Opioid manufacturers told to develop physician, patient education

As part of a new federal effort to reduce prescription drug abuse in the U.S., the FDA will begin requiring a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid medications.

The new REMS plan focuses primarily on educating doctors about proper pain management, patient selection and other requirements, and improving patient awareness about how to use the drugs safely. “The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks,” said FDA Commissioner Margaret A. Hamburg, MD.

Although doctor training is not mandatory under the REMS plan, other federal agencies are working to get Congress to link mandatory physician training to the already required Drug Enforcement Administration registration number for prescribing controlled substances, according to an FDA press release.

Doctor training, patient counseling, and other risk reduction measures developed by opioid makers as part of the REMS are expected to become effective by early 2012. They will be required for drugs including hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl and transdermal buprenorphine.

Elements of the overall federal plan, which is called Epidemic: Responding to America's Prescription Drug Abuse Crisis, include:

• expansion of state-based prescription drug monitoring programs,
• recommending convenient and environmentally responsible ways to remove unused medications from homes,
• supporting education for patients and clinicians, and
• reducing the number of “pill mills” and doctor-shopping through law enforcement.