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

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 Str...

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Bibliographic Details
Published in:JAMA network open 2019-03, Vol.2 (3), p.e191340
Main Authors: Fleischman, William, Auth, Doris, Shah, Nilay D, Agrawal, Shantanu, Ross, Joseph S
Format: Article
Language:English
Subjects:
Administration, Mucosal
Aged
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - adverse effects
Analgesics, Opioid - therapeutic use
Cancer
Drug Prescriptions - statistics & numerical data
FDA approval
Fentanyl
Fentanyl - administration & dosage
Fentanyl - adverse effects
Fentanyl - therapeutic use
Health Policy
Humans
Interrupted Time Series Analysis
Medicare
Middle Aged
Narcotics
Online Only
Original Investigation
Risk Evaluation and Mitigation
United States
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Summary: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. To evaluate the association of the TIRF-REMS Access Program with TIRF prescribing. 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 through July 2018. Prescribing of TIRF per 100 000 Medicare Part D beneficiaries, overall and stratified by cancer status; percentage of TIRF prescriptions for patients without cancer, overall and by brand; and percentage of TIRF prescriptions for patients without known opioid tolerance, defined as patients prescribed at least 60 morphine milligram equivalents per day, overall and by brand. There were 99 601 TIRF prescriptions written by 8619 clinicians to 10 472 patients. Most of the patients (79%) were younger than 65 years (mean [SD] age, 56 [13] years), and most (67%) did not have cancer. Implementation of TIRF-REMS was associated with a 26.7% relative level decrease in TIRF prescribing (95% CI, -33.3% to -19.4%; P 
ISSN:2574-3805
2574-3805
DOI:10.1001/jamanetworkopen.2019.1340