iPLEDGE Allegiance to the Pill: Evaluation of Year 1 of a Birth Defect Prevention and Monitoring System

Authors

  • Toby L. Schonfeld,

    1. Associate Professor of Health Care Ethics and Vice Chair of the Health Promotion, Social and Behavioral Health Department in the College of Public Health at the University of Nebraska Medical Center.
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  • N. Jean Amoura,

    1. Assistant Professor and Director of Family Planning in the Department of Obstetrics and Gynecology at the University of Nebraska Medical Center.
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  • Christopher J. Kratochvil

    1. Associate Professor in the Departments of Psychiatry and Pediatrics, and a member of the Graduate Faculty at the University of Nebraska Medical Center.
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Abstract

The United States Food and Drug Administration (FDA), in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin (Accutane), a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential (WCP) as it compares to the risk-benefit relationship of using isotretinoin.

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