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The Importance Of Gender-Neutral Terminology In Risk Evaluation And Mitigation Strategy Programs: A Call To Action., Colin Burnette, William Smithy, Daniel Strock, Torunn E. Sivesind, Robert Dellavalle

HPD Articles

The use of risk evaluation and mitigation strategy (REMS) programs is frequently required for prescriptions with potentially teratogenic effects, especially in the field of dermatology. Among these REMS programs, the most well-known example is isotretinoin, an oral retinoid that uses the iPLEDGE system. iPLEDGE has strict regulations and a lengthy approval process, and until recently, patients were grouped into 3 categories: male, female, or female of reproductive potential. This strict grouping has posed problems in the medical community, especially for gender-diverse individuals where their perceived gender conflates with their assigned grouping causing patient-specific distress. The distinction between gender-a multifactorial perception …