The Food and Drug Administration has announced that the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medications has been updated to better ensure the safe use of these products.
Specifically, the agency is requiring manufacturers of TIRF medications to make the following changes to the REMS:
- Prescribers are required to document a patient’s opioid tolerance concurrently with each prescription of a TIRF medicine for outpatient use.
- Inpatient pharmacies are required to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized.
- TIRF medicines should be dispensed for outpatient use with evidence or other documentation of safe use conditions, including concurrent documentation of opioid tolerance.
- The development of a new patient registry to monitor for serious adverse events, including overdose (both fatal and non-fatal).
“The current TIRF REMS requires only that prescribers attest to their understanding that patients must be opioid tolerant before using a TIRF medicine,” said FDA Commissioner Scott Gottlieb, MD. “That’s why we’re now requiring verification of opioid tolerance with each prescription written and dispensed to provide greater assurance that only opioid tolerant patients are treated with a TIRF medicine in order to lower the risks for adverse events, including overdose and death.” This new requirement is in addition to the patient-prescriber agreement form required for outpatient treatment with TIRF medications.
In a press statement, Gottlieb noted that while the use of TIRF products has declined over the years, the Agency remains concerned with inappropriate use, specifically, the prescribing of TIRF products to patients who are not opioid-tolerant. “The prescribing of these medicines for non-FDA approved uses to non-opioid-tolerant patients tells us that there may be a disconnect between prescriber knowledge and prescribing behavior,” he added.
The FDA has issued letters to manufacturers of TIRF products notifying them of the required changes; a proposed REMS modification must be submitted within 120 days of the letter.
For more information visit FDA.gov.