The Food and Drug Administration’s Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) is designed to prevent wrongful prescribing of TIRF products among patients who have no tolerance for opioids. However, research suggests the plan was not executed as intended, based on a review of FDA documents from 2012 to 2017 and surveys of nearly 790 people 12 months after the program launched.
The findings come from an analysis of claims 60 months after the initiative began which show that even though most pharmacists (86%), prescribers (87%) and patients (91%) correctly reported that TIRFs are contraindicated in patients with no opioid tolerance, 35% to 55% of nontolerant patients were prescribed TIRFs anyway and that FDA failed to act on this knowledge.
“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,” the researchers stated.
