CE Accreditors Respond to FDA REMS Proposal
The ACCME, the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) issued a joint response to the Food and Drug Administration (FDA) report Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS). In its description of the report, the FDA explained, “This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings.” The FDA asked for public comment in its Federal Register notice on September 23, 2014.
The accreditors responded to Project 2 in the report, “Prescriber Education under REMS: Prescriber Education—REMS and Continuing Education (CE) for Healthcare Providers.” In its description of Project 2, the FDA said: “Numerous stakeholders asked FDA to facilitate the provision of health care provider continuing education (CE) for the education and training that is provided in a REMS program. This project will assess whether it is feasible to provide CE certified by the Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and Accreditation Council for Pharmacy Education associated with a specific REMS.”
In their letter, the ACCME, ACPE, and ANCC said: “As the national continuing education accreditors for the professions of medicine, pharmacy, and nursing, we share the FDA’s aspiration to leverage the accredited continuing education (CE) system to deliver REMS to health care professionals, as described in your report Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)…. We believe that accredited CE can play a significant role in addressing the patient safety issues identified in REMS. We appreciate that the FDA recognizes the value of accredited CE and is exploring how to leverage the accredited CE system to carry out these important public health initiatives.”
The ACCME also sent a letter offering observations and suggestions for improvement in the REMS CE process, based on the experience of the Extended-Release and Long-Acting (ER/LA) Opioid REMS. In the letter, Murray Kopelow, MD, President and CEO, ACCME, said, “We observe that the project plan has many similarities to the process used to develop the ER/LA Opioid REMS, including the associated CE construct. We believe that we could apply some lessons learned from our recent experience with the ‘effort to develop and implement a class-wide REMS-based CE training module’ to augment the project process – without impinging on the FDA’s independence, authority, or procedural requirements…. We applaud the FDA for its willingness to utilize the accredited CE system as a strategic asset. We are respectful of the due-diligence process the FDA has outlined and look forward to participating.”
The ACCME sent the letters as part of its long-standing commitment to communicating the value of accredited CME as a strategic partner in public health and safety initiatives. Since 2009, the ACCME has supported the role of accredited CME as a strategic asset to FDA REMS, provided the proper controls are in place to ensure independence. For more information, please visit CME in Support of REMS.