FDA approves final opioid analgesic REMS, adds immediate-release formulations for outpatient use

Agency also approves new REMS education Blueprint, changes in safety labeling


On September 18, FDA approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This REMS now includes immediate-release opioid analgesics used in outpatient settings as well as the extended-release and long-acting opioid analgesics that have already been subject to a REMS since 2012.


Under this REMS, training must be made available to all health professionals, including pharmacists and nurses, who provide care for patients who have pain, and the education must offer broader information about pain management, such as alternatives to opioids. To that end, FDA also approved the new Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint), which includes updated educational content. Furthermore, FDA has approved new safety labeling changes for all outpatient opioid analgesics to include information about the availability of REMS-compliant education.


In a statement, Scott Gottlieb, MD, FDA commissioner, touted these measures as steps in addressing the nation’s opioid crisis.


“Many people who become addicted to opioids will have their first exposure in the medical setting,” Gottlieb said. “Providers have a critical role to play in making sure these products are appropriately prescribed to patients. Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain.”


There remains no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS, and the training is not required for prescribing opioid analgesics. However, FDA hasn’t ruled out that possibility for the future, acknowledging that there may be circumstances when it should require some form of mandatory education for providers.