A risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid analgesics has been approved by the FDA. The REMS, part of a federal initiative aimed at addressing the current prescription drug abuse, misuse, and overdose epidemic, introduces new safety measures designed to reduce risks and improve the safe use of ER and LA opioids while ensuring that patients who are experiencing pain have access to needed medications.
The new ER and LA opioid REMS will affect more than 20 companies that manufacture opioid analgesics. They will be required to make education programs available to prescribers based on an FDA Blueprint and will be expected to meet this obligation by providing educational grants to continuing education providers, who will develop and deliver the training.
The REMS also will require companies to make available FDA-approved patient education materials on the safe use of the drugs and to perform periodic assessments of the implementation and success of the program. The FDA will review the assessments and may require additional elements to achieve the program goals.
Key REMS components include the following:
• Training for prescribers. Educational programs for prescribers of ER and LA opioids will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, information will be provided on how to recognize evidence of and the potential for opioid misuse, abuse, and addiction, as well as general and specific drug information for ER and LA opioid analgesics.
• Updated Medication Guide and patient counseling document. These materials contain consumer-friendly information on the safe use, storage, and disposal of ER and LA opioid analgesics. Included are instructions to consult one's physician or other prescribing health care professional before changing doses, signs of potential overdose and emergency contact instructions, and specific advice on safe storage to prevent accidental exposure to family members and household visitors.
• Assessment/auditing. Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of ER and LA opioids who complete the training, as well as assess prescribers' understanding of important risk information over time. The assessments also cover whether the REMS is adversely affecting patients' access to necessary pain medications, which manufacturers must report to the FDA.
The first continuing education activities under the REMS are expected be offered to prescribers by March 1, 2013. There is no mandatory requirement that prescribers take the training and no precondition to prescribing ER and LA opioids for patients. For more information, visit the FDA Web site at http://www.fda.gov.