Risk evaluation and mitigation strategies (REMS): Building a framework for effective patient counseling on medication risks and benefits
Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for drugs or biologics that carry serious potential or known risks. Since that time, the REMS program has become an important tool in ensuring that riskier drugs are used safely, and it has allowed FDA to facilitate access to a host of drugs that may not otherwise have been approved. However, concerns have arisen regarding the effects of REMS programs on patient access to products, as well as the undue burden that the requirements place on the health care system. In response to these concerns, FDA has initiated reform efforts aimed at improving the standardization, assessment, and integration of REMS within the health care system. As part of this broader initiative, the agency is pursuing four priority projects, one of which focuses on improving provider-patient benefit-risk counseling for drugs that have a REMS attached.
Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held an expert workshop on July 24 titled, “Risk Evaluation and Mitigation Strategies (REMS): Building a Framework for Effective Patient Counseling on Medication Risks and Benefits”. This workshop was the first in a series of convening activities that will seek input from stakeholders across academia, industry, health systems, and patient advocacy groups, among others. Through these activities, Brookings and FDA will further develop and refine an evidence-based framework of best practices and principles that can be used to inform the development and effective use of REMS tools and processes.
Agenda
Welcome and introduction
Introduction to the REMS integration initiative
Claudia Manzo
Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration
Patient benefit-risk counseling in REMS
Reema Mehta
Acting Deputy Director, Division of Risk Management - U.S. Food and Drug Administration
Gary Slatko
Associate Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration
Session I: Principles and best practices for effective patient benefit-risk counseling and shared decision-making
Nananda Col
Principal - Shared Decision Making Resources
Betsy Sleath
Distinguished Professor and Chair of the Division of Pharmaceutical Outcomes and Policy - UNC Eshelman School of Pharmacy
Holly Witteman
Assistant Professor, Faculty of Medicine - Université Laval
Michael Wolf
Professor of Medicine, Feinberg School of Medicine - Northwestern University
Session II: Translating best practices into a benefit-risk counseling framework: Key challenges and facilitators
Paul Han
Director of the Center for Outcomes Research and Evaluation - Maine Medical Center Research Institute
Reema Mehta
Acting Deputy Director, Division of Risk Management - U.S. Food and Drug Administration
Theo Raynor
Professor of Pharmacy Practice - University of Leeds
Gary Slatko
Associate Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration
Pamela Williamson
Senior Vice President of Global Regulatory Affairs and Patient Safety - Alexion Pharmaceuticals
Session III: Translating best practices into a benefit-risk counseling framework (Cont.)
Paul Han
Director of the Center for Outcomes Research and Evaluation - Maine Medical Center Research Institute
Reema Mehta
Acting Deputy Director, Division of Risk Management - U.S. Food and Drug Administration
Theo Raynor
Professor of Pharmacy Practice - University of Leeds
Gary Slatko
Associate Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration
Pamela Williamson
Senior Vice President of Global Regulatory Affairs and Patient Safety - Alexion Pharmaceuticals
Session IV: Applying best practices to the design and implementation of a benefit-risk counseling support tool(s) in REMS
Gary Appio
Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation
Geri Baumblatt
Executive Director of Patient Engagement - Emmi Solutions
Charles Lee
President - Polyglot Systems
Nilay Shah
Associate Professor of Health Services Research - Mayo Clinic
Next Steps
Gary Appio
Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation
Geri Baumblatt
Executive Director of Patient Engagement - Emmi Solutions
Charles Lee
President - Polyglot Systems
Nilay Shah
Associate Professor of Health Services Research - Mayo Clinic
Closing remarks
Gary Appio
Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation
Geri Baumblatt
Executive Director of Patient Engagement - Emmi Solutions
Charles Lee
President - Polyglot Systems
Nilay Shah
Associate Professor of Health Services Research - Mayo Clinic
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