Incorporating continuing education into single-drug REMS: Exploring the challenges and opportunities
The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.
Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.
Agenda
Welcome, overview, and meeting objectives
Incorporating continuing education into REMS
Claudia Manzo
Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration
Lessons from the ER/LA opioid REMS development process
Linda Kitlinski
REMS Education Consultant and Retired Co-Chair of RPC CE Sub-team
Kate Regnier
Executive Vice President - Accreditation Council for Continuing Medical Education
Terry Toigo
Associate Director of Drug Safety Operations, Office of the Center Director - U.S. Food and Drug Administration
Session I: Defining the critical elements that are essential for CE as part of a REMS
Maureen Cahill
Associate, Nursing Regulation - National Council of State Boards of Nursing
Kathy Chappell
Vice President, Accreditation Program and Institute for Credentialing Research - American Nurses Credentialing Center
Anne Grupe
Director, Continuing Medical Education - American Society of Clinical Oncology
Rachel Sobel
Senior Director, Epidemiology - Pfizer
Julie Webb
Vice President, Office of Professional Development - American Society of Health-System Pharmacists
Session II: CE programs for single drug REMS: Developing valid and high-impact content
Gary Appio
Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation
Kishore Gopu
Director, REMS Operations - Teva
Eric Peterson
Senior Director, Performance Improvement CME - American Academy of Physician Assistants
Peter Vlasses
Executive Director - Accreditation Council for Pharmacy Education
Julie White
Director, The Barry M. Manuel Office of Continuing Medical Education - Boston University School of Medicine
Session III: CE programs for single drug REMS: Best-practices for implementation and uptake
Paul Coplan
Executive Director, Risk Management and Epidemiology - Purdue Pharmaceuticals
Eric Davis
Director of Medical Services - Mylan
Cyndi Grimes
Director, Continuing Medical Education - Medscape
Simone Karp
Chief Business Officer - CECity
Ann Karty
Medical Director, Continuing Education - American Academy of Family Physicians
Session IV: Identifying other key facilitators and barriers to REMS CE development and uptake
Session V: Major takeaways and next steps
Closing remarks
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