FDA Approves Shared System REMS for TIRF Products

January 4, 2012 5:48 pm

FDA approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products as announced in a news release on December 29, 2011. FDA explains that this new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system. “The shared system strategy, called the TIRF REMS Access Program, will be used by all sponsors of TIRF products and is expected to ease the burden on the health care system. The program will begin in March, 2012. Until that time, prescribers, patients, and pharmacies should continue to enroll in the individual REMS programs,” indicates the FDA news release.

The TIRF REMS Access Program is aimed to ensure patient access to important medications and mitigate the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors by:

• prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioid-tolerant patients.
• preventing inappropriate conversion between fentanyl products.
• preventing accidental exposure to children and others for whom TIRF medicines were not prescribed.
• educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose.

The FDA news release provides additional details about enrollment requirements for prescribers, pharmacies, and certain patients. Answers to common questions are also posted on the FDA Web site.