FDA Drug Info - FDA approves a class Risk Evaluation and Mitigation Strategy (REMS)

On December 28th, the U.S. Food and Drug Administration (FDA) approved a single, shared system Risk Evaluation and Mitigation Strategy (REMS) for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines. This REMS, called the TIRF REMS Access program, consists of a restricted distribution program to reduce the risk of misuse, abuse, addiction, and overdose with TIRF medicines. The TIRF REMS Access program is the first approved class REMS for drugs in the opioid class. We are continuing work on another class REMS for the class of long-acting and extended-release opioids.

The following questions and answers provide an overview of the new shared REMS for TIRF medicines. (Click questions below to read more)

Q1. What are transmucosal immediate-release fentanyl (TIRF) medicines?

Q2. What is a Risk Evaluation and Mitigation Strategy (REMS)?

Q3. Why did FDA approve a shared, single-system Risk Evaluation and Mitigation Strategy (REMS) for the entire class of transmucosal immediate-release fentanyl (TIRF) medicines, when the TIRF medicines already had individual REMS in place?

Q4. Does this new Risk Evaluation and Mitigation Strategy (REMS) apply to all opioids?

Q5. Will this action make it harder for patients to receive their transmucosal immediate-release fentanyl (TIRF) medicines?

Q6. What should prescribers know about the new shared TIRF REMS Access program?

Q7. What should pharmacies/pharmacists know about the new shared TIRF REMS Access program?

Q8. What should patients know about the new shared TIRF REMS Access program?

Q9. When does the TIRF REMS Access program “go live” or become fully operational? What do patients on transmucosal immediate-release fentanyl (TIRF) medicines do in the interim?