Pharmacy Times

FDA Releases REMS Plan For Opioids


As part of its attempt to fight the growing problem of prescription painkiller abuse, the FDA has announced that makers of extended-release (ER) and long-acting (LA) opioids will be required to fund voluntary continuing education (CE) programs for physicians who prescribe the drugs. The Risk Evaluation and Mitigation Strategy, which will apply to drugs including OxyContin (oxycodone) and Opana (oxymorphone), will also require the production of updated patient handouts on the risks and benefits of opioid use.

Approximately 320,000 providers wrote approximately 22.9 million prescriptions for ER or LA opioids in 2011. CE activities under the new directive, which will take 2 to 3 hours to complete, should be available starting in March 2013. The FDA expects that 60% of prescribers of the opioids in question will be trained through the program within the first 3 years.

In making the CE activities voluntary, the FDA has overridden the overwhelming recommendation of a panel of outside experts in 2010 that it require physicians to undergo training before being allowed to prescribe ER or LA opioids. An FDA press release announcing the new program expressed support for such a requirement, but noted that new legislation from Congress would be required to put it in place. A requirement along these lines has been opposed by physician groups such as the American Medical Association, which argues that it would reduce the number of physicians available to treat pain patients.