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FDA Approves Shared REMS (Risk Evaluation and Mitigation Strategy) Program for all TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments

Fri, 12/30/2011 - 11:34am
Bio-Medicine.Org

BEDMINSTER, N.J., Dec. 30, 2011 /PRNewswire/ -- ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd. (KHK), and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration (FDA) has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. This new REMS is a single shared system for all TIRF products, including ABSTRAL® (fentanyl) sublingual tablets, 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.

The goals of the TIRF REMS Access program are to 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, which includes use only in opioid-tolerant patients.
  • Preventing inappropriate conversion between fentanyl products.
  • Preventing accidental exposure to children and others for whom it was not prescribed.
  • Educating prescribers, pharmacists and patients on the potential for misuse, abuse, addiction and overdose of TIRF medicines.

TIRF products are available only through REMS programs, which require enrollment by prescribers, their patients, pharmacies and distributors. Today, TIRF manufacturers have separate REMS programs and a health care provider and pharmacy must enroll in multiple REMS programs, corresponding to the TIRF product they choose to prescribe or dispense.  The new shared REMS – modeled after the program created for ABSTRAL - will go live in March 2012; at that time, prescribers, pharmacies, patients, and distributors may all be enrolled in a single program for these products. All stakeholders currently enrolled

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