Background Aim Methods Results Conclusion
Transcription
Background Aim Methods Results Conclusion
EFEMERIS (Evaluation chez la Femme Enceinte des MEdicaments et de leur RISque), the French prescription database in pregnant women: a 4 year-follow up I. Lacroix, C. Hurault-Delarue, M.F. Sarramon, C. Guitard, A. Berrebi, S. Vidal, C. Albouy-Cossard, R. Bourrel, E. Elefant, J.L. Montastruc, C. Damase-Michel. Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’informations sur le Médicament, Unité « Médicaments, grossesse et Allaitement », CHU de Toulouse, Université de Toulouse, Inserm 1027, Toulouse, France. http://www.efemeris.fr Background Due to lack of evaluation, teratogenicity of many drugs is unknown and drug choice during pregnancy is often difficult for health professionnals. In France, there is no systematic follow up of women exposed to drugs and their newborns. Aim Results The main aim of this study is to move towards setting up the first French database of reimbursed drugs prescribed to pregnant women by associating records of the drugs prescribed and delivered during pregnancy until the outcome of these pregnancies . N=40355 mother-outcome of pregnancy Methods Population This study concerns pregnant women who gave birth to a baby from July 1st 2004 to June 30th 2008 in HauteGaronne and who are registered in the French Health Insurance Service (80% of the population). Data sources EFEMERIS database was set up using data on prescription drugs dispensed to pregnant women and recorded by the Caisse Primaire d'Assurance Maladie (CPAM) of HauteGaronne and the outcomes of these pregnancies obtained from both the Protection Maternelle et Infantile (child health certificates) and the Centre de Diagnostic Antenatal (medical pregnancy interruptions). CPAM Drugs prescribed during pregnancy PMI CDA Issues data CESSI: anonymous databases Final database « EFEMERIS » 40 355 mother-outcome of pregnancy pairs The data received from the 3 sources (CPAM, PMI, CDA) were made anonymous with a data-processing tool provided by the "Centre d'Etudes des Sécurités du Système d'Information" (CESSI). Data Collection - CPAM: - Age - Last menstruation and delivery dates - Reimbursed and delivered drugs during pregnancy, period of exposure - PMI: - Birth weight, length, APGAR - Malformations - Neonatal diseases - CDA: - Medical pregnancy interruptions: date, cause - Malformations Malformations (Eurocat classification) Number (Rate) Malformations 930 (2.3%) Musculoskeletal system malformations Urinary system malformations Chromosomal abnormalities Circulatory system malformations Nervous system malformations Genital organ malformations Cleft lip and palate Eye, ear, face and neck malformations Digestive system malformations Respiratory system malformations Other malformations 207 (5.1‰) 195 (4.8‰) 137 (3.4‰) 136 (3.4‰) 88 (2.2‰) 88 (2.2‰) 45 (1.1 ‰) 35 (0.9‰) 32 (0.8‰) 17 (0.4‰) 13 (0.3‰) - Drugs Pregnant women were prescribed 10.8 ± 7.6 [0-78] Different reimbursed drugs Top 20 of prescribed drugs during organogenesis 1. acetaminophen 26.2% 2. metoclopramide 12.9% 3. phloroglucinol 12.7% 4. folic acid 12.5% 5. domperidone 10.0% 6. magnesium 6.1% 7. amoxicillin 6.1% 8. levothyroxin sodium 5.4% 9. helicidine 5.3% 10. iron 4.9% 11. metopimazin 12. chlorhexidine 13. progesterone 14. econazole 15. sodium alginate 16. ibuprofen 17. tixocortol 18. tuaminoheptane 19. prednisolon 20. pyridoxine 4.9% 4.8% 4.7% 4.2% 3.6% 3.4% 3.3% 3.2% 3.2% 2.9% - Among the twenty most frequently prescribed drugs, around one third of them were drugs which have not been evaluated in pregnant women (phloroglucinol, dompéridone, tuaminoheptane…). - Among the drugs for which data is available, some with proven teratogenic or fœtotoxic effects were prescribed and delivered to pregnant patients included in the EFEMERIS database: retinoids, NSAIDs… Conclusion EFEMERIS is the first French database of drugs prescribed and dispensed during pregnancy including the outcome of these pregnancies (birth or medical termination of pregnancy). This database will allow us to study drugs which are largely prescribed in France in pregnancy and for which no data are available yet.