Update on Immediate-Release Fentanyl REMS
Posted by Dr. Julia Harder
In a step towards simplifying opioid Risk Evaluation and Mitigation Strategies (REMS), the FDA has approved a single, shared system REMS for the whole class of transmucosal immediate-release fentanyl (TIRF) drugs. The shared REMS system, called the TIRF REMS Access Program, will replace individual REMS for these agents, allowing prescribers and pharmacies to enroll into a single system. This is the first approved class REMS for any opioid drugs.
TIRF opioid agents include Abstral (sublingual tablet), Actiq (oral transmucosal lozenge), Fentora (buccal tablet), Lazanda (nasal spray) and Onsolis (buccal soluble film). The newly approved immediate-release fentanyl product SUBSYS sublingual spray (see the previous blog article) will also fall under the TIRF class REMS.
With the exception of SUBSYS, all of these products currently fall under individual REMS, with the exception of Fentora and Actiq, which are combined into one. That gives a total of 4 separate REMS in which prescribers, pharmacies and patients must enroll to be able to use these medications. When the new TIRF REMS Access Program launches in March of this year, there will be only one program in which healthcare providers and patients will have to enroll to use any TIRF product. This will ease some of the burden on the healthcare team, and will allow prescribers to decide which product is best for their patient without having to be concerned about which program they, or their patient, are enrolled in.
Until the TIRF REMS Access Program launches in March, the FDA has instructed that prescribers, patients, and pharmacies continue to enroll in the individual REMS programs. Then, prescribers and pharmacies already enrolled in an individual REMS program for at least 1 TIRF medication will automatically be transitioned to the shared TIRF REMS Access Program. Prescribers not yet enrolled in any TIRF REMS can enroll in the new program by reviewing an education program, successfully completing a knowledge assessment, and completing an enrollment form. All of this, and additional information about the enrollment process, will be available on the TIRF REMS Access Program website when the program launches in March.
The TIRF REMS Access Program will only apply to TIRF medications used on an outpatient basis. Healthcare professionals who prescribe TIRF medications that will only be used in an inpatient setting, including hospitals, hospices, or long-term care facilities, will not be required to enroll in the TIRF REMS Access Program, nor will patients who receive TIRF medications in an inpatient setting.