Removal of Isotretinoin Gender-Based Guidelines: Inclusivity Takes Precedence.

ABSTRACT

The iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) system recently underwent major structural changes. After many years of advocacy by physicians and patients, the program has changed to reflect more inclusivity in the enrollment process. Specifically, the risk categories of females of reproductive potential, females not of reproductive potential, and males were replaced by 2 categories (1) people who can get pregnant, and (2) people who cannot get pregnant. The importance of this change is detailed here along with proposed questions we can ask patients to understand their pregnancy-related risks with isotretinoin. As allies to our patients, we strive to create an environment of equal care for all, and this change moves us in a more inclusive, patient-centered direction.