New REMS Rules: FDA Gets Tougher on Fentanyl Prescribing

Megan Brooks

December 24, 2020

Concern about potentially inappropriate prescribing of transmucosal immediate-release fentanyl (TIRF) products has prompted the US Food and Drug Administration (FDA) to toughen requirements in the Risk Evaluation and Mitigation Strategies (REMS) program for these medications.

The goal is to help ensure that the benefits of these drugs continue to outweigh the risks, FDA Commissioner Stephen M. Hahn, MD, said in a statement

TIRF medications are used to manage breakthrough pain in adults with cancer who require other opioid pain medicines. Safe use of TIRF medicines requires that patients be opioid-tolerant based on concurrent regular use of another opioid medication.

Although use of TIRF medicines has declined in recent years, data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid-tolerant, Hahn said.

"With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices. These changes will also improve our ability to monitor for adverse events and ensure safe use of these medicines," Hahn said.

The strengthened TIRF REMS program now requires the following:

  • Prescribers must document a patient's opioid tolerance with each prescription of a TIRF medicine for outpatient use

  • Outpatient pharmacies dispensing TIRF medicines must document and verify a patient's opioid tolerance before dispensing

  • Inpatient pharmacies must develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized; and require a new patient registry for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

"While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the US Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis," Hahn said.

"We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication," he added.

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