Circumventing iPLEDGE: Circumventing ethical responsibility?

Prescribing isotretinoin in the United States is regulated through iPLEDGE, a program aimed at reducing the risk for fetal exposure to isotretinoin. Isotretinoin is a pregnancy category X medication and is associated with major birth defects affecting 4%-28% of exposed fetuses.1,2 This Food and Drug Administration—approved program strives to ensure that no woman of child-bearing potential starts the medication while pregnant or becomes pregnant while on the medication. It is a centralized pregnancy risk management program requiring registration from all parties involved in the chain of distribution: wholesalers, prescribers, pharmacies, and patients.