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

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

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 “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.

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Acknowledgements

Financial support: Agence Française de Sécurité SAnitaire des Produits de Santé (AFSSAPS), Caisse Nationale d’Assurance Maladie des travailleurs salariés (CNAMTS), Mutuelle Générale de l’Education Nationale (MGEN), Unions régionales des Caisses d’Assurance Maladie (URCAM).

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Authors and Affiliations

  1. Service de Pharmacologie Clinique, CHU de Toulouse, 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

    I. Lacroix, C. Hurault, J. L. Montastruc & C. Damase-Michel

  2. Centre de diagnostic anténatal, CHU de Toulouse, Toulouse, France

    M. F. Sarramon

  3. Service de Protection Maternelle et Infantile, Conseil Général de la Haute-Garonne, Toulouse, France

    C. Guitard & A. Berrebi

  4. Caisse Primaire d’Assurance Maladie de la Haute-Garonne, Toulouse, France

    M. Grau

  5. Centre d’Etudes des Sécurités du Système d’Information, CNAMTS, Paris, France

    C. Albouy-Cossard

  6. Caisse Régionale d’Assurance Maladie Midi-Pyrénées, Toulouse, France

    R. Bourrel

  7. Centre de Référence sur les Agents Tératogènes, Paris, France

    E. Elefant

Authors
  1. I. Lacroix
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  2. C. Hurault
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  3. M. F. Sarramon
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  4. C. Guitard
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  5. A. Berrebi
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  6. M. Grau
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  7. C. Albouy-Cossard
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  8. R. Bourrel
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  9. E. Elefant
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  10. J. L. Montastruc
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  11. C. Damase-Michel
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Corresponding author

Correspondence to I. Lacroix.

Additional information

EFEMERIS (Evaluation chez la Femme Enceinte des MEdicaments et de leurs RISques)

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Lacroix, I., Hurault, C., Sarramon, M.F. et al. Prescription of drugs during pregnancy: a study using EFEMERIS, the new French database. Eur J Clin Pharmacol 65, 839–846 (2009). https://doi.org/10.1007/s00228-009-0647-2

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  • DOI: https://doi.org/10.1007/s00228-009-0647-2

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