FDA: Opioid Analgesic REMS Expanded to Include Immediate-Release Products

The Food and Drug Administration (FDA) has expanded the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate-release (IR) opioid analgesics intended for use in an outpatient setting.  Extended-release and long-acting (ER/LA) opioids have been subject to the REMS since 2012.

As part of the REMS program, drug companies with approved opioid analgesics must make training available to prescribers and provide unrestricted grants to accredited continuing education providers for the development of education courses. The Agency expects that continuing education training under the modified REMS will be available to healthcare providers by March 2019.  The addition of IR opioid analgesics means that the REMS now includes 347 opioid analgesics.

In addition, the FDA is also approving labeling changes for all opioid analgesics intended for use in an outpatient setting to include information about the availability of education through the REMS for prescribers who are involved in the treatment and monitoring of patients with pain. The Boxed Warning and Warnings and Precautions sections of the labeling will include information about REMS-compliant education.

Prescribers are not required to take the training provided through the REMS, although the Agency stated today that their Opioid Policy Steering Committee “continues to consider whether there are circumstances when the FDA should require some form of mandatory education.”

“Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements,” said FDA Commission, Scott Gottlieb, MD. “Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products.”

For more information visit FDA.gov.