FDA Strengthens REMS for Transmucosal Immediate-Release Fentanyl

The Food and Drug Administration (FDA) announced that the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medications has been strengthened to help ensure that the benefits of these drugs continue to outweigh the risks.

Specifically, the REMS program has been updated to include the following:

  • Prescribers are required to document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use;
  • Outpatient pharmacies dispensing TIRF medicines are required  to document and verify a patient’s opioid tolerance before dispensing;
  • Inpatient pharmacies are required to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized; and
  • A new patient registry is required for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

In a press statement, the FDA noted that while the use of TIRF medications has declined in recent years, data have suggested that the prescribing of TIRF medications to patients who are not opioid tolerant still remains. According to FDA Commissioner Stephen M Hahn, MD, “the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices.” He added that these changes are expected to improve the ability of the FDA to monitor for adverse events and ensure the safe use of these agents.

For more information visit fda.gov.


FDA takes further steps to confront opioid crisis through risk evaluation and mitigation strategy programs. [press release]. Silver Spring, MD: U.S. Food and Drug Administration; December 23, 2020. 

This article originally appeared on MPR