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- Title
Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing.
- Authors
Fleischman, William; Auth, Doris; Shah, Nilay D.; Agrawal, Shantanu; Ross, Joseph S.
- Abstract
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. This cohort study investigates the association between implementation of a risk evaluation and mitigation strategy program with transmucosal fentanyl prescribing for Medicare Part D beneficiaries. 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 through July 2018. Main Outcomes and Measures: 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. Results: 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 <.001) but was followed by 2.0% monthly increases in prescribing (95% CI, 1.3% to 2.7%; P <.001). Sensitivity analyses that accounted for overall opioid prescribing trends were consistent with these findings. Furthermore, there were no significant changes associated with REMS implementation in the level (0.47%; 95% CI, −5.36% to 4.69%; P =.85) or trend (0.16%; 95% CI, −0.06% to 0.37%; P =.15) of the percentage of prescriptions for patients without cancer. However, a sensitivity analysis that used a broader cancer definition found implementation was associated with a 7.2% (95% CI, −13.5% to −0.48%; P =.04) level decrease in the percentage of TIRF prescriptions for patients without cancer. Lastly, the TIRF-REMS was associated with a 22.5% level decline in the percentage of TIRF prescriptions for patients without known opioid tolerance (95% CI, −36.1% to −5.95%; P =.01) followed by 1.98% monthly decreases (95% CI, −3.19% to −0.80%; P =.001). Conclusions and Relevance: Implementation of the TIRF-REMS Access Program, a restrictive drug distribution program, was associated with a temporary reduction in the rate of TIRF prescribing to Medicare Part D beneficiaries, and with a sustained decrease in the percentage of TIRF prescriptions for patients without known opioid tolerance. Implementation may have also been associated with a temporary decrease in the percentage of TIRF prescriptions for patients without cancer.
- Subjects
CONFIDENCE intervals; FENTANYL; LONGITUDINAL method; MEDICARE; MEDICAL prescriptions; TIME series analysis; UNITED States. Food &; Drug Administration; DESCRIPTIVE statistics; BREAKTHROUGH pain; LAW
- Publication
JAMA Network Open, 2019, Vol 2, Issue 3, pe191340
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2019.1340