Editors' ChoicePrescription drug use in pregnancy☆
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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Cited by (451)
LOCAL ANESTHETICS AND PREGNANCY. A REVIEW OF THE EVIDENCE AND WHY DENTISTS SHOULD FEEL SAFE TO TREAT PREGNANT PEOPLE
2023, Journal of Evidence-Based Dental PracticeMaternal Medical Disorders of Fetal Significance
2023, Avery's Diseases of the NewbornInclusion of pregnant and breastfeeding women in nonobstetrical randomized controlled trials
2022, American Journal of Obstetrics and Gynecology MFMCitation Excerpt :By hindering the development of an adequate evidence base for medical decisions, the exclusion of pregnant and breastfeeding women from clinical research has major detrimental effects on maternal and infant health. For example, up to 90% of women in high-income countries are prescribed at least 1 medication during pregnancy36–38; however, most prescriptions are off-label, with >90% of routinely used medications lacking essential data on efficacy, safety, teratogenicity, and pharmacokinetics in pregnancy.39,40 Moreover, physiological changes occurring throughout pregnancy and postpartum can dramatically affect drug exposure, yet pharmacokinetic studies rarely enroll pregnant women.35
Characterizing the inclusion of pregnant and breastfeeding people in infectious diseases randomized controlled trials: a targeted literature review
2022, Clinical Microbiology and InfectionCitation Excerpt :Medication use during pregnancy illustrates this problem. Approximately 65% of Canadians and 30–90% of people in other high-income countries are prescribed one or more medications during pregnancy; nine of the 20 most prescribed medications are antimicrobials [16–18]. However, the majority of this prescribing is ‘off-label’, with over 90% of routinely used medications lacking essential data on efficacy, safety, teratogenicity and pharmacokinetics in pregnancy [12,19].
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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).