On April 19, the Obama Administration introduced a plan to address prescription drug abuse and announced new federal requirements aimed at educating providers about proper prescribing practices. The plan will support the expansion of state-based prescription drug monitoring programs; recommend more convenient and environmentally responsible disposal methods for unused medications; support education for patients and health care providers; and reduce the prevalence of pill mills and doctor-shopping through enforcement efforts.
In support of the initiative, the FDA announced an Opioids Risk Evaluation and Mitigation Strategy (REMS) that will require manufacturers of long-acting and extended-release opioids to provide educational programs for prescribers along with materials they can use when counseling patients.
Opioid drugs “pose serious risks when used improperly, with serious negative consequences for individuals, families, and communities,” said FDA Commissioner Margaret A. Hamburg, MD. “The prescriber education component of this Opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks.”
The FDA is calling for drug makers to work together to develop a single system for implementing the REMS program, which must be presented within 120 days. Physician 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 various brand name products known under the generic names: hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine.
iPad EXTRA: Abuse is not the only risk associated with opioid therapy, and patients taking the drugs can benefit greatly from a pharmacist’s counsel. For a special analysis of opioid use, download our free iPad app from iTunes and go to Pharmacy Insights.