The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system.

Background: Preventing fetal exposure to isotretinoin is widely acknowledged as an important safety issue. The iPLEDGE program is the latest in a series of Food and Drug Administration-mandated risk management programs designed to prevent pregnancies in female patients of childbearing potential (FCBP) taking isotretinoin.

Objective: We sought to evaluate the effect of iPLEDGE relative to the prior risk management program (system to manage Accutane-related teratogenicity [SMART]) on the risk of isotretinoin fetal exposure in FCBP in a managed care setting.

A risk management program aimed at preventing fetal exposure to isotretinoin: retrospective cohort study.

Background: Preventing fetal exposure to isotretinoin is an important public health goal. Since approval of isotretinoin (1982), the Food and Drug Administration has implemented several unsuccessful risk management programs aimed at preventing fetal exposure. The Kaiser Permanente isotretinoin risk management program included electronic capture of all isotretinoin prescriptions and the documentation of pregnancy testing with each dispense.