste

Effects of organizational safety on employees' proactivity safety behaviors and occupational health and safety management systems in Chinese high-risk small-scale enterprises.

PubMed

Mei, Qiang; Wang, Qiwei; Liu, Suxia; Zhou, Qiaomei; Zhang, Jingjing

2018-06-07

Based on the characteristics of small-scale enterprises, the improvement of occupational health and safety management systems (OHS MS) needs an effective intervention. This study proposed a structural equation model and examined the relationships of perceived organization support for safety (POSS), person-organization safety fit (POSF) and proactivity safety behaviors with safety management, safety procedures and safety hazards identification. Data were collected from 503 employees of 105 Chinese high-risk small-scale enterprises over 6 months. The results showed that both POSS and POSF were positively related to improvement in safety management, safety procedures and safety hazards identification through proactivity safety behaviors. Our findings provide a new perspective on organizational safety for improving OHS MS for small-scale enterprises and extend the application of proactivity safety behaviors.

Identifying behaviour patterns of construction safety using system archetypes.

PubMed

Guo, Brian H W; Yiu, Tak Wing; González, Vicente A

2015-07-01

Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Art World's Concept of Negative Space Applied to System Safety Management

NASA Technical Reports Server (NTRS)

Goodin, James Ronald (Ronnie)

2005-01-01

Tools from several different disciplines can improve system safety management. This paper relates the Art World with our system safety world, showing useful art schools of thought applied to system safety management, developing an art theory-system safety bridge. This bridge is then used to demonstrate relations with risk management, the legal system, personnel management and basic management (establishing priorities). One goal of this presentation/paper is simply to be a fun diversion from the many technical topics presented during the conference.

Semiquantitative analysis of gaps in microbiological performance of fish processing sector implementing current food safety management systems: a case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-08-01

Fish processing plants still face microbial food safety-related product rejections and the associated economic losses, although they implement legislation, with well-established quality assurance guidelines and standards. We assessed the microbial performance of core control and assurance activities of fish exporting processors to offer suggestions for improvement using a case study. A microbiological assessment scheme was used to systematically analyze microbial counts in six selected critical sampling locations (CSLs). Nine small-, medium- and large-sized companies implementing current food safety management systems (FSMS) were studied. Samples were collected three times on each occasion (n = 324). Microbial indicators representing food safety, plant and personnel hygiene, and overall microbiological performance were analyzed. Microbiological distribution and safety profile levels for the CSLs were calculated. Performance of core control and assurance activities of the FSMS was also diagnosed using an FSMS diagnostic instrument. Final fish products from 67% of the companies were within the legally accepted microbiological limits. Salmonella was absent in all CSLs. Hands or gloves of workers from the majority of companies were highly contaminated with Staphylococcus aureus at levels above the recommended limits. Large-sized companies performed better in Enterobacteriaceae, Escherichia coli, and S. aureus than medium- and small-sized ones in a majority of the CSLs, including receipt of raw fish material, heading and gutting, and the condition of the fish processing tables and facilities before cleaning and sanitation. Fish products of 33% (3 of 9) of the companies and handling surfaces of 22% (2 of 9) of the companies showed high variability in Enterobacteriaceae counts. High variability in total viable counts and Enterobacteriaceae was noted on fish products and handling surfaces. Specific recommendations were made in core control and assurance activities associated with sampling locations showing poor performance.

The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation.

PubMed

Chawla, Anita; Carls, Ginger; Deng, Edmund; Tuttle, Edward

2015-07-01

Following withdrawals, failures, and significant litigation settlements, drug product launches in the anti-obesity category slowed despite a large and growing unmet need. Litigation concerns, a more risk-averse regulatory policy, and the difficulty of developing a product with a compelling risk-benefit profile in this category may have limited innovators' expected return on investment and restricted investment in this therapeutic area. The objective of the study was to estimate perceived manufacturer risk associated with product safety litigation and increased development costs vs. revenue expectations on anticipated return on investment and to determine which scenarios might change a manufacturer's investment decision. Expected net present value of a weight-management drug entering pre-clinical trials was calculated for a range of scenarios representing evolving expectations of development costs, revenue, and litigation risk over the past 25 years. These three factors were based on published estimates, historical data, and analogs from other therapeutic areas. The main driver in expected net present value calculations is expected revenue, particularly if one assumes that litigation risk and demand are positively correlated. Changes in development costs associated with increased regulatory concern with potential safety issues for the past 25 years likely did not impact investment decisions. Regulatory policy and litigation risk both played a role in anti-obesity drug development; however, product revenue-reflecting efficacy at acceptable levels of safety-was by far the most important factor. To date, relatively modest sales associated with recent product introductions suggest that developing a product that is sufficiently efficacious with an acceptable level of safety continues to be the primary challenge in this market.

The Evaluation Of Therapeutic Efficacy and Safety Profile of Simvastatin Prodrug Micelles in a Closed Fracture Mouse Model

PubMed Central

Zhang, Yijia; Jia, Zhenshan; Yuan, Hongjiang; Dusad, Anand; Ren, Ke; Wei, Xin; Fehringer, Edward V.; Purdue, P. Edward; Daluiski, Aaron; Goldring, Steven R.; Wang, Dong

2016-01-01

Purpose To evaluate the therapeutic efficiency of a micellar prodrug formulation of simvastatin (SIM/SIM-mPEG) and explore its safety in a closed femoral fracture mouse model. Methods The amphiphilic macromolecular prodrug of simvastatin (SIM-mPEG) was synthesized and formulated together with free simvastatin into micelles. It was also labeled with a near infrared dye for in vivo imaging purpose. A closed femoral fracture mouse model was established using a three-point bending device. The mice with established closed femoral fracture were treated with SIM/SIM-mPEG micelle, using free simvastatin and saline as controls. The therapeutic efficacy of the micelles was evaluated using a high-resolution micro-CT. Serum biochemistry and histology analyses were performed to explore the potential toxicity of the micelle formulation. Results Near Infrared Fluorescence (NIRF) imaging confirmed the passive targeting of SIM/SIM-mPEG micelles to the bone lesion of the mice with closed femoral fracture. The micelle was found to promote fracture healing with an excellent safety profile. In addition, the accelerated healing of the femoral fracture also helped to prevent disuse-associated same-side tibia bone loss accompanying the femur fracture. Conclusion SIM/SIM-mPEG micelle was found to be an effective and safe treatment for closed femoral fracture repair in mice. The evidence obtained in this study suggests that it may have the potential to be translated into a novel therapy for clinical management of skeletal fractures and non-union. PMID:27164897

Use of Oxycodone in Pain Management

PubMed Central

Moradi, Mohammad; Esmaeili, Sara; Shoar, Saeed; Safari, Saeid

2012-01-01

Oxycodone is widely used to alleviate moderate-to severe acute pain, It is an effective analgesic for many types of pain, and is especially useful for paroxysmal spontaneous pain, steady pain, allodynia associated with postherpetic neuralgia, and it is also increasingly used in the management of cancer-related and chronic pain, oxycodone has been found to improve the quality of life of patients with many types of pain. In 2011, following chemical and physical manipulation, an extended-release form of oxycodone was developed in order to maintain its rate-controlling mechanism. This new formulation significantly improved analgesia among patients with moderate-to-severe chronic osteoarthritis pain with an adverse event profile similar to that of other opioids. The long-term safety and efficacy of extended-release form of oxycodone in relieving moderate-to-severe chronic pain has been demonstrated. In this study we discussed about different aspects of this drug in managing of various types of pain. PMID:24904812

Understanding and Managing Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

PubMed Central

Weinstein, Alyona; Gordon, Ruth-Ann; Kasler, Mary Kate; Burke, Matthew; Ranjan, Smita; Hodgetts, Jackie; Reed, Vanessa; Shames, Yelena; Prempeh-Keteku, Nana; Lingard, Karla

2017-01-01

The immune checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab represent a substantial improvement in treating advanced melanoma but are associated with adverse events (AEs) likely related to general immunologic enhancement. To ensure that patients receive optimal benefit from these agents, prompt assessment and treatment of AEs are essential. We review the efficacy and safety profiles of these immune checkpoint inhibitors and describe guidelines for managing immune-related AEs. We also present case studies describing the management of toxicities in patients receiving immune checkpoint inhibitor therapy. These cases illustrate the importance of collecting a detailed medical history when administering immunotherapy, as this information is necessary to establish baseline, inform monitoring, and determine the etiology of symptoms. Advanced practice nurses and physician assistants are uniquely positioned to educate patients on the early recognition of AEs and have an important role in establishing appropriate monitoring and open dialogue among services. PMID:29900017

Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment.

PubMed

Sugiyama, Kazutoshi; Saisho, Yoshifumi

2018-05-24

Dyslipidemia is a major risk factor for cardiovascular disease (CVD), which is the leading cause of morbidity and mortality in type 2 diabetes (T2DM). Statins have played a crucial role in its management, but residual risk remains since many patients cannot achieve their desired low-density lipoprotein cholesterol (LDL-C) level and up to 20% of patients are statin-intolerant, experiencing adverse events perceived to be caused by statins, most commonly muscle symptoms. Recently, great advances have been made in nonstatin treatment with ezetimibe, a cholesterol absorption inhibitor, and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs), all showing a proven benefit with an excellent safety profile in cardiovascular outcome trials. This review summarizes the key aspects and the evolving role of these agents in the management of dyslipidemia in patients with T2DM, along with a brief introduction of novel drugs currently in development.

An update on the safety of current therapies for Alzheimer's disease: focus on rivastigmine.

PubMed

Khoury, Rita; Rajamanickam, Jayashree; Grossberg, George T

2018-03-01

Alzheimer's disease (AD) is the most common cause of major neurocognitive disorders worldwide. Despite all research efforts, therapeutic options for AD are still limited to two drug classes: cholinesterase inhibitors (ChEIs) and the NMDA-receptor antagonist memantine. Donepezil, rivastigmine and galantamine are the three ChEIs FDA-approved as first-line treatment for AD. Although they share the same mode of action, they differ in terms of their pharmacologic characteristics and route of administration, which can impact their safety and tolerability profile. Rivastigmine, available in both oral and transdermal patch formulations, is a slowly reversible dual inhibitor of acetyl and butyryl cholinesterase, selective for the G1 isoform of acetylcholinesterase, without hepatic metabolism by the CYP-450 system. Despite its unique features, it has been associated with a higher incidence of adverse events in comparison to other ChEIs. The oral form, approved for the treatment of mild to moderate AD, is associated with a higher incidence of gastrointestinal side effects. The transdermal patch formulation approved for use across all stages of AD has been shown to have a better tolerability profile in comparison to both the oral form and even other ChEIs. One important tolerability concern is adverse dermatologic reactions, which are mostly benign, and can be either preventable or manageable. One important safety concern is the risk of treatment overdose by administering multiple patches at the same time, potentially leading to fatal outcomes. This can be prevented by educating patients and caregivers about the proper use of the patch. The goal for the future would be to optimize the patch formulation to increase both efficacy and safety.

Efficacy and safety of valsartan/amlodipine single-pill combination in patients with essential hypertension (PEAK LOW).

PubMed

Kızılırmak, Pınar; Ar, Idilhan; Ilerigelen, Barış

2014-06-01

This study evaluated the efficacy as well as the safety and tolerability profile of low-dose valsartan/amlodipine (Val/Amlo) single-pill combination (SPC) (160/5 mg) in patients with essential hypertension in Turkey. Adult patients with essential hypertension [systolic blood pressure (SBP)>140 mmHg and/or diastolic blood pressure (DBP)>90 mmHg], who were on low dose Val/Amlo (160/5 mg) SPC before enrollment and gave informed consent, were accepted for this multi-centric observational study performed at 30 sites. The absolute changes in SBP and DBP from baseline were the primary efficacy outcomes. Safety assessments consisted of recording all adverse events. Of 381 patients enrolled, 327 completed the study; 39% were females. The mean age was 57.3±11.8 years. Median duration of hypertension was 38 months. Both SBP and DBP values showed reductions from 162.6±16.6 mmHg and 94.0±13.2 mmHg to 137.6±14.2 mmHg and 81.9±9.0 mmHg at 4th week and to 131.6±11.5 mmHg and 79.7±7.6 mmHg at 12th week, respectively. The control and response rates at the end of the study were 82.0% and 92.6%, respectively. Twelve patients (3.2%) experienced a total of 12 adverse events; there were no serious adverse events. The most common adverse event was edema (1.3%). Patient compliance was approximately 99%. Low-dose (160/5 mg) Val/Amlo SPC is efficacous and has a good tolerability and safety profile for the management of essential hypertension in Turkey.

Current treatment of dyslipidaemia: PCSK9 inhibitors and statin intolerance.

PubMed

Koskinas, Konstantinos; Wilhelm, Matthias; Windecker, Stephan

2016-01-01

Statins are the cornerstone of the management of dyslipidaemias and prevention of cardiovascular disease. Although statins are, overall, safe and well tolerated, adverse events can occur and constitute an important barrier to maintaining long-term adherence to statin treatment. In patients who cannot tolerate statins, alternative treatments include switch to another statin, intermittent-dosage regimens and non-statin lipid-lowering medications. Nonetheless, a high proportion of statin-intolerant patients are unable to achieve recommended low-density lipoprotein (LDL) cholesterol goals, thereby resulting in substantial residual cardiovascular risk. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a protease implicated in LDL receptor degradation and plays a central role in cholesterol metabolism. In recent studies, PCSK9 inhibition by means of monoclonal antibodies achieved LDL cholesterol reductions of 50% to 70% across various patient populations and background lipid-lowering therapies, while maintaining a favourable safety profile. The efficacy and safety of the monoclonal antibodies alirocumab and evolocumab were confirmed in statin-intolerant patients, indicating that PCSK9 inhibitors represent an attractive treatment option in this challenging clinical setting. PCSK9 inhibitors recently received regulatory approval for clinical use and may be considered in properly selected patients according to current consensus documents, including patients with statin intolerance. In this review we summarise current evidence regarding diagnostic evaluation of statin-related adverse events, particularly statin-associated muscle symptoms, and we discuss current recommendations on the management of statin-intolerant patients. In view of emerging evidence of the efficacy and safety of PCSK9 inhibitors, we further discuss the role of monoclonal PCSK9 antibodies in the management of statin-intolerant hypercholesterolaemic patients.

Achievements and Perspectives of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management

DOE Office of Scientific and Technical Information (OSTI.GOV)

Louvat, D.; Lacoste, A.C.

The Joint Convention on the Safety of Spent Fuel management and on the Safety of Radioactive Waste Management is the first legal instrument to directly address the safety of spent fuel and radioactive waste management on a global scale. The Joint Convention entered into force in 2001. This paper describes its process and its main achievements to date. The perspectives to establish of a Global Waste Safety Regime based on the Joint Convention are also discussed. (authors)

[Management of the cardiovascular disease risk during nilotinib treatment in chronic myeloid leukemia: 2015 recommendations from the France Intergroupe des Leucémies Myéloïdes Chroniques].

PubMed

Rea, Delphine; Ame, Shanti; Charbonnier, Aude; Coiteux, Valérie; Cony-Makhoul, Pascale; Escoffre-Barbe, Martine; Etienne, Gabriel; Gardembas, Martine; Guerci-Bresler, Agnès; Legros, Laurence; Nicolini, Franck; Tulliez, Michel; Hermet, Eric; Huguet, Françoise; Johnson-Ansah, Hyacinthe; Lapusan, Simona; Quittet, Philippe; Rousselot, Philippe; Mahon, François-Xavier; Messas, Emmanuel

2016-02-01

Tyrosine kinase inhibitors targeting the BCR-ABL oncoprotein represent an outstanding progress in chronic myeloid leukemia and long-term progression-free survival has become a reality for a majority of patients. However, tyrosine kinase inhibitors may at best chronicize rather than cure the disease thus current recommendation is to pursue treatment indefinitely. As a consequence, high quality treatment and care must integrate optimal disease control and treatment tolerability. Tyrosine kinase inhibitors have an overall favorable safety profile in clinical practice since most adverse events are mild to moderate in intensity. However, recent evidence has emerged that new generation tyrosine kinase inhibitors may sometimes damage vital organs and if not adequately managed, morbidity and mortality may increase. The 2nd generation tyrosine kinase inhibitor nilotinib is licensed for the treatment of chronic myeloid leukemia with resistance or intolerance to imatinib and newly diagnosed chronic phase-chronic myeloid leukemia. Nilotinib represents an important therapeutic option but it is associated with an increased risk of cardiovascular events. The purpose of this article by the France Intergroupe des Leucémies Myéloïdes Chroniques is to provide an overview of nilotinib efficacy and cardiovascular safety profile and to propose practical recommendations with the goal to minimize the risk and severity of cardiovascular events in nilotinib-treated patients. Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Apatinib: A Review in Advanced Gastric Cancer and Other Advanced Cancers.

PubMed

Scott, Lesley J

2018-05-01

Apatinib [Aitan ® (brand name in China)], also known as rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor and is the second anti-angiogenic drug to be approved in China for the treatment of advanced or metastatic gastric cancer. This article summarizes the pharmacological properties of apatinib and reviews its clinical use in chemotherapy-experienced patients with advanced gastric adenocarcinoma, including gastroesophageal adenocarcinoma (GEA), or with other advanced cancers such as non-small cell lung cancer (NSCLC), breast cancer, gynaecological cancers, hepatocellular carcinoma (HCC), thyroid cancer and sarcomas. As third- or subsequent-line therapy, oral apatinib significantly prolonged median progression-free survival (PFS) and overall survival (OS) compared with placebo and had a manageable safety profile in Chinese patients with advanced or metastatic gastric cancer or GEA participating in randomized, double-blind, multicentre, phase 2 and 3 trials. More limited evidence also supports it use as subsequent-line treatment in Chinese patients with other advanced or metastatic solid tumours, including NSCLC, breast cancer and HCC. Further clinical experience and long-term pharmacovigilance data are required to more definitively establish the efficacy and safety profile of apatinib, including its use in combination with other chemotherapy agents and its role in the management of other types of advanced or metastatic solid tumours. In the meantime, given its convenient administration regimen and the limited treatment options and poor prognosis for patients with advanced or metastatic solid tumours, apatinib is an important, emerging treatment option for adult patients with advanced gastric adenocarcinoma or GEA who have progressed or relapsed after chemotherapy.

A study for safety and health management problem of semiconductor industry in Taiwan.

PubMed

Chao, Chin-Jung; Wang, Hui-Ming; Feng, Wen-Yang; Tseng, Feng-Yi

2008-12-01

The main purpose of this study is to discuss and explore the safety and health management in semiconductor industry. The researcher practically investigates and interviews the input, process and output of the safety and health management of semiconductor industry by using the questionnaires and the interview method which is developed according to the framework of the OHSAS 18001. The result shows that there are six important factors for the safety and health management in Taiwan semiconductor industry. 1. The company should make employee clearly understand the safety and health laws and standards. 2. The company should make the safety and health management policy known to the public. 3. The company should put emphasis on the pursuance of the safety and health management laws. 4. The company should prevent the accidents. 5. The safety and health message should be communicated sufficiently. 6. The company should consider safety and health norm completely.

Environment, Health, and Safety | NREL

Science.gov Websites

property, and the environment. View the Environmental Stewardship, Health, Safety, and Quality Management (OHSAS) 18001 certification demonstrates NREL's commitment to a health and safety management system that into all activities. NREL's staff and management are committed to managing health and safety risk

Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

PubMed Central

Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

2015-01-01

We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine. PMID:25909814

National Safety Council

MedlinePlus

... Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the Journey What ... Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the Journey What ...

Findings From the National Machine Guarding Program

PubMed Central

Parker, David L.; Yamin, Samuel; Xi, Min; Gordon, Robert; Most, Ivan; Stanley, Rod

2017-01-01

Objectives: This manuscript assesses safety climate data from the National Machine Guarding Program (NMGP)—a nationwide intervention to improve machine safety. Methods: Baseline safety climate surveys were completed by 2161 employees and 341 owners or managers at 115 businesses. A separate onsite audit of safety management practices and machine guarding equipment was conducted at each business. Results: Safety climate measures were not correlated with machine guarding or safety management practices. The presence of a safety committee was correlated with higher scores on the safety management audit when contrasted with those without one. Conclusions: The presence of a safety committee is easily assessed and provides a basis on which to make recommendations with regard to how it functions. Measures of safety climate fail to provide actionable information. Future research on small manufacturing firms should emphasize the presence of an employee-management safety committee. PMID:28930801

The role of the ward manager in promoting patient safety.

PubMed

Pinnock, David

In this article the role of the ward manager in promoting patient safety is explored. The background to the development of the patient safety agenda is briefly discussed and the relationship between quality and safety is illustrated. The pivotal importance of the role of the ward manager in delivering services to patients is underlined and literature on patient safety is examined to identify what a ward manager can do to make care safer. Possible actions of the ward manager to improve safety discussed in the literature are structured around the Leadership Framework. This framework identifies seven domains for the leadership of service delivery. Ward managers use their personal qualities, and network and work within teams, while managing performance and facilitating innovation, change and measurement for improvement. The challenge of promoting patient safety for ward managers is briefly explored and recommendations for further research are made.

Safety intelligence: an exploration of senior managers' characteristics.

PubMed

Fruhen, L S; Mearns, K J; Flin, R; Kirwan, B

2014-07-01

Senior managers can have a strong influence on organisational safety. But little is known about which of their personal attributes support their impact on safety. In this paper, we introduce the concept of 'safety intelligence' as related to senior managers' ability to develop and enact safety policies and explore possible characteristics related to it in two studies. Study 1 (N = 76) involved direct reports to chief executive officers (CEOs) of European air traffic management (ATM) organisations, who completed a short questionnaire asking about characteristics and behaviours that are ideal for a CEO's influence on safety. Study 2 involved senior ATM managers (N = 9) in various positions in interviews concerning their day-to-day work on safety. Both studies indicated six attributes of senior managers as relevant for their safety intelligence, particularly, social competence and safety knowledge, followed by motivation, problem-solving, personality and interpersonal leadership skills. These results have recently been applied in guidance for safety management practices in a White Paper published by EUROCONTROL. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.

National Machine Guarding Program: Part 2. Safety management in small metal fabrication enterprises.

PubMed

Parker, David L; Yamin, Samuel C; Brosseau, Lisa M; Xi, Min; Gordon, Robert; Most, Ivan G; Stanley, Rodney

2015-11-01

Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem. The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers. Insurance safety consultants collected baseline data in 221 business using a 33-question safety management audit. Audits were completed during an interview with the business owner or manager. Most measures of safety management improved with an increasing number of employees. This trend was particularly strong for lockout/tagout. However, size was only significant for businesses without a safety committee. Establishments with a safety committee scored higher (55% vs. 36%) on the safety management audit compared with those lacking a committee (P < 0.0001). Critical safety management programs were frequently absent. A safety committee appears to be a more important factor than business size in accounting for differences in outcome measures. © 2015 The Authors. American Journal of Industrial Medicine Published by Wiley Periodicals, Inc.

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Safety management system document and data maintenance (1) Procedures which establish and maintain control of all documents and data relevant to the safety management system. (2) Documents are available at... safety management system have? 96.250 Section 96.250 Navigation and Navigable Waters COAST GUARD...

33 CFR 96.240 - What functional requirements must a safety management system meet?

Code of Federal Regulations, 2010 CFR

2010-07-01

... a safety management system meet? 96.240 Section 96.240 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.240 What functional...

33 CFR 96.230 - What objectives must a safety management system meet?

Code of Federal Regulations, 2010 CFR

2010-07-01

... management system meet? 96.230 Section 96.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.230 What objectives must a safety...

76 FR 14592 - Safety Management System; Withdrawal

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

...-06A] RIN 2120-AJ15 Safety Management System; Withdrawal AGENCY: Federal Aviation Administration (FAA... (``product/ service providers'') to develop a Safety Management System (SMS). The FAA is withdrawing the... management with a set of robust decision-making tools to use to improve safety. The FAA received 89 comments...

77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

The determinants of employee participation in occupational health and safety management.

PubMed

Masso, Märt

2015-01-01

This article focuses on employee direct participation in occupational health and safety (OHS) management. The article explains what determines employee opportunities to participate in OHS management. The explanatory framework focuses on safety culture and safety management at workplaces. The framework is empirically tested using Estonian cross-sectional, multilevel data of organizations and their employees. The analysis indicates that differences in employee participation in OHS management in the Estonian case could be explained by differences in OHS management practices rather than differences in safety culture. This indicates that throughout the institutional change and shift to the European model of employment relations system, change in management practices has preceded changes in safety culture which according to theoretical argument is supposed to follow culture change.

The influence of environmental conditions on safety management in hospitals: a qualitative study.

PubMed

Alingh, Carien W; van Wijngaarden, Jeroen D H; Huijsman, Robbert; Paauwe, Jaap

2018-05-02

Hospitals are confronted with increasing safety demands from a diverse set of stakeholders, including governmental organisations, professional associations, health insurance companies, patient associations and the media. However, little is known about the effects of these institutional and competitive pressures on hospital safety management. Previous research has shown that organisations generally shape their safety management approach along the lines of control- or commitment-based management. Using a heuristic framework, based on the contextually-based human resource theory, we analysed how environmental pressures affect the safety management approach used by hospitals. A qualitative study was conducted into hospital care in the Netherlands. Five hospitals were selected for participation, based on organisational characteristics as well as variation in their reputation for patient safety. We interviewed hospital managers and staff with a central role in safety management. A total of 43 semi-structured interviews were conducted with 48 respondents. The heuristic framework was used as an initial model for analysing the data, though new codes emerged from the data as well. In order to ensure safe care delivery, institutional and competitive stakeholders often impose detailed safety requirements, strong forces for compliance and growing demands for accountability. As a consequence, hospitals experience a decrease in the room to manoeuvre. Hence, organisations increasingly choose a control-based management approach to make sure that safety demands are met. In contrast, in case of more abstract safety demands and an organisational culture which favours patient safety, hospitals generally experience more leeway. This often results in a stronger focus on commitment-based management. Institutional and competitive conditions as well as strategic choices that hospitals make have resulted in various combinations of control- and commitment-based safety management. A balanced approach is required. A strong focus on control-based management generates extrinsic motivation in employees but may, at the same time, undermine or even diminish intrinsic motivation to work on patient safety. Emphasising commitment-based management may, in contrast, strengthen intrinsic motivation but increases the risk of priorities being set elsewhere. Currently, external pressures frequently lead to the adoption of control-based management. A balanced approach requires a shift towards more trust-based safety demands.

Associations between safety climate and safety management practices in the construction industry.

PubMed

Marín, Luz S; Lipscomb, Hester; Cifuentes, Manuel; Punnett, Laura

2017-06-01

Safety climate, a group-level measure of workers' perceptions regarding management's safety priorities, has been suggested as a key predictor of safety outcomes. However, its relationship with actual injury rates is inconsistent. We posit that safety climate may instead be a parallel outcome of workplace safety practices, rather than a determinant of workers' safety behaviors or outcomes. Using a sample of 25 commercial construction companies in Colombia, selected by injury rate stratum (high, medium, low), we examined the relationship between workers' safety climate perceptions and safety management practices (SMPs) reported by safety officers. Workers' perceptions of safety climate were independent of their own company's implementation of SMPs, as measured here, and its injury rates. However, injury rates were negatively related to the implementation of SMPs. Safety management practices may be more important than workers' perceptions of safety climate as direct predictors of injury rates. © 2017 Wiley Periodicals, Inc.

Safety profile: fifteen years of clinical experience with ibuprofen.

PubMed

Royer, G L; Seckman, C E; Welshman, I R

1984-07-13

Since its introduction in the United States in 1974, ibuprofen (Motrin, Upjohn) has been shown to be safe and effective for the treatment of pain, dysmenorrhea, inflammation, and fever. A careful review of pre-registration and postmarketing data from both patients and normal subjects clearly indicates ibuprofen's remarkable safety profile compared with that of aspirin and other commonly prescribed nonsteroidal anti-inflammatory agents. Continued safety can be anticipated on the basis of the past 15 years of review experience.

The role of bromocriptine-QR in the management of type 2 diabetes expert panel recommendations.

PubMed

Garber, Alan J; Blonde, Lawrence; Bloomgarden, Zachary T; Handelsman, Yehuda; Dagogo-Jack, Samuel

2013-01-01

To review available data on the efficacy and safety of bromocriptine-QR (BQR) and to consider its role in the management of Type 2 diabetes mellitus (T2DM). Published literature reporting the efficacy and safety of BQR in the treatment of T2DM was reviewed, including peer-reviewed abstracts and poster presentations. BQR is an oral hypoglycemic agent with a novel mechanism of action that appears to involve enhancement of morning central nervous system (CNS) dopaminergic activity, resulting in improved insulin sensitivity and reduced hepatic glucose output. Adjunctive treatment with BQR in the dosing range of 1.6 to 4.8 mg/d may result in a mean (95% confidence interval [CI]) reduction in glycated hemoglobin (A1c) levels of 0.69% (0.97%, 0.41%). Treatment with BQR appears to be associated with minimal intrinsic risk of hypoglycemia, and does not appear to be associated with clinically significant adverse effects on weight, triglycerides, free fatty acids, or blood pressure. The favorable cardiovascular risk profile of BQR suggests that it may be useful in the treatment of patients with T2DM with a history of cardiovascular disease (CVD) or who have significant risk factors for CVD. However, knowledge of the efficacy and safety of BQR is limited by the relatively small clinical trials database. As a result, there is currently insufficient information on the safety and efficacy of adjunctive BQR in T2DM patients being treated with several common diabetes regimens (e.g., thiazolidinediones, insulin).

Phase I / II study of brentuximab vedotin in Japanese patients with relapsed or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma

PubMed Central

Ogura, Michinori; Tobinai, Kensei; Hatake, Kiyohiko; Ishizawa, Kenichi; Uike, Naokuni; Uchida, Toshiki; Suzuki, Tatsuya; Aoki, Tomohiro; Watanabe, Takashi; Maruyama, Dai; Yokoyama, Masahiro; Takubo, Takatoshi; Kagehara, Hideaki; Matsushima, Takafumi

2014-01-01

Brentuximab vedotin is an antibody–drug conjugate that selectively delivers the antimicrotubule agent monomethyl auristatin E into CD30-expressing cells. To assess its safety, pharmacokinetics, and efficacy in Japanese patients with refractory or relapsed CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma, we carried out a phase I/II study. Brentuximab vedotin was given i.v. on day 1 of each 21-day cycle up to 16 cycles. In the phase I part of a dose-escalation design, three patients per cohort were treated at doses of 1.2 and 1.8 mg/kg. In the phase II part, a dose of 1.8 mg/kg was given to 14 patients (nine with Hodgkin's lymphoma and five with systemic anaplastic large-cell lymphoma). The median number of treatment cycles was 16 (range, 4–16). In the phase I part, no dose-limiting toxicity event was observed. In the total population, common adverse events included lymphopenia (80%), neutropenia (65%), leukopenia (65%), and peripheral sensory neuropathy (60%). Grade 3/4 adverse events in more than two patients were lymphopenia (50%) and neutropenia (15%). The pharmacokinetic profile was similar to that observed in the previous studies in the USA. In the phase II part, six patients (67%) with Hodgkin's lymphoma achieved an objective response with 56% of complete response rate, and five patients (100%) with systemic anaplastic large-cell lymphoma achieved an objective response with 80% of complete response rate. These results show that brentuximab vedotin has an acceptable safety profile and promising antitumor activity in the Japanese population. This trial was registered in JAPIC Clinical Trials Information (JapicCTI-111650). This phase I/II study was to investigate the tolerability, safety and efficacy of brentuximab vedotin. This study indicates that 1.8 mg/kg brentuximab vedotin given every 3 weeks has a manageable safety profile and has high overall tumor response rate in Japanese patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large-cell lymphoma. PMID:24814862

Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2.

PubMed

Oza, Amit M; Tinker, Anna V; Oaknin, Ana; Shapira-Frommer, Ronnie; McNeish, Iain A; Swisher, Elizabeth M; Ray-Coquard, Isabelle; Bell-McGuinn, Katherine; Coleman, Robert L; O'Malley, David M; Leary, Alexandra; Chen, Lee-May; Provencher, Diane; Ma, Ling; Brenton, James D; Konecny, Gottfried E; Castro, Cesar M; Giordano, Heidi; Maloney, Lara; Goble, Sandra; Lin, Kevin K; Sun, James; Raponi, Mitch; Rolfe, Lindsey; Kristeleit, Rebecca S

2017-11-01

An integrated analysis was undertaken to characterize the antitumor activity and safety profile of the oral poly(ADP-ribose) polymerase inhibitor rucaparib in patients with relapsed high-grade ovarian carcinoma (HGOC). Eligible patients from Study 10 (NCT01482715) and ARIEL2 (NCT01891344) who received a starting dose of oral rucaparib 600mg twice daily (BID) with or without food were included in these analyses. The integrated efficacy population included patients with HGOC and a deleterious germline or somatic BRCA1 or BRCA2 (BRCA1/2) mutation who received at least two prior chemotherapies and were sensitive, resistant, or refractory to platinum-based chemotherapy. The primary endpoint was investigator-assessed confirmed objective response rate (ORR). Secondary endpoints included duration of response (DOR) and progression-free survival (PFS). The integrated safety population included patients with HGOC who received at least one dose of rucaparib 600mg BID, irrespective of BRCA1/2 mutation status and prior treatments. In the efficacy population (n=106), ORR was 53.8% (95% confidence interval [CI], 43.8-63.5); 8.5% and 45.3% of patients achieved complete and partial responses, respectively. Median DOR was 9.2months (95% CI, 6.6-11.6). In the safety population (n=377), the most frequent treatment-emergent adverse events (AEs) were nausea, asthenia/fatigue, vomiting, and anemia/hemoglobin decreased. The most common grade ≥3 treatment-emergent AE was anemia/hemoglobin decreased. Treatment-emergent AEs led to treatment interruption, dose reduction, and treatment discontinuation in 58.6%, 45.9%, and 9.8% of patients, respectively. No treatment-related deaths occurred. Rucaparib has antitumor activity in advanced BRCA1/2-mutated HGOC and a manageable safety profile. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Recent RF Experiments and Application of RF Waves to Real-Time Control of Safety Factor Profile in JT-60U

NASA Astrophysics Data System (ADS)

Suzuki, T.; Isayama, A.; Ide, S.; Fujita, T.; Oikawa, T.; Sakata, S.; Sueoka, M.; Hosoyama, H.; JT-60 Team

2005-09-01

Two topics of applications of RF waves to current profile control in JT-60U are presented; application of lower-hybrid (LH) waves to safety factor profile control and electron cyclotron (EC) waves to neo-classical tearing mode (NTM) control. A real-time control system of safety factor (q) profile was developed. This system, for the first time, enables 1) real time evaluation of q profile using local magnetic pitch angle measurement by motional Stark effect (MSE) diagnostic and 2) control of current drive (CD) location (ρCD) by controlling the parallel refractive index N∥ of LH waves through control of phase difference (Δφ) of LH waves between multi-junction launcher modules. The method for real-time q profile evaluation was newly developed, without time-consuming reconstruction of equilibrium, so that the method requires less computational time. Safety factor profile by the real-time calculation agrees well with that by equilibrium reconstruction with MSE. The control system controls ρCD through Δφ in such a way to decrease the largest residual between the real-time evaluated q profile q(r) and its reference profile qref(r). The real-time control system was applied to a positive shear plasma (q(0)˜1). The reference q profile was set to monotonic positive shear profile having qref(0)=1.3. The real-time q profile approached to the qref(r) during application of real-time control, and was sustained for 3s, which was limited by the duration of the injected LH power. Temporal evolution of current profile was consistent with relaxation of inductive electric field induced by theoretical LH driven current. An m/n=3/2 NTM that appeared at βN˜3 was completely stabilized by ECCD applied to a fully-developed NTM. Precise ECCD at NTM island was essential for the stabilization. ECCD that was applied to resonant rational surface (q=3/2) before an NTM onset suppressed appearance of NTM. In order to keep NTM intensity below a level, ECCD before the mode onset was more effective than that after mode saturation.

Discovery of safety biomarkers for atorvastatin in rat urine using mass spectrometry based metabolomics combined with global and targeted approach.

PubMed

Kumar, Bhowmik Salil; Lee, Young-Joo; Yi, Hong Jae; Chung, Bong Chul; Jung, Byung Hwa

2010-02-19

In order to develop a safety biomarker for atorvastatin, this drug was orally administrated to hyperlipidemic rats, and a metabolomic study was performed. Atorvastatin was given in doses of either 70 mg kg(-1) day(-1) or 250 mg kg(-1) day(-1) for a period of 7 days (n=4 for each group). To evaluate any abnormal effects of the drug, physiological and plasma biochemical parameters were measured and histopathological tests were carried out. Safety biomarkers were derived by comparing these parameters and using both global and targeted metabolic profiling. Global metabolic profiling was performed using liquid chromatography/time of flight/mass spectrometry (LC/TOF/MS) with multivariate data analysis. Several safety biomarker candidates that included various steroids and amino acids were discovered as a result of global metabolic profiling, and they were also confirmed by targeted metabolic profiling using gas chromatography/mass spectrometry (GC/MS) and capillary electrophoresis/mass spectrometry (CE/MS). Serum biochemical and histopathological tests were used to detect abnormal drug reactions in the liver after repeating oral administration of atorvastatin. The metabolic differences between control and the drug-treated groups were compared using PLS-DA score plots. These results were compared with the physiological and plasma biochemical parameters and the results of a histopathological test. Estrone, cortisone, proline, cystine, 3-ureidopropionic acid and histidine were proposed as potential safety biomarkers related with the liver toxicity of atorvastatin. These results indicate that the combined application of global and targeted metabolic profiling could be a useful tool for the discovery of drug safety biomarkers. Copyright 2009 Elsevier B.V. All rights reserved.

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

Future of chronic obstructive pulmonary disease management.

PubMed

D'Urzo, Anthony; Vogelmeier, Claus

2012-06-01

Bronchodilators play a pivotal role in the management of symptomatic chronic obstructive pulmonary disease. Inhaled short-acting bronchodilators are used for all stages of chronic obstructive pulmonary disease, primarily for the immediate relief of symptoms; inhaled long-acting bronchodilators are recommended for maintenance therapy in patients with moderate-to-very severe disease and those with daily symptoms. When symptoms are not adequately controlled by a single bronchodilator, combining bronchodilators of different classes may prove effective. Several long-acting β(2)-agonists and long-acting muscarinic antagonists with 24-h duration of action and inhalers combining different classes of long-acting, once-daily bronchodilators are in development. The place of these agents in the treatment algorithm will be determined by their efficacy and safety profiles and their long-term impact on relevant clinical outcomes.

Before the experts arrive.

PubMed

Chandley, M

2001-06-01

This article addresses the rare event of the hostage situation in a forensic psychiatric nursing setting. It has a specific focus on the initial response and the accompanying issues for nurses at the clinical interface as the situation emerges. The intention of this article is to both offer guidance and raise the profile of this unique management issue because little attention is drawn to early-stage hostage situations at an organizational level. When a hostage situation occurs, inadequate preparation can mean the difference between life and death for the hostage, negotiator, or hostage taker. This article provides an overview of the relevant literature and offers guidance about the actions required when a nurse suddenly becomes responsible for managing the early stages of such a traumatic event. Responses, safety, and communication factors concerning the hostage taker are covered.

Recent advances and future directions in the management of knee osteoarthritis: Can biological joint reconstruction replace joint arthroplasty and when?

PubMed Central

Paschos, Nikolaos K

2015-01-01

In this article, a concise description of the recent advances in the field of osteoarthritis management is presented. The main focus is to highlight the most promising techniques that emerge in both biological joint replacement and artificial joint arthroplasty. A critical view of high quality evidence regarding outcome and safety profile of these techniques is presented. The potential role of kinematically aligned total knee replacement, navigation, and robotic-assisted surgery is outlined. A critical description of both primary and stem cell-based therapies, the cell homing theory, the use of biologic factors and recent advancements in tissue engineering and regenerative medicine is provided. Based on the current evidence, some thoughts on a realistic approach towards answering these questions are attempted. PMID:26495242

Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.

PubMed

Tatarewicz, Suzanna M; Mytych, Daniel T; Manning, Marta Starcevic; Swanson, Steven J; Moxness, Michael S; Chirmule, Narendra

2014-06-01

All therapeutic proteins have the potential to induce anti-drug antibodies (ADA). Clinically relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity assessment strategy evaluates binding and neutralizing ADA, and the need for additional characterization (e.g., epitope, titer and so on) is determined using a risk-based approach. The choice of characterization assays depends on the type, application and immunogenicity of the therapeutic. ADA characterization can impact the interpretation of the risk profile of a given therapeutic, and offers insight into opportunities for risk mitigation and management. This article describes common ADA characterization methods. Strategic assessment and characterization of clinically relevant ADA are discussed, in order to support clinical options for safe and effective patient care and disease management.

Research on the management and endorsement of nuclear safety standards in the United States and its revelation for China

NASA Astrophysics Data System (ADS)

Liu, Ting; Tian, Yu; Yang, Lili; Gao, Siyi; Song, Dahu

2018-01-01

This paper introduces the American standard system, the Nuclear Regulatory Commission (NRC)’s responsibility, NRC nuclear safety regulations and standards system, studies on NRC’s standards management and endorsement mode, analyzes the characteristics of NRC standards endorsement management, and points out its disadvantages. This paper draws revelation from the standard management and endorsement model of NRC and points suggestion to China’s nuclear and radiation safety standards management.The issue of the “Nuclear Safety Law”plays an important role in China’s nuclear and radiation safety supervision. Nuclear and radiation safety regulations and standards are strong grips on the implementation of “Nuclear Safety Law”. This paper refers on the experience of international advanced countriy, will effectively promote the improvement of the endorsed management of China’s nuclear and radiation safety standards.

76 FR 12300 - Safety Management System for Certificated Airports; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-07

...-0997; Notice No. 10-14] RIN 2120-AJ38 Safety Management System for Certificated Airports; Extension of...: Background On October 7, 2010, the FAA published Notice No. 10-14, entitled ``Safety Management System for... conclusions from the safety management systems proof of concept. The FAA anticipates making this report...

33 CFR 96.320 - What is involved to complete a safety management audit and when is it required to be completed?

Code of Federal Regulations, 2010 CFR

2010-07-01

... up the safety management system. (c) Actions required during safety management audits for a company... management system, as defined in subpart B of this part. (2) Make sure the audit complies with this subpart... safety management system is found during an audit, it must be reported in writing by the auditor: (1) For...

Predicting safety culture: the roles of employer, operations manager and safety professional.

PubMed

Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

2010-10-01

This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines.

PubMed

Zhou, Lu-Jie; Cao, Qing-Gui; Yu, Kai; Wang, Lin-Lin; Wang, Hai-Bin

2018-04-26

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines

PubMed Central

Zhou, Lu-jie; Cao, Qing-gui; Yu, Kai; Wang, Lin-lin; Wang, Hai-bin

2018-01-01

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines. PMID:29701715

Use of Intra-Articular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice

PubMed Central

Cooper, Cyrus; Rannou, François; Richette, Pascal; Bruyère, Olivier; Al-Daghri, Nasser; Altman, Roy D.; Brandi, Maria Luisa; Basset, Sabine Collaud; Herrero-Beaumont, Gabriel; Migliore, Alberto; Pavelka, Karel; Uebelhart, Daniel; Reginster, Jean-Yves

2017-01-01

This review emphasizes the safety profile of intra-articular hyaluronic acid treatment of knee osteoarthritis, as well as its moderate but real efficacy on symptoms, which is in the same range than other pharmacological modalities used in this indication. Effectiveness of intra-articular hyaluronic acid has also been highlighted based on ‘real-life’ data, together with the clinical benefit of systematic repeated treatment cycles, and the influence of the molecular weight of hyaluronic acid on treatment outcome. These aspects should be particularly helpful to clinicians when making personalized care decisions. PMID:28118523

Examining the Relationship between Safety Management System Implementation and Safety Culture in Collegiate Flight Schools

ERIC Educational Resources Information Center

Robertson, Mike Fuller

2017-01-01

Safety Management Systems (SMS) are becoming the industry standard for safety management throughout the aviation industry. As the Federal Aviation Administration (FAA) continues to mandate SMS for different segments, the assessment of an organization's safety culture becomes more important. An SMS can facilitate the development of a strong…

46 CFR 71.75-13 - Safety Management Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 3 2010-10-01 2010-10-01 false Safety Management Certificate. 71.75-13 Section 71.75-13... CERTIFICATION Certificates Under the International Convention for Safety of Life at Sea, 1960 § 71.75-13 Safety... valid Safety Management Certificate and a copy of their company's valid Document of Compliance...

National machine guarding program: Part 2. Safety management in small metal fabrication enterprises

PubMed Central

Yamin, Samuel C.; Brosseau, Lisa M.; Xi, Min; Gordon, Robert; Most, Ivan G.; Stanley, Rodney

2015-01-01

Background Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem. Methods The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers. Insurance safety consultants collected baseline data in 221 business using a 33‐question safety management audit. Audits were completed during an interview with the business owner or manager. Results Most measures of safety management improved with an increasing number of employees. This trend was particularly strong for lockout/tagout. However, size was only significant for businesses without a safety committee. Establishments with a safety committee scored higher (55% vs. 36%) on the safety management audit compared with those lacking a committee (P < 0.0001). Conclusions Critical safety management programs were frequently absent. A safety committee appears to be a more important factor than business size in accounting for differences in outcome measures. Am. J. Ind. Med. 58:1184–1193, 2015. © 2015 The Authors. American Journal of Industrial Medicine Published by Wiley Periodicals, Inc. PMID:26345591

Effective Safety Management in Construction Project

NASA Astrophysics Data System (ADS)

Othman, I.; Shafiq, Nasir; Nuruddin, M. F.

2017-12-01

Effective safety management is one of the serious problems in the construction industry worldwide, especially in large-scale construction projects. There have been significant reductions in the number and the rate of injury over the last 20 years. Nevertheless, construction remains as one of the high risk industry. The purpose of this study is to examine safety management in the Malaysian construction industry, as well as to highlight the importance of construction safety management. The industry has contributed significantly to the economic growth of the country. However, when construction safety management is not implemented systematically, accidents will happen and this can affect the economic growth of the country. This study put the safety management in construction project as one of the important elements to project performance and success. The study emphasize on awareness and the factors that lead to the safety cases in construction project.

Safety management in multiemployer worksites in the manufacturing industry: opinions on co-operation and problems encountered.

PubMed

Nenonen, Sanna; Vasara, Juha

2013-01-01

Co-operation between different parties and effective safety management play an important role in ensuring safety in multiemployer worksites. This article reviews safety co-operation and factors complicating safety management in Finnish multiemployer manufacturing worksites. The paper focuses on the service providers' opinions; however, a comparison of the customers' views is also presented. The results show that safety-related co-operation between providers and customers is generally considered as successful but strongly dependent on the partner. Safety co-operation is provided through, e.g., training, orientation and risk analysis. Problems encountered include ensuring adequate communication, identifying hazards, co-ordinating work tasks and determining responsibilities. The providers and the customers encounter similar safety management problems. The results presented in this article can help companies to focus their efforts on the most problematic points of safety management and to avoid common pitfalls.

Evaluation of the Quality of Occupational Health and Safety Management Systems Based on Key Performance Indicators in Certified Organizations.

PubMed

Mohammadfam, Iraj; Kamalinia, Mojtaba; Momeni, Mansour; Golmohammadi, Rostam; Hamidi, Yadollah; Soltanian, Alireza

2017-06-01

Occupational Health and Safety Management Systems are becoming more widespread in organizations. Consequently, their effectiveness has become a core topic for researchers. This paper evaluates the performance of the Occupational Health and Safety Assessment Series 18001 specification in certified companies in Iran. The evaluation is based on a comparison of specific criteria and indictors related to occupational health and safety management practices in three certified and three noncertified companies. Findings indicate that the performance of certified companies with respect to occupational health and safety management practices is significantly better than that of noncertified companies. Occupational Health and Safety Assessment Series 18001-certified companies have a better level of occupational health and safety; this supports the argument that Occupational Health and Safety Management Systems play an important strategic role in health and safety in the workplace.

Phase I dose-escalation study of afatinib, an ErbB family blocker, plus docetaxel in patients with advanced cancer.

PubMed

Marshall, John; Shapiro, Geoffrey I; Uttenreuther-Fischer, Martina; Ould-Kaci, Mahmoud; Stopfer, Peter; Gordon, Michael S

2013-02-01

To determine the maximum tolerated dose (MTD), safety and anti-tumor activity of afatinib combined with docetaxel in advanced cancer. The MTD was determined from dose-limiting toxicities in the first cycle. Thirty-one patients received 10, 20 and 30 mg oral afatinib, plus 60 and 75 mg/m(2) intravenous docetaxel (six cohorts; 3-week cycles). The MTD of afatinib was 20 mg/day (days 2-21) with 75 mg/m(2) docetaxel (day 1). Dose-limiting toxicities were grade 3/4 diarrhea (n = 3) and febrile neutropenia (n = 6). Most frequently occurring adverse events were diarrhea, neutropenia and rash. Disease stabilization occurred in 14 patients. Afatinib 20 mg/day plus docetaxel was suboptimal and the study could not yield Phase II dose recommendations. The combination resulted in a manageable safety profile.

Consensus Recommendations on Sulfonylurea and Sulfonylurea Combinations in the Management of Type 2 Diabetes Mellitus – International Task Force

PubMed Central

Kalra, Sanjay; Bahendeka, Silver; Sahay, Rakesh; Ghosh, Sujoy; Md, Fariduddin; Orabi, Abbas; Ramaiya, Kaushik; Al Shammari, Sameer; Shrestha, Dina; Shaikh, Khalid; Abhayaratna, Sachitha; Shrestha, Pradeep K.; Mahalingam, Aravinthan; Askheta, Mazen; A. Rahim, Aly Ahmed; Eliana, Fatimah; Shrestha, Hari K.; Chaudhary, Sandeep; Ngugi, Nancy; Mbanya, Jean Claude; Aye, Than Than; Latt, Tint Swe; Akanov, Zhanay A.; Syed, Abbas Raza; Tandon, Nikhil; Unnikrishnan, A. G.; Madhu, S. V.; Jawa, Ali; Chowdhury, Subhankar; Bajaj, Sarita; Das, Ashok Kumar

2018-01-01

For decades, sulfonylureas (SUs) have been important drugs in the antidiabetic therapeutic armamentarium. They have been used as monotherapy as well as combination therapy. Focus on newer drugs and concerns about the risk of severe hypoglycemia and weight gain with some SUs have led to discussion on their safety and utility. It has to be borne in mind that the adverse events associated with SUs should not be ascribed to the whole class, as many modern SUs, such as glimepiride and gliclazide modified release, are associated with better safety profiles. Furthermore, individualization of treatment, using SUs in combination with other drugs, backed with careful monitoring and patient education, ensures maximum benefits with minimal side effects. The current guidelines, developed by experts from Africa, Asia, and the Middle East, promote the safe and smart use of SUs in combination with other glucose-lowering drugs. PMID:29535952

Management Commitment to Safety, Teamwork, and Hospital Worker Injuries.

PubMed

McGonagle, Alyssa K; Essenmacher, Lynnette; Hamblin, Lydia; Luborsky, Mark; Upfal, Mark; Arnetz, Judith

2016-01-01

Although many studies link teamwork in health care settings to patient safety, evidence linking teamwork to hospital worker safety is lacking. This study addresses this gap by providing evidence linking teamwork perceptions in hospital workers to worker injuries, and further, finds a linkage between manager commitment to safety and teamwork. Organizational records of worker injuries and survey responses regarding management commitment to safety and teamwork from 446 hospital workers within 42 work units in a multi-site hospital system were examined. Results underscored the particular importance of teamwork on worker injuries as well as the importance of management commitment to safety as relating to teamwork. To improve worker safety, organizational leaders and unit managers should work to maintain environments wherein teamwork can thrive.

Management Commitment to Safety, Teamwork, and Hospital Worker Injuries

PubMed Central

McGonagle, Alyssa K.; Essenmacher, Lynnette; Hamblin, Lydia; Luborsky, Mark; Upfal, Mark; Arnetz, Judith

2016-01-01

Although many studies link teamwork in health care settings to patient safety, evidence linking teamwork to hospital worker safety is lacking. This study addresses this gap by providing evidence linking teamwork perceptions in hospital workers to worker injuries, and further, finds a linkage between manager commitment to safety and teamwork. Organizational records of worker injuries and survey responses regarding management commitment to safety and teamwork from 446 hospital workers within 42 work units in a multi-site hospital system were examined. Results underscored the particular importance of teamwork on worker injuries as well as the importance of management commitment to safety as relating to teamwork. To improve worker safety, organizational leaders and unit managers should work to maintain environments wherein teamwork can thrive. PMID:27867448

75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

SafetyAnalyst : software tools for safety management of specific highway sites

DOT National Transportation Integrated Search

2010-07-01

SafetyAnalyst provides a set of software tools for use by state and local highway agencies for highway safety management. SafetyAnalyst can be used by highway agencies to improve their programming of site-specific highway safety improvements. SafetyA...

Leadership for safety: industrial experience.

PubMed

Flin, R; Yule, S

2004-12-01

The importance of leadership for effective safety management has been the focus of research attention in industry for a number of years, especially in energy and manufacturing sectors. In contrast, very little research into leadership and safety has been carried out in medical settings. A selective review of the industrial safety literature for leadership research with possible application in health care was undertaken. Emerging findings show the importance of participative, transformational styles for safety performance at all levels of management. Transactional styles with attention to monitoring and reinforcement of workers' safety behaviours have been shown to be effective at the supervisory level. Middle managers need to be involved in safety and foster open communication, while ensuring compliance with safety systems. They should allow supervisors a degree of autonomy for safety initiatives. Senior managers have a prime influence on the organisation's safety culture. They need to continuously demonstrate a visible commitment to safety, best indicated by the time they devote to safety matters.

Safety climate and safety behaviors in the construction industry: The importance of co-workers commitment to safety.

PubMed

Schwatka, Natalie V; Rosecrance, John C

2016-06-16

There is growing empirical evidence that as safety climate improves work site safety practice improve. Safety climate is often measured by asking workers about their perceptions of management commitment to safety. However, it is less common to include perceptions of their co-workers commitment to safety. While the involvement of management in safety is essential, working with co-workers who value and prioritize safety may be just as important. To evaluate a concept of safety climate that focuses on top management, supervisors and co-workers commitment to safety, which is relatively new and untested in the United States construction industry. Survey data was collected from a cohort of 300 unionized construction workers in the United States. The significance of direct and indirect (mediation) effects among safety climate and safety behavior factors were evaluated via structural equation modeling. Results indicated that safety climate was associated with safety behaviors on the job. More specifically, perceptions of co-workers commitment to safety was a mediator between both management commitment to safety climate factors and safety behaviors. These results support workplace health and safety interventions that build and sustain safety climate and a commitment to safety amongst work teams.

First-Principles-Driven Model-Based Optimal Control of the Current Profile in NSTX-U

NASA Astrophysics Data System (ADS)

Ilhan, Zeki; Barton, Justin; Wehner, William; Schuster, Eugenio; Gates, David; Gerhardt, Stefan; Kolemen, Egemen; Menard, Jonathan

2014-10-01

Regulation in time of the toroidal current profile is one of the main challenges toward the realization of the next-step operational goals for NSTX-U. A nonlinear, control-oriented, physics-based model describing the temporal evolution of the current profile is obtained by combining the magnetic diffusion equation with empirical correlations obtained at NSTX-U for the electron density, electron temperature, and non-inductive current drives. In this work, the proposed model is embedded into the control design process to synthesize a time-variant, linear-quadratic-integral, optimal controller capable of regulating the safety factor profile around a desired target profile while rejecting disturbances. Neutral beam injectors and the total plasma current are used as actuators to shape the current profile. The effectiveness of the proposed controller in regulating the safety factor profile in NSTX-U is demonstrated via closed-loop predictive simulations carried out in PTRANSP. Supported by PPPL.

Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome.

PubMed

Yang, Young-Mo; Choi, Eun Joo

2015-01-01

Polycystic ovary syndrome (PCOS) is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles. A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS. Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported. The clinical trials suggest that metformin or oral contraceptives are at least patient convenient, efficacious, and safe for the treatment of PCOS. However, well-designed, prospective, long-term, large-scale, randomized clinical trials are necessary to elucidate the efficacy and safety of metformin, oral contraceptives, or both in the treatment of PCOS, and to elucidate their individual roles in the treatment of this condition.

Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome

PubMed Central

Yang, Young-Mo; Choi, Eun Joo

2015-01-01

Background Polycystic ovary syndrome (PCOS) is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles. Methods A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS. Results Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported. Conclusion The clinical trials suggest that metformin or oral contraceptives are at least patient convenient, efficacious, and safe for the treatment of PCOS. However, well-designed, prospective, long-term, large-scale, randomized clinical trials are necessary to elucidate the efficacy and safety of metformin, oral contraceptives, or both in the treatment of PCOS, and to elucidate their individual roles in the treatment of this condition. PMID:26366087

Bilastine: new insight into antihistamine treatment.

PubMed

Ridolo, Erminia; Montagni, Marcello; Bonzano, Laura; Incorvaia, Cristoforo; Canonica, Giorgio Walter

2015-01-01

Bilastine is a new second generation H1-antihistamine recently approved for the symptomatic treatment of allergic rhinitis (AR) and chronic urticaria (CU). Bilastine epitomizes the evolution of research on antihistamines concerning both efficacy and safety. In AR treatment, a number of large controlled clinical trials documented its efficacy, as assessed by improvement of all nasal and ocular symptoms and quality of life. These outcomes show that bilastine meets current EAACI/ARIA criteria for medications used in the treatment of AR. Also in CU, the review of the literature indicates that once-daily treatment with bilastine 20 mg was effective in managing symptoms and improving patient's quality of life. Concerning safety and tolerability, the profile of bilastine is very similar to placebo and in particular the adverse effects on central nervous system are insignificant. The balance of efficacy and safety of bilastine is particularly helpful when dosages higher than standard are needed to control the symptoms, as frequently occurs in patients with urticaria, in whom antihistamines doses up to four times the standard dose may be administered.

The safety of pharmacologic treatment for pediatric obesity.

PubMed

Chao, Ariana M; Wadden, Thomas A; Berkowitz, Robert I

2018-04-01

Pediatric obesity is a serious public health concern. Five medications have been approved by the Food and Drug Administration (FDA) for chronic weight management in adults with obesity, when used as an adjunct to lifestyle modification. Orlistat is the only FDA-approved medication for pediatric patients aged 12 years and above. Areas covered: This paper summarizes safety and efficacy data from clinical trials of weight loss medications conducted among pediatric samples. Relevant studies were identified through searches in PubMed. Expert opinion: Orlistat, as an adjunct to lifestyle modification, results in modest weight losses and may be beneficial for some pediatric patients with obesity. However, gastrointestinal side effects are common and may limit use. In adults taking orlistat, rare but severe adverse events, including liver and renal events, have been reported. Recent pediatric pharmacokinetic studies of liraglutide have demonstrated similar safety and tolerability profiles as found in adults, with gastrointestinal disorders being the most common adverse events. Clinical trials are needed of liraglutide, as well as other medications for obesity, that systematically evaluate their risks and benefits in pediatric patients.

Neural network evaluation of tokamak current profiles for real time control

NASA Astrophysics Data System (ADS)

Wróblewski, Dariusz

1997-02-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q0, minimum value of q, qmin, and the location of qmin. Very good performance of the trained neural network both for simulated test data and for experimental datais demonstrated.

Neural network evaluation of tokamak current profiles for real time control (abstract)

NASA Astrophysics Data System (ADS)

Wróblewski, Dariusz

1997-01-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q0, minimum value of q, qmin, and the location of qmin. Very good performance of the trained neural network both for simulated test data and for experimental data is demonstrated.

The Safety Attitudes of Senior Managers in the Chinese Coal Industry.

PubMed

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-11-17

Introduction: Senior managers' attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers' attitudes towards safety in the Chinese coal industry. Method : We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions : Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers' safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers' unions not playing their role effectively. Practical Applications : We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry.

[Quality management and safety culture in medicine: context and concepts].

PubMed

Wischet, Werner; Eitzinger, Claudia

2009-01-01

The publication of the IOM report "To err is human: building a safer health system" in 1999 put spotlight on the primacy of the principle of primum non nocere and made patient safety a central topic of quality management. A key conclusion of the report was the need for a well-developed safety culture. While concepts of quality management have evolved along the lines of ISO and Total Quality Management over the last decades patient safety still has not got the same amount of attention (PubMed). Evidence from other safety-critical areas but also from the field of medicine itself suggests that an efficient culture of safety is a conditio sine qua non for the sustainable improvement of patient safety. Considering these arguments the present paper aims at emphasizing the importance of an efficient culture of safety for patient safety and quality management in healthcare. In addition, key instruments of safety culture as well as their limitations will be presented.

How Safe Are Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review.

PubMed

Hartling, Lisa; Ali, Samina; Dryden, Donna M; Chordiya, Pritam; Johnson, David W; Plint, Amy C; Stang, Antonia; McGrath, Patrick J; Drendel, Amy L

2016-01-01

Background . Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. We examined evidence comparing the safety profiles of three groups of oral medications, acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, to manage acute nonsurgical pain in children (<18 years) treated in ambulatory settings. Methods . A comprehensive search was performed to July 2015, including review of national data registries. Two reviewers screened articles for inclusion, assessed methodological quality, and extracted data. Risks (incidence rates) were pooled using a random effects model. Results . Forty-four studies were included; 23 reported on adverse events. Based on limited current evidence, acetaminophen, ibuprofen, and opioids have similar nausea and vomiting profiles. Opioids have the greatest risk of central nervous system adverse events. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone. Conclusions . Ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids. Dual therapy with a nonopioid/opioid combination confers a protective effect for adverse events over opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials.

Overview of elagolix for the treatment of endometriosis.

PubMed

Melis, Gian Benedetto; Neri, Manuela; Corda, Valentina; Malune, Maria Elena; Piras, Bruno; Pirarba, Silvia; Guerriero, Stefano; Orrù, Marisa; D'Alterio, Maurizio Nicola; Angioni, Stefano; Paoletti, Anna Maria

2016-05-01

Suppression of sex-steroid secretion is required in a variety of gynecological conditions. This can be achieved using gonadotropin releasing hormone (GnRH) agonists that bind pituitary gonadotropin receptors and antagonize the link-receptor of endogenous GnRH, inhibiting the mechanism of GnRH pulsatility. On the other hand, GnRH antagonists immediately reduce gonadal steroid levels, avoiding the initial stimulatory phase of the agonists. Potential benefits of GnRH antagonists over GnRH agonists include a rapid onset and reversibility of action. Older GnRH antagonists are synthetic peptides, obtained by modifications of certain amino acids in the native GnRH sequence. They require subcutaneous injections, implantation of long-acting depots. The peptide structure is responsible for histamine-related adverse events and the tendency to elicit hypersensitivity reactions. Research has worked towards the development of non-peptidic molecules exerting antagonist action on GnRH. They are available for oral administration and may have a more beneficial safety profile in comparison with peptide GnRH antagonists. This article focuses on the data of the literature about elagolix, a novel non-peptidic GnRHantagonist, in the treatment of endometriosis. Elagolix demonstrated efficacy in the management of endometriosis-associated pain and had an acceptable safety and tolerability profile. However, further studies are necessary to evaluate its non-inferiority in comparison with other endometriosis's treatments.

Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.

PubMed

Ferris, Robert L; Blumenschein, George; Fayette, Jerome; Guigay, Joel; Colevas, A Dimitrios; Licitra, Lisa; Harrington, Kevin J; Kasper, Stefan; Vokes, Everett E; Even, Caroline; Worden, Francis; Saba, Nabil F; Docampo, Lara Carmen Iglesias; Haddad, Robert; Rordorf, Tamara; Kiyota, Naomi; Tahara, Makoto; Lynch, Mark; Jayaprakash, Vijayvel; Li, Li; Gillison, Maura L

2018-06-01

We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN). Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017. With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and  < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively. Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636). Copyright © 2018. Published by Elsevier Ltd.

Interventional procedures and future drug therapy for hypertension

PubMed Central

Lobo, Melvin D.; Sobotka, Paul A.; Pathak, Atul

2017-01-01

Hypertension management poses a major challenge to clinicians globally once non-drug (lifestyle) measures have failed to control blood pressure (BP). Although drug treatment strategies to lower BP are well described, poor control rates of hypertension, even in the first world, suggest that more needs to be done to surmount the problem. A major issue is non-adherence to antihypertensive drugs, which is caused in part by drug intolerance due to side effects. More effective antihypertensive drugs are therefore required which have excellent tolerability and safety profiles in addition to being efficacious. For those patients who either do not tolerate or wish to take medication for hypertension or in whom BP control is not attained despite multiple antihypertensives, a novel class of interventional procedures to manage hypertension has emerged. While most of these target various aspects of the sympathetic nervous system regulation of BP, an additional procedure is now available, which addresses mechanical aspects of the circulation. Most of these new devices are supported by early and encouraging evidence for both safety and efficacy, although it is clear that more rigorous randomized controlled trial data will be essential before any of the technologies can be adopted as a standard of care. PMID:27406184

41 CFR 102-80.110 - What must an equivalent level of safety analysis indicate?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What must an equivalent... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety...

Achieving Safety through Security Management

NASA Astrophysics Data System (ADS)

Ridgway, John

Whilst the achievement of safety objectives may not be possible purely through the administration of an effective Information Security Management System (ISMS), your job as safety manager will be significantly eased if such a system is in place. This paper seeks to illustrate the point by drawing a comparison between two of the prominent standards within the two disciplines of security and safety management.

41 CFR 128-1.8004 - Seismic Safety Coordinators.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false Seismic Safety... Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program § 128-1.8004 Seismic Safety Coordinators. (a) The Justice Management Division shall designate an...

41 CFR 128-1.8004 - Seismic Safety Coordinators.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Seismic Safety... Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program § 128-1.8004 Seismic Safety Coordinators. (a) The Justice Management Division shall designate an...

41 CFR 128-1.8004 - Seismic Safety Coordinators.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false Seismic Safety... Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program § 128-1.8004 Seismic Safety Coordinators. (a) The Justice Management Division shall designate an...

41 CFR 128-1.8004 - Seismic Safety Coordinators.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Seismic Safety... Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program § 128-1.8004 Seismic Safety Coordinators. (a) The Justice Management Division shall designate an...

Scale development of safety management system evaluation for the airline industry.

PubMed

Chen, Ching-Fu; Chen, Shu-Chuan

2012-07-01

The airline industry relies on the implementation of Safety Management System (SMS) to integrate safety policies and augment safety performance at both organizational and individual levels. Although there are various degrees of SMS implementation in practice, a comprehensive scale measuring the essential dimensions of SMS is still lacking. This paper thus aims to develop an SMS measurement scale from the perspective of aviation experts and airline managers to evaluate the performance of company's safety management system, by adopting Schwab's (1980) three-stage scale development procedure. The results reveal a five-factor structure consisting of 23 items. The five factors include documentation and commands, safety promotion and training, executive management commitment, emergency preparedness and response plan and safety management policy. The implications of this SMS evaluation scale for practitioners and future research are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

Initial development of a practical safety audit tool to assess fleet safety management practices.

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Safety, Health, and Fire Prevention Guide for Hospital Safety Managers

DTIC Science & Technology

1993-03-01

Safety committee S 2-5 Oxygen quality assurance program 0 2-6 Safety and fire prevention library 0 2-7 Safety services to Dental Activities • 2-8...Chapter 2 Safety Management 2-1. Safety policy statement Health Services Command (HSC) Supplement (Suppl) 1 to Army Regulation (AR) 385-10 and the...Management. (b) The medical staff. (c) The nursing service . (d) Logistics. (e) Nutritional care. (f) Preventive medicine. * 2-3 USAEHA TG No. 152 March 1993 (g

Evaluation and review of the safety management system implementation in the Royal Thai Air Force

NASA Astrophysics Data System (ADS)

Chaiwan, Sakkarin

This study was designed to determine situation and effectiveness of the safety management system currently implemented in the Royal Thai Air Force. Reviewing the ICAO's SMS and the RTAF's SMS was conducted to identify similarities and differences between the two safety management systems. Later, the researcher acquired safety statistics from the RTAF Safety Center to investigate effectiveness of its safety system. The researcher also collected data to identify other factors affecting effectiveness of the safety system during conducting in-depth interviews. Findings and Conclusions: The study shows that the Royal Thai Air Force has never applied the International Civil Aviation Organization's Safety management System to its safety system. However, the RTAF's SMS and the ICAO's SMS have been developed based on the same concepts. These concepts are from Richard H. Woods's book, Aviation safety programs: A management handbook. However, the effectiveness of the Royal Thai Air Force's safety system is in good stance. An accident rate has been decreasing regularly but there are no known factors to describe the increasing rate, according to the participants' opinion. The participants have informed that there are many issues to be resolved to improve the RTAF's safety system. Those issues are cooperation among safety center's staffs, attitude toward safety of the RTAF senior commanders, and safety standards.

Health and safety management systems: liability or asset?

PubMed

Bennett, David

2002-01-01

Health and safety management systems have a background in theory and in various interests among employers and workplace health and safety professionals. These have resulted in a number of national systems emanating from national standard-writing centres and from employers' organizations. In some cases these systems have been recognized as national standards. The contenders for an international standard have been the International Organization of Standardization (ISO) and the International Labour Organization (ILO). The quality and environmental management systems of ISO indicate what an ISO health and safety management standard would look like. The ILO Guidelines on Safety and Health Management Systems, by contrast, are stringent, specific and potentially effective in improving health and safety performance in the workplace.

Bilastine: a new H1 -antihistamine with an optimal profile for updosing in urticaria.

PubMed

Church, M K; Labeaga, L

2017-09-01

This review set out to examine published papers detailing the efficacy of bilastine in skin models and urticaria to assess whether it meets the optimal profile for updosing in urticaria, that is, strong clinical efficacy and freedom from unwanted side effects, particularly sedation. Bilastine is a highly effective H 1 -antihistamine even when used at the basic dose of 20 mg daily. Its facilitated uptake after oral dosage gives it a rapid onset and long duration of action. In both wheal and flare studies and in urticaria updosing fourfold showed increased effectiveness. With respect to somnolence, bilastine is a substrate for P-glycoprotein, a membrane pump which prevents it crossing the blood-brain barrier. Consequently, bilastine is a practically 'non-sedating' H 1 -antihistamine. In conclusion, the excellent profile of bilastine in both efficacy and safety make it the ideal H 1 -antihistamine for updosing the daily dose fourfold in difficult-to-treat urticaria as recommended by the EAACI/GA 2 LEN/EDF/WAO guideline for the management of urticaria. © 2017 European Academy of Dermatology and Venereology.

Thymidine analogue-sparing highly active antiretroviral therapy (HAART).

PubMed

Nolan, David; Mallal, Simon

2003-02-01

The use of alternative nucleoside reverse transcriptase inhibitors (NRTIs) to the thymidine analogues stavudine (d4T) and zidovudine(ZDV) has been advocated as a means of limiting long-term NRTI-associated toxicity, particularly the development of lipoatrophy or fat wasting. This approach reflects an increasing knowledge of the distinct toxicity profiles of NRTI drugs. However, recent clinical trials have demonstrated that the use of thymidine analogue NRTIs and newer alternative backbone NRTIs, such as tenofovir (TNF) and abacavir (ABC), is associated with comparable short-term efficacy and tolerability. Given the importance of toxicity profile differences in determining clinical management, it is important to recognise that d4T and ZDV cary significantly different risks for long-term NRTI toxicity. Recognising that all NRTIs, including thymidine analogues, have individual toxicity profiles provides a more appropriate basis for selecting optimal antiretroviral therapy. The safety and efficacy of TNF and ABC are also reviewed here, although the available data provide only limited knowledge of the long-term effects of these drugs in terms of toxicity and antiviral durability.

Tanezumab in the treatment of chronic musculoskeletal conditions.

PubMed

Jayabalan, Prakash; Schnitzer, Thomas J

2017-02-01

The management of pain associated with chronic musculoskeletal conditions represents a significant challenge for the clinician. There remains a need for novel medications that have a significant analgesic benefit and are also safe and well tolerated. Both pre-clinical and clinical data have provided evidence of the role of nerve growth factor (NGF) in a multitude of pain eliciting conditions. Therefore, the development of monoclonal antibodies to NGF for chronic painful musculoskeletal conditions has generated interest. Areas covered: This manuscript is a review that examines both the pharmacological properties and clinical studies of tanezumab, the most widely studied antibody to NGF, for management of osteoarthritis (OA) and low back pain. In addition, the safety and tolerability profile and development history of tanezumab are also discussed. Expert opinion: Most studies provide strong support for the ability of tanezumab to provide clinically meaningful pain relief in individuals with these conditions, with longer-term studies suggesting durability of effect. The adverse event profile appears favorable, assuming the risk mitigation strategies are effective at reducing the incidence of joint-related side effects. Further data are being collected to define the optimal dose and dosing strategy in both OA and chronic low back pain.

44 CFR 150.5 - Joint Public Safety Awards Board.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Joint Public Safety Awards Board. 150.5 Section 150.5 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY FIRE PREVENTION AND CONTROL PUBLIC SAFETY AWARDS TO PUBLIC SAFETY OFFICERS...

Safety and Waste Management for SAM Pathogen Methods

EPA Pesticide Factsheets

The General Safety and Waste Management page offers section-specific safety and waste management details for the pathogens included in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Safety and Waste Management for SAM Biotoxin Methods

EPA Pesticide Factsheets

The General Safety and Waste Management page offers section-specific safety and waste management details for the biotoxins included in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

Modified fully covered self-expandable metal stents with antimigration features for benign pancreatic-duct strictures in advanced chronic pancreatitis, with a focus on the safety profile and reducing migration.

PubMed

Moon, Sung-Hoon; Kim, Myung-Hwan; Park, Do Hyun; Song, Tae Joon; Eum, Junbum; Lee, Sang Soo; Seo, Dong Wan; Lee, Sung Koo

2010-07-01

Fully covered self-expandable metal stent (FCSEMS) placement has recently been tried in the management of refractory pancreatic-duct strictures associated with advanced chronic pancreatitis. The major limitation of FCSEMSs was frequent migration. To assess the safety, migration rate, and removability of modified FCSEMSs with antimigration features used for the treatment of benign pancreatic-duct strictures. Prospective study. Tertiary academic center. Thirty-two patients with chronic painful pancreatitis and dominant ductal stricture. Transpapillary endoscopic placement of FCSEMSs in the pancreatic duct with removal after 3 months. Technical and functional success and adverse events associated with the placement of metal stents. FCSEMSs were successfully placed in all patients through the major (n = 27) or minor (n = 5) duodenal papilla. All patients achieved pain relief from stent placement. There was no occurrence of stent-induced pancreatitis or pancreatic sepsis. No stent migrated, and all stents were easily removed. Follow-up ERCP 3 months after stent placement showed resolution of duct strictures in all patients. Pancreatograms obtained at FCSEMS removal displayed de novo focal pancreatic duct strictures in 5 patients, but all were asymptomatic. No long-term follow-up. Temporary 3-month placement of FCSEMSs was effective in resolving pancreatic-duct strictures in chronic pancreatitis, with an acceptable morbidity profile. Modified FCSEMSs can prevent stent migration, but may be associated with de novo duct strictures. Further trials are needed to assess long-term safety and efficacy. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

The hematopoietic effect of Epotin (recombinant human erythropoietin-alpha) on maintenance hemodialysis end-stage kidney disease patients.

PubMed

Al-Shohaib, S; Shaker, D S; Ghaedi, B B; Alyarim, M; Emara, S; Behairy, M

2010-04-01

Recombinant human erythropoietin (rHuEpo) has revolutionized the management of renal anemia, significantly improving patient quality of life. Great attention has been paid lately on how to optimally use this potent anti-anemic agent. Aiming to overview anemic patient management with Epotin (Julphar's rHuEpo) according to the new guidelines, we included in the study anemic (hemoglobin [Hb]or=18 years who were of iron replete (transeferene saturation (TSAT)>or=20% and serum ferritin>or=100 microg/L) with no evidence of serious inflammation (c-reactive protein (CRP)<30 mg/L) on thrice-weekly hemodialysis. The mean age and dialysis duration of 50.8+/-17 and 3.8+/-2.8 years, respectively, included 88.6% (n=31) de novo patients in the corrective phase with no previous exposure to erythropoietin. Safety-efficacy parameters showed insignificant changes throughout the 4-month study period, including iron profile that was maintained according to Kidney Disease Outcome Quality Initiative guidelines. Efficacy parameters revealed a significant increase (P<.0001) of Hb levels from a baseline of 8.5+/-1.0 to 11.1+/-1.1. Targeting an absolute increase of 2.5 g/dL in Hb throughout 3 months of the study period resulted in a 90.3% success rate. There were no dropouts due to intolerance, whereas all the recorded adverse events were classified as unrelated to the test product. In conclusion, Epotin was clinically effective to correct and maintain Hb levels in ESKD anemic patients on maintenance hemodialysis within the current recommended range and with a satisfactory safety profile consistent with previous international reports. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa.

PubMed

Lentz, S R; Ehrenforth, S; Karim, F Abdul; Matsushita, T; Weldingh, K N; Windyga, J; Mahlangu, J N

2014-08-01

Vatreptacog alfa, a recombinant factor VIIa (rFVIIa) analog with three amino acid substitutions and 99% identity to native FVIIa, was developed to improve the treatment of hemophilic patients with inhibitors. To confirm the safety and assess the efficacy of vatreptacog alfa in treating bleeding episodes in hemophilic patients with inhibitors. In this international, multicenter, randomized, double-blind, active-controlled, crossover, confirmatory phase III trial (adept(™) 2) in patients with hemophilia A or B and inhibitors, bleeds were randomized 3 : 2 to treatment with vatreptacog alfa (one to three doses at 80 μg kg(-1) ) or rFVIIa (one to three doses at 90 μg kg(-1) ). Treatment failures after three doses of trial product (TP) were managed according to the local standard of care. In the 72 patients enrolled, 567 bleeds were treated with TP. Both vatreptacog alfa and rFVIIa gave 93% effective bleeding control at 12 h. Vatreptacog alfa was superior to rFVIIa in secondary efficacy outcomes, including the number of doses used to treat a bleed and sustained bleeding control 24-48 h after the first dose. Eight patients (11%) developed antibodies against vatreptacog alfa, including four with cross-reactivity against rFVIIa and one with an in vitro neutralizing effect to vatreptacog alfa. This large randomized controlled trial confirmed the well-established efficacy and safety profile of rFVIIa, and showed that vatreptacog alfa had similar or better efficacy than rFVIIa. However, because of the development of anti-drug antibodies, a positive benefit-risk profile is unlikely to be achieved with vatreptacog alfa. © 2014 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

Protocol for a mixed-methods study on leader-based interventions in construction contractors' safety commitments.

PubMed

Pedersen, Betina Holbaek; Dyreborg, Johnny; Kines, Pete; Mikkelsen, Kim Lyngby; Hannerz, Harald; Andersen, Dorte Raaby; Spangenberg, Søren

2010-06-01

Owing to high injury rates, safety interventions are needed in the construction industry. Evidence-based interventions tailored to this industry are, however, scarce. Leader-based safety interventions have proven more effective than worker-based interventions in other industries. To test a leader-based safety intervention for construction sites. The intervention consists of encouraging safety coordinators to provide feedback on work safety to the client and line management. The intention is to increase communication and interactions regarding safety within the line management and between the client and the senior management. It is hypothesised that this, in turn, will lead to increased communication and interaction about safety between management and coworkers as well as an increased on-site safety level. A group-randomised double-blinded case study of six Danish construction sites (three intervention sites and three control sites). The recruitment of the construction sites is performed continuously from January 2010 to June 2010. The investigation of each site lasts 20 continuous weeks. Confirmatory statistical analysis is used to test if the safety level increased, and if the probability of safety communications between management and coworkers increases as a consequence of the intervention. The data collection will be blinded. Qualitative methods are used to evaluate if communication and interactions about safety at all managerial levels, including the client, increase. (1) The proportion of safety-related communications out of all studied communications between management and coworkers. (2) The safety level index of the construction sites.

46 CFR 107.415 - Safety Management Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Safety Management Certificate. 107.415 Section 107.415 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS INSPECTION AND CERTIFICATION Certificates Under International Convention for Safety of Life at Sea, 1974 § 107.415 Safety Management Certificate. (a)...

System safety education focused on flight safety

NASA Technical Reports Server (NTRS)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

Safety and Waste Management for SAM Chemistry Methods

EPA Pesticide Factsheets

The General Safety and Waste Management page offers section-specific safety and waste management details for the chemical analytes included in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

Safety and Waste Management for SAM Radiochemical Methods

EPA Pesticide Factsheets

The General Safety and Waste Management page offers section-specific safety and waste management details for the radiochemical analytes included in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

States Respond to School Safety Concerns with 2013 Legislation. School Safety: 2013 Legislative Session

ERIC Educational Resources Information Center

Wixom, Micah Ann

2014-01-01

School safety policies are constantly evolving, often in response to fatal events. After several high-profile and tragic shootings over the past 15 years, school safety has become a major focus for parents, school officials, policymakers and the public nationwide. ECS [Education Commission of the States] conducted a scan of school safety-related…

Leadership for safety: industrial experience

PubMed Central

Flin, R; Yule, S

2004-01-01

The importance of leadership for effective safety management has been the focus of research attention in industry for a number of years, especially in energy and manufacturing sectors. In contrast, very little research into leadership and safety has been carried out in medical settings. A selective review of the industrial safety literature for leadership research with possible application in health care was undertaken. Emerging findings show the importance of participative, transformational styles for safety performance at all levels of management. Transactional styles with attention to monitoring and reinforcement of workers' safety behaviours have been shown to be effective at the supervisory level. Middle managers need to be involved in safety and foster open communication, while ensuring compliance with safety systems. They should allow supervisors a degree of autonomy for safety initiatives. Senior managers have a prime influence on the organisation's safety culture. They need to continuously demonstrate a visible commitment to safety, best indicated by the time they devote to safety matters. PMID:15576692

An evaluation of two conducted electrical weapons and two probe designs using a swine comparative cardiac safety model.

PubMed

Dawes, Donald Murray; Ho, Jeffrey D; Moore, Johanna C; Miner, James R

2013-09-01

Despite human laboratory and field studies that have demonstrated a reasonable safety profile for TASER brand conducted electrical weapons (CEW), the results of some swine studies and arrest related deaths temporal to the use of the CEWs continue to raise questions regarding cardiac safety. TASER International, Inc., has released a new CEW, the TASER X2, touted to have a better safety profile than its long-standing predecessor, the TASER X26. We have developed a model to assess the relative cardiac safety of CEWs and used it to compare the TASER X2 and the TASER X26. This safety model was also used to assess the relative safety of an experimental probe design as compared to the standard steel probe. Our results suggest that the TASER X2 has an improved safety margin over the TASER X26. The new probe design also has promise for enhanced cardiac safety, although may have some disadvantages when compared to the existing design which would make field use impractical.

Efficacy and Safety Profile of Diclofenac/Cyclodextrin and Progesterone/Cyclodextrin Formulations: A Review of the Literature Data.

PubMed

Scavone, Cristina; Bonagura, Angela Colomba; Fiorentino, Sonia; Cimmaruta, Daniela; Cenami, Rosina; Torella, Marco; Fossati, Tiziano; Rossi, Francesco

2016-06-01

According to health technology assessment, patients deserve the best medicine. The development of drugs associated with solubility enhancers, such as cyclodextrins, represents a measure taken in order to improve the management of patients. Different drugs, such as estradiol, testosterone, dexamethasone, opioids, non-steroidal anti-inflammatories (NSAIDs; i.e. diclofenac), and progesterone are associated with cyclodextrins. Products containing the association of diclofenac/cyclodextrins are available for subcutaneous, intramuscular, and intravenous administration in doses that range from 25 to 75 mg. Medicinal products containing the association of progesterone/cyclodextrins are indicated for intramuscular and subcutaneous injection at a dose equal to 25 mg. The effects of cyclodextrins have been discussed in the solubility profile and permeability through biological membranes of drug molecules. A literature search was performed in order to give an overview of the pharmacokinetic characteristics, and efficacy and safety profiles of diclofenac/hydroxypropyl-β-cyclodextrin (HPβCD) and progesterone/HPβCD associations. The results of more than 20 clinical studies were reviewed. It was suggested that the new diclofenac/HPβCD formulation gives a rapid and effective response to acute pain and, furthermore, has pharmacokinetic and efficacy/safety profiles comparable to other medicinal products not containing cyclodextrins. One of the principal aspects of these new diclofenac formulations is that in lowering the dose (lower than 50 mg) the drugs could be more tolerable, especially in patients with comorbid conditions. Moreover, results of studies investigating the characteristics of progesterone and cyclodextrins showed that the new formulation (progesterone/HPβCD 25 mg solution) has the same bioavailability as other products containing progesterone. It is more rapidly absorbed and allows the achievement of peak plasma concentrations in a shorter time. Finally, the new formulation of progesterone was shown to be safe and not inferior to other products already on the market, with the exception of progesterone administered vaginally. As shown by the results of clinical studies presented in this review, the newly approved medicines containing cyclodextrins have been found to be as effective and as well-tolerated as other medicinal products that do not contain cyclodextrins. Moreover, the newly approved lower dose of diclofenac associated with cyclodextrins is consistent with the European Medicines Agency recommendations reported in the revision of the Assessment Report for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Cardiovascular Risk. Finally, the use of cyclodextrins led to significant increases in solubility and bioavailability of drugs, such as diclofenac and progesterone, and improvement in the efficacy and safety of these drugs.

Insulin Aspart in the Management of Diabetes Mellitus: 15 Years of Clinical Experience.

PubMed

Hermansen, Kjeld; Bohl, Mette; Schioldan, Anne Grethe

2016-01-01

Limiting excessive postprandial glucose excursions is an important component of good overall glycemic control in diabetes mellitus. Pharmacokinetic studies have shown that insulin aspart, which is structurally identical to regular human insulin except for the replacement of a single proline amino acid with an aspartic acid residue, has a more physiologic time-action profile (i.e., reaches a higher peak and reaches that peak sooner) than regular human insulin. As expected with this improved pharmacokinetic profile, insulin aspart demonstrates a greater glucose-lowering effect compared with regular human insulin. Numerous randomized controlled trials and a meta-analysis have also demonstrated improved postprandial control with insulin aspart compared with regular human insulin in patients with type 1 or type 2 diabetes, as well as efficacy and safety in children, pregnant patients, hospitalized patients, and patients using continuous subcutaneous insulin infusion. Studies have demonstrated that step-wise addition of insulin aspart is a viable intensification option for patients with type 2 diabetes failing on basal insulin. Insulin aspart has shown a good safety profile, with no evidence of increased receptor binding, mitogenicity, stimulation of anti-insulin antibodies, or hypoglycemia compared with regular human insulin. In one meta-analysis, there was evidence of a lower rate of nocturnal hypoglycemia compared with regular human insulin and, in a trial that specifically included patients with a history of recurrent hypoglycemia, a significantly lower rate of severe hypoglycemic episodes. The next generation of insulin aspart (faster-acting insulin aspart) is being developed with a view to further improving on these pharmacokinetic/pharmacodynamic properties.

77 FR 54615 - Strategic Management Program; Fiscal Year 2013-2016 Strategic Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

... Manager, Strategic Management Program; National Transportation Safety Board, 490 L'Enfant Plaza SW., MD-1... NATIONAL TRANSPORTATION SAFETY BOARD Strategic Management Program; Fiscal Year 2013-2016 Strategic Plan AGENCY: National Transportation Safety Board. ACTION: Notice: Request for comments. SUMMARY: This...

Patient Safety Culture in Mutual Insurance Companies in Spain.

PubMed

Manzanera, Rafael; Mira, José Joaquín; Plana, Manel; Moya, Daniel; Guilabert, Mercedes; Ortner, Jordi

2017-02-22

The aim of the study was to assess the safety culture in a mutual insurance sector, searching for improvement opportunities. This sector offers health insurance for work-related injuries and occupational illnesses and represents an annual volume of patients corresponding to approximately 10% of the working population in Europe. A cross-sectional study was conducted to assess the safety culture in the mutual insurance sector in Spain. All physicians, nurses, and physiotherapists (N = 816) working in the organization in hospitals, outpatient clinics, and managerial settings were invited to reply to an online survey. A total of 499 professionals completed the questionnaire (response rate, 61%). Two dimensions were assessed: attitudinal (5 items) and instrumental (5 items). There were no differences between professional profiles or centers in the attitudinal (7.8; standard deviation, 1.3; 95% confidence interval, 7.6-7.9) or instrumental (8.5; standard deviation, 1.0; 95% confidence interval, 8.5-8.6) factors. The lowest level of implementation (<9 points) was related to the following: open disclosure after an adverse event (73%), having a quality and safety plan (75%), prioritizing the improvement of patient care (75%), and involving patients when making decisions on potential treatments (63%). Managers showed lower scores than the rest of professionals' groups (P < 0.05). This intent is to introduce a patient safety culture assessment in the mutual insurance companies. These results may encourage the implementation of quality and safety plans in this sector by paying more attention to attitudinal aspects.

Denosumab for the Treatment of Osteoporosis

PubMed Central

Zaheer, Sarah; LeBoff, Meryl; Lewiecki, E. Michael

2015-01-01

Introduction Low trauma fractures due to osteoporosis are a major health concern worldwide. Despite the availability of many therapeutic compounds to reduce fracture risk, osteoporosis remains undertreated and the burden of osteoporotic fractures remains high. Denosumab is a novel agent that acts to reduce bone turnover, improve bone mineral density, and reduce fracture risk, offering a favorable efficacy and safety profile. Areas covered This review covers the pharmacology and major clinical trials with extension/post-marketing follow-up, including trials for all FDA-approved indications of denosumab to date. Expert Opinion Denosumab is an efficacious and safe osteoporosis treatment option, with current data up to 8 years of continued use showing continued improvement in bone density with sustained fracture risk reduction. Safety profiles overall are similar to placebo, with no new safety concerns in extension trials, though a theoretical increased risk of infection exists with RANKL inhibition. Future considerations include safety of prolonged treatment beyond 8 years, and efficacy/fracture risk after discontinuation or with non-adherence, given the characteristic pharmacodynamic profile of denosumab. PMID:25614274

Supervisor vs. employee safety perceptions and association with future injury in US limited-service restaurant workers.

PubMed

Huang, Yueng-Hsiang; Verma, Santosh K; Chang, Wen-Ruey; Courtney, Theodore K; Lombardi, David A; Brennan, Melanye J; Perry, Melissa J

2012-07-01

Many studies have found management commitment to safety to be an important construct of safety climate. This study examined the association between supervisor and employee (shared and individual) perceptions of management commitment to safety and the rate of future injuries in limited-service restaurant workers. A total of 453 participants (34 supervisors/managers and 419 employees) from 34 limited-service restaurants participated in a prospective cohort study. Employees' and managers' perceptions of management commitment to safety and demographic variables were collected at the baseline. The survey questions were made available in three languages: English, Spanish, and Portuguese. For the following 12 weeks, participants reported their injury experience and weekly work hours. A multivariate negative binomial generalized estimating equation model with compound symmetry covariance structure was used to assess the association between the rate of self-reported injuries and measures of safety perceptions. There were no significant relationships between supervisor and either individual or shared employee perceptions of management commitment to safety. Only individual employee perceptions were significantly associated with future employee injury experience but not supervisor safety perceptions or shared employee perceptions. Individual employee perception of management commitment to safety is a significant predictor for future injuries in restaurant environments. A study focusing on employee perceptions would be more predictive of injury outcomes than supervisor/manager perceptions. Copyright © 2012 Elsevier Ltd. All rights reserved.

General Safety and Waste Management Related to SAM

EPA Pesticide Factsheets

The General Safety and Waste Management page offers section-specific safety and waste management details for chemicals, radiochemicals, pathogens, and biotoxins included in EPA's Selected Analytical Methods for Environmental Remediation and Recovery (SAM).

The role of health and safety experts in the management of hazardous and toxic wastes in Indonesia

NASA Astrophysics Data System (ADS)

Supriyadi; Hadiyanto

2018-02-01

Occupational Safety and Health Experts in Indonesia have an important role in integrating environmental health and safety factors, including in this regard as human resources assigned to undertake hazardous waste management. Comprehensive knowledge and competence skills need to be carried out responsibly, as an inherent professional occupational safety and health profession. Management leaders should continue to provide training in external agencies responsible for science in the management of toxic waste to enable occupational safety and health experts to improve their performance in the hierarchy of control over the presence of hazardous materials. This paper provides an overview of what strategies and competencies the Occupational Safety and Health expert needs to have in embracing hazardous waste management practices.

Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes

PubMed Central

Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

2016-01-01

Objective. Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. Methods. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. Results. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. Conclusion. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. Trial registration: ClincialTrials.gov, clinicaltrials.gov, NCT00069329 PMID:27143789

Measurement of worker perceptions of trust and safety climate in managers and supervisors at commercial grain elevators.

PubMed

Mosher, G A; Keren, N; Freeman, S A; Hurburgh, C R

2013-04-01

The safety climate of an agricultural workplace may be affected by several things, including the level of trust that workers have in their work group supervisor and organizational management. Safety climate has been used by previous safety researchers as a measure of worker perceptions of the relative importance of safety as compared with other operational goals. Trust has been linked to several positive safety outcomes, particularly in hazardous work environments, but has not been examined relative to safety climate in the perennially hazardous work environment of a commercial grain elevator. In this study, 177 workers at three Midwest grain elevator companies completed online surveys measuring their perceptions of trust and safety at two administrative levels: organizational management and work group supervisors. Positive and significant relationships were noted between trust and safety climate perceptions for organizational managers and for work group supervisors. Results from this research suggest that worker trust in organizational management and work group supervisors has a positive influence on the employees' perceptions of safety climate at the organizational and work group levels in an agricultural workplace.

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

PubMed

Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

2015-12-01

Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher rate of adverse events among cannabis users compared with controls but not for serious adverse events at an average dose of 2.5 g herbal cannabis per day. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Longitudinal study of Salmonella 1,4,[5],12:i:- shedding in five Australian pig herds.

PubMed

Weaver, T; Valcanis, M; Mercoulia, K; Sait, M; Tuke, J; Kiermeier, A; Hogg, G; Pointon, A; Hamilton, D; Billman-Jacobe, H

2017-01-01

The shedding patterns of Salmonella spp. and MLVA profiles of Salmonella enterica subspecies enterica (I) serotype 1,4,[5],12:i:- were monitored in a 12-month longitudinal observational study of five pig herds to inform management; provide indications of potential hazard load at slaughter; and assist evaluation of MLVA for use by animal and public health practitioners. Twenty pooled faecal samples, stratified by age group, were collected quarterly. When Salmonella was cultured, multiple colonies were characterized by serotyping and where S. Typhimurium-like serovars were confirmed, isolates were further characterized by phage typing and multiple locus variable number tandem repeat analysis (MLVA). Salmonella was detected in 43% of samples. Salmonella 1,4,[5],12:i- was one of several serovars that persisted within the herds and was found among colonies from each production stage. Virtually all Salmonella 1,4,[5],12:i:- isolates were phage type 193, but exhibited 12 different, closely-related MLVA profiles. Salmonella 1,4,[5],12:i:- diversity within herds was low and MLVA profiles were stable indicating colonization throughout the herds and suggesting each farm had an endemic strain. High prevalence of S. 1,4,[5],12:i:- specific shedding among terminal animals indicated high hazard load at slaughter, suggesting that primary production may be an important pathway of S. 1,4,[5],12:i:- into the human food chain, this has implications for on-farm management and the application and targeting control measures and further evidence of the need for effective process control procedures to be in place during slaughter and in pork boning rooms. These findings have implications for animal health and food safety risk mitigation and risk management. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

A patient-centred approach to treatment with incretin-based agents in patients with type 2 diabetes.

PubMed

Cornell, Susan A

2013-06-01

The 2012 position statement from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommends a haemoglobin A1c level of <7% for most patients with type 2 diabetes (T2D). Initial therapy consists of lifestyle changes plus metformin, with an emphasis on a patient-centred approach to management. Addition of incretin-based therapy is recommended as an add-on after metformin failure, and later on in combination with basal insulin. Basal insulin is recommended from the onset in patients with A1c ≥10%. The possibility of incorporating incretin-based therapy in the patient-centred approach will be investigated both in the literature and clinical experience. Incretin-based therapy targets multiple dysfunctional organ systems in T2D and provides sustained glycaemic control, with extraglycaemic benefits and low risk of hypoglycaemia. To initiate an incretin-based therapy that best fits an individual patient's needs, the patient's A1c level, preference and comorbid conditions should be considered along with any drug safety and adherence-related issues. There is good evidence to support the patient-centred approach to T2D management. This approach allows patient treatment goals and personal preferences to be matched with the clinical profile(s) of one or more agents to formulate a treatment plan that can best achieve the goals. Incretin-based therapies are an important class of agents to consider after metformin monotherapy failure and later in combination with basal insulin. By matching patient needs with the clinical profiles of the various treatment options, pharmacists can actively engage in the practice of patient-centred care and management. © 2013 Blackwell Publishing Ltd.

41 CFR 102-80.110 - What must an equivalent level of safety analysis indicate?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., and reliability of all building systems impacting fire growth, occupant knowledge of the fire, and... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety...

41 CFR 102-80.110 - What must an equivalent level of safety analysis indicate?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., and reliability of all building systems impacting fire growth, occupant knowledge of the fire, and... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety...

41 CFR 102-80.110 - What must an equivalent level of safety analysis indicate?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., and reliability of all building systems impacting fire growth, occupant knowledge of the fire, and... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety...

41 CFR 102-80.110 - What must an equivalent level of safety analysis indicate?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., and reliability of all building systems impacting fire growth, occupant knowledge of the fire, and... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety...

The effect of safety factor profile on transport in steady-state, high-performance scenarios

DOE PAGES

Holcomb, C. T.; Ferron, J. R.; Luce, T. C.; ...

2012-03-09

In this study, an analysis of the dependence of transport on the safety factor profile in high-performance, steady-state scenario discharges is presented. This is based on experimental scans of q 95 and q min taken with fixed β N, toroidal field, double-null plasma shape, divertor pumping, and electron cyclotron current drive input. The temperature and thermal diffusivity profiles were found to vary considerably with the q-profile, and these variations were significantly different for electrons and ions. With fixed q 95, both temperature profiles increase and broaden as q min is increased and the magnetic shear becomes low or negative inmore » the inner half radius, but these temperature profile changes are stronger for the electrons. Power balance calculations show the peak in the ion thermal diffusivity (χ i) at ρ – 0.6 – 0.8 increases with q 95 or q min.« less

Highly selective peroxisome proliferator-activated receptor δ (PPARδ) modulator demonstrates improved safety profile compared to GW501516.

PubMed

Lagu, Bharat; Kluge, Arthur F; Goddeeris, Matthew M; Tozzo, Effie; Fredenburg, Ross A; Chellur, Shekar; Senaiar, Ramesh S; Jaleel, Mahaboobi; Babu, D Ravi Krishna; Tiwari, Nirbhay K; Takahashi, Taisuke; Patane, Michael A

2017-11-04

Compound 1 regulates significantly fewer genes than the PPARδ modulator, GW501516. Both compounds are efficacious in a thermal injury model of muscle regeneration. The restricted gene profile of 1 relative to GW501516 suggests that 1 may be pharmacoequivalent to GW501516 with fewer PPAR-related safety concerns. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety of Silicone Oil Removal in Cases of Gunshot Perforating Eye Injuries.

PubMed

Ghoraba, Hammouda Hamdy; Elgouhary, Sameh Mohamed; Mansour, Hosam Osman; Abdel-Fattah, Hitham Mamoun; Heikal, Mohamed Amin; Elgemaey, Emad Mohamed

2017-03-01

To evaluate the feasibility and safety of silicone oil (SO) removal in cases of gunshot perforating eye injuries (PEI). A retrospective, consecutive, interventional study from medical records regarding cases of gunshot PEI during the periods of Egyptian political instability (January 2011 until December 2013). The main outcomes were to evaluate the feasibility of SO removal in cases of gunshot PEI and management of retinal detachment (RD) after SO removal in such cases. One hundred ninety-six eyes of 193 patients were reviewed. SO was removed in 72 eyes of 70 patients (36.7%). After SO removal, five eyes (6.9%) developed RD. One case refused any other intervention. RD in the remaining four cases was treated with revision surgery and SO reinjection. The retina remained stable throughout follow-up. None of the eyes developed phthisis bulbi after SO removal. Mean follow-up after SO removal was 10.86 months (range: 3 months to 30 months). Mean follow-up after management of RD after SO removal was 17.7 months (range: 13 months to 21 months). Patients aged younger than 20 years were associated with extensive fibrous proliferation, which might affect the safety profile of SO removal in cases of gunshot PEI. Rate of RD after SO removal in cases of apparent retinal stability and localized fibrous proliferation was 6.9%. Retinal detachment after SO removal in such cases can be treated with revision surgery and SO reinjection. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:242-250.]. Copyright 2017, SLACK Incorporated.

Review of the efficacy and safety of transanal irrigation for neurogenic bowel dysfunction.

PubMed

Emmanuel, A

2010-09-01

Neurogenic bowel dysfunction (NBD) is a common occurrence after spinal cord injury (SCI) and in patients with spina bifida or multiple sclerosis. The impact of NBD on well-being is considerable, affecting both physical and psychological aspects of quality of life. Transanal irrigation (TAI) of the colon promotes the evacuation of faeces by introducing water into the colon and rectum through a catheter inserted into the anus. Regular and controlled evacuation in this manner aims at preventing both constipation and faecal soiling. The aim of this study was to review current evidence for the efficacy and safety of TAI in patients with NBD. A literature search was conducted in PubMed. All identified papers were assessed for relevance based on the title and abstract; this yielded 23 studies that were considered to be of direct relevance to the topic of the review. A multicentre, randomized, controlled trial has supported observational reports in demonstrating that TAI offers significant benefits over conservative bowel management in patients with SCI, in terms of managing constipation and faecal incontinence, reducing NBD symptoms and improving quality of life. Among other populations with NBD, TAI shows the greatest promise in children with spina bifida; however, further investigation is required. The overall safety profile of TAI is good, with few, and rare, adverse effects. Building on the positive data reported for patients with SCI, continued evaluation in the clinical trial setting is required to further define the utility of TAI in other populations with NBD.

Pharmacovigilance in oncology: evaluation of current practice and future perspectives.

PubMed

Baldo, Paolo; De Paoli, Paolo

2014-10-01

Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.

Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

PubMed

Di Pasquale, Alberta; Bonanni, Paolo; Garçon, Nathalie; Stanberry, Lawrence R; El-Hodhod, Mostafa; Tavares Da Silva, Fernanda

2016-12-20

Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile. Copyright © 2016. Published by Elsevier Ltd.

49 CFR 385.321 - What failures of safety management practices disclosed by the safety audit will result in a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... disclosed by the safety audit will result in a notice to a new entrant that its USDOT new entrant... MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.321 What failures of safety management practices disclosed by the safety audit will result in a notice...

41 CFR 102-80.130 - Who must perform the equivalent level of safety analysis?

Code of Federal Regulations, 2010 CFR

2010-07-01

...-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety Analysis... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who must perform the equivalent level of safety analysis? 102-80.130 Section 102-80.130 Public Contracts and Property Management...

46 CFR 91.60-30 - Safety Management Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Safety Management Certificate. 91.60-30 Section 91.60-30 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) CARGO AND MISCELLANEOUS VESSELS INSPECTION AND CERTIFICATION Certificates Under International Convention for Safety of Life at Sea, 1974 § 91.60-30 Safety Management Certificate. All...

The safety of vedolizumab for the treatment of ulcerative colitis.

PubMed

Novak, Gregor; Hindryckx, Pieter; Khanna, Reena; Jairath, Vipul; Feagan, Brian G

2017-04-01

Vedolizumab is a humanized monoclonal antibody to the α4β7-integrin that blocks lymphocyte trafficking to the gut and is approved for treatment of patients with moderate-to-severe ulcerative colitis (UC). The gut-selective mechanism of action has the potential to improve vedolizumab's safety profile compared to other approved biologic drugs. Areas covered: We review the mechanism of action, efficacy and safety of vedolizumab treatment for UC. The positioning of vedolizumab in management algorithms is also discussed. Expert opinion: The highly selective mechanism of action of vedolizumab restricts immunosuppressive effects to the gut. Vedolizumab is efficacious as induction and maintenance therapy in UC patients who are naïve or refractory to tumor necrosis factor antagonists. No clinically important safety signals have been identified. Infusion reactions are reported in <5% of cases. The rates of adverse events (AE), serious AEs, and serious infections were not different between patients treated with placebo and those who received vedolizumab in a pooled analysis of six randomized controlled trials. Rates of malignancy and mortality in vedolizumab-exposed patients are similar to those of the general UC patient population. Progressive multifocal leukoencephalopathy has not been observed. Vedolizumab is a safe and effective therapy for UC with a unique mechanism of action.

76 FR 35130 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors AGENCY: Pipeline and Hazardous Materials Safety Administration... safety standards, risk assessments, and safety policies for natural gas pipelines and for hazardous...

49 CFR 237.31 - Adoption of bridge management programs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Adoption of bridge management programs. 237.31... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRIDGE SAFETY STANDARDS Railroad Bridge Safety Assurance § 237.31 Adoption of bridge management programs. Each track owner shall adopt a bridge safety management program to...

41 CFR 102-80.35 - What are Federal agencies' responsibilities concerning the monitoring of hazardous materials and...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 102-80.35 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and... Safety and Health Administration (OSHA), Department of Transportation, EPA, and applicable State and...

49 CFR 237.31 - Adoption of bridge management programs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Adoption of bridge management programs. 237.31... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRIDGE SAFETY STANDARDS Railroad Bridge Safety Assurance § 237.31 Adoption of bridge management programs. Each track owner shall adopt a bridge safety management program to...

77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-08

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA...

The perceived compatibility of safety and production expectations in hazardous occupations.

PubMed

McLain, David L; Jarrell, Kimberly A

2007-01-01

Safety hazards are unavoidable in many work environments. Employees must be both productive and safe, however, conflicting safety and production demands can negatively affect safety, production, or both. The employee's perception of the compatibility of management's safety and production expectations is a possible predictor of such consequences. This paper defines "safety-production compatibility" and describes how measures of safety-production compatibility, as well as safety pressure and production pressure, were developed. We used LISREL structural equation modeling to test the influences of safety-production compatibility, safety pressure, and production pressure on safe work behavior and interference with performing other work tasks. The 239 study participants were workers employed in diverse but hazardous occupations. Pressure to work safely was positively associated with safe work behavior. The perceived compatibility of safety and production demands positively influenced safe work behavior and reduced the interference of safety hazards performing other tasks. Safety-production compatibility was also found to mediate the relationship between trust in management and safe work behavior. The results of this field study suggest increased compatibility, and thus less conflict, between safety and production demands influences safe work behavior and the interference of safety hazards with performing other work tasks. More broadly, the worker's reaction to multiple work demands is a safety and performance influence. Safety management efforts that focus only on the hazards fail to eliminate many accidents because accidents arise from many factors including technology, safety climate, social influences, production, and safety demands. This study suggests that workers differ in their perception of the compatibility of safety and production demands. These differences will show up in safe work behavior, influencing the effectiveness of safety management efforts and the trust workers have in management's concern for safety.

Impact of access management practices to pedestrian safety.

DOT National Transportation Integrated Search

2017-03-31

This study focused on the impact of access management practices to the safety of pedestrians. Some : of the access management practices considered to impact pedestrian safety included limiting direct : access to and from major streets, locating signa...

33 CFR 96.300 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems... international certification for the company's and vessel's safety management system. ...

Applying Sensor-Based Technology to Improve Construction Safety Management.

PubMed

Zhang, Mingyuan; Cao, Tianzhuo; Zhao, Xuefeng

2017-08-11

Construction sites are dynamic and complicated systems. The movement and interaction of people, goods and energy make construction safety management extremely difficult. Due to the ever-increasing amount of information, traditional construction safety management has operated under difficult circumstances. As an effective way to collect, identify and process information, sensor-based technology is deemed to provide new generation of methods for advancing construction safety management. It makes the real-time construction safety management with high efficiency and accuracy a reality and provides a solid foundation for facilitating its modernization, and informatization. Nowadays, various sensor-based technologies have been adopted for construction safety management, including locating sensor-based technology, vision-based sensing and wireless sensor networks. This paper provides a systematic and comprehensive review of previous studies in this field to acknowledge useful findings, identify the research gaps and point out future research directions.

Applying Sensor-Based Technology to Improve Construction Safety Management

PubMed Central

Zhang, Mingyuan; Cao, Tianzhuo; Zhao, Xuefeng

2017-01-01

Construction sites are dynamic and complicated systems. The movement and interaction of people, goods and energy make construction safety management extremely difficult. Due to the ever-increasing amount of information, traditional construction safety management has operated under difficult circumstances. As an effective way to collect, identify and process information, sensor-based technology is deemed to provide new generation of methods for advancing construction safety management. It makes the real-time construction safety management with high efficiency and accuracy a reality and provides a solid foundation for facilitating its modernization, and informatization. Nowadays, various sensor-based technologies have been adopted for construction safety management, including locating sensor-based technology, vision-based sensing and wireless sensor networks. This paper provides a systematic and comprehensive review of previous studies in this field to acknowledge useful findings, identify the research gaps and point out future research directions. PMID:28800061

Influenza vaccines: Evaluation of the safety profile

PubMed Central

Trombetta, Claudia Maria; Gianchecchi, Elena; Montomoli, Emanuele

2018-01-01

ABSTRACT The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated. Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines. Both display a good safety profile in adults and children. However, they can cause adverse events and/or rare adverse events, some of which are more prevalent in children, while others with a higher prevalence in adults. The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods. PMID:29297746

CSHM: Web-based safety and health monitoring system for construction management.

PubMed

Cheung, Sai On; Cheung, Kevin K W; Suen, Henry C H

2004-01-01

This paper describes a web-based system for monitoring and assessing construction safety and health performance, entitled the Construction Safety and Health Monitoring (CSHM) system. The design and development of CSHM is an integration of internet and database systems, with the intent to create a total automated safety and health management tool. A list of safety and health performance parameters was devised for the management of safety and health in construction. A conceptual framework of the four key components of CSHM is presented: (a) Web-based Interface (templates); (b) Knowledge Base; (c) Output Data; and (d) Benchmark Group. The combined effect of these components results in a system that enables speedy performance assessment of safety and health activities on construction sites. With the CSHM's built-in functions, important management decisions can theoretically be made and corrective actions can be taken before potential hazards turn into fatal or injurious occupational accidents. As such, the CSHM system will accelerate the monitoring and assessing of performance safety and health management tasks.

Road Infrastructure Safety Management in Poland

NASA Astrophysics Data System (ADS)

Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

2017-10-01

The objective of road safety infrastructure management is to ensure that when roads are planned, designed, built and used road risks can be identified, assessed and mitigated. Road transport safety is significantly less developed than that of rail, water and air transport. The average individual risk of being a fatality in relation to the distance covered is thirty times higher in road transport that in the other modes. This is mainly because the different modes have a different approach to safety management and to the use of risk management methods and tools. In recent years Poland has had one of the European Union’s highest road death numbers. In 2016 there were 3026 fatalities on Polish roads with 40,766 injuries. Protecting road users from the risk of injury and death should be given top priority. While Poland’s national and regional road safety programmes address this problem and are instrumental in systematically reducing the number of casualties, the effects are far from the expectations. Modern approaches to safety focus on three integrated elements: infrastructure measures, safety management and safety culture. Due to its complexity, the process of road safety management requires modern tools to help with identifying road user risks, assess and evaluate the safety of road infrastructure and select effective measures to improve road safety. One possible tool for tackling this problem is the risk-based method for road infrastructure safety management. European Union Directive 2008/96/EC regulates and proposes a list of tools for managing road infrastructure safety. Road safety tools look at two criteria: the life cycle of a road structure and the process of risk management. Risk can be minimized through the application of the proposed interventions during design process as reasonable. The proposed methods of risk management bring together two stages: risk assessment and risk response occurring within the analyzed road structure (road network, road stretch, road section, junction, etc.). The objective of the methods is to help road authorities to take rational decisions in the area of road safety and road infrastructure safety and understand the consequences occurring in the particular phases of road life cycle. To help with assessing the impact of a road project on the safety of related roads, a method was developed for long-term forecasts of accidents and accident cost estimation as well as a risk classification to identify risks that are not acceptable risks. With regard to road safety audits and road safety inspection, a set of principles was developed to identify risks and the basic classification of mistakes and omissions. This work has added to the Polish experience of preparing and implementing such tools within the competent road authorities.

Pesticide-Induced Stress in Arthropod Pests for Optimized Integrated Pest Management Programs.

PubMed

Guedes, R N C; Smagghe, G; Stark, J D; Desneux, N

2016-01-01

More than six decades after the onset of wide-scale commercial use of synthetic pesticides and more than fifty years after Rachel Carson's Silent Spring, pesticides, particularly insecticides, arguably remain the most influential pest management tool around the globe. Nevertheless, pesticide use is still a controversial issue and is at the regulatory forefront in most countries. The older generation of insecticide groups has been largely replaced by a plethora of novel molecules that exhibit improved human and environmental safety profiles. However, the use of such compounds is guided by their short-term efficacy; the indirect and subtler effects on their target species, namely arthropod pest species, have been neglected. Curiously, comprehensive risk assessments have increasingly explored effects on nontarget species, contrasting with the majority of efforts focused on the target arthropod pest species. The present review mitigates this shortcoming by hierarchically exploring within an ecotoxicology framework applied to integrated pest management the myriad effects of insecticide use on arthropod pest species.

A comprehensive approach to managing threats of violence on a university or college campus.

PubMed

Regehr, Cheryl; Glancy, Graham D; Carter, Andrea; Ramshaw, Lisa

Horrifying, high profile acts of violence on campuses remain relatively rare, nevertheless, academic administrators are required to manage threats of violence on campus on an increasingly regular basis. These threats take two primary forms, those in which the perpetrator and the intended victim(s) are clearly identified, often involving repeated threats and threatening behaviour towards an individual; and those involving anonymous threats to commit acts of larger scale violence. Complicating factors in managing these threats include: fear contagion; mass media and social media attention; responsibilities to all members of the university community sometimes including individuals issuing the threat and the intended victims; demands for safety and security measures that are often at odds with professional advice; and permeable campus boundaries that cause security challenges. This paper considers the changing landscape of threat assessment and risk assessment on university and college campuses and suggests opportunities for partnerships between forensic mental health professionals and academic administrators. Copyright © 2017 Elsevier Ltd. All rights reserved.

Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

PubMed

Sinclair, Robert R; Martin, James E; Sears, Lindsay E

2010-09-01

Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research. 2009 Elsevier Ltd. All rights reserved.

Cross-modal work helps OMC improve the safety of commercial transportation

DOT National Transportation Integrated Search

1997-01-01

This article describes the Commercial Vehicle Information System (CVIS), designed to deploy a national safety program for the U.S. commercial trucking fleet. CVIS is built around a safety analysis algorithm called SafeStat which constructs a profile ...

Safety awareness, pilot education, and incident reporting programs

NASA Technical Reports Server (NTRS)

Enders, J.

1984-01-01

Education in safety awareness, pilot training, and accident reporting is discussed. Safety awareness and risk management are examined. Both quantitative and qualitive risk management are explored. Information dissemination on safety is considered.

76 FR 62035 - Privacy Act of 1974: Notice of Proposed Privacy Act System of Records Revision

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... the purpose of the Radiation Safety Management System (RSMS). The RSMS was developed by the Radiation Safety Division, a component of USDA's DM, as a tool for the management of the USDA's radiation safety... USDA employees and the Radiation Safety Division (RSD) of USDA to manage information required by the...

Atorvastatin calcium encapsulated eudragit nanoparticles with enhanced oral bioavailability, safety and efficacy profile.

PubMed

Kumar, Nagendra; Chaurasia, Sundeep; Patel, Ravi R; Khan, Gayasuddin; Kumar, Vikas; Mishra, Brahmeshwar

2017-03-01

Atorvastatin calcium (ATR), a second generation statin drug, was encapsulated in eudragit RSPO-based polymeric nanoparticles. The effect of independent variables (polymer content, stabilizer concentration, volume of chloroform and homogenization speed) on response variables (mean diameter particle size and entrapment efficiency) were investigated by employing central composite experimental design. All the independent variables were found to be significant for determining the response variables. Solid-state characterization study indicated the absence of physicochemical interaction between drug and polymer in formulation. Morphological study exhibited homogenous spherical shape of formulated nanoparticles. In vitro release study in phosphate buffer (pH 7.4) demonstrated sustained release profile over 24 h. Pharmacokinetic study in Charles Foster rats showed significant enhancement in oral bioavailability as compared to pure drug suspension. Efficacy study (lipid profile and blood glucose level) significantly justified the effectiveness of formulation having 50% less dose of ATR as compared to pure drug suspension. The effectiveness of formulation was further justified with an improved plasma safety profile of treated rats. Hence, ATR encapsulated eudragit RSPO nanoparticles can serve as potential drug delivery approach to enhance drug bioavailability, efficacy and safety profiles to alter existing marketed drug products.

A system safety model for developmental aircraft programs

NASA Technical Reports Server (NTRS)

Amberboy, E. J.; Stokeld, R. L.

1982-01-01

Basic tenets of safety as applied to developmental aircraft programs are presented. The integration of safety into the project management aspects of planning, organizing, directing and controlling is illustrated by examples. The basis for project management use of safety and the relationship of these management functions to 'real-world' situations is presented. The rationale which led to the safety-related project decision and the lessons learned as they may apply to future projects are presented.

Novel treatment options for transfusional iron overload in patients with myelodysplastic syndromes.

PubMed

Goldberg, Stuart L

2007-12-01

Red blood cell transfusion dependency is common in myelodysplastic syndromes and is associated with inferior survival. The use of parenteral deferoxamine therapy for transfusional iron overload has been sparse, in part due to cumbersome administration schedules. Deferasirox is an oral iron-chelating agent with favorable pharmacokinetics, including a long half-life allowing continuous 24-hour chelation with once-daily dosing. Deferasirox produces dose-dependent reductions in liver iron content and reduces cardiac iron levels. In-vitro studies with deferasirox suggest improved cardiomyocyte contractility potentially important in reducing excess cardiac mortality noted in transfusion-dependent MDS. Deferasirox has a manageable safety profile with favorable patient satisfaction reports.

The apelinergic system as an alternative to catecholamines in low-output septic shock.

PubMed

Coquerel, David; Sainsily, Xavier; Dumont, Lauralyne; Sarret, Philippe; Marsault, Éric; Auger-Messier, Mannix; Lesur, Olivier

2018-01-19

Catecholamines, in concert with fluid resuscitation, have long been recommended in the management of septic shock. However, not all patients respond positively and controversy surrounding the efficacy-to-safety profile of catecholamines has emerged, trending toward decatecholaminization. Contextually, it is time to re-examine the "maintaining blood pressure" paradigm by identifying safer and life-saving alternatives. We put in perspective the emerging and growing knowledge on a promising alternative avenue: the apelinergic system. This target exhibits invaluable pleiotropic properties, including inodilator activity, cardio-renal protection, and control of fluid homeostasis. Taken together, its effects are expected to be greatly beneficial for patients in septic shock.

USDOT guidance summary for connected vehicle deployments : safety management.

DOT National Transportation Integrated Search

2016-07-01

This document provides guidance material in regards to safety management plan for the CV Pilots DeploymentConcept Development Phase. This guidance provides key concepts and references in developing the SafetyManagement Plan in Task 4, lists relevant ...

Management algorithms for cervical cancer screening and precancer treatment for resource-limited settings.

PubMed

Basu, Partha; Meheus, Filip; Chami, Youssef; Hariprasad, Roopa; Zhao, Fanghui; Sankaranarayanan, Rengaswamy

2017-07-01

Management algorithms for screen-positive women in cervical cancer prevention programs have undergone substantial changes in recent years. The WHO strongly recommends human papillomavirus (HPV) testing for primary screening, if affordable, or if not, then visual inspection with acetic acid (VIA), and promotes treatment directly following screening through the screen-and-treat approach (one or two clinic visits). While VIA-positive women can be offered immediate ablative treatment based on certain eligibility criteria, HPV-positive women need to undergo subsequent VIA to determine their eligibility. Simpler ablative methods of treatment such as cryotherapy and thermal coagulation have been demonstrated to be effective and to have excellent safety profiles, and these have become integral parts of new management algorithms. The challenges faced by low-resource countries are many and include, from the management perspective, identifying an affordable point-of-care HPV detection test, minimizing over-treatment, and installing an effective information system to ensure high compliance to treatment and follow-up. © 2017 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.

A comparative review of the options for treatment of erectile dysfunction: which treatment for which patient?

PubMed

Hatzimouratidis, Konstantinos; Hatzichristou, Dimitrios G

2005-01-01

The field of erectile dysfunction (ED) has been revolutionised over the last two decades. Several treatment options are available today, most of which are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken in order to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice of most physicians and patients for the treatment of ED. PDE5 inhibitors have differences in their pharmacological profiles, the most obvious being the long duration of action of tadalafil, but there are no data supporting superiority for any one of them in terms of efficacy or safety. Sublingual apomorphine has limited efficacy compared with the PDE5 inhibitors, and its use is limited to patients with mild ED. Treatment failures with oral drugs may be due to medication, clinician and patient issues. The physician needs to address all of these issues in order to identify true treatment failures. Patients who are truly unresponsive to oral drugs may be offered other treatment options.Intracavernous injections of alprostadil alone, or in combination with other vasoactive agents (papaverine and phentolamine), remain an excellent treatment option, with proven efficacy and safety over time. Topical pharmacotherapy is appealing in nature, but currently available formulations have limited efficacy. Vacuum constriction devices may be offered mainly to elderly patients with occasional intercourse attempts, as younger patients show limited preference because of the unnatural erection that is associated with this treatment modality. Penile prostheses are generally the last treatment option offered, because of invasiveness, cost and non-reversibility; however, they are associated with high satisfaction rates in properly selected patients. All treatment options are associated with particular strengths and weaknesses. A patient-centred approach based on patient needs and expectations is necessary for the management of ED. The clinician must educate the patient and provide a supportive environment for shared decision making. The management strategy must be supplemented by careful follow-up in order to identify changes in patient health and relationship/emotional status that may necessitate treatment optimisation.

23 CFR 630.1106 - Policy and procedures for work zone safety management.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 23 Highways 1 2011-04-01 2011-04-01 false Policy and procedures for work zone safety management... Policy and procedures for work zone safety management. (a) Each agency's policy and processes, procedures... established in accordance with 23 CFR 630.1006, shall include the consideration and management of road user...

77 FR 34123 - Pipeline Safety: Public Meeting on Integrity Management of Gas Distribution Pipelines

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-08

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2012-0100] Pipeline Safety: Public Meeting on Integrity Management of Gas Distribution Pipelines AGENCY: Office of Pipeline Safety, Pipeline and Hazardous Materials Safety Administration, DOT. ACTION...

Safety cost management in construction companies: A proposal classification.

PubMed

López-Alonso, M; Ibarrondo-Dávila, M P; Rubio, M C

2016-06-16

Estimating health and safety costs in the construction industry presents various difficulties, including the complexity of cost allocation, the inadequacy of data available to managers and the absence of an accounting model designed specifically for safety cost management. Very often, the costs arising from accidents in the workplace are not fully identifiable due to the hidden costs involved. This paper reviews some studies of occupational health and safety cost management and proposes a means of classifying these costs. We conducted an empirical study in which the health and safety costs of 40 construction worksites are estimated. A new classification of the health and safety cost and its categories is proposed: Safety and non-safety costs. The costs of the company's health and safety policy should be included in the information provided by the accounting system, as a starting point for analysis and control. From this perspective, a classification of health and safety costs and its categories is put forward.

The Perception, Level of Safety Satisfaction and Safety Feedback on Occupational Safety and Health Management among Hospital Staff Nurses in Sabah State Health Department.

PubMed

Cheah, Whye Lian; Giloi, Nelbon; Chang, Ching Thon; Lim, Jac Fang

2012-07-01

This study aimed to determine the perception and level of safety satisfaction of staff nurses with regards to Occupational Safety and Health (OSH) management practice in the Sabah Health Department, and to associate the OSH management dimensions, to Safety Satisfaction and Safety Feedback. A cross-sectional study using a validated self-administered questionnaire was conducted among randomly respondents. 135 nurses responded the survey. Mean (SD) score for each dimension ranged from 1.70 ± 0.68-4.04 ± 0.65, with Training and Competence dimension (mean [SD], 4.04 ± 0.65) had the highest while Safety Incidence was the least score (mean [SD], 1.70 ± 0.68). Both mean (SD) scores for Safety Satisfaction and Safety Feedback was high, 3.28 ± 0.51 and 3.57 ± 0.73, respectively. Pearson's correlation analysis indicated that all OSH dimensions had significant correlation with Safety Satisfaction and Safety Feedback (r coefficient ranged from 0.176-0.512) except for Safety Incidence. The overall perception of OSH management was rather low. Significant correlation between Safety Satisfaction and Safety Feedback and several dimensions, suggest that each organization to put in place the leaders who have appropriate leadership and supervisory skills and committed in providing staff training to improve staff's competency in OSH practice. In addition, clear goals, rules, and reporting system will help the organization to implement proper OSH management practice.

Quantitative PCR and disaccharide profiling to characterize the animal origin of low-molecular-weight heparins.

PubMed

Houiste, Céline; Auguste, Cécile; Macrez, Céline; Dereux, Stéphanie; Derouet, Angélique; Anger, Pascal

2009-02-01

Low-molecular-weight heparins (LMWHs) are widely used in the management of thrombosis and acute coronary syndromes. They are obtained by the enzymatic or chemical depolymerization of porcine intestinal heparin. Enoxaparin sodium, a widely used LMWH, has a unique and reproducible oligosaccharide profile which is determined by the origin of the starting material and a tightly controlled manufacturing process. Although other enoxaparin-like LMWHs do exist, specific release criteria including the origin of the crude heparin utilized for their production, have not been established. A quantitative polymerase chain reaction method has been developed to ensure the purity of the porcine origin of crude heparin, with a DNA detection limit as low as 1 ppm for bovine, or 10 ppm for ovine contaminants. This method is routinely used as the release acceptance criterion during enoxaparin sodium manufacturing. Furthermore, when the process removes DNA, other analytical techniques can be used to assess any contamination. Disaccharide profiling after exhaustive depolymerization can determine the presence of at least 10% bovine or 20% ovine material; multivariate analysis is useful to perform the data analysis. Consistent with the availability of newer technology, these methods should be required as acceptance criteria for crude heparins used in the manufacture of LMWHs to ensure their safety, quality, and immunologic profile.

Novel therapeutics in multiple sclerosis management: clinical applications.

PubMed

Leist, Thomas; Hunter, Samuel F; Kantor, Daniel; Markowitz, Clyde

2014-01-01

Multiple sclerosis (MS) affects an estimated 300,000 individuals in the United States. No cure exists and although there is a lack of consensus on management, strategies to modify disease course are available. These strategies involve initiating disease-modifying therapies that have been found to slow disease progression and prevent disability symptoms, thereby improving function for MS patients. The overall goal of early disease management is to intervene prior to irreversible neuronal destruction in order to delay disability progression and improve quality of life. Maintaining a lower level of disability for a longer period of time postpones and ultimately attempts to prevent reaching a level of immobility and irreversible disability. However, due to the complex nature of disease and its unique, individual patient course, no patient can be treated alike and no patient responds to therapy similarly. Therefore, MS research is continuous in its evolution of therapeutic development, focusing on neuroprotective effects and agents with distinctive mechanisms of action allowing for unique safety and efficacy profiles. Investigations include novel oral agents and monoclonal antibodies. Many of the approved agents also are continually being investigated in order to evaluate comparative data, the most appropriate means of implementing subsequent therapy upon failure, responsiveness to therapeutic agent when switched, and long-term safety and efficacy. This multimedia webcast educational activity will cover the current state of MS science, current therapies in MS, emerging treatments in clinical trials for MS as well as differences between physicians in diagnosis and management of MS and their evolving practices. Copyright © 2014. Published by Elsevier Inc.

Managed approaches to multiple sclerosis in special populations.

PubMed

Sperandeo, Kara; Nogrady, Lisa; Moreo, Kathleen; Prostko, Chris R

2011-01-01

Multiple sclerosis (MS) is a chronic demyelinating disorder of the central nervous system that is classified as an immune-mediated inflammatory disease. In managed care, patients with MS can be managed through care coordination that engages an interprofessional approach to a comprehensive spectrum of preventive, medical, rehabilitative, cognitive, and long-term health care services. In addition, the management paradigm for MS is currently in a stage of rapid evolution, with a number of new agents, including more oral drugs, expected to become available in the near future. Pharmacy and therapeutic committees may soon be faced with evaluating a hierarchy of new scientific data to differentiate the safety and efficacy of these new agents. Decisions will need to be made regarding the utility of these potential new agents among existing therapies with longer-term safety and efficacy data available in the scientific literature. For those MS patients managed under Medicaid, formulary and medication management decisions may be further impacted by psychosocial, cultural, educational, attitudinal, and/or economic factors that may be unique to the Medicaid population. The need to maximize immediate and long-term resource utilization is usually an important consideration when managing a Medicaid population. There is also an increasing focus on quality measures and quality outcomes by the Centers for Medicare and Medicaid Services. Many managed care professionals can be involved in establishing quality measures and quality improvement processes to effectively appropriate and manage the resources required for Medicaid patients with MS. As a result, medication and medical management of this special population can involve a comprehensive approach by managed care professionals. For purposes of this article, the term "special populations" applies to patients with MS who are managed under Medicaid plans. To review (a) particular challenges managed care organizations (MCOs) encounter when managing special populations of Medicaid patients with MS, (b) recent efficacy and safety data for oral therapies for relapsing forms of MS, (c) costs of current MS therapies, and (d) potential strategies for managed care to improve care of their MS patient population and optimize clinical and economic outcomes. Review of recent published literature, abstracts related to MS presented at major medical conferences, and recommendations from key organizations including the U.S. Department of Health and Human Services and the National Multiple Sclerosis Society. The health economics of MS are a central issue for MCOs managing Medicaid patient populations. Additional challenges include the anticipated expansion of the marketplace to include several new oral agents and the lack of consensus guidelines for management of patients with MS. The benefit-risk profile of new agents will need to be considered in the context of established first-line parenteral drugs. Management of patients with MS should include an individualized approach for each patient as part of a shared decision-making process. In the overall management of special patient populations, case management and collaborative practice models in managed care may help to ensure that critical benchmarks are achieved.

30 CFR 585.811 - When must I follow my Safety Management System?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., COPs and GAPs Safety Management Systems § 585.811 When must I follow my Safety Management System? Your... COP, SAP, or GAP. You must conduct all activities described in your approved COP, SAP, or GAP in...

30 CFR 585.811 - When must I follow my Safety Management System?

Code of Federal Regulations, 2014 CFR

2014-07-01

..., COPs and GAPs Safety Management Systems § 585.811 When must I follow my Safety Management System? Your... COP, SAP, or GAP. You must conduct all activities described in your approved COP, SAP, or GAP in...

30 CFR 585.811 - When must I follow my Safety Management System?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., COPs and GAPs Safety Management Systems § 585.811 When must I follow my Safety Management System? Your... COP, SAP, or GAP. You must conduct all activities described in your approved COP, SAP, or GAP in...

NYC CV Pilot Deployment : Safety Management Plan : New York City.

DOT National Transportation Integrated Search

2016-04-22

This safety management plan identifies preliminary safety hazards associated with the New York City Connected Vehicle Pilot Deployment project. Each of the hazards is rated, and a plan for managing the risks through detailed design and deployment is ...

Construction managers' perceptions of construction safety practices in small and large firms: a qualitative investigation.

PubMed

Gillen, Marion; Kools, Susan; McCall, Cade; Sum, Juliann; Moulden, Kelli

2004-01-01

Despite the institution of explicit safety practices in construction, there continue to be exceedingly high rates of morbidity and mortality from work-related injury. This study's purpose was to identify, compare and contrast views of construction managers from large and small firms regarding construction safety practices. A complementary analysis was conducted with construction workers. A semi-structured interview guide was used to elicit information from construction managers (n = 22) in a series of focus groups. Questions were designed to obtain information on direct safety practices and indirect practices such as communication style, attitude, expectations, and unspoken messages. Data were analyzed using thematic content analysis. Managers identified a broad commitment to safety, worker training, a changing workplace culture, and uniform enforcement as key constructs in maintaining safe worksites. Findings indicate that successful managers need to be involved, principled, flexible, and innovative. Best practices, as well as unsuccessful injury prevention programs, were discussed in detail. Obstacles to consistent safety practice include poor training, production schedules and financial constraints. Construction managers play a pivotal role in the definition and implementation of safety practices in the workplace. In order to succeed in this role, they require a wide variety of management skills, upper management support, and tools that will help them instill and maintain a positive safety culture. Developing and expanding management skills of construction managers may assist them in dealing with the complexity of the construction work environment, as well as providing them with the tools necessary to decrease work-related injuries.

Perceived safety management practices in the logistics sector.

PubMed

Auyong, Hui-Nee; Zailani, Suhaiza; Surienty, Lilis

2016-03-09

Malaysia's progress on logistics has been slowed to keep pace with its growth in trade. The Government has been pressing companies to improve the safety of their activities in order to reduce society's loss due to occupational accidents and illnesses. Occupational safety and health is a crucial part of a workplace because every worker has to take care of his/her own safety and health. The main occupational safety and health (OSH) national policy in Malaysia is the enactment of the Occupational Safety and Health Act (OSHA) 1994. Only those companies which have excellent health and safety care have good quality and productive employees. This study investigated safety management practices in the logistics sector. The present study is concerned with the human factors to safety in the logistics industry. The authors examined the perceived safety management practices of workers in the logistics sector. The purpose was to identify the perception of safety management practices of Malaysian logistics personnel. Survey questionnaires were distributed to assess logistics personnel about management commitment. The quantitative method using the availability sampling method was applied. The data gathered from the survey were analysed using SPSS software. The responses to the survey were rated according to the Likert scale type, with '1' indicating strongly disagree and '5' indicating strongly agree. One hundred and three employees of logistics functions completed the survey. The highest mean scores were found for fire apparatus, prioritisation of safety, and safety policy. The results from this study also emphasise the importance of the management's commitment in enhancing workplace safety. Specifically, companies should maintain good relations between the employer and the employee to help reduce workplace injuries.

Safety management as a foundation for evidence-based aeromedical standards and reporting of medical events.

PubMed

Evans, Anthony D; Watson, Dougal B; Evans, Sally A; Hastings, John; Singh, Jarnail; Thibeault, Claude

2009-06-01

The different interpretations by States (countries) of the aeromedical standards established by the International Civil Aviation Organization has resulted in a variety of approaches to the development of national aeromedical policy, and consequently a relative lack of harmonization. However, in many areas of aviation, safety management systems have been recently introduced and may represent a way forward. A safety management system can be defined as "A systematic approach to managing safety, including the necessary organizational structures, accountabilities, policies, and procedures" (1). There are four main areas where, by applying safety management principles, it may be possible to better use aeromedical data to enhance flight safety. These are: 1) adjustment of the periodicity and content of routine medical examinations to more accurately reflect aeromedical risk; 2) improvement in reporting and analysis of routine medical examination data; 3) improvement in reporting and analysis of in-flight medical events; and 4) support for improved reporting of relevant aeromedical events through the promotion of an appropriate culture by companies and regulatory authorities. This paper explores how the principles of safety management may be applied to aeromedical systems to improve their contribution to safety.

Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes.

PubMed

Kullenberg, Torbjörn; Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

2016-08-01

Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. ClincialTrials.gov, clinicaltrials.gov, NCT00069329. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Modeling for influenza vaccines and adjuvants profile for safety prediction system using gene expression profiling and statistical tools

PubMed Central

Sasaki, Eita; Momose, Haruka; Hiradate, Yuki; Furuhata, Keiko; Takai, Mamiko; Asanuma, Hideki; Ishii, Ken J.

2018-01-01

Historically, vaccine safety assessments have been conducted by animal testing (e.g., quality control tests and adjuvant development). However, classical evaluation methods do not provide sufficient information to make treatment decisions. We previously identified biomarker genes as novel safety markers. Here, we developed a practical safety assessment system used to evaluate the intramuscular, intraperitoneal, and nasal inoculation routes to provide robust and comprehensive safety data. Influenza vaccines were used as model vaccines. A toxicity reference vaccine (RE) and poly I:C-adjuvanted hemagglutinin split vaccine were used as toxicity controls, while a non-adjuvanted hemagglutinin split vaccine and AddaVax (squalene-based oil-in-water nano-emulsion with a formulation similar to MF59)-adjuvanted hemagglutinin split vaccine were used as safety controls. Body weight changes, number of white blood cells, and lung biomarker gene expression profiles were determined in mice. In addition, vaccines were inoculated into mice by three different administration routes. Logistic regression analyses were carried out to determine the expression changes of each biomarker. The results showed that the regression equations clearly classified each vaccine according to its toxic potential and inoculation amount by biomarker expression levels. Interestingly, lung biomarker expression was nearly equivalent for the various inoculation routes. The results of the present safety evaluation were confirmed by the approximation rate for the toxicity control. This method may contribute to toxicity evaluation such as quality control tests and adjuvant development. PMID:29408882

Profiling contextual factors which influence safety in heavy vehicle industries.

PubMed

Edwards, Jason R D; Davey, Jeremy; Armstrong, Kerry A

2014-12-01

A significant proportion of worker fatalities within Australia result from truck-related incidents. Truck drivers face a number of health and safety concerns. Safety culture, viewed here as the beliefs, attitudes and values shared by an organisation's workers, which interact with their surrounding context to influence behaviour, may provide a valuable lens for exploring safety-related behaviours in heavy vehicle operations. To date no major research has examined safety culture within heavy vehicle industries. As safety culture provides a means to interpret experiences and generate behaviour, safety culture research should be conducted with an awareness of the context surrounding safety. The current research sought to examine previous health and safety research regarding heavy vehicle operations to profile contextual factors which influence health and safety. A review of 104 peer-reviewed papers was conducted. Findings of these papers were then thematically analysed. A number of behaviours and scenarios linked with crashes and non-crash injuries were identified, along with a selection of health outcomes. Contextual factors which were found to influence these outcomes were explored. These factors were found to originate from government departments, transport organisations, customers and the road and work environment. The identified factors may provide points of interaction, whereby culture may influence health and safety outcomes. Copyright © 2014. Published by Elsevier Ltd.

Managing Safety and Operations: The Effect of Joint Management System Practices on Safety and Operational Outcomes.

PubMed

Tompa, Emile; Robson, Lynda; Sarnocinska-Hart, Anna; Klassen, Robert; Shevchenko, Anton; Sharma, Sharvani; Hogg-Johnson, Sheilah; Amick, Benjamin C; Johnston, David A; Veltri, Anthony; Pagell, Mark

2016-03-01

The aim of this study was to determine whether management system practices directed at both occupational health and safety (OHS) and operations (joint management system [JMS] practices) result in better outcomes in both areas than in alternative practices. Separate regressions were estimated for OHS and operational outcomes using data from a survey along with administrative records on injuries and illnesses. Organizations with JMS practices had better operational and safety outcomes than organizations without these practices. They had similar OHS outcomes as those with operations-weak practices, and in some cases, better outcomes than organizations with safety-weak practices. They had similar operational outcomes as those with safety-weak practices, and better outcomes than those with operations-weak practices. Safety and operations appear complementary in organizations with JMS practices in that there is no penalty for either safety or operational outcomes.

The evolving role and care management approaches of safety-net Medicaid managed care plans.

PubMed

Gusmano, Michael K; Sparer, Michael S; Brown, Lawrence D; Rowe, Catherine; Gray, Bradford

2002-12-01

This article provides new empirical data about the viability and the care management activities of Medicaid managed-care plans sponsored by provider organizations that serve Medicaid and other low-income populations. Using survey and case study methods, we studied these "safety-net" health plans in 1998 and 2000. Although the number of safety-net plans declined over this period, the surviving plans were larger and enjoying greater financial success than the plans we surveyed in 1998. We also found that, based on a partnership with providers, safety-net plans are moving toward more sophisticated efforts to manage the care of their enrollees. Our study suggests that, with supportive state policies, safety-net plans are capable of remaining viable. Contracting with safety-net plans may not be an efficient mechanism for enabling Medicaid recipients to "enter the mainstream of American health care," but it may provide states with an effective way to manage and coordinate the care of Medicaid recipients, while helping to maintain the health care safety-net for the uninsured.

Underlying influence of perception of management leadership on patient safety climate in healthcare organizations - A mediation analysis approach.

PubMed

Weng, Shao-Jen; Kim, Seung-Hwan; Wu, Chieh-Liang

2017-02-01

We aim to draw insights on how medical staff's perception of management leadership affects safety climate with key safety related dimensions-teamwork climate, job satisfaction and working conditions. A cross-sectional survey using Safety Attitude Questionnaire (SAQ) was performed in a medical center in Taichung City, Taiwan. The relationships among the dimensions in SAQ were then analyzed by structural equation modeling with a mediation analysis. 2205 physicians and nurses of the medical center participated in the survey. Because not all questions in the survey are suitable for entire hospital staff, only the valid responses (n = 1596, response rate of 72%) were extracted for analysis. Key measures are the direct and indirect effects of teamwork climate, job satisfaction, perception of management leadership, and working conditions on safety climate. Outcomes show that effect of perception of management leadership on safety climate is significant (standardized indirect effect of 0.892 with P-value 0.002) and fully mediated by other dimensions, where 66.9% is mediated through teamwork climate, 24.1% through working conditions and 9.0% through job satisfaction. Our findings point to the importance of management leadership and the mechanism of its influence on safety climate. To improve safety climate, the implication is that commitment by management on leading safety improvement needs to be demonstrated when it implements daily supportive actions for other safety dimensions. For future improvement, development of a management system that can facilitate two-way trust between management and staff over the long term is recommended. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

76 FR 64110 - Safety and Health Management Programs for Mines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... DEPARTMENT OF LABOR Mine Safety and Health Administration RIN 1219-AB71 Safety and Health Management Programs for Mines AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice of public meetings. SUMMARY: The Mine Safety and Health Administration (MSHA) is holding a public meeting, and plans...

78 FR 48046 - Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

...-AA00 Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone on the navigable..., 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew...

Comparing Occupational Health and Safety Management System Programming with Injury Rates in Poultry Production.

PubMed

Autenrieth, Daniel A; Brazile, William J; Douphrate, David I; Román-Muñiz, Ivette N; Reynolds, Stephen J

2016-01-01

Effective methods to reduce work-related injuries and illnesses in animal production agriculture are sorely needed. One approach that may be helpful for agriculture producers is the adoption of occupational health and safety management systems. In this replication study, the authors compared the injury rates on 32 poultry growing operations with the level of occupational health and safety management system programming at each farm. Overall correlations between injury rates and programming level were determined, as were correlations between individual management system subcomponents to ascertain which parts might be the most useful for poultry producers. It was found that, in general, higher levels of occupational health and safety management system programming were associated with lower rates of workplace injuries and illnesses, and that Management Leadership was the system subcomponent with the strongest correlation. The strength and significance of the observed associations were greater on poultry farms with more complete management system assessments. These findings are similar to those from a previous study of the dairy production industry, suggesting that occupational health and safety management systems may hold promise as a comprehensive way for producers to improve occupational health and safety performance. Further research is needed to determine the effectiveness of such systems to reduce farm work injuries and illnesses. These results are timely given the increasing focus on occupational safety and health management systems.

Connecticut Department of Transportation safety techniques enhancement plan.

DOT National Transportation Integrated Search

2015-03-15

The Highway Safety Manual (HSM) defines a six-step cycle of safety management processes. This report evaluates the : Conncituct Department on how well conform to the six safety management steps. The methods recommended in the HSM : require additional...

Safety culture: analysis of the causal relationships between its key dimensions.

PubMed

Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

2007-01-01

Several fields are showing increasing interest in safety culture as a means of reducing accidents in the workplace. The literature shows that safety culture is a multidimensional concept. However, considerable confusion surrounds this concept, about which little consensus has been reached. This study proposes a model for a positive safety culture and tests this on a sample of 455 Spanish companies, using the structural equation modeling statistical technique. Results show the important role of managers in the promotion of employees' safe behavior, both directly, through their attitudes and behaviors, and indirectly, by developing a safety management system. This paper identifies the key dimensions of safety culture. In addition, a measurement scale for the safety management system is validated. This will assist organizations in defining areas where they need to progress if they wish to improve their safety. Also, we stress that managers need to be wholly committed to and personally involved in safety activities, thereby conveying the importance the firm attaches to these issues.

Safety and tolerability of new-generation anti-obesity medications: a narrative review.

PubMed

Patel, Dhiren K; Stanford, Fatima Cody

2018-03-01

The prevalence of obesity and associated comorbidities is rising. Despite their weight-loss efficacy, new generation anti-obesity medications are only prescribed to a minority of adults with obesity, possibly, which in part may be due to safety concerns. This review presents detailed safety profiles for orlistat, phentermine/topiramate, lorcaserin, naltrexone/bupropion and liraglutide 3.0 mg, and discusses the associated risk-benefit profiles. Two anti-obesity medications presented safety issues that warranted further discussion; phentermine/topiramate (fetal toxicity) and liraglutide 3.0 mg (risk of gallstone disease and mild, acute pancreatitis), whereas the adverse events associated with orlistat, lorcaserin, and naltrexone/bupropion were mostly transient tolerability issues. The difficulties surrounding the objective determination of risk-benefit for anti-obesity medications is discussed. The need for more long-term data, thorough patient assessment, individualization of pharmacological interventions and adherence to stopping rules to maximize risk-benefit are highlighted. Overall, the majority of new generation anti-obesity medications present encouraging tolerability profiles; however, in some cases a lack of long-term clinical trials confounds the accurate determination of risk-benefit.

An update of safety of clinically used atypical antipsychotics.

PubMed

Orsolini, L; Tomasetti, C; Valchera, A; Vecchiotti, R; Matarazzo, I; Vellante, F; Iasevoli, F; Buonaguro, E F; Fornaro, M; Fiengo, A L C; Martinotti, G; Mazza, M; Perna, G; Carano, A; De Bartolomeis, A; Di Giannantonio, M; De Berardis, D

2016-10-01

The atypical antipsychotic (APs) drugs have become the most widely used agents to treat a variety of psychoses because of their superiority with regard to safety and tolerability profile compared to conventional/'typical' APs. We aimed at providing a synthesis of most current evidence about the safety and tolerability profile of the most clinically used atypical APs so far marketed. Qualitative synthesis followed an electronic search made inquiring of the following databases: MEDLINE, Embase, PsycINFO and the Cochrane Library from inception until January 2016, combining free terms and MESH headings for the topics of psychiatric disorders and all atypical APs as following: ((safety OR adverse events OR side effects) AND (aripiprazole OR asenapine OR quetiapine OR olanzapine OR risperidone OR paliperidone OR ziprasidone OR lurasidone OR clozapine OR amisulpride OR iloperidone)). A critical issue in the treatment with atypical APs is represented by their metabolic side effect profile (e.g. weight gain, lipid and glycaemic imbalance, risk of diabetes mellitus and diabetic ketoacidosis) which may limit their use in particular clinical samples. Electrolyte imbalance, ECG abnormalities and cardiovascular adverse effects may recommend a careful baseline and periodic assessments.

Ethical issues in patient safety: Implications for nursing management.

PubMed

Kangasniemi, Mari; Vaismoradi, Mojtaba; Jasper, Melanie; Turunen, Hannele

2013-12-01

The purpose of this article is to discuss the ethical issues impacting the phenomenon of patient safety and to present implications for nursing management. Previous knowledge of this perspective is fragmented. In this discussion, the main drivers are identified and formulated in 'the ethical imperative' of patient safety. Underlying values and principles are considered, with the aim of increasing their visibility for nurse managers' decision-making. The contradictory nature of individual and utilitarian safety is identified as a challenge in nurse management practice, together with the context of shared responsibility and identification of future challenges. As a conclusion, nurse managers play a strategic role in patient safety. Their role is to incorporate ethical values of patient safety into decision-making at all levels in an organization, and also to encourage clinical nurses to consider values in the provision of care to patients. Patient safety that is sensitive to ethics provides sustainable practice where the humanity and dignity of all stakeholders are respected.

Safety management of a complex R and D ground operating system

NASA Technical Reports Server (NTRS)

Connors, J. F.; Maurer, R. A.

1975-01-01

A perspective on safety program management was developed for a complex R&D operating system, such as the NASA-Lewis Research Center. Using a systems approach, hazardous operations are subjected to third-party reviews by designated-area safety committees and are maintained under safety permit controls. To insure personnel alertness, emergency containment forces and employees are trained in dry-run emergency simulation exercises. The keys to real safety effectiveness are top management support and visibility of residual risks.

Safety management of a complex R&D ground operating system

NASA Technical Reports Server (NTRS)

Connors, J. F.; Maurer, R. A.

1975-01-01

A perspective on safety program management has been developed for a complex R&D operating system, such as the NASA-Lewis Research Center. Using a systems approach, hazardous operations are subjected to third-party reviews by designated area safety committees and are maintained under safety permit controls. To insure personnel alertness, emergency containment forces and employees are trained in dry-run emergency simulation exercises. The keys to real safety effectiveness are top management support and visibility of residual risks.

76 FR 15953 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-22

... CONSUMER PRODUCT SAFETY COMMISSION Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Publicly Available Consumer Product Safety Information Database... Product Safety Information Database has been approved by the Office of Management and Budget (OMB) under...

75 FR 5244 - Pipeline Safety: Integrity Management Program for Gas Distribution Pipelines; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

... Management Program for Gas Distribution Pipelines; Correction AGENCY: Pipeline and Hazardous Materials Safety... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Regulations to require operators of gas distribution pipelines to develop and implement integrity management...

Towards integrated hygiene and food safety management systems: the Hygieneomic approach.

PubMed

Armstrong, G D

1999-09-15

Integrated hygiene and food safety management systems in food production can give rise to exceptional improvements in food safety performance, but require high level commitment and full functional involvement. A new approach, named hygieneomics, has been developed to assist management in their introduction of hygiene and food safety systems. For an effective introduction, the management systems must be designed to fit with the current generational state of an organisation. There are, broadly speaking, four generational states of an organisation in their approach to food safety. They comprise: (i) rules setting; (ii) ensuring compliance; (iii) individual commitment; (iv) interdependent action. In order to set up an effective integrated hygiene and food safety management system a number of key managerial requirements are necessary. The most important ones are: (a) management systems must integrate the activities of key functions from research and development through to supply chain and all functions need to be involved; (b) there is a critical role for the senior executive, in communicating policy and standards; (c) responsibilities must be clearly defined, and it should be clear that food safety is a line management responsibility not to be delegated to technical or quality personnel; (d) a thorough and effective multi-level audit approach is necessary; (e) key activities in the system are HACCP and risk management, but it is stressed that these are ongoing management activities, not once-off paper generating exercises; and (f) executive management board level review is necessary of audit results, measurements, status and business benefits.

The Perception, Level of Safety Satisfaction and Safety Feedback on Occupational Safety and Health Management among Hospital Staff Nurses in Sabah State Health Department

PubMed Central

Cheah, Whye Lian; Giloi, Nelbon; Chang, Ching Thon; Lim, Jac Fang

2012-01-01

Background: This study aimed to determine the perception and level of safety satisfaction of staff nurses with regards to Occupational Safety and Health (OSH) management practice in the Sabah Health Department, and to associate the OSH management dimensions, to Safety Satisfaction and Safety Feedback. Methods: A cross-sectional study using a validated self-administered questionnaire was conducted among randomly respondents. Results: 135 nurses responded the survey. Mean (SD) score for each dimension ranged from 1.70 ± 0.68–4.04 ± 0.65, with Training and Competence dimension (mean [SD], 4.04 ± 0.65) had the highest while Safety Incidence was the least score (mean [SD], 1.70 ± 0.68). Both mean (SD) scores for Safety Satisfaction and Safety Feedback was high, 3.28 ± 0.51 and 3.57 ± 0.73, respectively. Pearson’s correlation analysis indicated that all OSH dimensions had significant correlation with Safety Satisfaction and Safety Feedback (r coefficient ranged from 0.176–0.512) except for Safety Incidence. Conclusion: The overall perception of OSH management was rather low. Significant correlation between Safety Satisfaction and Safety Feedback and several dimensions, suggest that each organization to put in place the leaders who have appropriate leadership and supervisory skills and committed in providing staff training to improve staff’s competency in OSH practice. In addition, clear goals, rules, and reporting system will help the organization to implement proper OSH management practice. PMID:23610550

Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

PubMed

Ziemssen, Tjalf; Lang, Michael; Tackenberg, Björn; Schmidt, Stephan; Albrecht, Holger; Klotz, Luisa; Haas, Judith; Lassek, Christoph; Medin, Jennie; Cornelissen, Christian

2018-01-01

The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment. Patients were divided into 2 cohorts: fingolimod starter [first received fingolimod in PANGAEA (n = 3315)] and previous study [received fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of multiple sclerosis in the real world versus RCTs, fingolimod remains effective, with a manageable safety profile.

Environmental Assessment: T-6 Aircraft Basing and Operation

DTIC Science & Technology

2004-06-01

The operating characteristics of the T -6 are similar to the T-37. Thus, the T-6 traffic pattern aircraft ground tracks, profiles , and airspeeds are...low-income populations.” Adverse is defined by the Federal Interagency Working Group on Environmental Justice as “having a deleterious effect on...types of aircraft (i.e., large and trainer) was considered a significant safety issue. Safety concerns include mixing the flight profiles of two

Integrating environmental management into food safety and food packaging in Malaysia: review of the food regulation 1985

NASA Astrophysics Data System (ADS)

Nordin, N. H.; Hara, H.; Kaida, N.

2017-05-01

Food safety is an important issue that is related to public safety to prevent the toxicity threats of the food. Management through legal approach has been used in Malaysia as one of the predominant approaches to manage the environment. In this regard, the Food Regulation 1985 has been one of the mechanisms of environmental management through legal approach in controlling the safety of packaged food in food packaging industry in Malaysia. The present study aims to analyse and to explain the implementation of the Food Regulation 1985 in controlling the safety of packaged food in Malaysia and to integrate the concept of environmental management into the food safety issue. Qualitative analysis on the regulation document revealed that there are two main themes, general and specific, while their seven sub themes are included harmful packages, safety packages, reuse packages, polyvinyl chloride (PVC), alcoholic bottle, toys, money and others and iron powder. The implementation of the Food Regulation 1985 in controlling the safety of packaged food should not be regarded solely for regulation purposes but should be further developed for a broader sense of food safety from overcoming the food poisoning.

[Road map for health and safety management systems in healthcare facilities, according to the OHSAS 18001:2007 standard].

PubMed

Pugliese, F; Albini, E; Serio, O; Apostoli, P

2011-01-01

The 81/2008 Act has defined a model of a health and safety management system that can contribute to prevent the occupational health and safety risks. We have developed the structure of a health and safety management system model and the necessary tools for its implementation in health care facilities. The realization of a model is structured in various phases: initial review, safety policy, planning, implementation, monitoring, management review and continuous improvement. Such a model, in continuous evolution, is based on the responsibilities of the different corporate characters and on an accurate analysis of risks and involved norms.

The efficacy and safety of adjuvant interferon-alfa therapy in the evolving treatment landscape for resected high-risk melanoma.

PubMed

Trinh, Van Anh; Zobniw, Chrystia; Hwu, Wen-Jen

2017-08-01

Patients with resected stage II or III melanoma are at high risk of recurrence, with 5-year mortality rate of 40-60%. Adjuvant interferon-alfa has demonstrated a small RFS and OS benefit versus observation in this patient population. However, the adjuvant treatment landscape is evolving rapidly. Areas covered: This review aims to summarize the safety and efficacy profiles of adjuvant IFNα/PEG-IFNα, revisit the controversy surrounding its application, and reappraise its position in the rapidly changing treatment landscape of resected melanoma. A literature search using PubMed database was undertaken using search words melanoma, interferon-alfa, pegylated interferon-alfa, adjuvant therapy. Expert opinion: Currently, there is no international consensus regarding the optimal dosing schedule for adjuvant IFNα, but HD IFNα-2b remains the most widely used regimen. The AEs of HD IFNα-2b are substantial; however, toxicity management experience amassed over the past 2 decades has significantly improved safety. Many exciting studies are ongoing to examine the roles of immune checkpoint inhibitors and BRAF-targeted therapies in the adjuvant setting and will further delineate the role of adjuvant IFNα.

Managing Drawbacks in Unconventional Successful Glaucoma Surgery: A Case Report of Stent Exposure

PubMed Central

Fea, Antonio; Cannizzo, Paola Maria Loredana; Consolandi, Giulia; Lavia, Carlo Alessandro; Pignata, Giulia; Grignolo, Federico M.

2015-01-01

Traditional options in managing failed trabeculectomy (bleb needling, revision, additional incisional surgery and tube surgery) have a relatively high failure and complication rate. The use of microinvasive glaucoma surgery (MIGS) has generally been reserved to mild to moderate glaucoma cases, proving good safety profiles but significant limitations in terms of efficacy. We describe a patient who underwent MIGS (XEN Aquesys subconjunctival shunt implantation) after a prior failed trabeculectomy. After the surgery, the IOP was well controlled but as the stent was close to an area of scarred conjunctiva of the previous trabeculectomy, it became partially exposed. As a complete success was achieved, we decided to remove the conjunctiva over the exposed area and replace it by an amniotic membrane transplantation and a conjunctiva autograft. Six months after surgery, the unmedicated IOP is still well controlled with complete visual acuity recovery. PMID:26294994

Botulinum toxin in the treatment of vocal fold nodules.

PubMed

Allen, Jacqui E; Belafsky, Peter C

2009-12-01

Promising new techniques in the management of vocal fold nodules have been developed in the past 2 years. Simultaneously, the therapeutic use of botulinum toxin has rapidly expanded. This review explores the use of botulinum toxin in treatment of vocal nodules and summarizes current therapeutic concepts. New microsurgical instruments and techniques, refinements in laser technology, radiosurgical excision and steroid intralesional injections are all promising new techniques in the management of vocal nodules. Botulinum toxin-induced 'voice rest' is a new technique we have employed in patients with recalcitrant nodules. Successful resolution of nodules is possible with this technique, without the risk of vocal fold scarring inherent in dissection/excision techniques. Botulinum toxin usage is exponentially increasing, and large-scale, long-term studies demonstrate its safety profile. Targeted vocal fold temporary paralysis induced by botulinum toxin injection is a new, well tolerated and efficacious treatment in patients with persistent vocal fold nodules.

Outage management and health physics issue, 2009

DOE Office of Scientific and Technical Information (OSTI.GOV)

Agnihotri, Newal

2009-05-15

The focus of the May-June issue is on outage management and health physics. Major articles include the following: Planning and scheduling to minimize refueling outage, by Pat McKenna, AmerenUE; Prioritizing safety, quality and schedule, by Tom Sharkey, Dominion; Benchmarking to high standards, by Margie Jepson, Energy Nuclear; Benchmarking against U.S. standards, by Magnox North, United Kingdom; Enabling suppliers for new build activity, by Marcus Harrington, GE Hitachi Nuclear Energy; Identifying, cultivating and qualifying suppliers, by Thomas E. Silva, AREVA NP; Creating new U.S. jobs, by Francois Martineau, Areva NP. Industry innovation articles include: MSL Acoustic source load reduction, by Amirmore » Shahkarami, Exelon Nuclear; Dual Methodology NDE of CRDM nozzles, by Michael Stark, Dominion Nuclear; and Electronic circuit board testing, by James Amundsen, FirstEnergy Nuclear Operating Company. The plant profile article is titled The future is now, by Julia Milstead, Progress Energy Service Company, LLC.« less

Management of actinic cheilitis using ingenol mebutate gel: A report of seven cases.

PubMed

Flórez, Ángeles; Batalla, Ana; de la Torre, Carlos

2017-03-01

Actinic cheilitis (AC) can precede the development of squamous cell carcinoma of the lip, a location with high risk of invasiveness and metastasis. We communicate the good results that we obtained when treating seven patients suffering from AC with ingenol mebutate (IM) 0,015% concentration gel on three consecutive days. Three patients achieved complete clearance and four significant improvement. IM is a topical field treatment approved for actinic keratosis. To our knowledge, reported experience in the management of AC with IM is very limited. Local skin responses grade 3 were the main adverse event observed and they resolved in all patients without specific therapy within 1 to 2 weeks. IM is characterized by its rapid clinical effect, its favorable safety profile and its dosing period of only 3 days, shorter than with other field therapies. All these facts make it an attractive new therapy for AC, with need for further study.

Is the LINX reflux management system an effective treatment for gastro-oesophageal reflux disease?

PubMed

Loh, Yiwen; McGlone, Emma Rose; Reddy, Marcus; Khan, Omar A

2014-01-01

A best evidence topic in surgery was written according to a structured protocol. The question addressed whether LINX™ Reflux management system is an efficacious treatment for patients with symptoms of gastro-oesophageal reflux disease (GORD) not controlled by proton pump inhibitors (PPI). Forty-eight LINX-related papers were identified using the reported search, of which three represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group, study type, relevant outcomes and results of these papers are tabulated. All three studies were prospective case studies. They demonstrated that LINX is an efficacious treatment for GORD patients with good short and medium term outcomes and an acceptable safety profile. Further studies are required to determine its long term outcomes and its relative efficacy as compared to other established treatments. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Relative response of patients with myelodysplastic syndromes and other transfusion-dependent anaemias to deferasirox (ICL670): a 1-yr prospective study

PubMed Central

Porter, John; Galanello, Renzo; Saglio, Giuseppe; Neufeld, Ellis J; Vichinsky, Elliott; Cappellini, Maria Domenica; Olivieri, Nancy; Piga, Antonio; Cunningham, Melody J; Soulières, Denis; Gattermann, Norbert; Tchernia, Gilbert; Maertens, Johan; Giardina, Patricia; Kwiatkowski, Janet; Quarta, Giovanni; Jeng, Michael; Forni, Gian Luca; Stadler, Michael; Cario, Holger; Debusscher, Louisette; Porta, Matteo Della; Cazzola, Mario; Greenberg, Peter; Alimena, Giuliana; Rabault, Bertrand; Gathmann, Insa; Ford, John Malcolm; Alberti, Daniele; Rose, Christian

2008-01-01

Objectives/methods This 1-yr prospective phase II trial evaluated the efficacy of deferasirox in regularly transfused patients aged 3–81 yrs with myelodysplastic syndromes (MDS; n = 47), Diamond–Blackfan anaemia (DBA; n = 30), other rare anaemias (n = 22) or β-thalassaemia (n = 85). Dosage was determined by baseline liver iron concentration (LIC). Results In patients with baseline LIC ≥7 mg Fe/g dry weight, deferasirox initiated at 20 or 30 mg/kg/d produced statistically significant decreases in LIC (P < 0.001); these decreases were greatest in MDS and least in DBA. As chelation efficiency and iron excretion did not differ significantly between disease groups, the differences in LIC changes are consistent with mean transfusional iron intake (least in MDS: 0.28 ± 0.14 mg/kg/d; greatest in DBA: 0.4 ± 0.11 mg/kg/d). Overall, LIC changes were dependent on dose (P < 0.001) and transfusional iron intake (P < 0.01), but not statistically different between disease groups. Changes in serum ferritin and LIC were correlated irrespective of disease group (r = 0.59), supporting the potential use of serum ferritin for monitoring deferasirox therapy. Deferasirox had a safety profile compatible with long-term use. There were no disease-specific safety/tolerability effects: the most common adverse events were gastrointestinal disturbances, skin rash and non-progressive serum creatinine increases. Conclusions Deferasirox is effective for reducing iron burden with a defined, clinically manageable safety profile in patients with various transfusion-dependent anaemias. There were no disease-specific adverse events. Once differences in transfusional iron intake are accounted for, dose-dependent changes in LIC or serum ferritin are similar in MDS and other disease groups. PMID:18028431

An In-home Advanced Robotic System to Manage Elderly Home-care Patients' Medications: A Pilot Safety and Usability Study.

PubMed

Rantanen, Pekka; Parkkari, Timo; Leikola, Saija; Airaksinen, Marja; Lyles, Alan

2017-05-01

We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic malfunctions would hinder the device's safe use. Phase II involved home-care patients from 3 sites (n = 27) who were on long-term medication. On-time dispensing and missed doses were recorded by the robotic system. Patients' and nurses' experiences were assessed with structured interviews. The 17 nursing home patients had 457 total days using the device (Phase I; mean, 26.9 per patient). On-time sachet retrieval occurred with 97.7% of the alerts, and no medication doses were missed. At baseline, Phase II home-dwelling patients reported difficulty remembering to take their medicines (23%), and 18% missed at least 2 doses per week. Most Phase II patients (78%) lived alone. The device delivered and patients retrieved medicine sachets for 99% of the alerts. All patients and 96% of nurses reported the device was easy to use. This trial demonstrated the safety profile and usability of an in-home advanced robotic device and telecare system and its acceptability to patients and nurses. It supports individualized patient dosing schedules, patient-provider communications, and on-time, in-home medication delivery to promote adherence. Real time dose-by-dose monitoring and communication with providers if a dose is missed provide oversight generally not seen in home care. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A Randomized Trial Investigating the Efficacy and Safety of Water Soluble Micellar Paclitaxel (Paccal Vet) for Treatment of Nonresectable Grade 2 or 3 Mast Cell Tumors in Dogs

PubMed Central

Vail, D.M.; von Euler, H.; Rusk, A.W.; Barber, L.; Clifford, C.; Elmslie, R.; Fulton, L.; Hirschberger, J.; Klein, M.; London, C.; Martano, M.; McNiel, E.A.; Morris, J.S.; Northrup, N.; Phillips, B.; Polton, G.; Post, G.; Rosenberg, M.; Ruslander, D.; Sahora, A.; Siegel, S.; Thamm, D.; Westberg, S.; Winter, J.; Khanna, C.

2013-01-01

Background Effective treatments for dogs with advanced stage mast cell tumors (MCT) remain a pressing need. A micellar formulation of paclitaxel (paclitaxel [micellar]) has shown promise in early-phase studies. Hypothesis/Objectives The objective was to demonstrate greater activity for paclitaxel (micellar) compared with lomustine. The null hypothesis was μp = μL (ie, proportion of responders for the paclitaxel [micellar] and lomustine groups, respectively). Animals Two hundred and fifty-two dogs with advanced stage nonresectable grade 2 or 3 MCT. Methods Prospective multicenter randomized double-blind positive-controlled clinical trial. The primary endpoint was confirmed overall response rate (CORR) at 14 weeks. A secondary endpoint, biologic observed response rate (BORR), also was calculated. Safety was assessed by the characterization and grading of adverse events (AE). Results Overall CORR (7% versus 1%; P = .048) and BORR (23% versus 10%; P = .012) were greater for paclitaxel (micellar) compared with lomustine. Paclitaxel (micellar)-treated dogs were 6.5 times more likely to have a confirmed response and 3.1 times more likely to experience a biologic observed response. The majority of AE with paclitaxel (micellar) were transient and clinically manageable. Twenty-seven dogs (33%) receiving lomustine were discontinued because of hepatopathy compared with 3 dogs (2%) receiving paclitaxel (micellar) (P < .0001; odds ratio 26.7). Conclusions and Clinical Importance Paclitaxel (micellar)’s activity and safety profile are superior to lomustine. The addition of an active and novel taxane to the veterinary armamentarium could fill a substantial need and, as its mechanism of action and AE profile do not overlap with currently available TKI, its availability could lead to effective combination protocols. PMID:22390318

Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis. Results of the INJOURNEY Trial.

PubMed

Vancheri, Carlo; Kreuter, Michael; Richeldi, Luca; Ryerson, Christopher J; Valeyre, Dominique; Grutters, Jan C; Wiebe, Sabrina; Stansen, Wibke; Quaresma, Manuel; Stowasser, Susanne; Wuyts, Wim A

2018-02-01

Nintedanib and pirfenidone slow the progression of idiopathic pulmonary fibrosis (IPF), but the disease continues to progress. More data are needed on the safety and efficacy of combination therapy with nintedanib and add-on pirfenidone. To investigate safety, tolerability, and pharmacokinetic and exploratory efficacy endpoints in patients treated with nintedanib and add-on pirfenidone versus nintedanib alone. Patients with IPF and FVC greater than or equal to 50% predicted at screening who completed a 4- to 5-week run-in with nintedanib 150 mg twice daily without dose reduction or treatment interruption were randomized to receive nintedanib 150 mg twice daily with add-on pirfenidone (titrated to 801 mg three times daily) or nintedanib 150 mg twice daily alone in an open-label manner for 12 weeks. The primary endpoint was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to Week 12. Analyses were descriptive and exploratory. On-treatment gastrointestinal adverse events were reported in 37 of 53 patients (69.8%) treated with nintedanib with add-on pirfenidone and 27 of 51 patients (52.9%) treated with nintedanib alone. Predose plasma trough concentrations of nintedanib were similar when it was administered alone or with add-on pirfenidone. Mean (SE) changes from baseline in FVC at Week 12 were -13.3 (17.4) ml and -40.9 (31.4) ml in patients treated with nintedanib with add-on pirfenidone (n = 48) and nintedanib alone (n = 44), respectively. Nintedanib with add-on pirfenidone had a manageable safety and tolerability profile in patients with IPF, in line with the adverse event profiles of each drug. These data support further research into combination regimens in the treatment of IPF. Clinical trial registered with www.clinicaltrials.gov (NCT02579603).

Nonbibliographic Databases in a Corporate Health, Safety, and Environment Organization.

ERIC Educational Resources Information Center

Cubillas, Mary M.

1981-01-01

Summarizes the characteristics of TOXIN, CHEMFILE, and the Product Profile Information System (PPIS), nonbibliographic databases used by Shell Oil Company's Health, Safety, and Environment Organization. (FM)

Lesinurad for the treatment of hyperuricaemia in people with gout.

PubMed

Robinson, Philip C; Dalbeth, Nicola

2017-12-01

Gout is a common form of inflammatory arthritis caused by deposition of monosodium urate crystals. The central strategy for effective long-term management of gout is serum urate lowering. Current urate-lowering drugs include both xanthine oxidase inhibitors and uricosuric agents. Lesinurad is a URAT1 inhibitor that selectively inhibits urate rebsorption at the proximal renal tubule. Lesinurad 200mg daily in combination with a xanthine oxidase is approved for urate-lowering therapy in patients with gout. Areas covered: The published literature was searched using Pubmed and additional information was obtained from publically available regulatory documents. Pre-clinical data and clinical trials of lesinurad are described. Serum urate-lowering efficacy and effects on other clinical endpoints are discussed. Adverse event data, focusing on renal safety are also presented. Expert opinion: Lesinurad is an effective urate-lowering drug that has a generally acceptable safety profile when used at 200mg daily dosing in combination with a xanthine oxidase inhibitor. The recent approval of fixed dose combination pills of lesinurad with allopurinol is an important step in improving adherence and reducing risk of renal adverse events. It remains to be seen if this therapy will provide additional benefit for gout management above improved use of widely available generic therapies.

Enzymes in cleaning products: an overview of toxicological properties and risk assessment/management.

PubMed

Basketter, David; Berg, Ninna; Broekhuizen, Cees; Fieldsend, Mark; Kirkwood, Sheila; Kluin, Cornelia; Mathieu, Sophie; Rodriguez, Carlos

2012-10-01

Enzymes used in cleaning products have an excellent safety profile, with little ability to cause adverse responses in humans. For acute toxicity, genotoxicity, sub-acute and repeated dose toxicity, enzymes are unremarkable. Reproductive toxicity and carcinogenicity are also not endpoints of concern. Exceptions are the ability of some proteases to produce irritating effects at high concentrations and more importantly, the intrinsic potential of these bacterial/fungal proteins to act as respiratory sensitizers. It is a reasonable assumption that the majority of enzyme proteins possess this hazard. However, methods for characterising the respiratory sensitisation hazard of enzymes are lacking and the information required for risk assessment and risk management, although sufficient, remains limited. Previously, most data was generated in animal models and in in vitro immunoassays that assess immunological cross-reactivity. Nevertheless, by the establishment of strict limits on airborne exposure (based on a defined minimal effect limit of 60ng active enzyme protein/m(3)) and air and health monitoring, occupational safety can be assured. Similarly, by ensuring that airborne exposure is kept similarly low, coupled with knowledge of the fate of these enzymes on skin and fabrics, it has proven possible to establish a long history of safe consumer use of enzyme containing products. Copyright © 2012 Elsevier Inc. All rights reserved.

Phase I study of afatinib combined with nintedanib in patients with advanced solid tumours.

PubMed

Bahleda, Rastislav; Hollebecque, Antoine; Varga, Andrea; Gazzah, Anas; Massard, Christophe; Deutsch, Eric; Amellal, Nadia; Farace, Françoise; Ould-Kaci, Mahmoud; Roux, Flavien; Marzin, Kristell; Soria, Jean-Charles

2015-11-17

This Phase I study evaluated continuous- and intermittent-dosing (every other week) of afatinib plus nintedanib in patients with advanced solid tumours. In the dose-escalation phase (n=45), maximum tolerated doses (MTDs) were determined for continuous/intermittent afatinib 10, 20, 30 or 40 mg once daily plus continuous nintedanib 150 or 200 mg twice daily. Secondary objectives included safety and efficacy. Clinical activity of continuous afatinib plus nintedanib at the MTD was further evaluated in an expansion phase (n=25). The most frequent dose-limiting toxicities were diarrhoea (11%) and transaminase elevations (7%). Maximum tolerated doses were afatinib 30 mg continuously plus nintedanib 150 mg, and afatinib 40 mg intermittently plus nintedanib 150 mg. Treatment-related adverse events (mostly Grade⩽3) included diarrhoea (98%), asthenia (64%), nausea (62%) and vomiting (60%). In the dose-escalation phase, two patients had partial responses (PRs) and 27 (60%) had stable disease (SD). In the expansion phase, one complete response and three PRs were observed (all non-small cell lung cancer), with SD in 13 (52%) patients. No pharmacokinetic interactions were observed. MTDs of continuous or intermittent afatinib plus nintedanib demonstrated a manageable safety profile with proactive management of diarrhoea. Antitumour activity was observed in patients with solid tumours.

Interventional procedures and future drug therapy for hypertension.

PubMed

Lobo, Melvin D; Sobotka, Paul A; Pathak, Atul

2017-04-14

Hypertension management poses a major challenge to clinicians globally once non-drug (lifestyle) measures have failed to control blood pressure (BP). Although drug treatment strategies to lower BP are well described, poor control rates of hypertension, even in the first world, suggest that more needs to be done to surmount the problem. A major issue is non-adherence to antihypertensive drugs, which is caused in part by drug intolerance due to side effects. More effective antihypertensive drugs are therefore required which have excellent tolerability and safety profiles in addition to being efficacious. For those patients who either do not tolerate or wish to take medication for hypertension or in whom BP control is not attained despite multiple antihypertensives, a novel class of interventional procedures to manage hypertension has emerged. While most of these target various aspects of the sympathetic nervous system regulation of BP, an additional procedure is now available, which addresses mechanical aspects of the circulation. Most of these new devices are supported by early and encouraging evidence for both safety and efficacy, although it is clear that more rigorous randomized controlled trial data will be essential before any of the technologies can be adopted as a standard of care. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson's disease.

PubMed

Müller, Thomas; Tolosa, Eduardo; Badea, Letitia; Asgharnejad, Mahnaz; Grieger, Frank; Markowitz, Michael; Nondonfaz, Xavier; Bauer, Lars; Timmermann, Lars

2018-06-01

Real-world data from large cohorts of patients with Parkinson's disease on the long-term effectiveness of different dopamine-substituting drug therapies are rare. The objective of this study was to obtain information on real-world management of PD with dopamine-substituting drugs. SP0854 (NCT00599339) was a prospective, multicenter, non-interventional, multiple-cohort, post-authorization safety study of rotigotine versus other dopaminergic therapies. The study was also part of a European Medicines Agency risk-management plan for the non-ergoline dopamine agonist rotigotine, focussing on cardiovalvular fibrosis. Eligible patients requiring monotherapy with a dopamine agonist, or levodopa in combination with a dopamine agonist were followed for ≤ 33 months; 1531 of 2195 patients completed the study. Mean motor scores improved for all dopamine-substituting treatments. Patients with more severe motor-symptoms/increased disability were more likely to receive levodopa alone or in combination with a DA at study onset. More patients who started on combination therapy with levodopa remained on this treatment versus those starting on dopaminergic monotherapy. This real-world study showed that the dopamine-substituting therapies were efficacious, with a safety profile consistent with that expected of dopaminergic treatments. Cardiovalvular pathology was rare and not found to be causally-related to rotigotine.

49 CFR 192.911 - What are the elements of an integrity management program?

Code of Federal Regulations, 2010 CFR

2010-10-01

...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Gas Transmission Pipeline Integrity Management § 192.911 What are the elements of an integrity management program...

75 FR 57898 - NIST Blue Ribbon Commission on Management and Safety-II

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-23

... DEPARTMENT OF COMMERCE National Institute of Standards and Technology NIST Blue Ribbon Commission... Commerce. ACTION: Notice of establishment of the NIST Blue Ribbon Commission on Management and Safety--II... NIST Blue Ribbon Commission on Management and Safety--II ``Commission''. The Commission will assess...

49 CFR 192.909 - How can an operator change its integrity management program?

Code of Federal Regulations, 2010 CFR

2010-10-01

... (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Gas Transmission Pipeline Integrity Management § 192.909 How can an operator change its integrity management...

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

Safety profile of snake antivenom (use) in Hong Kong - a review of 191 cases from 2008 to 2015.

PubMed

Mong, Rupeng; Ng, Vember C H; Tse, Man Li

2017-12-01

The mainstay of treatment for significant envenoming from snakebites is antivenom. However, there is insufficient data regarding the safety of antivenom used in Hong Kong. We describe the incidence of hypersensitivity reactions from antivenom use and review the frequency and reasons for intensive care unit (ICU) admission. The Hong Kong Poisons Information Centre database was reviewed. All patients given snake antivenom between 2008 and 2015 were included. Patient demographics, species of snake involved, details of antivenom used, treatment location, use of pre-treatment, reasons for ICU admission (where applicable) and details of early and late antivenom reactions were extracted. There were 191 patients who received snake antivenom. Most (93%) were treated with either the green pit viper antivenom from Thailand or the Agkistrodon halys antivenom from China. The incidences of early hypersensitivity reactions to green pit viper antivenom and Agkistrodon Halys antivenom were 4.7% and 1.4%, respectively. Most patients (69%) were managed in the ED observation ward or general ward. There were 59 patients managed in ICU, most (90%) of whom were admitted for close monitoring during antivenom administration. There were no cases of significant morbidity from antivenom administration. Eight patients (5.6%) had features suggestive of mild serum sickness. The incidence of immediate hypersensitivity reaction to antivenom commonly used in Hong Kong is low. Majority of patients were managed safely in the emergency department observation ward or general ward. Serum sickness appears to be uncommon and possible cases presented with mild features.

MANAGING UNCERTAINTIES ASSOCIATED WITH RADIOACTIVE WASTE DISPOSAL: TASK GROUP 4 OF THE IAEA PRISM PROJECT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Seitz, R.

2011-03-02

It is widely recognized that the results of safety assessment calculations provide an important contribution to the safety arguments for a disposal facility, but cannot in themselves adequately demonstrate the safety of the disposal system. The safety assessment and a broader range of arguments and activities need to be considered holistically to justify radioactive waste disposal at any particular site. Many programs are therefore moving towards the production of what has become known as a Safety Case, which includes all of the different activities that are conducted to demonstrate the safety of a disposal concept. Recognizing the growing interest inmore » the concept of a Safety Case, the International Atomic Energy Agency (IAEA) is undertaking an intercomparison and harmonization project called PRISM (Practical Illustration and use of the Safety Case Concept in the Management of Near-surface Disposal). The PRISM project is organized into four Task Groups that address key aspects of the Safety Case concept: Task Group 1 - Understanding the Safety Case; Task Group 2 - Disposal facility design; Task Group 3 - Managing waste acceptance; and Task Group 4 - Managing uncertainty. This paper addresses the work of Task Group 4, which is investigating approaches for managing the uncertainties associated with near-surface disposal of radioactive waste and their consideration in the context of the Safety Case. Emphasis is placed on identifying a wide variety of approaches that can and have been used to manage different types of uncertainties, especially non-quantitative approaches that have not received as much attention in previous IAEA projects. This paper includes discussions of the current results of work on the task on managing uncertainty, including: the different circumstances being considered, the sources/types of uncertainties being addressed and some initial proposals for approaches that can be used to manage different types of uncertainties.« less

The Safety Attitudes of Senior Managers in the Chinese Coal Industry

PubMed Central

Zhang, Jiangshi; Chen, Na; Fu, Gui; Yan, Mingwei; Kim, Young-Chan

2016-01-01

Introduction: Senior managers’ attitudes towards safety are very important regarding the safety practices in an organization. The study is to describe the current situation of senior managers′ attitudes towards safety in the Chinese coal industry. Method: We evaluated the changing trends as well as the reasons for these changes in the Chinese coal industry in 2009 and in 2014 with 168 senior manager samples from large Chinese state-owned coal enterprises. Evaluations of 15 safety concepts were performed by means of a questionnaire. Results and Conclusions: Results indicate that, in 2014, three concepts were at a very high level (mean > 4.5), and six were at a relatively high level (4.5 > mean > 4.0). Analyses of changing trends revealed that nine concepts improved significantly, while four greatly declined in 2014 compared to those in 2009. The data reported here suggest that the reasons for the significant improvement with respect to the nine concepts include the improvement in social and legal environments, the improvement of the culture of social safety, workers′ safety demands being met, and scientific and technical advances in the coal industry. The decline of the four concepts seemed to be caused by a poor awareness of managers in the coal industry that safety creates economic benefits, insufficient information on safety, inadequate attention to the development of a safety culture and safety management methods, and safety organizations and workers′ unions not playing their role effectively. Practical Applications: We therefore recommend strengthening the evidence that safety creates economic benefits, providing incentives for employees to encourage their participation in safety management, and paying more attention to the prevention of accidents in coal mines via safety organizations and unions. These results can provide guidelines for workers, industrialists, and government regarding occupational safety in the whole coal industry. PMID:27869654

Treatment of bipolar disorders during pregnancy: maternal and fetal safety and challenges

PubMed Central

Epstein, Richard A; Moore, Katherine M; Bobo, William V

2015-01-01

Treating pregnant women with bipolar disorder is among the most challenging clinical endeavors. Patients and clinicians are faced with difficult choices at every turn, and no approach is without risk. Stopping effective pharmacotherapy during pregnancy exposes the patient and her baby to potential harms related to bipolar relapses and residual mood symptom-related dysfunction. Continuing effective pharmacotherapy during pregnancy may prevent these occurrences for many; however, some of the most effective pharmacotherapies (such as valproate) have been associated with the occurrence of congenital malformations or other adverse neonatal effects in offspring. Very little is known about the reproductive safety profile and clinical effectiveness of atypical antipsychotic drugs when used to treat bipolar disorder during pregnancy. In this paper, we provide a clinically focused review of the available information on potential maternal and fetal risks of untreated or undertreated maternal bipolar disorder during pregnancy, the effectiveness of interventions for bipolar disorder management during pregnancy, and potential obstetric, fetal, and neonatal risks associated with core foundational pharmacotherapies for bipolar disorder. PMID:25565896

Use of new once-daily 5-aminosalicylic acid preparations in the treatment of ulcerative colitis: Is there anything new under the sun?

PubMed Central

Lakatos, Peter Laszlo

2009-01-01

5-aminosalicylate (5-ASA) agents remain the mainstay treatment in ulcerative colitis (UC). A number of oral 5-ASA agents are commercially available, including azobond pro-drugs, as well as delayed- and controlled-release forms of mesalazine. However, poor adherence due to frequent daily dosing and a large number of tablets has been shown to be an important barrier to successful management of patients with UC. Recently, new, once-daily formulations of mesalazine, including the unique multi-matrix delivery system and mesalazine granules, were proven to be efficacious in inducing and maintaining remission in mild-to-moderate UC, with a good safety profile comparable to that of other oral mesalazine formulations. In addition, they offer the advantage of a low pill burden and might contribute to increased long-term compliance and treatment success in clinical practice. This editorial summarizes the available literature on the short- and medium-term efficacy and safety of the new once-daily mesalazine formulations. PMID:19370774

Use of new once-daily 5-aminosalicylic acid preparations in the treatment of ulcerative colitis: Is there anything new under the sun?

PubMed

Lakatos, Peter Laszlo

2009-04-21

5-aminosalicylate (5-ASA) agents remain the mainstay treatment in ulcerative colitis (UC). A number of oral 5-ASA agents are commercially available, including azobond pro-drugs, as well as delayed- and controlled-release forms of mesalazine. However, poor adherence due to frequent daily dosing and a large number of tablets has been shown to be an important barrier to successful management of patients with UC. Recently, new, once-daily formulations of mesalazine, including the unique multi-matrix delivery system and mesalazine granules, were proven to be efficacious in inducing and maintaining remission in mild-to-moderate UC, with a good safety profile comparable to that of other oral mesalazine formulations. In addition, they offer the advantage of a low pill burden and might contribute to increased long-term compliance and treatment success in clinical practice. This editorial summarizes the available literature on the short- and medium-term efficacy and safety of the new once-daily mesalazine formulations.

Gonadotropin-releasing hormone antagonist in the management of prostate cancer.

PubMed

Debruyne, Frans M J

2004-01-01

Luteinizing hormone-releasing hormone (LHRH) agonist therapy to induce medical castration has become the most common form of hormonal therapy for advanced and metastatic prostate cancer. When treatment is started, LHRH agonists initially stimulate the release of LH, causing a surge in serum testosterone that can precipitate a "flare" phenomenon or worsening of disease, particularly in patients with bone metastatic disease. Gonadotropin-releasing hormone (GnRH) receptor antagonism represents a newer approach to medical castration. Abarelix is a pure GnRH receptor antagonist that is devoid of any LHRH agonist activity. Results from 1 phase II and 3 phase III clinical trials demonstrate that abarelix produces medical castration more quickly and without causing testosterone surge, as compared with LHRH agonists with or without a nonsteroidal antagonist. The safety profile in terms of adverse events is comparable between the 2 types of treatment, but the lack of testosterone surge with abarelix might confer a safety advantage by abolishing the risk of a disease flare.

A structural equation modelling approach examining the pathways between safety climate, behaviour performance and workplace slipping

PubMed Central

Swedler, David I; Verma, Santosh K; Huang, Yueng-Hsiang; Lombardi, David A; Chang, Wen-Ruey; Brennan, Melayne; Courtney, Theodore K

2015-01-01

Objective Safety climate has previously been associated with increasing safe workplace behaviours and decreasing occupational injuries. This study seeks to understand the structural relationship between employees’ perceptions of safety climate, performing a safety behaviour (ie, wearing slip-resistant shoes) and risk of slipping in the setting of limited-service restaurants. Methods At baseline, we surveyed 349 employees at 30 restaurants for their perceptions of their safety training and management commitment to safety as well as demographic data. Safety performance was identified as wearing slip-resistant shoes, as measured by direct observation by the study team. We then prospectively collected participants’ hours worked and number of slips weekly for the next 12 weeks. Using a confirmatory factor analysis, we modelled safety climate as a higher order factor composed of previously identified training and management commitment factors. Results The 349 study participants experienced 1075 slips during the 12-week follow-up. Confirmatory factor analysis supported modelling safety climate as a higher order factor composed of safety training and management commitment. In a structural equation model, safety climate indirectly affected prospective risk of slipping through safety performance, but no direct relationship between safety climate and slips was evident. Conclusions Results suggest that safety climate can reduce workplace slips through performance of a safety behaviour as well as suggesting a potential causal mechanism through which safety climate can reduce workplace injuries. Safety climate can be modelled as a higher order factor composed of safety training and management commitment. PMID:25710968

Quality management and perceptions of teamwork and safety climate in European hospitals.

PubMed

Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

2015-12-01

This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

School Bus Fleet Safety: Planning and Development.

ERIC Educational Resources Information Center

Bieber, Robert M.

1984-01-01

To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

41 CFR 128-1.8005 - Seismic safety standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Seismic safety standards. 128-1.8005 Section 128-1.8005 Public Contracts and Property Management Federal Property Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program § 128-1.8005...

41 CFR 128-1.8009 - Review of Seismic Safety Program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Review of Seismic Safety Program. 128-1.8009 Section 128-1.8009 Public Contracts and Property Management Federal Property Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program...

23 CFR 973.212 - Indian lands safety management system (SMS).

Code of Federal Regulations, 2010 CFR

2010-04-01

... implementation of public information and education activities on safety needs, programs, and countermeasures... 23 Highways 1 2010-04-01 2010-04-01 false Indian lands safety management system (SMS). 973.212... HIGHWAYS MANAGEMENT SYSTEMS PERTAINING TO THE BUREAU OF INDIAN AFFAIRS AND THE INDIAN RESERVATION ROADS...

44 CFR 7.6 - Life, health, and safety.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Life, health, and safety. 7.6 Section 7.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF... in FEMA-Assisted Programs-General § 7.6 Life, health, and safety. Notwithstanding the provisions of...

44 CFR 7.6 - Life, health, and safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Life, health, and safety. 7.6 Section 7.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF... in FEMA-Assisted Programs-General § 7.6 Life, health, and safety. Notwithstanding the provisions of...

78 FR 59082 - Privacy Act of 1974; Department of Transportation, Federal Motor Carrier Safety Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-25

... Carrier Management Information System (MCMIS) System of Records AGENCY: Federal Motor Carrier Safety... Administration DOT/FMCSA 001 Motor Carrier Management Information System System of Records.'' This system of... Federal Motor Carrier Safety Administration--DOT/FMCSA 001 Motor Carrier Management Information System...

33 CFR 96.380 - How will the Coast Guard handle compliance and enforcement of these regulations?

Code of Federal Regulations, 2010 CFR

2010-07-01

... safety management system while operating the vessel or transferring cargoes. (b) A foreign vessel that... GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems Be Certificated and Enforced...

75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a...

The Design of a Practical Enterprise Safety Management System

NASA Astrophysics Data System (ADS)

Gabbar, Hossam A.; Suzuki, Kazuhiko

This book presents design guidelines and implementation approaches for enterprise safety management system as integrated within enterprise integrated systems. It shows new model-based safety management where process design automation is integrated with enterprise business functions and components. It proposes new system engineering approach addressed to new generation chemical industry. It will help both the undergraduate and professional readers to build basic knowledge about issues and problems of designing practical enterprise safety management system, while presenting in clear way, the system and information engineering practices to design enterprise integrated solution.

Database management systems for process safety.

PubMed

Early, William F

2006-03-17

Several elements of the process safety management regulation (PSM) require tracking and documentation of actions; process hazard analyses, management of change, process safety information, operating procedures, training, contractor safety programs, pre-startup safety reviews, incident investigations, emergency planning, and compliance audits. These elements can result in hundreds of actions annually that require actions. This tracking and documentation commonly is a failing identified in compliance audits, and is difficult to manage through action lists, spreadsheets, or other tools that are comfortably manipulated by plant personnel. This paper discusses the recent implementation of a database management system at a chemical plant and chronicles the improvements accomplished through the introduction of a customized system. The system as implemented modeled the normal plant workflows, and provided simple, recognizable user interfaces for ease of use.

Future clinical challenges in multiple sclerosis: Relevance to sphingosine 1-phosphate receptor modulator therapy.

PubMed

Hohlfeld, Reinhard; Barkhof, Frederik; Polman, Chris

2011-02-22

The limitations of established therapies for multiple sclerosis (MS) are well-known and include the need for injections, treatment adherence and convenience issues, partial efficacy, and, in some cases, a risk of potentially life-threatening adverse events, such as progressive multifocal leukoencephalopathy. Recently, attention has focused on developing more effective therapies that are administered orally and target neurodegeneration as well as inflammation. In this review, we provide an outlook on the future clinical challenges for MS treatment and management, and focus specifically on the emerging sphingosine 1-phosphate receptor (S1PR) modulators. We highlight the importance of improving our understanding of the neurobiological basis of MS to develop well-tolerated targeted therapies and the need to include advanced MRI assessments that quantify neurodegeneration in interventional studies in MS. As more treatments become available, often with complex pharmacodynamic actions, objective assessment of benefit-to-risk profiles becomes increasingly important to ensure that patients receive appropriate care. Pharmacovigilance and immune monitoring will become important aspects of patient treatment and management in the future. With respect to S1PR modulation, we review the experimental agents that are in clinical development for MS and summarize the steps taken in postmarketing surveillance to ensure that fingolimod (FTY720) has a well-characterized safety profile.

Effect of Occupational Health and Safety Management System on Work-Related Accident Rate and Differences of Occupational Health and Safety Management System Awareness between Managers in South Korea's Construction Industry

PubMed Central

Yoon, Seok J.; Lin, Hsing K.; Chen, Gang; Yi, Shinjea; Choi, Jeawook; Rui, Zhenhua

2013-01-01

Background The study was conducted to investigate the current status of the occupational health and safety management system (OHSMS) in the construction industry and the effect of OHSMS on accident rates. Differences of awareness levels on safety issues among site general managers and occupational health and safety (OHS) managers are identified through surveys. Methods The accident rates for the OHSMS-certified construction companies from 2006 to 2011, when the construction OHSMS became widely available, were analyzed to understand the effect of OHSMS on the work-related injury rates in the construction industry. The Korea Occupational Safety and Health Agency 18001 is the certification to these companies performing OHSMS in South Korea. The questionnaire was created to analyze the differences of OHSMS awareness between site general managers and OHS managers of construction companies. Results The implementation of OHSMS among the top 100 construction companies in South Korea shows that the accident rate decreased by 67% and the fatal accident rate decreased by 10.3% during the period from 2006 to 2011. The survey in this study shows different OHSMS awareness levels between site general managers and OHS managers. The differences were motivation for developing OHSMS, external support needed for implementing OHSMS, problems and effectiveness of implementing OHSMS. Conclusion Both work-related accident and fatal accident rates were found to be significantly reduced by implementing OHSMS in this study. The differences of OHSMS awareness between site general managers and OHS managers were identified through a survey. The effect of these differences on safety and other benefits warrants further research with proper data collection. PMID:24422176

Effect of Occupational Health and Safety Management System on Work-Related Accident Rate and Differences of Occupational Health and Safety Management System Awareness between Managers in South Korea's Construction Industry.

PubMed

Yoon, Seok J; Lin, Hsing K; Chen, Gang; Yi, Shinjea; Choi, Jeawook; Rui, Zhenhua

2013-12-01

The study was conducted to investigate the current status of the occupational health and safety management system (OHSMS) in the construction industry and the effect of OHSMS on accident rates. Differences of awareness levels on safety issues among site general managers and occupational health and safety (OHS) managers are identified through surveys. The accident rates for the OHSMS-certified construction companies from 2006 to 2011, when the construction OHSMS became widely available, were analyzed to understand the effect of OHSMS on the work-related injury rates in the construction industry. The Korea Occupational Safety and Health Agency 18001 is the certification to these companies performing OHSMS in South Korea. The questionnaire was created to analyze the differences of OHSMS awareness between site general managers and OHS managers of construction companies. The implementation of OHSMS among the top 100 construction companies in South Korea shows that the accident rate decreased by 67% and the fatal accident rate decreased by 10.3% during the period from 2006 to 2011. The survey in this study shows different OHSMS awareness levels between site general managers and OHS managers. The differences were motivation for developing OHSMS, external support needed for implementing OHSMS, problems and effectiveness of implementing OHSMS. Both work-related accident and fatal accident rates were found to be significantly reduced by implementing OHSMS in this study. The differences of OHSMS awareness between site general managers and OHS managers were identified through a survey. The effect of these differences on safety and other benefits warrants further research with proper data collection.

41 CFR 102-80.60 - Are Federal agencies responsible for performing facility assessments?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Facility Assessments... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Are Federal agencies...

Research on station management in subway operation safety

NASA Astrophysics Data System (ADS)

Li, Yiman

2017-10-01

The management of subway station is an important part of the safe operation of urban subway. In order to ensure the safety of subway operation, it is necessary to study the relevant factors that affect station management. In the protection of subway safety operations on the basis of improving the quality of service, to promote the sustained and healthy development of subway stations. This paper discusses the influencing factors of subway operation accident and station management, and analyzes the specific contents of station management security for subway operation, and develops effective suppression measures. It is desirable to improve the operational quality and safety factor for subway operations.

Patient safety in psychiatric inpatient care: a literature review.

PubMed

Kanerva, A; Lammintakanen, J; Kivinen, T

2013-08-01

Patient safety is widely discussed, but little has been written from the perspective of psychiatric inpatient care, nor on which factors create its patient safety. This paper seeks to understand the concept of patient safety and its intension in psychiatric inpatient care, and to identify factors in organization management, staff and patients' roles which constitute patient safety in such units. A literature search was conducted, and the articles selected were analysed by identifying factors defined to be connected to patient safety and classifying them according to their connection to organization management, staff and patient roles. According to the literature, organization safety culture is present in all aspects of patient safety. Organization management has the main role in patient safety within the organization culture, for example, through leadership, safety practices and creating good working conditions and environment for the staff. Staff's role is influenced by management, but has more individual input in different areas, while the patient's role is more that of an informant so that care can be planned according to the patient's preferences. When developing patient safety it is important to remember the diversity of the concept so that all areas are considered in the developmental work. © 2012 John Wiley & Sons Ltd.

Bridging the Divide between Safety and Risk Management for your Project or Program

NASA Technical Reports Server (NTRS)

Lutomski, Mike

2005-01-01

This presentation will bridge the divide between these separate but overlapping disciplines and help explain how to use Risk Management as an effective management decision support tool that includes safety. Risk Management is an over arching communication tool used by management to prioritize and effectively mitigate potential problems before they concur. Risk Management encompasses every kind of potential problem that can occur on a program or project. Some of these are safety issues such as hazards that have a specific likelihood and consequence that need to be controlled and included to show an integrated picture of accepted) mitigated, and residual risk. Integrating safety and other assurance disciplines is paramount to accurately representing a program s or projects risk posture. Risk is made up of several components such as technical) cost, schedule, or supportability. Safety should also be a consideration for every risk. The safety component can also have an impact on the technical, cost, and schedule aspect of a given risk. The current formats used for communication of safety and risk issues are not consistent or integrated. The presentation will explore the history of these disciplines, current work to integrate them, and suggestions for integration for the future.

41 CFR 102-34.250 - Do Federal employees in Government motor vehicles have to use all safety devices and follow all...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do Federal employees in Government motor vehicles have to use all safety devices and follow all safety guidelines? 102-34.250 Section 102-34.250 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATIO...

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme.

PubMed

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-09-01

Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%). Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

PubMed Central

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-01-01

Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need. PMID:23850682

Improving Sustainability of Ion Implant Modules

NASA Astrophysics Data System (ADS)

Mayer, Jim

2011-01-01

Semiconductor fabs have long been pressured to manage capital costs, reduce energy consumption and increasingly improve efforts to recycle and recover resources. Ion implant tools have been high-profile offenders on all three fronts. They draw such large volumes of air for heat dissipation and risk reduction that historically, they are the largest consumer of cleanroom air of any process tool—and develop energy usage and resource profiles to match. This paper presents a documented approach to reduce their energy consumption and dramatically downsize on-site facilities support for cleanroom air manufacture and abatement. The combination produces significant capital expenditure savings. The case entails applying SAGS Type 1 (sub-atmospheric gas systems) toxic gas packaging to enable engineering adaptations that deliver the energy savings and cost benefits without any reduction in environmental health and safety. The paper also summarizes benefits as they relate to reducing a fabs carbon emission footprint (and longer range advantages relative to potential cap and trade programs) with existing technology.

Trenonacog alfa for prophylaxis, on-demand and perioperative management of hemophilia B.

PubMed

Brennan, Yvonne; Curnow, Jennifer; Favaloro, Emmanuel J

2018-01-01

Current treatment for hemophilia B involves replacing the missing coagulation factor IX (FIX) with either plasma-derived or recombinant (r) FIX. Trenonacog alfa is the third normal half-life rFIX that has been granted FDA approval. Area covered: In this review, the authors examine trenonacog alfa for the treatment of hemophilia B including prophylaxis, on-demand and perioperative hemostasis. They compare the PK profile to nonacog alfa and evaluate the drug's efficacy and safety from published studies. Expert opinion: Trenonacog alfa appears to be an effective and safe treatment option for patients with hemophilia B with a PK profile similar to that of nonacog alfa. Despite the advent of extended half-life rFIX and other novel therapeutic approaches, normal half-life rFIX products, including trenonacog alfa, are likely to continue to have a place in hemophilia B treatment for at least the immediate future while the new landscape takes shape, particularly in countries that cannot afford the newer treatments.

Management commitment to safety as organizational support: relationships with non-safety outcomes in wood manufacturing employees

Treesearch

Judd H. Michael; Demetrice D. Evans; Karen J. Jansen; Joel M. Haight

2005-01-01

Employee perceptions of management commitment to safety are known to influence important safety-related outcomes. However, little work has been conducted to explore nonsafety-related outcomes resulting from a commitment to safety. Method: Employee-level outcomes critical to the effective functioning of an organization, including attitudes such as job...

Healthcare managers' leadership profiles in relation to perceptions of work stressors and stress.

PubMed

Lornudd, Caroline; Bergman, David; Sandahl, Christer; von Thiele Schwarz, Ulrica

2016-05-03

Purpose The purpose of this study is to investigate the relationship between leadership profiles and differences in managers' own levels of work stress symptoms and perceptions of work stressors causing stress. Design/methodology/approach Cross-sectional data were used. Healthcare managers ( n = 188) rated three dimensions of their leadership behavior and levels of work stressors and stress. Hierarchical cluster analysis was performed to identify leadership profiles based on leadership behaviors. Differences in stress-related outcomes between profiles were assessed using one-way analysis of variance. Findings Four distinct clusters of leadership profiles were found. They discriminated in perception of work stressors and stress: the profile distinguished by the lowest mean in all behavior dimensions, exhibited a pattern with significantly more negative ratings compared to the other profiles. Practical implications This paper proposes that leadership profile is an individual factor involved in the stress process, including work stressors and stress, which may inform targeted health promoting interventions for healthcare managers. Originality/value This is the first study to investigate the relationship between leadership profiles and work stressors and stress in healthcare managers.

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis.

PubMed

Cecchin, Vanessa; Zannin, Maria Elisabetta; Ferrari, Daniele; Pontikaki, Irene; Miserocchi, Elisabetta; Paroli, Maria P; Bracaglia, Claudia; Marafon, Denise Pires; Pastore, Serena; Parentin, Fulvio; Simonini, Gabriele; De Libero, Cinzia; Falcini, Fernanda; Petaccia, Antonella; Filocamo, Giovanni; De Marco, Riccardo; La Torre, Francesco; Guerriero, Silvana; Martino, Silvana; Comacchio, Francesco; Muratore, Valentina; Martini, Giorgia; Vittadello, Fabio; Zulian, Francesco

2018-04-15

Anti-TNF-α agents have significantly changed the management of juvenile idiopathic arthritis (JIA). We evaluated the safety and efficacy of adalimumab (ADA) and infliximab (IFX) for the treatment of JIA-associated uveitis in patients treated for ≥ 2 years. Patients with JIA-associated uveitis treated with IFX and ADA were managed by a standardized protocol and data were entered in the ORCHIDEA registry. At baseline, all patients were refractory to standard immunosuppressive treatment or were corticosteroid-dependent. Data recorded every 3 months were uveitis course, number/type of ocular flares and complications, drug-related adverse events (AE), and treatment switch or withdrawal. Data of patients treated for ≥ 2 years were analyzed by descriptive statistics. Up to December 2014, 154 patients with ≥ 24 months followup were included in the study. Fifty-nine patients were treated with IFX and 95 with ADA. Clinical remission, defined as the absence of flares for > 6 months on treatment, was achieved in 69 patients (44.8%), with a better remission rate for ADA (60.0%) as compared to IFX (20.3%; p < 0.001). A significant reduction of flares was observed in all patients without difference between the 2 treatment modalities. The number of new ocular complications decreased in both groups but was lower for ADA (p = 0.015). No serious AE were recorded; 16.4% of patients experienced 35 minor AE and the incidence rate was lower with ADA than with IFX. At the 2-year followup, ADA showed a better efficacy and safety profile than IFX for the treatment of refractory JIA-associated uveitis.

An integrative model of organizational safety behavior.

PubMed

Cui, Lin; Fan, Di; Fu, Gui; Zhu, Cherrie Jiuhua

2013-06-01

This study develops an integrative model of safety management based on social cognitive theory and the total safety culture triadic framework. The purpose of the model is to reveal the causal linkages between a hazardous environment, safety climate, and individual safety behaviors. Based on primary survey data from 209 front-line workers in one of the largest state-owned coal mining corporations in China, the model is tested using structural equation modeling techniques. An employee's perception of a hazardous environment is found to have a statistically significant impact on employee safety behaviors through a psychological process mediated by the perception of management commitment to safety and individual beliefs about safety. The integrative model developed here leads to a comprehensive solution that takes into consideration the environmental, organizational and employees' psychological and behavioral aspects of safety management. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Thesis - keeping the management system {open_quotes}live{close_quotes} and reaching the workforce

DOE Office of Scientific and Technical Information (OSTI.GOV)

Primrose, M.J.; Bentley, P.D.; Graaf, G.C. van der

1996-12-31

Previous papers given to SPE conferences have described the Shell Group approach to Safety Management Systems and to Safety Cases. Their extension to HSE MS and to HSE Cases has also been addressed. Since 1984 the Enhanced Safety Management (ESM) programme within Shell companies has led to a significant improvement in the management of safety but it was only when structured management systems (based upon an understanding of the business processes) were introduced that true integration of HSE as a line responsibility became a reality. This paper describes the THESIS software package and the way that management systems have beenmore » made {open_quote}live{close_quote} and how workforce involvement can be demonstrated.« less

Proceedings of the IEEE International Workshop on Safety of Systems (1st) held in Monterey, California on 15-16 Mar 2007

DTIC Science & Technology

2007-03-01

Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302, and to the Office of Management and Budget...participation included the following list of topics: Safety engineering of systems-of-systems; Building a safety culture and management of safety...provide Practitioner competence Realistic expectations on practitioners Risk management , such as how to model security problems vii

Nurse case management for pregnant women experiencing or at risk for abuse.

PubMed

Curry, Mary Ann; Durham, Laurel; Bullock, Linda; Bloom, Tina; Davis, Jan

2006-01-01

To determine whether individualized nursing case management can decrease stress among pregnant women at risk for or in abusive relationships. A multisite randomized controlled trial. Two prenatal clinics in the Pacific Northwest and rural Midwest. 1,000 women who spoke English and were 13 to 23 weeks pregnant at time of recruitment. All intervention group women (N = 499) were offered an abuse video and had access to a nurse case manager 24/7. Additionally, participants at risk for or in abusive relationships received individualized nursing care management throughout the pregnancy. The most frequent nursing care management activities were providing support (38%) and assessing needs (32%). The nursing care management group received an average of 22 contacts, most (80%) by telephone and had a significant reduction in stress scores as measured by the Prenatal Psychosocial Profile. Compared to the control group, the differences were in the predicted direction, but not statistically different. A major finding was the choice by abused women to focus on basic needs and their pregnancies rather than the abuse, although all received safety planning. Pregnant women at risk for or in abusive relationships experience very stressful and complex lives. Nurses need to focus on the needs they identify, which may not be the abusive relationship.

Knowledge, Attitude and Practice of Healthcare Managers to Medical Waste Management and Occupational Safety Practices: Findings from Southeast Nigeria.

PubMed

Anozie, Okechukwu Bonaventure; Lawani, Lucky Osaheni; Eze, Justus Ndulue; Mamah, Emmanuel Johnbosco; Onoh, Robinson Chukwudi; Ogah, Emeka Onwe; Umezurike, Daniel Akuma; Anozie, Rita Onyinyechi

2017-03-01

Awareness of appropriate waste management procedures and occupational safety measures is fundamental to achieving a safe work environment, and ensuring patient and staff safety. This study was conducted to assess the attitude of healthcare managers to medical waste management and occupational safety practices. This was a cross-sectional study conducted among 54 hospital administrators in Ebonyi state. Semi-structured questionnaires were used for qualitative data collection and analyzed with SPSS statistics for windows (2011), version 20.0 statistical software (Armonk, NY: IBM Corp). Two-fifth (40%) of healthcare managers had received training on medical waste management and occupational safety. Standard operating procedure of waste disposal was practiced by only one hospital (1.9%), while 98.1% (53/54) practiced indiscriminate waste disposal. Injection safety boxes were widely available in all health facilities, nevertheless, the use of incinerators and waste treatment was practiced by 1.9% (1/54) facility. However, 40.7% (22/54) and 59.3% (32/54) of respondents trained their staff and organize safety orientation courses respectively. Staff insurance cover was offered by just one hospital (1.9%), while none of the hospitals had compensation package for occupational hazard victims. Over half (55.6%; 30/54) of the respondents provided both personal protective equipment and post exposure prophylaxis for HIV. There was high level of non-compliance to standard medical waste management procedures, and lack of training on occupational safety measures. Relevant regulating agencies should step up efforts at monitoring and regulation of healthcare activities and ensure staff training on safe handling and disposal of hospital waste.

Series: Pragmatic trials and real world evidence: Paper 7. Safety, quality and monitoring.

PubMed

Irving, Elaine; van den Bor, Rutger; Welsing, Paco; Walsh, Veronica; Alfonso-Cristancho, Rafael; Harvey, Catherine; Garman, Nadia; Grobbee, Diederick E

2017-11-01

Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorization. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials. This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that all serious adverse events and all drug-related events must be reported in an interventional trial. In line with current guidance, we propose a risk-based approach to the collection of non-drug-related non-serious adverse events and even serious events not related to treatment based on the risk profile of the medicine/class in the patient population of interest. Different options available to support the collection and reporting of safety data while minimizing study-related follow-up visits are discussed. A risk-based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials and the careful consideration that must be given to the mitigation and management of these risks to maintain routine care. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A hierarchical factor analysis of a safety culture survey.

PubMed

Frazier, Christopher B; Ludwig, Timothy D; Whitaker, Brian; Roberts, D Steve

2013-06-01

Recent reviews of safety culture measures have revealed a host of potential factors that could make up a safety culture (Flin, Mearns, O'Connor, & Bryden, 2000; Guldenmund, 2000). However, there is still little consensus regarding what the core factors of safety culture are. The purpose of the current research was to determine the core factors, as well as the structure of those factors that make up a safety culture, and establish which factors add meaningful value by factor analyzing a widely used safety culture survey. A 92-item survey was constructed by subject matter experts and was administered to 25,574 workers across five multi-national organizations in five different industries. Exploratory and hierarchical confirmatory factor analyses were conducted revealing four second-order factors of a Safety Culture consisting of Management Concern, Personal Responsibility for Safety, Peer Support for Safety, and Safety Management Systems. Additionally, a total of 12 first-order factors were found: three on Management Concern, three on Personal Responsibility, two on Peer Support, and four on Safety Management Systems. The resulting safety culture model addresses gaps in the literature by indentifying the core constructs which make up a safety culture. This clarification of the major factors emerging in the measurement of safety cultures should impact the industry through a more accurate description, measurement, and tracking of safety cultures to reduce loss due to injury. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Operating & Environmental Standards « Coast Guard Maritime Commons

Science.gov Websites

: Marine Safety Information Bulletin 03-18, Oily bilge water management This bulletin summarizes key legal updates to Marine Safety Center's ballast water management system website The Marine Safety Center recently updated two tools posted to its ballast water management system website to assist industry when

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2011 CFR

2011-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2013 CFR

2013-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2010 CFR

2010-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2012 CFR

2012-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2014 CFR

2014-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

33 CFR 96.360 - Interim Safety Management Certificate: what is it and when can it be used?

Code of Federal Regulations, 2010 CFR

2010-07-01

... section, when— (1) The company's valid Document of Compliance certificate or Interim Document of Compliance certificate applies to that vessel type; (2) The company's safety management system for the vessel... to the responsible person or their company. (b) An Interim Safety Management Certificate is valid for...

78 FR 67326 - Safety and Environmental Management System Requirements for Vessels on the U.S. Outer Continental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... 1625-AC05 Safety and Environmental Management System Requirements for Vessels on the U.S. Outer... ``Safety and Environmental Management System Requirements for Vessels on the U.S. Outer Continental Shelf... of industry to ensure stakeholders have adequate time to submit complete responses. DATES: Comments...

46 CFR 126.480 - Safety Management Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Safety Management Certificate. 126.480 Section 126.480 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS INSPECTION AND CERTIFICATION Inspection for Certification § 126.480 Safety Management Certificate. (a) All offshore supply vessels of 500 gross tons or over to...

76 FR 23708 - Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

...-AA00 Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East... the Regional Water Rescue Exercise. Basis and Purpose The Pierce County, Washington, Department of... to read as follows: Sec. 165.T13-0251 Safety Zone; Pierce County Department of Emergency Management...

Design an optimum safety policy for personnel safety management - A system dynamic approach

NASA Astrophysics Data System (ADS)

Balaji, P.

2014-10-01

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.

Motor carrier industry profile study : financial and operating performance profiles by industry segment, 2001-2002.

DOT National Transportation Integrated Search

2004-09-01

This report profiles the motor carrier industry and its significant operating segments. It is one of a series of reports analyzing various aspects of the motor carrier industry. Other reports in the series focus on the safety performance of the indus...

The Research on the Impact of Management Level's Charismatic Leadership Style on Miners' Unsafe Behavior.

PubMed

Li, Hongxia; Di, Hongxi; Tian, Shuicheng; Li, Jian

2015-01-01

The aim of this study is research the impact of management level's charismatic leadership style on miners' unsafe behavior by using the questionnaires on charismatic leadership style, safety attitude and the miners' unsafe behavior measurement to investigate 200 employees in Shen Dong Company. The research results suggest that management level's charismatic leadership style have very important influence on miners' unsafe behavior and the influence is affected by the safety attitude which is the intermediary function. In the end, this study propose advice on how to improve the coal mine enterprise managers charismatic leadership style in the coal mine enterprise's safety management work, including attach great importance to a variety of incentive methods, set up safety moral models, practice of inductive leadership concept, create a good atmosphere of safety, etc for reference for coal mining enterprises.

Practices of US health insurance companies concerning MS therapies interfere with shared decision-making and harm patients.

PubMed

Bourdette, Dennis N; Hartung, Daniel M; Whitham, Ruth H

2016-04-01

The US Food and Drug Administration has registered 13 multiple sclerosis (MS) disease-modifying therapies (DMTs). The medications are not interchangeable as they vary in route of administration, efficacy, and safety profile. Selecting the appropriate MS DMT for individual patients requires shared decision-making between patients and neurologists. To reduce costs, insurance companies acting through pharmacy benefit companies restrict access to MS DMTs through tiered coverage and other regulations. We discuss how policies established by insurance companies that limit access to MS DMTs interfere with the process of shared decision-making and harm patients. We present potential actions that neurologists can take to change how insurance companies manage MS DMTs.

Current treatment recommendations and considerations for cryopyrin-associated periodic syndrome.

PubMed

Koné-Paut, Isabelle; Galeotti, Caroline

2015-01-01

Cryopyrin-associated periodic syndrome (CAPS) encompasses a spectrum of three phenotypes of increasing severity. The syndrome is due to dominant mutations in NLRP3, which encodes a key component of the innate immunity that regulates the secretion of IL-1β. CAPS manifests as systemic inflammation, which compromises quality of life and leads to serious complications and handicap. Anti-IL-1 drugs have shown remarkable efficacy in treating CAPS symptoms and have significantly changed patients' lives. They have acceptable safety profiles but do have some differences. We review three drugs that are currently marketed for CAPS, give additional information for the practical use of these drugs, and provide some recommendations for management.

A case report on toxic epidermal necrolysis with etoricoxib

PubMed Central

Kameshwari, J. S.; Devde, Raju

2015-01-01

Etoricoxib is a selective cyclo-oxygenase 2 (COX-2) enzyme inhibitor and is exploited for its analgesic activity in various disease conditions like osteoarthritis, gouty arthritis, acute pain including postoperative dental pain and primary dysmenorrhea, etc. Although highly efficacious in pain management the safety profile of this COX-2 inhibitor is yet to be established in a broader sense. Short-term clinical trials and postmarketing surveillance have shown a very rare incidence of very serious skin reactions like Steven Johnson syndrome or toxic epidermal necrolysis (TEN). In this case report, we summarize regarding a patient who developed TEN after treatment with etoricoxib for osteoarthritis that later resolved in 15 days after withdrawal and symptomatic treatment. PMID:25878388

Safety evaluation of access management policies and techniques, TechBrief

DOT National Transportation Integrated Search

2015-08-01

Access management is the process that provides (or manages) access to land development while simultaneously preserving the flow of traffic on the surrounding road network for safety, capacity, and speed. Access management provides important benefits ...

Factors Influencing Implementation of OHSAS 18001 in Indian Construction Organizations: Interpretive Structural Modeling Approach

PubMed Central

Rajaprasad, Sunku Venkata Siva; Chalapathi, Pasupulati Venkata

2015-01-01

Background Construction activity has made considerable breakthroughs in the past two decades on the back of increases in development activities, government policies, and public demand. At the same time, occupational health and safety issues have become a major concern to construction organizations. The unsatisfactory safety performance of the construction industry has always been highlighted since the safety management system is neglected area and not implemented systematically in Indian construction organizations. Due to a lack of enforcement of the applicable legislation, most of the construction organizations are forced to opt for the implementation of Occupational Health Safety Assessment Series (OHSAS) 18001 to improve safety performance. Methods In order to better understand factors influencing the implementation of OHSAS 18001, an interpretive structural modeling approach has been applied and the factors have been classified using matrice d'impacts croises-multiplication appliqué a un classement (MICMAC) analysis. The study proposes the underlying theoretical framework to identify factors and to help management of Indian construction organizations to understand the interaction among factors influencing in implementation of OHSAS 18001. Results Safety culture, continual improvement, morale of employees, and safety training have been identified as dependent variables. Safety performance, sustainable construction, and conducive working environment have been identified as linkage variables. Management commitment and safety policy have been identified as the driver variables. Conclusion Management commitment has the maximum driving power and the most influential factor is safety policy, which states clearly the commitment of top management towards occupational safety and health. PMID:26929828

Achieving a physiological cortisol profile with once-daily dual-release hydrocortisone: a pharmacokinetic study.

PubMed

Johannsson, Gudmundur; Lennernäs, Hans; Marelli, Claudio; Rockich, Kevin; Skrtic, Stanko

2016-07-01

Oral once-daily dual-release hydrocortisone (DR-HC) replacement therapy was developed to provide a cortisol exposure-time profile that closely resembles the physiological cortisol profile. This study aimed to characterize single-dose pharmacokinetics (PK) of DR-HC 5-20mg and assess intrasubject variability. Thirty-one healthy Japanese or non-Hispanic Caucasian volunteers aged 20-55 years participated in this randomized, open-label, PK study. Single doses of DR-HC 5, 15 (3×5), and 20mg were administered orally after an overnight fast and suppression of endogenous cortisol secretion. After estimating the endogenous cortisol profile, PK of DR-HC over 24h were evaluated to assess dose proportionality and impact of ethnicity. Plasma cortisol concentrations were analyzed using liquid chromatography-tandem mass spectrometry. PK parameters were calculated from individual cortisol concentration-time profiles. DR-HC 20mg provided higher than endogenous cortisol plasma concentrations 0-4h post-dose but similar concentrations later in the profile. Cortisol concentrations and PK exposure parameters increased with increasing doses. Mean maximal serum concentration (Cmax) was 82.0 and 178.1ng/mL, while mean area under the concentration-time curve (AUC)0-∞ was 562.8 and 1180.8h×ng/mL with DR-HC 5 and 20mg respectively. Within-subject PK variability was low (<15%) for DR-HC 20mg. All exposure PK parameters were less than dose proportional (slope <1). PK differences between ethnicities were explained by body weight differences. DR-HC replacement resembles the daily normal cortisol profile. Within-subject day-to-day PK variability was low, underpinning the safety of DR-HC for replacement therapy. DR-HC PK were less than dose proportional - an important consideration when managing intercurrent illness in patients with adrenal insufficiency. © 2016 The authors.

30 CFR 285.800 - How must I conduct my activities to comply with safety and environmental requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... safety and environmental requirements? 285.800 Section 285.800 Mineral Resources MINERALS MANAGEMENT... OUTER CONTINENTAL SHELF Environmental and Safety Management, Inspections, and Facility Assessments for... safety and environmental requirements? (a) You must conduct all activities on your lease or grant under...

10 CFR 851.20 - Management responsibilities and worker rights and responsibilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... responsibilities. 851.20 Section 851.20 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Specific...) Management responsibilities. Contractors are responsible for the safety and health of their workforce and... objectives for the worker safety and health program; (2) Use qualified worker safety and health staff (e.g...

An Assessment of Software Safety as Applied to the Department of Defense Software Development Process

DTIC Science & Technology

1992-12-01

provide program 5 managers some level of confidence that their software will operate at an acceptable level of risk. A number of structured safety...safety within the constraints of operational effectiveness, schedule, and cost through timely application of system safety management and engineering...Master of Science in Software Systems Management Peter W. Colan, B.S.E. Robert W. Prouhet, B.S. Captain, USAF Captain, USAF December 1992 Approved for

[Design, implementation and evaluation of a management model of patient safety in hospitals in Catalonia, Spain].

PubMed

Saura, Rosa Maria; Moreno, Pilar; Vallejo, Paula; Oliva, Glòria; Alava, Fernando; Esquerra, Miquel; Davins, Josep; Vallès, Roser; Bañeres, Joaquim

2014-07-01

Since its inception in 2006, the Alliance for Patient Safety in Catalonia has played a major role in promoting and shaping a series of projects related to the strategy of the Ministry of Health, Social Services and Equality, for improving patient safety. One such project was the creation of functional units or committees of safety in hospitals in order to facilitate the management of patient safety. The strategy has been implemented in hospitals in Catalonia which were selected based on criteria of representativeness. The intervention was based on two lines of action, one to develop the model framework and the other for its development. Firstly the strategy for safety management based on EFQM (European Foundation for Quality Management) was defined with the development of standards, targets and indicators to implement security while the second part involved the introduction of tools, methodologies and knowledge to the management support of patient safety and risk prevention. The project was developed in four hospital areas considered higher risk, each assuming six goals for safety management. Some of these targets such as the security control panel or system of adverse event reporting were shared. 23 hospitals joined the project in Catalonia. Despite the different situations in each centre, high compliance was achieved in the development of the objectives. In each of the participating areas the security control panel was developed. Stable structures for safety management were established or strengthened. Training in patient safety played and important role, 1415 professionals participated. Through these kind of projects not only have been introduced programs of proven effectiveness in reducing risks, but they also provide to the facilities a work system that allows autonomy in diagnosis and analysis of the different risk situations or centre specific safety issues. Copyright © 2014. Published by Elsevier Espana.

Tolerability and Efficacy of Ipragliflozin in The Management of Inadequately Controlled Type 2 Diabetes mellitus: A Systematic Review and Meta-analysis.

PubMed

Elgebaly, Ahmed; Abdelazeim, Nesrine; Abdelazeim, Bassant; El Ashal, Gehad; Mattar, Omar; Namous, Lubaba; Nasreldin, Noha

2018-06-18

Ipragliflozin is a new antidiabetic agent that works through enhancing renal glucose excretion. We aim to synthesize evidence from published randomized controlled trials (RCTs) on the safety and efficacy of ipragliflozin in the management of type 2 diabetes mellitus (T2DM). We searched PubMed, Scopus, Web of Science, and Cochrane Central register of clinical trials using relevant keywords. Records were screened for eligible studies and data were extracted and synthesized using Review Manager Version 5.3 for windows. Subgroup and sensitivity analyses were conducted. We included 13 RCTs (N=2535 patients) in the final analysis. The overall effect estimates favoured ipragliflozin 50mg monotherapy group over placebo in terms of: HbA1c (Standardized mean difference (SMD)=-1.20%, 95% Confidence interval (95% CI)=[-1.47, -0.93]; p<0.001), fasting plasma glucose (SMD=-1.30 mg/dL, 95% CI [-1.93, -0.67]; p<0.001), fasting serum insulin (SMD=-1.64 μU/mL, 95% CI [-2.70, -0.59]; p=0.002), and body weight (SMD=-0.85 kg, 95% CI [-1.19, -0.51]; p<0.001). Similarly, better glycemic control and significant body weight reduction compared to placebo were attained in ipragliflozin 50 mg combination with metformin, insulin with/without dipeptidyl peptidase-4 inhibitor, sulfonylurea, and pioglitazone. Ipragliflozin, either alone or in combination, exhibits acceptable safety profile. The presented meta-analysis provides class one evidence that ipragliflozin is safe and effective in the management of T2DM either as monotherapy or an add-on. © Georg Thieme Verlag KG Stuttgart · New York.

Evaluation and Synthesis of Polar Aryl- and Heteroaryl Spiroazetidine-Piperidine Acetamides as Ghrelin Inverse Agonists

PubMed Central

2014-01-01

Several polar heteroaromatic acetic acids and their piperidine amides were synthesized and evaluated as ghrelin or type 1a growth hormone secretagogue receptor (GHS-R1a) inverse agonists. Efforts to improve pharmacokinetic and safety profile was achieved by modulating physicochemical properties and, more specifically, emphasizing increased polarity of our chemical series. ortho-Carboxamide containing compounds provided optimal physicochemical, pharmacologic, and safety profile. pH-dependent chemical stability was also assessed with our series. PMID:25699143

Assessing the Food Safety Attitudes and Awareness of Managers of School Feeding Programmes in Mpumalanga, South Africa.

PubMed

Sibanyoni, J J; Tabit, F T

2017-08-01

The managers of school feeding programmes are responsible for ensuring the safety of the food which is provided to schoolchildren, but very few studies have been conducted on the food safety knowledge and awareness of these managers. The objective of this study is to evaluate the food safety attitudes and awareness of managers of the National School Nutrition Programme (NSNP) in schools in Mpumalanga, a province of South Africa. A cross-sectional survey study was conducted in which questionnaires were used to collect data from 300 NSNP food service managers. The majority of schools offering NSNP meals were located in informal settlements and most were found to lack basic resources such as electricity (power supplies to the food preparation facility) and potable tap water in their kitchens. No school was found to have implemented the hazard analysis and critical control points (HACCP) programme, and only a few staff had received food safety training. Food safety implementation is worst in informal schools in rural areas due to limited resources and infrastructure. The NSNP food service managers in some schools-especially those located in rural settlements-were found to have little knowledge and awareness of HACCP. These results indicate an urgent need to provide NSNP managers with food safety training and resources (potable water supplies, electricity, dedicated food preparation facilities), particularly in schools in rural settlements.

30 CFR 285.811 - When must I follow my Safety Management System?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Activities Conducted Under SAPs, COPs and GAPs Safety Management Systems § 285.811 When must I follow my... activities described in your approved COP, SAP, or GAP. You must conduct all activities described in your approved COP, SAP, or GAP in accordance with the Safety Management System you described, as required by...

Forest management practices and the occupational safety and health administration logging standard

Treesearch

John R. Myers; David Elton Fosbroke

1995-01-01

The Occupational Safety and Health Administration (OSHA) has established safety and health regulations for the logging industry. These new regulations move beyond the prior OSHA pulpwood harvesting standard by including sawtimber harvesting operations. Because logging is a major tool used by forest managers to meet silvicultural goals, managers must be aware of what...

33 CFR 96.390 - When will the Coast Guard deny entry into a U.S. port?

Code of Federal Regulations, 2010 CFR

2010-07-01

... HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems Be Certificated and Enforced? § 96.390 When will the... force majeure, no vessel shall enter any port or terminal of the U.S. without a safety management system...

33 CFR 96.390 - When will the Coast Guard deny entry into a U.S. port?

Code of Federal Regulations, 2011 CFR

2011-07-01

... HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS How Will Safety Management Systems Be Certificated and Enforced? § 96.390 When will the... force majeure, no vessel shall enter any port or terminal of the U.S. without a safety management system...

75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

Safety assessment of adjuvanted vaccines: Methodological considerations

PubMed Central

Da Silva, Fernanda Tavares; Di Pasquale, Alberta; Yarzabal, Juan P; Garçon, Nathalie

2015-01-01

Adjuvants mainly interact with the innate immune response and are used to enhance the quantity and quality of the downstream adaptive immune response to vaccine antigens. Establishing the safety of a new adjuvant-antigen combination is achieved through rigorous evaluation that begins in the laboratory, and that continues throughout the vaccine life-cycle. The strategy for the evaluation of safety pre-licensure is guided by the disease profile, vaccine indication, and target population, and it is also influenced by available regulatory guidelines. In order to allow meaningful interpretation of clinical data, clinical program methodology should be optimized and standardized, making best use of all available data sources. Post-licensure safety activities are directed by field experience accumulated pre- and post-licensure clinical trial data and spontaneous adverse event reports. Continued evolution of safety evaluation processes that keep pace with advances in vaccine technology and updated communication of the benefit-risk profile is necessary to maintain public confidence in vaccines. PMID:26029975

Development of Integrated Magnetic and Kinetic Control-oriented Transport Model for q-profile Response Prediction in EAST Discharges

NASA Astrophysics Data System (ADS)

Wang, Hexiang; Schuster, Eugenio; Rafiq, Tariq; Kritz, Arnold; Ding, Siye

2016-10-01

Extensive research has been conducted to find high-performance operating scenarios characterized by high fusion gain, good confinement, plasma stability and possible steady-state operation. A key plasma property that is related to both the stability and performance of these advanced plasma scenarios is the safety factor profile. A key component of the EAST research program is the exploration of non-inductively driven steady-state plasmas with the recently upgraded heating and current drive capabilities that include lower hybrid current drive and neutral beam injection. Anticipating the need for tight regulation of the safety factor profile in these plasma scenarios, a first-principles-driven (FPD)control-oriented model is proposed to describe the safety factor profile evolution in EAST in response to the different actuators. The TRANSP simulation code is employed to tailor the FPD model to the EAST tokamak geometry and to convert it into a form suitable for control design. The FPD control-oriented model's prediction capabilities are demonstrated by comparing predictions with experimental data from EAST. Supported by the US DOE under DE-SC0010537,DE-FG02-92ER54141 and DE-SC0013977.

Preliminary Assessment of Operational Hazards and Safety Requirements for Airborne Trajectory Management (ABTM) Roadmap Applications

NASA Technical Reports Server (NTRS)

Cotton, William B.; Hilb, Robert; Koczo, Stefan, Jr.; Wing, David J.

2016-01-01

A set of five developmental steps building from the NASA TASAR (Traffic Aware Strategic Aircrew Requests) concept are described, each providing incrementally more efficiency and capacity benefits to airspace system users and service providers, culminating in a Full Airborne Trajectory Management capability. For each of these steps, the incremental Operational Hazards and Safety Requirements are identified for later use in future formal safety assessments intended to lead to certification and operational approval of the equipment and the associated procedures. Two established safety assessment methodologies that are compliant with the FAA's Safety Management System were used leading to Failure Effects Classifications (FEC) for each of the steps. The most likely FEC for the first three steps, Basic TASAR, Digital TASAR, and 4D TASAR, is "No effect". For step four, Strategic Airborne Trajectory Management, the likely FEC is "Minor". For Full Airborne Trajectory Management (Step 5), the most likely FEC is "Major".

The Research on the Impact of Management Level’s Charismatic Leadership Style on Miners' Unsafe Behavior

PubMed Central

Li, Hongxia; Di, Hongxi; Tian, Shuicheng; Li, Jian

2015-01-01

The aim of this study is research the impact of management level’s charismatic leadership style on miners' unsafe behavior by using the questionnaires on charismatic leadership style, safety attitude and the miners' unsafe behavior measurement to investigate 200 employees in Shen Dong Company. The research results suggest that management level’s charismatic leadership style have very important influence on miners' unsafe behavior and the influence is affected by the safety attitude which is the intermediary function. In the end, this study propose advice on how to improve the coal mine enterprise managers charismatic leadership style in the coal mine enterprise's safety management work, including attach great importance to a variety of incentive methods, set up safety moral models, practice of inductive leadership concept, create a good atmosphere of safety, etc for reference for coal mining enterprises. PMID:26628936

Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

PubMed

Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

2017-07-01

Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-12-01

Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS ® software. The PROSPERO registration number was CRD42016032606. Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase. No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics. Copyright © 2016 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2014 CFR

2014-01-01

...) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life...

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2013 CFR

2013-07-01

...) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life...

41 CFR 102-80.120 - What analytical and empirical tools should be used to support the life safety equivalency...

Code of Federal Regulations, 2012 CFR

2012-01-01

...) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire... used to support the life safety equivalency evaluation? Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life...

Focus on patient safety all day, every day.

PubMed

2015-06-01

Case managers may think their job doesn't involve patient safety, but they promote safety by ensuring a safe discharge and are in a position to see safety breaches and mistakes all over the hospital. CMS includes discharge planning in its worksheets for surveyors to use to assess a hospital's compliance with Medicare Conditions of Participation. Because they work with patients from admission to discharge, case managers know which clinicians are competent, those who are not, and may observe safety breaches like failure to wash hands and leaving the catheter in too long. Case managers should spend enough time with their patients to know their situations at home and their support systems and use the information to create workable and safe discharge plans. Hospitals should create an environment and a culture where case managers and other clinicians feel comfortable speaking up when they see safety breaches.

Cytotoxic Drug Dispersal, Cytotoxic Safety, and Cytotoxic Waste Management: Practices and Proposed India-specific Guidelines

PubMed Central

Capoor, Malini R; Bhowmik, Kumar Tapas

2017-01-01

This article deals with practices related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management and attempts at India-specific guidelines for their dispersal and disposal. The articles related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management were reviewed from PubMed and their applicability in Indian health-care facilities (HCFs) was also reviewed. All HCFs dealing with cytotoxic drugs should consider cytotoxic policy, patient safety and health-care worker safety, and environmental monitoring program as per the available international guidelines customized as per Indian conditions. Utmost care in handling cytotoxic waste is quintessential. The formation of India-specific cytotoxic guidelines requires the inputs from all stakeholders. Cytotoxic waste, cytotoxic safety, and cytotoxic waste management should be the subject of a national strategy with an infrastructure, cradle-to-grave legislation, competent regulatory authority, and trained personnel. PMID:28900329

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What information must be... Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level...

Safety and tolerability of extended-release niacin-laropiprant: Pooled analyses for 11,310 patients in 12 controlled clinical trials.

PubMed

McKenney, James; Bays, Harold; Gleim, Gilbert; Mitchel, Yale; Kuznetsova, Olga; Sapre, Aditi; Sirah, Waheeda; Maccubbin, Darbie

2015-01-01

The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) showed that adding extended-release niacin-laropiprant (ERN-LRPT) to statin provided no incremental cardiovascular benefit vs placebo (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led to the withdrawal of ERN-LRPT from all markets. We examined the safety profile of ERN-LRPT vs the comparators ERN alone and statins in the ERN-LRPT development program to assess whether similar safety signals were observed to those seen in HPS-THRIVE and whether these might be attributed to ERN or LRPT. Postrandomization safety data from 12 clinical studies, 12 to 52 weeks in duration and involving 11,310 patients, were analyzed across 3 treatments: (1) ERN-LRPT; (2) ERN-NSP (ERN, Merck & Co, Inc or Niaspan [NSP], Abbott Laboratories); and (3) statin-PBO (statin or PBO). The safety profiles of ERN-LRPT and ERN-NSP were similar, except for less flushing with ERN-LRPT. Nonflushing AEs reported more frequently with ERN-LRPT or ERN-NSP than with statin-PBO were mostly nonserious and typical of niacin (nausea, diarrhea, and increased blood glucose). There was no evidence for an increased risk of serious AEs related to diabetes, muscle, infection, or bleeding. Pooled data from 11,310 patients revealed that, except for reduced flushing, the safety profile of ERN-LRPT was similar to that of ERN-NSP; LRPT did not appear to adversely affect the side-effect profile of ERN. The inability to replicate the unexpected AE findings in HPS2-THRIVE could be because of the smaller sample size and substantially shorter duration of these studies. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

A comparative safety review between GLP-1 receptor agonists and SGLT2 inhibitors for diabetes treatment.

PubMed

Consoli, Agostino; Formoso, Gloria; Baldassarre, Maria Pompea Antonia; Febo, Fabrizio

2018-03-01

Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it is more and more important to gather and discuss information about their safety profile. Area Covered: adverse events and the safety concerns most often emerged in trials with GLP-1RA namely, exenatide long acting release (LAR), dulaglutide, liraglutide, semaglutide, lixisenatide or SGLT2i, namely empagliflozin, dapagliflozin, canagliflozin and SGLT2i with an attempt at comparing the safety profiles of molecules of these two classes. Expert opinion: GLP-1RA and SGLT2i, although each associated with different specific side effects, share a 'similar' safety profile and are both drugs relatively easy to handle. The potentially complementary mechanisms of action, the cardio and nephroprotective effects demonstrated by molecules of both classes, make these drugs potentially useful even in add on to each other.

A case for safety leadership team training of hospital managers.

PubMed

Singer, Sara J; Hayes, Jennifer; Cooper, Jeffrey B; Vogt, Jay W; Sales, Michael; Aristidou, Angela; Gray, Garry C; Kiang, Mathew V; Meyer, Gregg S

2011-01-01

Delivering safe patient care remains an elusive goal. Resolving problems in complex organizations like hospitals requires managers to work together. Safety leadership training that encourages managers to exercise learning-oriented, team-based leadership behaviors could promote systemic problem solving and enhance patient safety. Despite the need for such training, few programs teach multidisciplinary groups of managers about specific behaviors that can enhance their role as leadership teams in the realm of patient safety. The aims of this study were to describe a learning-oriented, team-based, safety leadership training program composed of reinforcing exercises and to provide evidence confirming the need for such training and demonstrating behavior change among management groups after training. Twelve groups of managers from an academic medical center based in the Northeast United States were randomly selected to participate in the program and exposed to its customized, experience-based, integrated, multimodal curriculum. We extracted data from transcripts of four training sessions over 15 months with groups of managers about the need for the training in these groups and change in participants' awareness, professional behaviors, and group activity. Training transcripts confirmed the need for safety leadership team training and provided evidence of the potential for training to increase targeted behaviors. The training increased awareness and use of leadership behaviors among many managers and led to new routines and coordinated effort among most management groups. Enhanced learning-oriented leadership often helped promote a learning orientation in managers' work areas. Team-based training that promotes specific learning-oriented leader behaviors can promote behavioral change among multidisciplinary groups of hospital managers.

Relationship between ethical leadership and organisational commitment of nurses with perception of patient safety culture.

PubMed

Lotfi, Zahra; Atashzadeh-Shoorideh, Foroozan; Mohtashami, Jamileh; Nasiri, Maliheh

2018-03-12

To determine the relationship between ethical leadership, organisational commitment of nurses and their perception of patient safety culture. Patient safety, organisational commitment and ethical leadership styles are very important for improving the quality of nursing care. In this descriptive-correlational study, 340 nurses were selected using random sampling from the hospitals in Tehran in 2016. Data were analysed using descriptive and inferential statistics in SPSS v.20. There was a significant positive relationship between the ethical leadership of nursing managers, perception of patient safety culture and organisational commitment. The regression analysis showed that nursing managers' ethical leadership and nurses' organisational commitment is a predictor of patient safety culture and confirms the relationship between the variables. Regarding the relationship between the nurses' safety performance, ethical leadership and organisational commitment, it seems that the optimisation of the organisational commitment and adherence to ethical leadership by administrators and managers in hospitals could improve the nurses' performance in terms of patient safety. Implementing ethical leadership seems to be one feasible strategy to improve nurses' organisational commitment and perception of patient safety culture. Efforts by nurse managers to develop ethical leadership reinforce organisational commitment to improve patient outcomes. Nurse managers' engagement and performance in this process is vital for a successful result. © 2018 John Wiley & Sons Ltd.

Process safety improvement--quality and target zero.

PubMed

Van Scyoc, Karl

2008-11-15

Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

Safety behavior: Job demands, job resources, and perceived management commitment to safety.

PubMed

Hansez, Isabelle; Chmiel, Nik

2010-07-01

The job demands-resources model posits that job demands and resources influence outcomes through job strain and work engagement processes. We test whether the model can be extended to effort-related "routine" safety violations and "situational" safety violations provoked by the organization. In addition we test more directly the involvement of job strain than previous studies which have used burnout measures. Structural equation modeling provided, for the first time, evidence of predicted relationships between job strain and "routine" violations and work engagement with "routine" and "situational" violations, thereby supporting the extension of the job demands-resources model to safety behaviors. In addition our results showed that a key safety-specific construct 'perceived management commitment to safety' added to the explanatory power of the job demands-resources model. A predicted path from job resources to perceived management commitment to safety was highly significant, supporting the view that job resources can influence safety behavior through both general motivational involvement in work (work engagement) and through safety-specific processes.

Design an optimum safety policy for personnel safety management - A system dynamic approach

DOE Office of Scientific and Technical Information (OSTI.GOV)

Balaji, P.

2014-10-06

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamicsmore » model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.« less

Model-Based Battery Management Systems: From Theory to Practice

NASA Astrophysics Data System (ADS)

Pathak, Manan

Lithium-ion batteries are now extensively being used as the primary storage source. Capacity and power fade, and slow recharging times are key issues that restrict its use in many applications. Battery management systems are critical to address these issues, along with ensuring its safety. This dissertation focuses on exploring various control strategies using detailed physics-based electrochemical models developed previously for lithium-ion batteries, which could be used in advanced battery management systems. Optimal charging profiles for minimizing capacity fade based on SEI-layer formation are derived and the benefits of using such control strategies are shown by experimentally testing them on a 16 Ah NMC-based pouch cell. This dissertation also explores different time-discretization strategies for non-linear models, which gives an improved order of convergence for optimal control problems. Lastly, this dissertation also explores a physics-based model for predicting the linear impedance of a battery, and develops a freeware that is extremely robust and computationally fast. Such a code could be used for estimating transport, kinetic and material properties of the battery based on the linear impedance spectra.

A consensus statement on the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis-From evidence-based medicine to the real-life setting.

PubMed

Bruyère, Olivier; Cooper, Cyrus; Pelletier, Jean-Pierre; Maheu, Emmanuel; Rannou, François; Branco, Jaime; Luisa Brandi, Maria; Kanis, John A; Altman, Roy D; Hochberg, Marc C; Martel-Pelletier, Johanne; Reginster, Jean-Yves

2016-02-01

The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a treatment algorithm for the management of knee osteoarthritis (OA) in 2014, which provides practical guidance for the prioritization of interventions. Further analysis of real-world data for OA provides additional evidence in support of pharmacological interventions, in terms of management of OA pain and function, avoidance of adverse events, disease-modifying effects and long-term outcomes, e.g., delay of total joint replacement surgery, and pharmacoeconomic factors such as reduction in healthcare resource utilization. This article provides an updated assessment of the literature for selected interventions in OA, focusing on real-life data, with the aim of providing easy-to-follow advice on how to establish a treatment flow in patients with knee OA in primary care clinical practice, in support of the clinicians' individualized assessment of the patient. In step 1, background maintenance therapy with symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) is recommended, for which high-quality evidence is provided only for the prescription formulations of patented crystalline glucosamine sulfate and chondroitin sulfate. Paracetamol may be added for rescue analgesia only, due to limited efficacy and increasing safety signals. Topical non-steroidal anti-inflammatory drugs (NSAIDs) may provide additional symptomatic treatment with the same degree of efficacy as oral NSAIDs without the systemic safety concerns. Oral NSAIDs maintain a central role in step 2 advanced management of persistent symptoms. However, oral NSAIDs are highly heterogeneous in terms of gastrointestinal and cardiovascular safety profile, and patient stratification with careful treatment selection is advocated to maximize the risk:benefit ratio. Intra-articular hyaluronic acid as a next step provides sustained clinical benefit with effects lasting up to 6 months after a short-course of weekly injections. As a last step before surgery, the slow titration of sustained-release tramadol, a weak opioid, affords sustained analgesia with improved tolerability. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

A safety assessment of biological therapies targeting the IL-23/IL-17 axis in inflammatory bowel diseases.

PubMed

Verstockt, Bram; Deleenheer, Barbara; Van Assche, Gert; Vermeire, Séverine; Ferrante, Marc

2017-07-01

Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab. Firstly, the authors discuss briefly how genetics can inform about potential safety issues. Secondly, they extensively describe safety issues (common adverse events, infections, malignancies…), immunogenicity, exposure to ustekinumab in specific populations and provide advice for vaccination. Finally, they address safety profiles of secukinumab and other biological targeting the IL-23/17 axis in IBD. Expert opinion: Current evidence suggests that ustekinumab therapy overweigh the potential drug-related risks. Additional safety data beyond randomized-controlled trials, derived from statistically powered, large prospective studies with long-term follow-up are urgently needed to assess the real-life ustekinumab-related risks and to establish the correct position of these novel class of biologicals in IBD treatment. Combining immunomodulators with ustekinumab seems to be safe, though prospective data specifically addressing this topic are currently missing. Similarly, the combination of different biological therapies still has to be studied.

Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

DOE Office of Scientific and Technical Information (OSTI.GOV)

G. L. Sharp; R. T. McCracken

The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzedmore » in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR safety basis. The need for a design basis reconstitution program for the ATR has been identified along with the use of sound configuration management principles in order to support safe and efficient facility operation.« less

The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

PubMed

Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

2015-06-18

Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.

PubMed

Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

2014-05-01

To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010). Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information. Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Emotions at work: what is the link to patient and staff safety? Implications for nurse managers in the NHS.

PubMed

Smith, Pam; Pearson, Pauline H; Ross, Fiona

2009-03-01

This paper sets the discussion of emotions at work within the modern NHS and the current prioritisation of creating a safety culture within the service. The paper focuses on the work of students, frontline nurses and their managers drawing on recent studies of patient safety in the curriculum, and governance and incentives in the care of patients with complex long term conditions. The primary research featured in the paper combined a case study design with focus groups, interviews and observation. In the patient safety research the importance of physical and emotional safety emerged as a key finding both for users and professionals. In the governance and incentives research, risk emerged as a key concern for managers, frontline workers and users. The recognition of emotions and the importance of emotional labour at an individual and organizational level managed by emotionally intelligent leaders played an important role in promoting worker and patient safety and reducing workplace risk. Nurse managers need to be aware of the emotional complexities of their organizations in order to set up systems to support the emotional wellbeing of professionals and users which in turn ensures safety and reduces risk.