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Risk Evaluation and Mitigation Strategies

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1. Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. (PubMed)

Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately.To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF (...) use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments.Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues.A REMS program to reduce the risk of adverse outcomes, including misuse, abuse

2019 JAMA

2. Assessing prescribing practices of clozapine before and after the implementation of an updated risk evaluation and mitigation strategy (PubMed)

Assessing prescribing practices of clozapine before and after the implementation of an updated risk evaluation and mitigation strategy Clozapine is an atypical antipsychotic medication approved for treatment-resistant schizophrenia and suicidal behavior in schizophrenia or schizoaffective disorders. Despite its therapeutic efficacy, clozapine is associated with several adverse effects, including agranulocytosis. In late 2015, the Food and Drug Administration updated the risk evaluation (...) and mitigation strategy (REMS) for clozapine with new requirements for monitoring, prescribing, and dispensing. The purpose of this study was to evaluate clozapine prescribing practices at a Kentucky state psychiatric hospital before and after the implementation of the updated REMS program.The primary outcome of this study was to evaluate clozapine prescribing practices by identifying the number of patients on clozapine therapy in the 6 months pre and post updated REMS implementation. Included in the study

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2018 The Mental Health Clinician

3. Evaluating safety and cost-effectiveness of platelets stored in additive solution (PAS-F) as a hemolysis risk mitigation strategy. (PubMed)

Evaluating safety and cost-effectiveness of platelets stored in additive solution (PAS-F) as a hemolysis risk mitigation strategy. Platelet inventory constraints can result in minor ABO incompatibility and possible hemolysis. The aims of this study were to determine the reduction of isoagglutinin in titers of platelets stored in additive solution (PAS) and compare its safety, efficiency, and cost-effectiveness with full-volume and plasma-reduced platelets.Isoagglutinin titers were performed (...) -effective when compared to routine plasma reduction as a strategy to mitigate hemolysis risk from minor incompatible platelet transfusion.© 2018 AABB.

2018 Transfusion

4. Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU) (PubMed)

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU) Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug safety. We conducted a literature search (...) and a survey of relevant websites (FDA, manufacturers, and REMSs). ETASU characteristics were summarized. REMS risks were compared with labeled risks, including black box warnings. Forty-two programs were analyzed. Seven incorporated drugs of the same class. Most drugs (57%) were indicated for an orphan disease. A single risk was mentioned in 24 REMSs, and multiple risks in 18. Embryo-fetal toxicity and abuse or misuse were the most frequent risks. All risks were identified during clinical development

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2017 Drugs in R&D

5. Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention (PubMed)

Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages.Results from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between (...) June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category.In total, 73,645 patients were enrolled into the REMS programs for lenalidomide and thalidomide and completed mandatory surveys prior to medication dispense. Of these, 2790 (3.8%) completed an additional voluntary survey. Among voluntary survey participants, for all patient pregnancy risk categories

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2017 Drug Safety

6. Randomized program evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM): A research and clinical operations partnership to examine effectiveness. (PubMed)

Randomized program evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM): A research and clinical operations partnership to examine effectiveness. The United States is facing an opioid crisis in which overdose is the leading cause of injury death-misuse of opioids constitutes the vast majority of those deaths. In 2016 alone, over 42,000 people died from opioid overdose, an increase of 27% from the prior year. Deployment of the Stratification (...) Tool for Opioid Risk Mitigation (STORM), a clinical decision support tool to improve opioid safety, is one response by the Veterans Health Administration (VHA) to the opioid crisis. STORM identifies VHA patients at very high risk of opioid-related adverse events and lists potential risk mitigation strategies. Deployment of STORM also helps VHA meet certain requirements of the Comprehensive Addiction and Recovery Act of 2016. In alignment with the VHA's learning health care system initiative

2019 Substance Abuse

7. A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food: Workshop Proceedings (PubMed)

A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food: Workshop Proceedings Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical (...) Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessing the need for and benefit of mitigation of process-formed compounds, including criteria to objectively assess the impact of mitigation as well as research needed to support this process. Workshop participants provided real-time feedback on a draft framework

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2016 International Journal of Toxicology

8. Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies Risk Evaluation and Mitigation Strategies Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 (...) Risk Evaluation and Mitigation Strategies Risk Evaluation and Mitigation Strategies Aka: Risk Evaluation and Mitigation Strategies , REMS From Related Chapters II. Definitions Risk Evaluation and Mitigation Strategies (REMS) FDA programs for high risk medications Requires mandatory provider certification, patient counseling by pharmacist, III. Preparations: Examples ( ) Thalidomide IV. Resources FDA: Risk Evaluation and Mitigation Strategies (REMS) Images: Related links to external sites (from Bing

2018 FP Notebook

9. Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies Risk Evaluation and Mitigation Strategies Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 (...) Risk Evaluation and Mitigation Strategies Risk Evaluation and Mitigation Strategies Aka: Risk Evaluation and Mitigation Strategies , REMS From Related Chapters II. Definitions Risk Evaluation and Mitigation Strategies (REMS) FDA programs for high risk medications Requires mandatory provider certification, patient counseling by pharmacist, III. Preparations: Examples ( ) Thalidomide IV. Resources FDA: Risk Evaluation and Mitigation Strategies (REMS) Images: Related links to external sites (from Bing

2018 FP Notebook

10. Don’t sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S. (PubMed)

Don’t sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S. As medicines are becoming more targeted and complex in the U.S., ensuring patients' safe use of medications with known dangerous risks is critical for public health and safety. Therefore, the Risk Evaluation and Mitigation Strategies (REMS) program is more important than ever. The REMS programs mandates that manufacturers utilize tools to manage known (...) or potential serious risks (e.g., death, severe birth defects, prolonged hospitalization) associated with certain drugs while still making these medications available to patients with unmet medical needs. Yet, recently federal policy makers have proposed legislation to force manufacturers to sell medications with known serious risks in a manner that weakens the medications' REMS programs.The author reviewed U.S. legislation, statutes, case law, government agency policies and guidelines, scholarly articles

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2016 Journal of pharmaceutical policy and practice

11. Ethical Concerns of and Risk Mitigation Strategies for Crowdsourcing Contests and Innovation Challenges: Scoping Review. (PubMed)

Ethical Concerns of and Risk Mitigation Strategies for Crowdsourcing Contests and Innovation Challenges: Scoping Review. Crowdsourcing contests (also called innovation challenges, innovation contests, and inducement prize contests) can be used to solicit multisectoral feedback on health programs and design public health campaigns. They consist of organizing a steering committee, soliciting contributions, engaging the community, judging contributions, recognizing a subset of contributors (...) , and sharing with the community.This scoping review describes crowdsourcing contests by stage, examines ethical problems at each stage, and proposes potential ways of mitigating risk.Our analysis was anchored in the specific example of a crowdsourcing contest that our team organized to solicit videos promoting condom use in China. The purpose of this contest was to create compelling 1-min videos to promote condom use. We used a scoping review to examine the existing ethical literature on crowdsourcing

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2018 Journal of medical Internet research

12. Assessment of mitigation strategies as tools for risk management under future uncertainties: a multi-model approach (PubMed)

Assessment of mitigation strategies as tools for risk management under future uncertainties: a multi-model approach Although the world understands the possible threat of the future of climate changes, there remain serious barriers to be resolved in terms of policy decisions. The scientific and the societal uncertainties in the climate change policies must be the large part of this barrier. Following the Paris Agreement, the world comes to the next stage to decide the next actions. Without (...) ) analysis of critical climate risks, (4) evaluation of climate risk management options, and (5) interactions between scientific and social rationalities. We participated in the fourth theme to provide the quantitative assessment of technology options and policy measures by integrating assessment model simulations. We employ the multi-model approach to deal with the complex relationships among various fields such as technology, economics, and land use changes. Four different types of integrated

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2018 Sustainability Science

13. Effectiveness of policy and risk targeting for opioid-related risk mitigation: a randomised programme evaluation with stepped-wedge design. (PubMed)

Effectiveness of policy and risk targeting for opioid-related risk mitigation: a randomised programme evaluation with stepped-wedge design. There is an epidemic of opioid use related to adverse events and deaths in the USA. The rates of chronic pain, mental illness and substance use disorder are higher at the Veterans Health Administration (VHA) compared with the general US population. The 2016 Comprehensive Addiction and Recovery Act requires the VHA to improve opioid therapy strategies (...) in treating patients and to ensure responsible prescribing practices. The Stratification Tool for Opioid Risk Mitigation (STORM) is a web-based dashboard that prioritises review of VHA patients receiving opioids based on their risk. The VHA Partnered Evidence-based Policy Resource Center is coordinating a multiyear evaluation of STORM and aspects of the VHA policy that mandate case review of patients identified by STORM as very high risk.This stepped-wedge cluster randomised controlled trial will test two

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2018 BMJ open

14. Household air pollution (HAP), microenvironment and child health: Strategies for mitigating HAP exposure in urban Rwanda (PubMed)

Household air pollution (HAP), microenvironment and child health: Strategies for mitigating HAP exposure in urban Rwanda Exposure to household air pollution (HAP) from cooking and heating with solid fuels is major risk factor for morbidity and mortality in sub-Saharan Africa. Children under five are particularly at risk for acute lower respiratory infection. We use baseline data from randomized controlled trial evaluating a household energy intervention in Gisenyi, Rwanda to investigate (...) to tree cover, are significantly more likely to experience symptoms of respiratory infection, illness with cough and difficulty breathing. On the other hand, children in households with cemented floors and ventilation holes in the cooking area, are significantly less likely to experience the same symptoms. Our findings suggest that in addition to promoting increased access to clean cooking technologies, there are important infrastructure and micro-environment related interventions that mitigate HAP

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2018 Environmental research letters : ERL [Web site]

15. Mitigating the risk of musculoskeletal injury: A systematic review of the most effective injury prevention strategies for military personnel. (PubMed)

Mitigating the risk of musculoskeletal injury: A systematic review of the most effective injury prevention strategies for military personnel. To update the current injury prevention strategy evidence base for making recommendations to prevent physical training-related musculoskeletal injury.We conducted a systematic review to update the evidence base on injury prevention strategies for military personnel.Literature was systematically searched and extracted from five databases, and reported (...) according to PRISMA guidelines. Sixty one articles meeting the inclusion criteria and published during the period 2008-2015 were selected for systematic review.The retrieved articles were broadly categorised into six injury prevention strategies; (1) conditioning, (2) footwear modifications, (3) bracing, (4) physical activity volume, (5) physical fitness, and (6) leadership/supervision/awareness. The majority of retrieved articles (n=37 (of 61) evaluated or systematically reviewed a conditioning

2017 Journal of Science and Medicine in Sport

16. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. (PubMed)

remain elusive.This multinational, retrospective study of 2026 DPs involved 52 surgeons at 10 institutions (2001-2016). CR-POPFs were defined by 2016 International Study Group criteria, and risk models generated using stepwise logistic regression analysis were evaluated by c-statistic. Mitigation strategies were assessed by regression modeling while controlling for identified risk factors and treating institution.CR-POPF occurred following 306 (15.1%) DPs. Risk factors independently associated (...) Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. To identify a clinical fistula risk score following distal pancreatectomy.Clinically relevant pancreatic fistula (CR-POPF) following distal pancreatectomy (DP) is a dominant contributor to procedural morbidity, yet risk factors attributable to CR-POPF and effective practices to reduce its occurrence

2017 Annals of Surgery

17. A Deterministic Model to Quantify Risk and Guide Mitigation Strategies to Reduce Bluetongue Virus Transmission in California Dairy Cattle. (PubMed)

A Deterministic Model to Quantify Risk and Guide Mitigation Strategies to Reduce Bluetongue Virus Transmission in California Dairy Cattle. The global distribution of bluetongue virus (BTV) has been changing recently, perhaps as a result of climate change. To evaluate the risk of BTV infection and transmission in a BTV-endemic region of California, sentinel dairy cows were evaluated for BTV infection, and populations of Culicoides vectors were collected at different sites using carbon dioxide (...) . A deterministic model was developed to quantify risk and guide future mitigation strategies to reduce BTV infection in California dairy cattle. The greatest risk of BTV transmission was predicted within the warm Central Valley of California that contains the highest density of dairy cattle in the United States. Temperature and parameters associated with Culicoides vectors (transmission probabilities, carrying capacity, and survivorship) had the greatest effect on BTV's basic reproduction number, R0. Based

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2016 PLoS ONE

18. Mitigating the Safety Risks of Drugs With a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer? (PubMed)

Mitigating the Safety Risks of Drugs With a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer? Approximately 40% of all newly approved drugs are subject to safety restrictions inclusive of Risk Evaluation and Mitigation Strategies (REMS), which were created with the US Food and Drug Administration Amendments Act of 2007. This law expanded Food and Drug Administration (FDA) authority to require REMS of manufacturers but left implementation to the FDA. As a result (...) REMS into the overall health care system. So, are REMS, which were conceived as a tool to improve medication safety, working? Specifically, are REMS achieving their intended outcomes (mitigating safety risks of effective drugs) without causing unintended consequences (creating a burden to the health care system and physicians and/or diminishing patient access to drugs)? Sitting squarely in the crosshairs, the approved shared REMS for extended-release/long-acting opioid analgesics provide a lens

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2014 Mayo Clinic Proceedings

19. SCOPE of Pain: An Evaluation of an Opioid Risk Evaluation and Mitigation Strategy Continuing Education Program. (PubMed)

SCOPE of Pain: An Evaluation of an Opioid Risk Evaluation and Mitigation Strategy Continuing Education Program. Due to the high prevalence of prescription opioid misuse, the US Food and Drug Administration (FDA) mandated a Risk Evaluation and Mitigation Strategy (REMS) requiring manufacturers of extended-release/long-acting (ER/LA) opioid analgesics to fund continuing education based on a FDA Blueprint. This article describes the Safe and Competent Opioid Prescribing Education (SCOPE of Pain

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2015 Pain Medicine

20. A community-based One Health education program for disease risk mitigation at the human-animal interface (PubMed)

more likely for females than males (OR = 7.315, 95% CI = 2.258-23.705, p = 0.0009) and participants with a higher versus lower education level, albeit borderline non-significant (OR = 4.781, 95% CI = 0.942-24.264, p = 0.0590). Qualitative analysis revealed the implementation of risk mitigation strategies by 98% (60/61) of workshop participants during the three-month follow-up and included improved personal and domestic hygiene practices and enhanced animal housing. Although further evaluation (...) A community-based One Health education program for disease risk mitigation at the human-animal interface The interface between humans, domestic animals, and wildlife has been implicated in the emergence of infectious diseases and the persistence of endemic human and animal diseases. For individuals who reside at this interface, particularly those in low-resource settings, the development of disease risk assessment and mitigation skills must be prioritized. Using a community engagement-One

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2017 One health

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