The Case: Risa Mitigator, director of education for a state medical society, is frantic when her CEO tasks her with developing education regarding the “new REMS program.” Risa recalls hearing about the Food and Drug Administration’s Risk Evaluation and Management Strategies for extended-release and long-acting opioids. Prescription drug abuse is a crisis in her state.
While eager to proceed, Risa is puzzled about how to plan continuing medical education activities in compliance with Accreditation Council for CME policies when the opioid manufacturers (be they commercial supporters or educational partners, or both, in this case) would need to be involved in order to comply with the FDA requirements.
What is REMS and how is it related to CME?
Overstreet: Since the enactment of the FDA Amendments Act in September 2007, the agency has issued more than 150 drug-specific REMS. They are intended to ensure that the benefits of drugs outweigh their risks, to p promote informed, appropriate prescribing and dispensing, and to provide information to patients about risks and optimal use of their medications. These risk management strategies often require education for prescribers and dispensers.
Parochka: The recently applauded the federal government’s 2011 Prescription Drug Abuse Prevention Plan and the FDA’s REMS for opioids, which states: “Educating prescribers on substance abuse is critically important, because even brief interventions by primary care providers have proven effective in reducing or eliminating substance abuse in people who abuse drugs but are not yet addicted to them.”
Overstreet: The education mandated for physicians and pharmacists can be accomplished effectively through activities certified for CME/CE credit, and the FDA has said that it expects that the education will be developed by accredited, independent CME providers “to the extent practicable.” The accrediting bodies for medical and pharmacy continuing education believe that their accredited providers can serve a vital role in creating effective REMS education in many drug classes.
How can CME directed by commercial interests be compliant with ACCME standards?
Parochka: ACCME reports that it will work with the FDA, manufacturers, and accredited providers to ensure that CME regarding REMS meets the ACCME’s standards for independence as well as FDA expectations. ACCME also says it will develop guidance for CME providers.
What should Risa do in the meantime?
Overstreet: Risa should determine her members’ knowledge about REMS and their involvement with the components of existing risk mitigation strategies. In my experience, many physicians are not even aware of REMS programs and their implications for clinical practice.
Parochka: She can learn more from the REMS-related resources on ACCME’s Web site (accme.org), including an audio recording about how accredited CME can be a strategic asset to this public health and public safety initiative. In addition, providers can use the resources at fda.gov, including FDA’s content outline for a REMS education program.
Overstreet: Risa could also plan CME about REMS in general. Clinicians need to be aware of these evolving requirements and their implications for practice. To do so, they will need to recognize, access, and be able to use the resources mandated by the FDA as part of individual REMS. The initial CME activities could include a list of products with a REMS and provide case studies of how clinicians comply with the REMS features. Effective communication to allay patient safety concerns could be an important component of this education.
Karen Overstreet, EdD, RPh, FACME, CCMEP, is
executive director, instructional design and outcomes with Medscape Education, Blue Bell, Pa. Reach her at Koverstreet@webmd.net.
Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education Ltd., Gurnee, Ill.; and partner, PTR Educational Consultants. Reach her at JacquelineParochka@comcast.net.
More Ethical Hypotheticals: