Every once in a while, the CME stars seem to align.
We have identified clear gaps in both knowledge and performance. Physicians’ and allied healthcare professionals’ thirst for more education in specific therapeutic areas is giving rise to a unique opportunity to improve both patient and practitioner outcomes. And here’s the kicker: The federal government wants to work with industry and mandate some educational components.
Too good to be true? Not if you consider the Risk Evaluation and Mitigation Strategy that was approved in the Food and Drug Administration Amendments Act of 2007. This law gave the FDA the authority to require a REMS from drug manufacturers to ensure that the benefits of a drug or biologic outweigh its risks. While each REMS is unique, the components can include a medication guide, package insert for the patient, and “elements to assure safe use.” Are you starting to see the light for CME?
In addition to a September 2009 guidance document, the FDA held several recent hearings addressing REMS in different therapeutic areas. An August 2010 hearing on the safety of extended-release and long-acting opioids included comments from executives of both the Accreditation Council for CME and the Accreditation Council for Pharmacy Education.
The result? CME could be a key component in helping launch a successful REMS. But there are a couple of hurdles we need to clear before moving forward. First, due to the mandate and the unique risks of each drug, some of the REMS education will need to focus on just one drug. Certified CME usually steers clear of addressing particular agents. Second, the manufacturers themselves are required to develop the education on their products. The ACCME Standards do not allow collaboration with industry on CME content.
Bob Rappaport, MD, the director of FDA’s division of anesthetic and analgesic products, recently said that the REMS content developed by industry would ultimately be approved by the FDA. The ACCME has said it will not allow industry-developed content to be incorporated into CME; however, government-approved REMS content could potentially be incorporated in addition to CME activities to improve patient care.
The ACCME seems to be validating the idea of CME as a REMS component. Murray Kopelow, MD, ACCME’s chief executive, has reached out to several accredited provider groups to encourage collaboration regarding REMS. In addition, a recent interview quoted Kopelow as being very supportive of CME in REMS. “Because the FDA has offered itself and its processes to retain control over educational content, now is the time accredited CME can step up,” Kopelow said. “It’s now time to bring industry to conversations with accredited CME providers who will negotiate this and implement this.”
We have to be careful in how we approach and implement any CME components of future REMS programs. But if we define our mission objectives appropriately, the FDA-approved REMS could help launch certified CME into a higher orbit.
Stephen M. Lewis, MA, CCMEP, is president of Littleton, Colo.–based Global Education Group. He can be reached at
slewis@globaleducationgroup.com.
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