LAUSR

Background iPLEDGE is the mandatory regulatory program for isotretinoin in the United States, aimed to prevent isotretinoin-related teratogenicity. However, little is known about potential unintended impact of the program, including delay in isotretinoin initiation, course interruption, and premature termination, which may vary across sex and racial domains. Objective To determine whether differences in isotretinoin start, interruption, and completion exist across sex and racial domains and whether iPLEDGE regulations contribute to such differences. Methods Retrospective review of isotretinoin courses of patients prescribed isotretinoin for acne at the Brigham & Women’s Hospital and Massachusetts General Hospital from 2008–2016. Results 418 patients were included in analysis after being tightly matched across age and gender. 43.5% of non-white patients ended their course early compared to 30.1% of white patients (p = 0.010). iPLEDGE -related barriers were the most commonly specified reasons for delayed starting and interruption. Conclusion iPLEDGE may disproportionately contribute to access barriers for non-white patients. Continued evaluation of iPLEDGE is needed to minimize unintended barriers to access.