Documentation of Contraception and Pregnancy When Prescribing Potentially Teratogenic Medications for Reproductive-Age Women

18 September 2007 | Volume 147 Issue 6 | Pages 370-376

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.

Editors' Notes Context Many women of childbearing age receive prescriptions for potentially teratogenic drugs. Contribution In this review of administrative data from a large health maintenance organization in 2001, prescriptions for class D or X drugs were no more likely to be accompanied by documented claims for contraceptive services or for a subsequent pregnancy than were prescriptions for class A or B drugs. Cautions This study may overestimate the frequency of inadequate contraceptive counseling because the researchers did not have access to data about a patient's sexual activity or fertility potential, or about contraceptive advice that did not result in an administrative claim. Implication There is probably room for improvement in contraceptive counseling for women who receive prescriptions for potentially teratogenic drugs. —The Editors

 

Author and Article Information

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.

Acknowledgments: The authors thank Ruth Shaber, MD, and Fiona Sinclair, PA-C, MHS, for their assistance in coordinating this study.

Grant Support: By unrestricted funding from Duramed Pharmaceuticals and National Institute of Child Health and Human Development grant K23 HD051585-01.

Potential Financial Conflicts of Interest: None disclosed.

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.

Current Author Addresses: Dr. Schwarz: Center for Research on Health Care, 230 McKee Place, Suite 600, Pittsburgh, PA 15213.

Ms. Postlethwaite: Kaiser Permanente Women's Health Research Institute, 1950 Franklin Street, 19th Floor, Oakland, CA 94612.

Dr. Hung and Ms. Armstrong: Division of Research, Kaiser Permanente, Northern California, 2000 Broadway, Oakland, CA 94612.

Author Contributions: Conception and design: E.B. Schwarz, D.A. Postlethwaite.

Analysis and interpretation of the data: E.B. Schwarz, D.A. Postlethwaite, Y.Y. Hung, M.A. Armstrong.

Drafting of the article: E.B. Schwarz.

Critical revision of the article for important intellectual content: D.A. Postlethwaite, Y.Y. Hung, M.A. Armstrong.

Final approval of the article: E.B. Schwarz, D.A. Postlethwaite, Y.Y. Hung, M.A. Armstrong.

Provision of study materials or patients: D.A. Postlethwaite.

Statistical expertise: E.B. Schwarz, Y.Y. Hung, M.A. Armstrong.

Obtaining of funding: E.B. Schwarz, D.A. Postlethwaite.

Administrative, technical, or logistic support: Debbie A. Postlethwaite.

Collection and assembly of data: D.A. Postlethwaite, Y.Y. Hung.