New REMS for Immediate-Release Opioids in Outpatient Settings

Training for Pharmacists and Nurses, Not Just Prescribers

The FDA has approved a final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) that includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.

The REMS program requires, for the first time, that training be made available to health care providers who are involved in the management of patients with pain (e.g., nurses and pharmacists), and not only to prescribers. The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS.

Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component that training be made available to prescribers of those products. However, the IR drugs account for about 90 percent of all opioid pain medications prescribed for outpatient use. The entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.

In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content.

The ER/LA Opioid Analgesic REMS previously included 62 products, but the modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements.

There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients. However, the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal.

Source: FDA.gov, September 18, 2018