Racial Effects of the 2021 iPLEDGE Update on Isotretinoin Access

Abstract: The iPLEDGE REMS system has previously been associated with disparities in isotretinoin access by sex and race, but the racial impact of the 2021 system update remains unclear. We conducted a retrospective cohort study of patients prescribed isotretinoin at an urban academic center between 2018 and 2023, evaluating iPLEDGE-related medication delays and interruptions using interrupted time series analyses stratified by race. Following the December 2021 update, iPLEDGE-related delays increased significantly among Asian and Black patients, with no significant change among White patients. Black patients also experienced increased treatment interruptions. Given the single-center design and sample size limitations, further multicenter studies are needed to assess generalizability and fully characterize racial disparities in isotretinoin access.