Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidencebased approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.

We evaluated the performance of 116 U.S. drug information centers in responding to specific questions about drugs. The primary measures were correctness of responses and extent of probing for patient data. Questions addressed the effect of ranitidine on blood alcohol concentrations, the potential interaction between didanosine and dapsone, prevention of nonsteroidal antiinflammatory drug (NSAID)-induced peptic ulcers, and use of erythromycin for diabetic gastroparesis. The percentages of centers providing correct overall responses were 70% for the ranitidine question, 90% for the didanosine-dapsone question, 8% for the NSAID question, and 20% for the erythromycin question. For the three patient-specific questions, the percentages of centers eliciting vital patient data were 27% for the didanosine-dapsone question, 86% for the NSAID question, and 5% for the erythromycin question. In providing pharmacotherapy consultations, drug information centers generally failed to obtain pertinent patient data, thereby risking incorrect responses and inappropriate recommendations.

Key Points Question Was the implementation of the Transmucosal Immediate-Release Fentanyl (TIRF)–Risk Evaluation and Mitigation Strategy (REMS) associated with changes in prescribing of TIRF medications? Findings In this cohort study using interrupted times series analysis, implementation of TIRF-REMS was associated with a temporary reduction in the rate of overall TIRF prescribing to Medicare Part D beneficiaries and with a sustained decrease in the percentage of TIRF prescribed to patients without known opioid tolerance. The TIRF-REMS program may have also been associated with a temporary decrease in the percentage of TIRF prescribed to patients without cancer. Meaning Mandatory, restrictive drug distribution programs, such as the TIRF-REMS, may be associated with changes in opioid prescribing, although the changes may be temporary.

In 2016, 116 people died each day from opioid-related drug overdoses and in 2017, the Department of Health and Human Services declared the opioid crisis a public health emergency. During the preceding years, the continuing education (CE) accreditors in the health professions identified a need for a strategic, coordinated effort that would involve an interprofessional coalition of multiple stakeholders to respond to this emerging public health challenge. The Conjoint Committee on Continuing Education, a national coalition of organizations in the professions of medicine, nursing, dentistry, pharmacy, and physician assistants, stepped up to assume a leadership position. To address the scope of safety issues involved in opioids, the US Food and Drug Administration required that extended-release and long-acting opioid analgesic product manufacturers make training available to prescribers of their products and recommended that the training should be conducted by accredited, independent CE providers. CE accreditors in the health professions initiated an unprecedented collaboration that leveraged the accredited CE community to deliver prescriber education as part of the Food and Drug Administration Opioid Analgesics Risk Evaluation and Mitigation Strategy. This article describes the history of this interprofessional collaboration including lessons learned and opportunities for future collaboration to address public health issues.