A program that would educate health care professionals about prescribing long-acting and extended-release opioid drugs is among the elements of the proposed risk management plan for this class of drugs, the Food and Drug Administration has announced.
At this time, however, mandatory registration of patients and prescribers in the risk management program is not included in the FDA’s proposed Risk Evaluation and Mitigation Strategy (REMS) for long-acting (LA) and extended-release (ER) opioid drugs, an idea that had been considered a possibility and one that is included in the risk management programs for some other drugs. But the agency plans to monitor the program’s effects “and may consider further steps if the REMS does not prove effective in curbing serious adverse outcomes resulting from inappropriate prescribing, abuse, and misuse,” according to the proposal, which was posted on the FDA Web site June 28.
The proposed REMS – developed with input from manufacturers and groups representing health care providers, pharmacies, and patients – is “intended to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of LA and ER opioids, while maintaining patient access to these medications,” according to the statement. These drugs include morphine ER, oxymorphone ER, oxycodone ER, hydromorphone ER, fentanyl transdermal patches, and methadone.
Some of the input for the proposed plan was provided at meetings held by the FDA, including one in December 2009, where an industry working group presented its ideas. The FDA has scheduled a joint meeting of two of its advisory panels, the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for July 22-23, where the proposal will be reviewed by outside experts on the panels. The public has the opportunity to provide comments during an open public hearing portion of these meetings.
The agency will consider the comments made at this meeting in finalizing the proposal, and once finalized, will request that the manufacturers of the affected products develop a REMS based on the finalized proposal and submit it for approval by the agency, according to the statement.
Under the proposed REMS, the FDA would require manufacturers of these products to develop a prescriber education program that would be “designed to further train healthcare professionals on appropriate patient selection, dosing and patient monitoring when using LA and ER opioids,” according to the statement. The full proposal says that the agency would encourage sponsors to partner with “an appropriate, independent third party” to develop the prescriber training program and to consider incentives such as continuing medical education credit to encourage prescribers to undergo this training.
The proposal states that requiring patient enrollment would be “overly burdensome” and could create a stigma for patients, ultimately affecting access to those drugs. An idea proposed at the December meeting – requiring clinicians to provide proof that they had undergone training in prescribing LA opioids in order to obtain Drug Enforcement Agency registration to prescribe these products – would necessitate legislation and is not included in the proposal at this time, according to background information in the proposal.