FDA panel rejects REMS proposal for long-acting opioids

September 15, 2010

FDA advisory committee members voted 25 to 10 to reject a proposed plan to establish a risk evaluation and mitigation strategy for extended-release and long-acting opioid analgesics during the joint meeting on July 23 of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in Adelphi, Md.

Key Points

After many months of soliciting input from stakeholders, FDA called for a vote on its proposal to establish a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid analgesics. FDA advisory committee members voted 25 to 10 to reject the proposed plan during the joint meeting on July 23 of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in Adelphi, Md.

The proposal called for manufacturers to develop programs to guide physicians in selecting, dosing, and monitoring patients taking long-acting opioids. It also required that physicians receive training to counsel patients on safe opioid storage and disposal, and drug manufacturers to provide physicians with patient-education sheets. Each prescription would also require a medication guide, highlighting the safe use of these drugs.

"There is an agreement among the committee members about the crucial need for monitoring the use of extended-release and long-acting opioids, but no consensus on what the extent of the FDA's actions should be," said Knox H. Todd, MD, MPH, professor of emergency medicine, Albert Einstein College of Medicine in New York City, and Director of the Pain and Emergency Medicine Institute at Beth Israel Medical Center in Manhattan, who voted for the proposal. "The larger the program, the greater the challenge and the more time it will take to find a solution. What's most important is that we find a pragmatic answer and adopt it quickly."

The primary issues provoking discussion during the 2-day advisory meeting included:

The FDA proposal is "focused on the patient-prescriber interface for legitimate medical use of the products or the uses that are labeled on their improved package inserts," said John Jenkins MD, director, Office of New Drugs, Center for Drug Evaluation and Research, during a media briefing after the vote. "We think the program we've put forward would have an impact but ... we were very clear that the REMS program wouldn't address the entire societal problem of prescription opioid abuse and misuse."

Pharmacist participation

Marcie Bough, director of federal regulatory affairs for the American Pharmacists Association (APhA), would like to see the REMS proposal place more emphasis on the role of the pharmacist, who she feels is an integral part of a collaborative team of medical experts working closely with patients. "We want to ensure that pharmacists understand the REMS so that they can inform their patients of what is required for compliance," she said. Although APhA recognizes the importance of the REMS, Bough said, the organization believes the proposal needs strengthening. "Opioid abuse is a growing public issue, and I'm not sure a REMS alone is sufficient."

Allen J. Vaida, PharmD, FASHP, executive vice president, Institute for Safe Medication Practices in Horsham, Penn., who voted "no" on the proposal, agreed with Bough that the educational component of REMS should also apply to pharmacists, not just prescribers. Vaida recommended that rather than advocate for mandatory training of healthcare providers, state licensing boards should require providers to earn REMS-related continuing education credits in order to renew their licenses. He also expressed concern over the proposal's omission of mandatory patient counseling and would like the REMS proposal extended to include all kinds of opioids.

CE credits for pharmacists

The Accreditation Council for Pharmacy Education (ACPE) also wants to see the role of pharmacists strengthened, recommending the use of accredited continuing pharmacy education for effective REMS education. "We advocate for accredited providers to play a large role in educating pharmacists about opioids because they provide consistent standards," said Peter H. Vlasses, PharmD, BCPHS, DSc (Hon), executive director of ACPE. "We would also like to ensure that if pharmacists are required to learn about REMS, they could count that education towards their continuing education credits."

Despite the vote to reject the FDA REMS proposal, both proponents and opponents applauded the FDA for its commitment and efforts to develop a viable solution to the management of extended-release and long-acting opioids.

Although FDA is not bound by the decisions of its committees, the agency often follows their advice. FDA spokewoman Crystal Rice said that with the input received at the recent meeting, "the FDA is working to finalize the REMS proposal and issue letters directing the sponsors of the affected drug products to develop and submit the REMS program for FDA review and approval."

MARI EDLIN is a healthcare writer in Mill Valley, Calif.