Last year saw several key developments in risk evaluation and mitigation strategy (REMS) programs as FDA sought to address public health needs. The agency expanded the opioid REMS program to include immediate-release (IR) opioids, provided a framework for counseling patients, and published draft guidance for industry on the format and content of REMS documents.
“With their recent activity, FDA is trying to improve the REMS program by making it less burdensome and more effective at meaningfully addressing risks medications pose,” said Jenna Ventresca, JD, director of health policy at APhA.
As part of its response to the opioid crisis, in July FDA expanded the existing REMS programs for extended-release and long-acting (ER/LA) opioids, initiated 5 years ago, to include IR opioids.
“The REMS for IR opioids is the same in terms of dispensing, medication guides, and meeting other requirements that are already in place for extended-release opioids,” said Marcie Bough, PharmD, executive officer of the Montana Board of Pharmacy in Helena. “It should clear up lingering confusion about which opioids are subject to REMS, because now the requirements apply to all of them.”
FDA also revised its Blueprint for training and education for health professionals to take a broader approach to pain, with more focus on pain management, nonpharmacologic treatments for pain, safe use of opioids, and basic information about addiction medicine and opioid use disorders.
Despite an FDA advisory panel’s recommendation to make education mandatory for opioid prescribers, the agency has yet to include such a requirement in the REMS program for opioids. Whether FDA will mandate education as part of the opioid REMS program remains to be seen, said Ventresca.
In September, FDA released A Framework for Benefit–Risk Counseling to Patients About Drugs with a REMS, a 33-page guide that offers background on REMS programs, goals for patient counseling within the context of a REMS, and examples of counseling discussions.
Meanwhile, FDA continues to update its REMS webpage so that specific requirements are linked within the listing of each REMS program. “Such information should also be helpful for pharmacists navigating REMS programs and counseling information,” said Bough.
FDA released draft guidance about standardizing REMS with Format and Content of a REMS Document: Guidance for Industry in October. Here, FDA aims to clarify who is responsible for what in a REMS program, said Ventresca.
For the full article, please visit www.pharmacytoday.org for the upcoming January 2018 issue of Pharmacy Today.