Which REMS program is required for transmucosal forms of fentanyl such as Actiq and Subsys?

The TIRF REMS program is specifically designed for the management of transmucosal immediate-release fentanyl (TIRF) products, such as Actiq and Subsys. This program is essential because transmucosal forms of fentanyl are potent opioids that have a high potential for misuse and overdose if not used appropriately.

The TIRF REMS program provides comprehensive safety information and risk management strategies to ensure that these medications are prescribed and dispensed safely. It mandates that healthcare providers who prescribe TIRF products undergo training and certification, and it requires patients to be informed about the risks associated with their use. This program helps to promote safe usage among patients who are prescribed these potent opioid formulations, aiming to prevent misuse and encourage appropriate use within the guidelines established.

Other options do not pertain to the specific requirements or management of transmucosal fentanyl products. For instance, the Clozapine REMS program focuses on managing the risks associated with clozapine use in patients susceptible to agranulocytosis, while the Opioid Safety REMS program encompasses broader opioid prescribing practices. The Fentanyl Safety REMS program is not a recognized entity; rather, the TIRF REMS program is the specific regulatory framework that