Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing
| Autor: | Joseph S. Ross, Doris Auth, Nilay Shah, Shantanu Agrawal, William Fleischman |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Risk Evaluation and Mitigation Pharmacy OPIOID TOLERANCE Medicare Drug Prescriptions Fentanyl medicine Administration Mucosal Humans Medicare Part D Medical prescription Original Investigation Aged business.industry Research Health Policy Interrupted Time Series Analysis General Medicine Middle Aged United States Risk evaluation Analgesics Opioid Online Only Emergency medicine business Opioid analgesics medicine.drug Cohort study |
| Zdroj: | JAMA Network Open |
| ISSN: | 2574-3805 |
| DOI: | 10.1001/jamanetworkopen.2019.1340 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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