May 13, 2016
While surveys have identified decreasing rates of abuse, overdose and death from prescription opioids in the United States, they cannot necessarily be attributed to the Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting (ER/LA) opioids, because the REMS was interwoven with other state and national opioid abuse interventions.
This message rang throughout the joint meeting on the ER/LA opioid REMS of the FDA Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.
Representatives of the FDA, industry and the medical community discussed how well the ER/LA opioid REMS is working and whether it needs tweaks. The FDA’s committees recently voted to change the REMS, which will most likely include mandatory prescriber education. The REMS, approved in July 2012, is one strategy to combat the opioid abuse crisis facing the country.
Paul Coplan, ScD, MBA, the director of medical affairs at Purdue Pharma, led the discussion for the REMS Program Companies (RPC). The RPC, a consortium of 23 companies that manufacture ER/LA opioids, pooled funds to develop educational programs, which are voluntary under the current REMS. Mr. Coplan cited some of the successes of their efforts, including 839 REMS-compliant continuing education (CE) courses conducted with roughly 438,000 participants. Results from various surveys were discussed, showing the education has an effect. More than 3 million “Dear Prescriber” letters were mailed to inform clinicians of the REMS.
Charles Argoff, MD, a professor of neurology at Albany Medical College in New York, said that in a survey of 441 health care providers who received REMS training and 4,669 providers who did not, those who received training had a 10% reduction in ER/LA prescribing, compared with a 4% increase in providers who did not receive training.
While surveys, including one from the Rocky Mountain Poison and Drug Center in Denver, have identified decreasing rates of abuse, overdose and death from prescription painkillers, this decrease started before the REMS was launched and came at a time when other strategies were being used to address the opioid abuse problem.
“Is REMS making any progress? That is a difficult question to answer,” said Jana McAninch, MD, MPH, MS, a medical officer in the Division of Epidemiology at the FDA Center for Drug Evaluation and Research.
The FDA reviewers said they supported legislative changes that would require mandatory opioid education for prescribers to obtain and renew Drug Enforcement Administration (DEA) registration to prescribe controlled substances. Laura Wallace, MPH, the director of Risk Management and Epidemiology at Purdue Pharma, pointed out that the ER/LA opioid REMS is novel in its scope in use of CE activities. “The RPC does not believe it is necessary to make training mandatory, but if it is, the majority of the RPC supports tying Schedule II and III narcotic DEA registration to completion of REMS-compliant opiate education or some other recognition, such as board certification in pain medicine,” said Ms. Wallace.
Ms. Wallace said the RPC had several recommendations to tweaking the REMS, including enhancing communication about the REMS through online avenues and by promoting REMS awareness through appropriate health care professional organizations. The RPC also recommended expanding the REMS to include the extended health care team, pharmacists, nurse practitioners and physician assistants, and slightly tweaking CE activities to use more cases studies; include tools to manage opioid risks, such as the coprescribing of naloxone; and address other topics of pain management, such as how to deal with patients suspected of abuse or diversion. “Establishing a standard assessment across CE activities will also allow the effectiveness of different activity types and delivery format to be compared over time to aid course improvement,” said Ms. Wallace. She added that the RPC believes harmonizing the safety topics covered by federal opioid education will help.
FDA officials noted that a national registry tracking which providers have completed the REMS training would be useful.