Prescription of drugs during pregnancy: a study using EFEMERIS, the new French database

Abstract

Background Because of the limited data concerning drug risks in pregnancy, health professionals are often deprived of relevant and sufficient information related to prescribing or dispensing during pregnancy. However, previous studies have emphasised the widespread French prescription of several drugs (sometimes "typically French") which have not been assessed in pregnant women. Objectives The aim of the present study was to create the first French database of drugs prescribed and dispensed during pregnancy and the outcome of these pregnancies. Methods This feasibility study concerns pregnant women who gave birth to a baby between 1 July 2004 to 30 June 2005 in Haute-Garonne and who are registered in the French Health Insurance Service. Data sources include (1) the French Health Insurance Database (drugs prescribed during pregnancy), (2) the Mother and Child Protection Centre Database (newborn health at birth and 9 months after) and (3) the Antenatal Diagnostic Centre Database (medical pregnancy interruptions). Results The database is composed of 10,174 "motheroutcome" pairs. The prevalence rate of congenital anomalies was 2.2%. Pregnant women were prescribed 11.3±8.2 different drugs. Among the 20 most frequently prescribed drugs, around half of them have not been evaluated in pregnant women. Conclusions The first results of this study show that implementation of a French database on prescription of drugs and pregnancy outcomes is feasible. Compared with several databases available in other countries, EFEMERIS provides exact data on period of exposure to drugs, pregnancy terminations, and follow up of the baby 9 months after birth. Recording these data would make it possible to assess the risk of malformations due Eur J Clin Pharmacol (2009) to a greater number of drugs and would contribute to international drug evaluation studies.

How reimbursement databases can be used to support drug utilisation studies: example using the main French national health insurance system database

“…However, to be reimbursed the drugs need to be prescribed, which excludes capture of drugs obtained OTC. This is illustrated by a study reported by Lacroix et al who did not succeed in assessing OTC use during pregnancy using the French health insurance reimbursement database of southeastern France [9]. Furthermore, certain prescription-only drugs, for example thirdgeneration oral contraceptives, are prescription-only but are not reimbursed.…”

Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders

“…Engeland et al [7] found that among more than 100,000 pregnant women in Norway in 2004 -2006, approximately 57 % received a prescription medication. Studies from France and Germany showed an even higher rate of more than 85 % [6,15] .…”

La mise en place des cohortes en France : pourquoi, pour qui, comment et avec quels moyens ?

“…La cohorte Éva-luation chez la femme enceinte des médicaments et de leur risque (EFEMERIS) [8] a pour but de détecter les médicaments à risque pour le foetus et d'assurer un rôle d'alerte sur le plan des effets malformatifs mais également d'apporter des informations sur des médicaments encore mal évalués. Initiée en 2004, 48 000 femmes, ayant accouché en Haute-Garonne, ont ainsi été incluses dans l'étude.…”