FDA Issues One REMS for All Transmucosal Fentanyl


The Food and Drug Administration on Dec. 28 approved a class-wide risk management program for all transmucosal immediate-release fentanyl formulations.

The TIRF REMS [transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy] Access program is the agency’s first class-wide REMS for opioids. It replaces the individual REMS that exists for each product in the class now.

It will likely be the model for a REMS that the agency is developing for long-acting and extended-release opioids.

The REMS program is designed to reduce the risk of misuse, abuse, addiction, and overdose. REMS only applies to outpatient prescriptions. Hospitals, hospices and long-term care providers do not have to participate.

The TIRF REMS covers 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 soluble film.

The FDA said that it developed a single risk management program for all the drugs to make management of these druigs easier for prescribers, pharmacists, distributors and outpatients. They all need to enroll only once to prescribe, dispense, or receive any of the products.

The program will start in March 2012. At that time, physicians will be able to enroll, after having completed an education program and assessment. Patients and health providers will also have to complete and sign an agreement form with the first prescription. And prescribers will have to give patients a Medication Guide that explains the risks, benefits, and proper use of the drug.

Health care providers who are already enrolled in an individual REMS program for at least one transmucosal immediate-release fentanyl medicine will not need to re-enroll because they will be automatically transitioned to the shared TIRF REMS Access program. Prescribers will be required to re-enroll in the TIRF REMS program every 2 years from the date of enrollment into either the individual REMS or TIRF REMS program, whichever was earlier.

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