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Contraindications to Combined Oral Contraceptives Among Over-the-Counter Compared With Prescription Users

Grossman, Daniel MD; White, Kari MA, MPH; Hopkins, Kristine PhD; Amastae, Jon PhD; Shedlin, Michele PhD; Potter, Joseph E. PhD

doi: 10.1097/AOG.0b013e31820b0244
Original Research

OBJECTIVE: To compare the estimated proportion of contraindications to combined oral contraceptives between women who obtained combined oral contraceptives in U.S. public clinics compared with women who obtained combined oral contraceptives over the counter (OTC) in Mexican pharmacies.

METHODS: We recruited a cohort of 501 women who were residents of El Paso, Texas, who obtained OTC combined oral contraceptives in Mexico and 514 women who obtained combined oral contraceptives from family planning clinics in El Paso. Based on self-report of World Health Organization category 3 and 4 contraindications and interviewer-measured blood pressure, we estimated the proportion of contraindications and, using multivariable-adjusted logistic regression, identified possible predictors of contraindications.

RESULTS: The estimated proportion of any category 3 or 4 contraindication was 18%. Relative contraindications (category 3) were more common among OTC users (13% compared with 9% among clinic users, P=.006). Absolute contraindications (category 4) were not different between the groups (5% for clinic users compared with 7% for OTC users, P=.162). Hypertension was the most prevalent contraindication (5.6% of clinic users and 9.8% of OTC users). After multivariable adjustment, OTC users had higher odds of having contraindications compared with clinic users (odds ratio [OR] 1.59, 95% confidence interval [CI] 1.11–2.29). Women aged 35 years or older (OR 5.30, 95% CI 3.59–7.81) and those with body mass index 30.0 or more (OR 2.24, 95% CI 1.40–3.56) also had higher odds of having contraindications.

CONCLUSION: Relative combined oral contraceptive contraindications are more common among OTC users in this setting. Progestin-only pills might be a better candidate for the first OTC product given their fewer contraindications.

LEVEL OF EVIDENCE: II

Prevalence of relative, but not absolute, contraindications to combined oral contraceptive use is higher in women obtaining pills over the counter compared with by prescription.

From Ibis Reproductive Health, Oakland, California; the Population Research Center, University of Texas at Austin, Austin, Texas; the College of Health Sciences and Department of Languages and Linguistics, University of Texas at El Paso, El Paso, Texas; and the College of Nursing, New York University, New York, New York.

See related articles on pages 551 and 566.

Funded by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD047816).

The authors thank Sandra G. García, Leticia Fernández, and the late Charlotte Ellertson for their contributions to the project design and help with writing the proposal that funded the work.

Presented at the annual meeting of the Society of Family Planning and the Association of Reproductive Health Professionals, September 30–October 3, 2009, Los Angeles, California.

Corresponding author: Daniel Grossman, Ibis Reproductive Health, 1330 Broadway, Suite 1100, Oakland, CA 94612; e-mail: DGrossman@ibisreproductivehealth.org.

Financial Disclosure The authors did not report any potential conflicts of interest.

© 2011 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.