Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing

Key Points Question Was the implementation of the Transmucosal Immediate-Release Fentanyl (TIRF)–Risk Evaluation and Mitigation Strategy (REMS) associated with changes in prescribing of TIRF medications? Findings In this cohort study using interrupted times series analysis, implementation of TIRF-REMS was associated with a temporary reduction in the rate of overall TIRF prescribing to Medicare Part D beneficiaries and with a sustained decrease in the percentage of TIRF prescribed to patients without known opioid tolerance. The TIRF-REMS program may have also been associated with a temporary decrease in the percentage of TIRF prescribed to patients without cancer. Meaning Mandatory, restrictive drug distribution programs, such as the TIRF-REMS, may be associated with changes in opioid prescribing, although the changes may be temporary.