JMIR Publications

ABSTRACT

The use of risk evaluation and mitigation strategy programs (REMS) is frequently required for prescriptions with potentially teratogenic effects, especially in the field of dermatology. Out of these REMS programs, the most well-known example is isotretinoin, an oral retinoid which utilizes the iPLEDGE system. iPLEDGE has strict regulations and a lengthy approval process requiring two negative pregnancy tests, two forms of birth control, and until recently patients were grouped into three 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 conflicts with their assigned grouping causing gender dysmorphia. The distinction between gender, a multifactorial perception of identity, and biological sex is addressed under new iPLEDGE guidelines which include gender neutral terminology, improving accessibility and limiting the barriers of gender diverse individuals to receive isotretinoin. We propose for other REM programs to follow the standard set by the iPLEDGE system including medications thalidomide, acitretin, and mycophenolate mofetil, all of which use which currently have similar taxonomy to the old iPLEDGE system. These changes are vital for quality of care of transgender patients, especially when treating conditions which may disproportionately affect these communities.