Documentation of Contraception and Pregnancy When Prescribing Potentially Teratogenic Medications for Reproductive-Age Women
- Eleanor Bimla Schwarz, MD, MS;
- Debbie A. Postlethwaite, RNP, MPH;
- Yun-Yi Hung, PhD; and
- Mary Anne Armstrong, MA
- From the Center for Research on Health Care, University of Pittsburgh, Pittsburgh, Pennsylvania, and Women's Health Research Institute, Kaiser Permanente Northern California, Oakland, California.
Abstract
Background: Certain medications are identified by the U.S. Food and Drug Administration (FDA) as class D or X because they increase the risk for birth defects if used during pregnancy.
Objective: To assess pregnancy rates and the frequency of contraceptive counseling documented with prescriptions for class D or X drugs filled by women of reproductive age.
Design: Description of prescriptions filled in 2001.
Setting: A large health maintenance organization in northern California in 2001.
Patients: 488 175 women age 15 to 44 years who filled a total of 1 011 658 class A, B, D, or X prescriptions.
Measurements: Medications dispensed, contraceptive counseling, and pregnancy testing.
Results: A class D or X prescription was filled by 1 of every 6 women studied. Women who filled a prescription for class D or X medications were no more likely than women who filled prescriptions for safer, class A or B medications to have received contraceptive counseling, filled a contraceptive prescription, or been sterilized (48% vs. 51% of prescriptions). There was little variation by clinical indication in rates of contraceptive counseling with class D or X prescriptions, except for isotretinoin. Women who filled a class D or X prescription were only slightly less likely to have a pregnancy documented within 3 months than women filling a class A or B prescription (1.0% vs. 1.4% of prescriptions).
Limitations: International Classification of Diseases, Ninth Revision, codes underestimate contraceptive counseling. Documentation of a positive pregnancy test after filling a prescription may overestimate medication use in early pregnancy. Women who filled several prescriptions are overrepresented in prescription analyses.
Conclusion: Prescriptions for potentially teratogenic medications are frequently filled by women of childbearing age without documentation of contraceptive counseling.
Article and Author Information
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Acknowledgments: The authors thank Ruth Shaber, MD, and Fiona Sinclair, PA-C, MHS, for their assistance in coordinating this study.
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Grant Support: By unrestricted funding from Duramed Pharmaceuticals and National Institute of Child Health and Human Development grant K23 HD051585-01.
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Potential Financial Conflicts of Interest: None disclosed.
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Requests for Single Reprints: Eleanor Bimla Schwarz, MD, MS, Center for Research on Health Care, 230 McKee Place, Suite 600, Pittsburgh, PA 15213; e-mail, schwarzeb{at}upmc.edu.
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Current Author Addresses: Dr. Schwarz: Center for Research on Health Care, 230 McKee Place, Suite 600, Pittsburgh, PA 15213.
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Ms. Postlethwaite: Kaiser Permanente Women's Health Research Institute, 1950 Franklin Street, 19th Floor, Oakland, CA 94612.
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Dr. Hung and Ms. Armstrong: Division of Research, Kaiser Permanente, Northern California, 2000 Broadway, Oakland, CA 94612.
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Author Contributions: Conception and design: E.B. Schwarz, D.A. Postlethwaite.
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Analysis and interpretation of the data: E.B. Schwarz, D.A. Postlethwaite, Y.Y. Hung, M.A. Armstrong.
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Drafting of the article: E.B. Schwarz.
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Critical revision of the article for important intellectual content: D.A. Postlethwaite, Y.Y. Hung, M.A. Armstrong.
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Final approval of the article: E.B. Schwarz, D.A. Postlethwaite, Y.Y. Hung, M.A. Armstrong.
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Provision of study materials or patients: D.A. Postlethwaite.
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Statistical expertise: E.B. Schwarz, Y.Y. Hung, M.A. Armstrong.
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Obtaining of funding: E.B. Schwarz, D.A. Postlethwaite.
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Administrative, technical, or logistic support: Debbie A. Postlethwaite.
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Collection and assembly of data: D.A. Postlethwaite, Y.Y. Hung.
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