The Food and Drug Administration (FDA) announced that the Risk Assessment and Reduction (REMS) strategy for immediate-release fentanyl transmucosal drugs (TIRF) has been strengthened to ensure that the benefits of these drugs continue to outweigh the risks.
In particular, the REMS program has been updated to include the following:
- Prescribers must document a patient’s opioid tolerance each time they prescribe a TIRF drug for outpatient use.
- Outpatient pharmacies that dispense TIRF drugs must document and review a patient’s opioid tolerance prior to dispensing.
- Inpatient pharmacies need internal policies and procedures to be developed to assess opioid tolerance in patients who require TIRF medication in the hospital. and
- A new patient registry is needed to monitor, along with other data sources, for accidental exposure, abuse, abuse, addiction and overdose.
In a press release, the FDA noted that while TIRF drug use has declined in recent years, the data suggests that TIRF drug prescriptions remain in place for patients who are not opioid tolerant. According to FDA Commissioner Stephen M. Hahn, MD, “The FDA has completed changes to the REMS program to address the persistence of these changes to prescribing practices.” He added that these changes are expected to improve the FDA’s ability to monitor adverse events and ensure the safe use of these agents.
For more information, see fda.gov.
The FDA is taking further steps to address the opioid crisis through risk assessment and mitigation strategy programs. [press release]. Silver Spring, MD: US Food and Drug Administration; December 23, 2020.
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