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# ‘Substantial Rates of Inappropriate TIRF Use’ Seen: Study
- URL: https://www.fdaweb.com/substantial-rates-of-inappropriate-tirf-use-seen-study/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143417

Researchers who examined the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products and surveyed providers, pharmacists, and patients say that while there generally was adequate knowledge about using TIRFs, some survey items and claims-based analyses indicated substantial rates of inappropriate use.

A *Journal of the American Medical Association* article (subscription required) [says](https://jamanetwork.com/journals/jama/article-abstract/2725216?ref=fdaweb.com) that TIRFs are subject to a REMS to prevent them from being prescribed inappropriately.

A review of FDA documents, the researchers write, showed that 12 months after program inception, 86% of pharmacists, 87% of prescribers, and 91% of patients correctly reported that TIRFs are contraindicated in opioid non-tolerant patients. However, claims-based analyses 60 months after program inception indicated that 35% to 55% of patients prescribed TIRFs were opioid-nontolerant.

In a related [editorial](https://jamanetwork.com/journals/jama/article-abstract/2725216?ref=fdaweb.com) (subscription required) Harvard Medical School researchers suggest three reforms they say would help improve the structure and administration of REMS: 

- REMS should be designed by FDA with manufacturers’ input, rather than vice versa, and should be administered by a neutral third party paid by FDA from newly instituted REMS user fees;
- REMS assessments submitted to FDA should be publicly available; and
- for REMS to ensure safe use of clinically useful prescription drugs with potentially significant adverse effects, FDA should be more assertive in requesting specific analyses pertaining to the performance of REMS programs and in restructuring elements to assure safe use in response to concerns raised in the analyses.

The editorial authors conclude that if FDA is going to continue to rely on REMS when approving dangerous drugs, as with the 11/2018 approval of Dsuvia (sufentanil), “better systems are needed to ensure that REMS programs work as intended.”