FDA Pain REMS Advisory Committee to Include Presentations on Continuing Education in the Health Professions as a Tool for Implementation

 Today, Murray Kopelow, M.D., M.S., Chief Executive and Secretary for the Accreditation Council for Continuing Medical Education (ACCME) and Peter H. Vlasses, Pharm.D, D.Sc.  Education Executive Director Accreditation Council for Pharmacy Education will be presenting at a Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM), hosted by the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER).

Dr. Kopelow will be advocating to FDA and CDER that continuing medical education (CME) would be an extremely useful and tremendous tool to help educate physicians and health care providers regarding opioid use.

The purpose of the meeting is to discuss Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics, which we discussed previously. Consequently, one of the goals of the meeting for FDA is to present a proposal for a class-wide opioid REMS, and to solicit feedback from the Advisory Committee and public on the components of that proposal.

The agenda also noted the need for REMS regarding adequate pain control because although it is an element of good medical practice, “inappropriate prescribing, addiction and death due to prescription opioid abuse and misuse have been increasing over the last decade.”

The meeting, which is being held in Adelphi, Maryland, over two days, will include various remarks from government agencies and officials, pain management organizations, and members from industry. Accordingly, the agenda will address a series of issues as follows:

–    The Nature of the Problem of Prescription Opioid Misuse and Abuse

–    A Summary of the Efforts to Address this Problem

–    Final REMS Proposal

–    Metrics for Evaluation

–    The Safe Use Initiative

–    Continuing Education; and

–    Presentations from Industry

Since pain management is an extremely important aspect of medical care for numerous diseases and patients, FDA and CDER should certainly consider the impact CME programs could have bringing doctors up to date with REMS and other ways to address problems of opioid misuse and abuse.