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

ABSTRACT:

Importance

Transmucosal immediate-release fentanyl (TIRF) drugs are potent, rapid-acting opioids approved to treat breakthrough pain in patients with cancer who are tolerant to other around-the-clock opioid analgesics. In March 2012, a US Food and Drug Administration-approved Risk Evaluation and Mitigation Strategy (REMS) was implemented, mandating prescribers, distributors, pharmacies, and patients to enroll in the REMS to prescribe, dispense, or receive TIRF drugs.

Objective

To evaluate the association of the TIRF-REMS Access Program with TIRF prescribing.

Design, setting, and participants

Cohort study using an interrupted time series analysis of TIRF prescriptions to Medicare Part D beneficiaries nationwide from 2010 to 2014. Data were analyzed from August 2017 thr

SUBMITTER: Fleischman W 

PROVIDER: S-EPMC6450314 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature