| A risk management program aimed at preventing fetal exposure to isotretinoin: retrospective cohort study. | |
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MedLine Citation:
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PMID: 16908350 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. OBJECTIVE: Our aim was to analyze the success of Kaiser Permanente's program at improving pregnancy testing rates and reducing fetal exposure. METHODS: This was a retrospective cohort study. RESULTS: Pregnancy testing rates improved after implementation of the Kaiser Permanente program. However, the rate of fetal exposure to isotretinoin did not change (0.21% before vs 0.23% after, P = .85). LIMITATIONS/CONCLUSION: In this study, linking a negative pregnancy test to isotretinoin dispensing did not reduce fetal exposures. Patient failure to use two contraceptive methods was the most common reason for fetal exposure. These results have important implications for iPLEDGE, the new isotretinoin risk management program mandated by the Food and Drug Administration. |
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Authors:
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T Craig Cheetham; Richard A Wagner; Gene Chiu; Jennifer M Day; Monica A Yoshinaga; Linda Wong |
Publication Detail:
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Type: Journal Article Date: 2006-07-13 |
Journal Detail:
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Title: Journal of the American Academy of Dermatology Volume: 55 ISSN: 1097-6787 ISO Abbreviation: J. Am. Acad. Dermatol. Publication Date: 2006 Sep |
Date Detail:
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Created Date: 2006-08-15 Completed Date: 2006-09-12 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7907132 Medline TA: J Am Acad Dermatol Country: United States |
Other Details:
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Languages: eng Pagination: 442-8 Citation Subset: IM |
Affiliation:
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Pharmacy Analytical Service Kaiser Permanente, Downey, California 90242, USA. craig.t.cheetham@kp.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acne Vulgaris
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drug therapy* Adolescent Adult Aged Child Cohort Studies Female Fetus* Humans Isotretinoin / contraindications* Male Maternal-Fetal Exchange* Middle Aged Pregnancy Pregnancy Tests* Retrospective Studies Risk Management / methods* |
| Chemical | |
Reg. No./Substance:
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4759-48-2/Isotretinoin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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