Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products
| Autor: | G. Caleb Alexander, Peter Lurie, Lily Olson, Joshua M. Sharfstein, Jeffrey Eric Rollman, James Heyward |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Health Knowledge Attitudes Practice Prescription Drugs media_common.quotation_subject Risk Evaluation and Mitigation MEDLINE Off-label use Pharmacists 01 natural sciences Fentanyl 03 medical and health sciences 0302 clinical medicine medicine Product Surveillance Postmarketing Administration Mucosal Humans 030212 general & internal medicine Immediate release 0101 mathematics Practice Patterns Physicians' Prescription Drug Misuse health care economics and organizations Original Investigation media_common business.industry United States Food and Drug Administration Addiction 010102 general mathematics Breakthrough Pain Contraindications Drug General Medicine Cancer Pain Off-Label Use medicine.disease United States Risk evaluation Analgesics Opioid Family medicine Health Care Surveys Clinical Competence business Cancer pain Addictive behavior medicine.drug |
| Zdroj: | JAMA. 321(7) |
| ISSN: | 1538-3598 |
| Popis: | Importance Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately. Objectives To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments. Design, Setting, and Participants Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. Exposure A REMS program to reduce the risk of adverse outcomes, including misuse, abuse, addiction, and overdose, arising from use of TIRFs. Main Outcomes and Measures (1) Knowledge assessments of pharmacists, prescribers, and patients; (2) survey and claims-based prescribing assessments; (3) FDA and TIRF sponsor communications; (4) modifications to the REMS program; and (5) disenrollment of noncompliant prescribers. Results Twelve months after initiation of the program, 24 of 302 pharmacists (7.9%), 35 of 302 prescribers (11.6%), and 5 of 192 patients (2.6%) incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in the subsequent reports. At 60 months, product-specific analyses of claims data indicated that between 34.6% and 55.4% of patients prescribed TIRFs were opioid-nontolerant. In the 48-month survey, 106 of 310 prescribers (34.2%) reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 54 of 302 prescribers (18.4%) and 148 of 310 patients (47.7%) erroneously reported that TIRFs were FDA-approved for such use. Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing. Conclusions and Relevance In this review of FDA documents pertaining to the TIRF REMS, surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge regarding proper TIRF prescribing, yet some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program. |
| Databáze: | OpenAIRE |
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