BETHESDA, MD 30 July 2012—The new risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid analgesics reduces the length of each product’s medication guide to one page and emphasizes education of prescribers and patients, FDA announced July 9.
FDA Commissioner Margaret Hamburg described the medication guides as straightforward documents that will help patients better understand how to safely use their medication.
The medication guide for Purdue Pharma L.P.’s Oxycontin, for example, now has 24 bulleted items. Until FDA approved the new REMS, the medication guide had dozens of bulleted items, including details on each of the seven strengths of the extended-release oxycodone product.
Education of prescribers will occur through continuing-education programs based on the blueprint from FDA.
The agency set a deadline of March 1, 2013, for the first "REMS-compliant training" to be available to prescribers. There is no deadline or requirement for prescribers to complete the training.
Gil Kerlikowski, director of the White House Office of National Drug Control Policy, told reporters that the administration wants to make the training mandatory for prescribers. He said the administration will work with Congress to amend the Controlled Substances Act so that completion of REMS-compliant training is a prerequisite for registration to prescribe extended-release and long-acting opioid analgesics.
Education of patients will occur through medication guides and the new "patient counseling document" that FDA wants prescribers to use as part of their discussion when prescribing opioid analgesics.
Formally known as the "Patient Counseling Document on Extended-Release and Long-Acting Opioid Analgesics," the document provides instructions on safe use, serious risks, storage, and disposal.
FDA said the goal of the REMS is to reduce addiction, unintentional overdoses, and deaths resulting from inappropriate prescribing, misuse, and abuse of extended-release and long-acting opioid analgesics while maintaining patients’ access to pain medications.
As of July 9, the classwide REMS program covered 12 brand-name and 21 generic products containing buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, or tapentadol.
The medication guides are available at www.er-la-opioidrems.com.