April 9, 2019

FDA Tightens Restrictions for Transmucosal Fentanyl Products

The FDA has announced changes to the Risk Evaluation and Mitigation Strategy (REMS) program for transmucosal immediate-release fentanyl (TIRF) products, implementing new safety requirements for the utilization of these medications.

REMS programs are drug safety programs required for certain medications, meant to reinforce behaviors and actions that support safe use of powerful medications with serious safety concerns. Though TIRF products already have comprehensive REMS requirements, further safety measures are being introduced as FDA data indicates that 35-55% of patients treated with a TIRF product were not opioid tolerant.

TIRF products are indicated for the treatment of breakthrough pain –sudden extra pain experienced for short periods of time that is not alleviated by a patient’s normal drug regimen – in cancer patients. According to the FDA, many patients who receive a TIRF prescription received them for the treatment of pain not indicated on the drug label, which is concerning due to the sheer strength of fentanyl products.

New REMS requirements for immediate-release TIRF products include:

  • Documenting opioid tolerance concurrently with each prescription of a TIRF product for outpatient use
  • Requiring inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized
  • Requiring TIRF products to be dispensed for outpatients only with evidence or other documentation of safe use conditions
  • Requiring the development of a new patient registry to monitor for serious adverse events including overdose

These actions further demonstrate the many initiatives that the FDA and a variety of other organizations are undertaking to combat the opioid epidemic, especially as fentanyl products in particular have led to higher opioid overdose death rates, as noted by the Centers for Disease Control and Prevention (CDC).

For more information, read the FDA press announcement.

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