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Viewpoint |

We Pledge to Change iPLEDGE

Joseph C. Pierson, MD1; Laura K. Ferris, MD2; Eleanor B. Schwarz, MD3
[+] Author Affiliations
1Division of Dermatology, University of Vermont Medical Center, Burlington
2Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
3Division of General Internal Medicine, University of California, Davis Medical Center, Sacramento
JAMA Dermatol. 2015;151(7):701-702. doi:10.1001/jamadermatol.2015.0736.
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This Viewpoint calls attention to the failure of the iPLEDGE program, which is intended to reduce fetal exposure to the teratogenic acne medication isotretinoin, and suggests ways to overhaul iPLEDGE.

The US Food and Drug Administration’s mandatory pregnancy prevention program iPLEDGE has the noble intention of reducing the incidence of exposure to the teratogenic acne medication isotretinoin during pregnancy. Unfortunately, it is not working. Nearly a decade into the iPLEDGE era, the pregnancy rate among isotretinoin users is no lower than it was under the prior program, SMART (System to Manage Accutane-Related Teratogenicity); it is estimated that 2.7 isotretinoin-exposed pregnancies occur per 1000 treatment courses.1 Our country can do better, and we propose overhauling iPLEDGE in 2 areas: (1) by emphasizing the relative effectiveness of contraceptive measures for the target audience, women of child-bearing potential, and (2) removing other requirements that do not contribute to the mission of the program.

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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