The U.S. Food and Drug Administration approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.

This new REMS is a single shared system for all TIRF products, including fentanyl sublingual tablets (Abstral?, ProStrakan/Orexo AB), an opioid analgesic used in the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Other TIRF medicines used to manage pain in adults with cancer who routinely take other opioid pain medicines around-the-clock include fentanyl citrate (Actiq?,Cephalon), fentanyl buccal (Fentora?, Cephalon), fentanyl nasal spray (Lazanda, Archimedes Pharma) and fentanyl buccal soluble film (Onsolis?, Meda Pharmaceuticals).

Quality of Life
Breakthrough cancer pain, common in up to two-thirds of people with cancer-related pain, affects a patient’s quality of life, including physical and emotional health, interpersonal relationships and the ability to engage in certain activities. Breakthrough pain (BTP) is described as severe pain that “breaks through” the patient’s round-the-clock pain medicine.[1] Opioids are among the most potent and effective analgesics, or medicines given to reduce pain, but unfortunately are also some of the most misused and abused medicines.

Easing the burden
Several TIRF products already have an individual REMS in place. This new shared system is designed to replace these 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.

Streamlining the process
“This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the health care system.”

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Mitigate the risk of misuse and abuse
The goals of the TIRF REMS Access Program are 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.

For more information:
TIRF REMS Questions and Answers

[1]Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41: 273-281.

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