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


OBJECTIVE
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 "mother-outcome" 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 to a greater number of drugs and would contribute to international drug evaluation studies.
Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Information sur le Médicament, Unité de Pharmacoépidémiologie, EA3696, Université de Toulouse, 37 Allées Jules Guesde, 31000 Toulouse, France. lacroix@cict.fr
I
I
Lacroix
C
C
Hurault
M F
MF
Sarramon
C
C
Guitard
A
A
Berrebi
M
M
Grau
C
C
Albouy-Cossard
R
R
Bourrel
E
E
Elefant
J L
JL
Montastruc
C
C
Damase-Michel
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D000013:Congenital Abnormalities / Q000453:epidemiology*; D016208:Databases, Factual; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D005240:Feasibility Studies; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011256:Pregnancy Outcome; D055553:Prescription Drugs / Q000627:therapeutic use; D018570:Risk Assessment
D055553:Prescription Drugs