The first class-wide risk evaluation and mitigation strategies (REMS) program for the transmucosal immediate-release fentanyl (TIRF) class of medications
ATLANTA, February 8, 2012 - The first class-wide risk evaluation and mitigation strategies (REMS) program for the transmucosal immediate-release fentanyl (TIRF) class of medications was approved in December by the Food and Drug Administration (FDA) and will be administered by RelayHealth and McKesson Specialty Health. The TIRF REMS Access program covers the TIRF medications, which are fast-acting opioid pain relievers used to manage breakthrough pain in opioid-tolerant cancer patients.
This class-wide TIRF REMS Access Program implements a common framework for all TIRF medications that may be prescribed and dispensed while addressing the FDA’s REMS requirements. The program maintains access to these important medications by integrating the REMS program into the pharmacist’s daily workflow to reduce additional administrative burden.
“By approving a single REMS program for an entire class of medications, the FDA has created a system that maintains patient access while reducing the burden on our healthcare system,” said Jeff Felton, President, RelayHealth. “When the program begins in March, retail pharmacies will have the ability to dispense an entire class of drugs through a single REMS program, rather than through the multiple programs that exist today.”
According to the FDA’s press release, 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….1”
Pharmacies are encouraged to enroll in the TIRF REMS Access program by March 2012. Retail pharmacies that have questions about the program can email email@example.com for more information.
RelayHealth, McKesson’s connectivity business, enables the secure exchange of clinical, financial and administrative information between patients, providers, payers, pharmacies, pharmaceutical manufacturers and government agencies. RelayHealth processes nearly 15 billion healthcare transactions annually by integrating the delivery of high-quality care and improving the financial outcomes for its customers. For more information, call 888.743.8735, or visit our Web site at www.RelayHealth.com. Follow us on Twitter (@RelayHealth) or visit the RelayHealth Facebook page.
About McKesson Specialty
Health McKesson Specialty Health, a division of McKesson Corporation, empowers the community patient care delivery system to advance the science, technology, and quality of care. Through innovative clinical, research, business and operational solutions, facilitated by integrated technology systems, we improve the financial health of our customers and help them provide quality care for patients. For more information, visit www.mckessonspecialtyhealth.com.
1 “FDA approves shared system REMS for TIRF products.” Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285345.htm
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