Beneath the Surface: A deep dive into iPledge changes with John Barbieri, MD
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Beneath the Surface is a video series in which Joel M. Gelfand, MD, MSCE, Healio Dermatology Chief Medical Editor, discusses hot topics in the field with leading experts.
In this edition, Gelfand, who is also the James J. Leyden Professor of Clinical Investigation and professor of dermatology and epidemiology at University of Pennsylvania’s Perelman School of Medicine, discusses proposed changes to the iPledge system with John Barbieri, MD, MBA, assistant professor at Harvard Medical School, director of the advanced acne therapeutics clinic at Brigham and Women’s Hospital and co-chair of the AAD Acne Guidelines Work Group.
The FDA recommended changes to the iPledge Risk Mitigation Strategy (REMS) system late in 2023. These modifications include the use of at-home pregnancy tests; the removal of a required waiting period if patients did not obtain isotretinoin within the first 7 days of receiving the prescription, as long as a follow-up pregnancy test is obtained; and a change to counseling for patients who cannot become pregnant.
These changes aim to minimize procedural burdens for physicians, pharmacists and patients.
“We still have to see how this implementation process is going to go, but it’s very exciting to see the FDA considering how we can make this program better for our patients,” Barbieri said.
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