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.