New REMS for long-acting opioids require prescriber training on safe use

May 15, 2011

As part of an overall federal strategy on the prescription drug epidemic, FDA announced in late April that it will require a Risk Evaluation and Mitigation Strategy for all long-acting and extended-release opioids.

As part of an overall federal strategy on the prescription drug epidemic, FDA announced in late April that it will require a Risk Evaluation and Mitigation Strategy (REMS) for all long-acting and extended-release opioids.

The REMS, expected to be completed within 12 months, will mandate that manufacturers of such medications ensure that prescribers be trained in use of the medications and that they provide information on opioid use for patient counseling.

The new federal strategy calls for Congress to mandate within 2 years that prescribers complete training on safe use, storage, and disposal of schedule II and III opioids in order to obtain DEA registration. That requirement is the plan's main difference from the proposed REMS an FDA advisory committee rejected last year as not strong enough, said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research.

Asked whether the abuse problems might move to more immediate-release medications if this program works, Dr. Woodcock said, "We have the authority, if we receive new information about safety, to take actions."

"These products are the most egregious problem," she added. "But if we see problems in other areas, we can take further actions."

The REMS letter was sent to manufacturers of hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine. Manufacturers have 120 days to create the educational materials, which FDA will review to ensure that information is conveyed in an unbiased manner.

The companies are to provide the material to providers of continuing medical education (CME); the agency hopes CME providers will present it to prescribers, according to Dr. Woodcock. FDA has contacted a number of CME providers about the issue. Sponsors will also be required to monitor outcomes to see whether the effort is achieving its goals.

Other parts of the new federal strategy place greater emphasis on tactics already under way, including calling on all 50 states to establish prescription drug monitoring programs, which are now operational in 34 states, and completing the rules for drug disposal.

According to R. Gil Kerlikowske, director of the White House Office of National Drug Control Policy (ONDCP), there is little new money for the new strategy, but it involves new cooperation and pooling of resources among agencies.

"Frankly, in this austere budget climate ... this is what the American citizenry really expects of us: to be smart, to work together, to be strategic."

ONDCP said that it is requesting $123 million in increased funding for drug prevention and $99 million for treatment programs for fiscal year 2012, which is due to begin October 1.

Visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm for more information.

- Kathryn Foxhall