FDA Approves a Class REMS for TIRF Products

The Food and Drug Administration (FDA) recently approved a single Risk Evaluation and Mitigation Strategy (REMS) for the entire class of transmucosal immediate-release fentanyl (TIRF) products.  This single REMS, called the TIRF REMS Access Program, will replace the individual REMS for TIRF products and allow physicians to enroll in just one system.  Physicians who prescribe TIRF products for outpatient use will be required to enroll in the TIRF REMS Access Program, whereas physicians who prescribe TIRF medications for inpatient use only will not be required to enroll in this program. 

The TIRF REMS Access Program will begin in March 2012.  Until that time, physicians will continue to enroll in the individual TIRF REMS programs.  Physicians who are already enrolled in individual REMS for at least one TIRF product will be automatically transitioned into the TIRF REMS Access Program.  Physicians must then re-enroll in the TIRF REMS Access Program every two years from the date of enrollment in the individual REMS or the date of enrollment in the TIRF REMS Access Program, whichever was earlier. 

To enroll, physicians must review the Education Program, complete the Knowledge Assessment, and complete an enrollment form.  Physicians must complete and sign a TIRF REMS Access Patient-Prescriber Agreement Form with each new patient before prescribing the patient’s first TIRF product.  Physicians must also provide patients with a Medication Guide.

Currently, TIRF medicines include Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal. 

According to the FDA, a REMS is a “risk management plan that FDA can require a drug company to develop and implement to manage serious risks associated with a drug.”  Under the Food and Drug Administration Amendments Act of 2007, the FDA may require a manufacturer to develop and implement REMS when the FDA finds it is necessary to ensure that the benefits of a drug outweigh its risks.  All REMS include a timetable for submission of assessments of the strategy, and may also include a Medication Guide, communication plan, other elements to assure safe use of the drug and an implementation system.  The FDA continues to work on another class-wide REMS for long-acting and extended-release opioids. 

Read the FDA’s press release and Questions & Answers on the TIRF REMS Access Program.

Learn more about the enrollment process on the TIRF REMS Access Program website.