Volume 116, Issue 13 p. 1788-1795
Epidemiology

Prescriptions filled during pregnancy for drugs with the potential of fetal harm

S Kulaga

S Kulaga

Faculty of Pharmacy, University of Montreal, Montréal, QC, Canada

Research Center, CHU Sainte-Justine, Montreal, QC, Canada

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A Zagarzadeh

A Zagarzadeh

Research Center, CHU Sainte-Justine, Montreal, QC, Canada

Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran

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A Bérard

A Bérard

Faculty of Pharmacy, University of Montreal, Montréal, QC, Canada

Research Center, CHU Sainte-Justine, Montreal, QC, Canada

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First published: 11 November 2009
Citations: 42
Dr A Bérard, CHU Sainte-Justine, 3175 chemin de la Cote-Ste-Catherine, Montréal, QC, Canada H3T 1C5.
Email [email protected]

Sophie Kulaga is a postdoctoral fellow at the Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada, and at the Research Center of CHU Ste-Justine, Montreal, Quebec, Canada.

Amir H. Zargarzadeh is a visiting professor from the Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran, to the Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.

Anick Bérard is the recipient of a career award from the Canadian Institutes of Health Research (CIHR), and is on the Endowment Research Chair on’Medications, Pregnancy and Lactation’ at the Faculty of Pharmacy of the University of Montreal.

Abstract

Objective To assess the extent of prescriptions filled by pregnant women for drugs with recognised potential of fetal harm, and to document the outcomes of these pregnancies.

Design Cross-sectional study.

Population Quebec Pregnancy Registry.

Methods We identified women who were pregnant during a five-year period and who were insured for prescription medications under the provincial drug plan. We obtained information on prescriptions filled during pregnancy for drugs with known potential of fetal harm.

Main outcome measures Prescriptions filled for study drugs during the first, second and third trimesters of pregnancy; termination of pregnancy (TOP) or delivery, and whether the baby was diagnosed with a major congenital malformation (MCM).

Results Of 109 344 women, 56% filled at least one prescription for a medication during pregnancy; 6.3% filled at least one prescription for a drug known to pose a risk to the fetus. Overall, 47% (95% CI, 45.8–48.2) of pregnancies exposed to drugs under study ended in TOP versus 36.2% (95% CI, 35.9–36.5) of those not exposed; 8.2% (95% CI, 8.0–10.0) of live births were diagnosed with an MCM during the first year of life versus 7.1% (95% CI, 6.9–7.3) of those not exposed.

Conclusions This study documents an important level of prescriptions filled during pregnancy for drugs harmful to the developing fetus. The proportions of both TOPs and babies born with MCMs were elevated compared with the expected values. Clinicians caring for women during pregnancy should conduct a medication inventory prior to a planned pregnancy, or as soon as an unplanned pregnancy is recognised.