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Prescription drug use in pregnancy

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Abstract

Objective

The purpose of this study was to provide information on the prevalence of the use of prescription drugs among pregnant women in the United States.

Study design

A retrospective study was conducted with the use of the automated databases of 8 health maintenance organizations that are involved in the Health Maintenance Research Network Center for Education and Research on Therapeutics. Women who delivered of an infant in a hospital from January 1, 1996, through December 31, 2000, were identified. Prescription drug use according to therapeutic class and the United States Food and Drug Administration risk classification system was evaluated, with the assumption of a gestational duration of 270 days, with three 90-day trimesters of pregnancy, and with a 90-day period before pregnancy. Nonprescription drug use was not assessed.

Results

During the period 1996 through 2000, 152,531 deliveries were identified that met the criteria for study. For 98,182 deliveries (64%), a drug other than a vitamin or mineral supplement was prescribed in the 270 days before delivery: 3595 women (2.4%) received a drug from category A; 76,292 women (50.0%) received a drug from category B; 57,604 women (37.8%) received a drug from category C; 7333 women (4.8%) received a drug from category D, and 6976 women (4.6%) received a drug from category X of the United States Food and Drug Administration risk classification system. Overall, 5157 women (3.4%) received a category D drug, and 1653 women (1.1%) received a category X drug after the initial prenatal care visit.

Conclusion

Our finding that almost one half of all pregnant women received prescription drugs from categories C, D, or X of the United States Food and Drug Administration risk classification system highlights the importance of the need to understand the effects of these medications on the developing fetus and on the pregnant woman.

Section snippets

Study setting

Eight HMOs that were involved in the HMO Research Network CERTs participated in this study. The CERTs program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics through education and research. The 8 HMOs, which include Fallon Community Health Plan (Worcester, Mass), Group Health Cooperative (Seattle, Wash), Harvard Pilgrim Health Care (Boston, Mass), HealthPartners (Minneapolis, Minn), Henry Ford Health Systems (Detroit,

Results

We identified 152,531 deliveries during the study period that met the inclusion criteria. For 124,695 deliveries (82%), a drug or medical supply was dispensed in the 270 days before delivery. For 82,974 deliveries (54%), a vitamin/mineral supplement was dispensed, and for 98,182 deliveries (64%), a drug other than a vitamin or mineral supplement was dispensed in the 270 days before delivery.

Of the 20 most commonly dispensed chemical entities, 9 entities were oral anti-infectives (Table I). In

Comment

In this large cohort of pregnant women that was drawn from defined, representative populations, we found that a substantial proportion of pregnant women received a drug other than vitamin or mineral supplements. For nearly 40% of deliveries, the woman received a drug from category C (drugs for which human safety during pregnancy has not been established) of the US FDA risk classification system. Although the proportion of women who received drugs with evidence of fetal risk (drugs from category

Acknowledgements

We thank Jackie Cernieux, Jim Livingston, Jill Auger, and Courtney Adams for their technical support.

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Supported by grant HS10391 from the Agency for Healthcare Research and Quality to The HMO Research Network Center for Education and Research in Therapeutics (CERT).

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