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College Hosts REMS Discussion
Many in the pharmacy profession don’t know what a Risk Evaluation and Mitigation Strategy (REMS) is, which was even more reason to have a Meeting of the Minds panel discussion about the subject, according to the event’s expert panel.
A REMS is a strategy to manage a known or potentially serious risk associated with a drug or biological product. It is required if the U.S. Food and Drug Administration (FDA) determines that it is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a medication guide, patient package insert, a communication plan, elements to assure safe use, and an implementation system.
This year’s Meeting of the Minds – an annual college-sponsored panel discussion of a current topic in health care – focused on REMS. The discussion, which includes audience questions and input, was held Nov. 5 at Bluffs on Broadway in St. Louis. Dozens of faculty, students, and alumni attended the event and participated in a thoughtful, hearty discussion about REMS. The discussion was led by an expert panel that included three alumni: Kevin James ’90, vice president of managed markets for Avella Specialty Pharmacy; Leah LaRue ’10, manager of medical advocacy at Mallinckrodt; and Mike Schultz ’78, co-founder and CFO of Foundation Care. They were joined by Dean Erhardt, principal at D2 Pharma Consulting. Terry Seaton, professor of pharmacy practice and associate division director for research at the College, moderated the discussion.
The event began with the experts explaining how they were first introduced to REMS. Schultz said his experience with REMS began when he was at Express Scripts. He has worked on REMS for a number of different medications, including a medication commonly referred to as the “morning after pill.” LaRue has participated in REMS work with opioids at Mallinckrodt. James said he first heard the term REMS used in 2009, two years after Congress passed the Food and Drug Administration Amendments Act of 2007, which authorized the FDA to require REMS.
James has advised drug manufacturers on REMS for Isotretinoin, or Accutane. The side effects of Accutane, a form of vitamin A that is used to treat severe nodular acne, have been well documented and include severe eye irritation, severe skin infection, severe joint pain, and severe nosebleed.
Schultz said that drug manufacturers were initially outspoken opponents of the Food and Drug Administration Amendments Act of 2007, mainly because it would take more time for new drugs to receive FDA approval and would cost more money for drug manufacturers to produce the drugs in the first place. Now drug manufacturers use REMS to differentiate their product from very similar products. They can use REMS to show that their drug has fewer side effects than similar drugs. “It’s come full circle,” Schultz says.
James added that if a drug manufacturer already has REMS in place, it might be able to go out on the market sooner than other manufacturers with similar products.
Speaking from the perspective of a retail pharmacist, he said drug manufacturers provide patients with more information than is really necessary, thanks to REMS. “Being a retail pharmacist, I can say we’ve definitely killed more trees since the implementation of REMS,” James said. “We’re just deluging patients with all types of printed drug information.”
James called REMS an administrative headache. “We have to have the right protocol in place for each and every drug,” he said.
LaRue said she sees changes to the program going forward, whether that means a federally operated online database of REMS or more face-to-face education. James added that REMS are “not going to go away.”
“There’s a lot of interest in some form of regulation,” he said.
The panelists agreed that pharmacists need to know what REMS are, whether they are dispensing medications or working for drug manufacturers. As a retail pharmacist, it is important to know what medications you are dispensing and if the medication has a REMS; as a drug manufacturer, it is important to know what sort of REMS is attached to your product.
For a complete video recording of the event, please click here.