Originally published on MPR - Monthly Prescribing Reference.
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REMS programs were created by the Food and Drug Administration (FDA) Amendments Act of 2007. Under this act, the FDA may require a REMS program for a drug to ensure that the benefit of that drug will continue to outweigh its risks. To date, a REMS is required for drugs containing fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
"Increasing prescription opioid abuse and previously used strategies that have not sufficiently addressed existing issues of abuse or misuse have made REMS necessary", Steven D. Passik, PhD, of Memorial Sloan-Kettering Cancer Center and Cornell University Medical Center, New York, N.Y., told attendees at the American Pain Society's 29th Annual Scientific Meeting.
REMS can also help assure safe use and assess therapy efficacy by improving patient safety and minimizing patient harm; managing known—or potential—serious risks; drive awareness of important safety measures in both healthcare professionals and patients; and maintain and ensure medication access to the right patient.
Implementation of REMS programs can affect pain management and patient safety by reducing opioid abuse and diversion; educating healthcare professionals to improve selection of opioids for different types of patients; lessening fears or concerns associated with opioids; increasing appropriate opioid use; and empowering patients to manage their pain, including ensuring access to opioid medication by legitimate patients.
"REMS may also have negative effects, among them, fewer patients receiving treatment and restricted or limited use of opioids by third-party payers", Dr. Passik said. These negative outcomes can be addressed by educating patients, emphasizing potential risk associated with opioids if not used as directed; highlighting the importance of appropriate drug use and proper storage; and providing medication guides and educational materials. Overall, an educated healthcare professional can help ensure patients of continued access to the therapy they need.
Meda Pharmaceuticals Inc., has created one of the first REMS programs, the FOCUS™ Program, for its fentanyl buccal soluble film, Onsolis®. The purpose of FOCUS—Full Ongoing Commitment to User Safety—is to mitigate risk of Onsolis® overdose, abuse, addiction, and serious complications due to medication errors. A toll-free telephone number and a Web site (www.OnsolisFocus.com) are available for healthcare providers and patients to access trained professionals and resources such as educational materials.