EPI–PHARE has published in the British Journal of Clinical Pharmacology the results of a proof–of–concept study on the identification of major congenital malformations (MCMs) using data from the National Health Data System (SNDS).

This study was conducted using the French National EPI–MERES Registry, developed by EPI–PHARE based on the SNDS. It included 10.5 million births in France between 2010 and 2023.

By analyzing hospital diagnoses, medical procedures (such as corrective surgeries), and causes of death up to one year after birth, 72 specific MCMs, grouped into 11 organ categories based on the EUROCAT list, were evaluated.

Some key findings:

• 213,153 infants born between 2010 and 2023 (representing 203.0 per 10,000 births) had at least one congenital malformation.
• The prevalence rates observed in EPI-MERES are close to those reported by EUROCAT (an overall difference of only -1%), confirming the reliability of the SNDS in identifying major congenital malformations.
• Nearly half of the MCMs (47%) were identified using a medical procedure code, highlighting the importance of capturing information on medical procedures for identifying MCMs using data from health databases.
• The study also found the expected strong associations between prenatal exposure to valproate and the risks of MCMs (a 2.82-fold increased risk for any MCM, and up to 17.88-fold for spina bifida).

The EPI-MERES registry, built using data from the SNDS, provides a responsive, powerful, and operational tool for improving our understanding of the teratogenicity of medications. It not only allows for the accurate measurement of the prevalence of congenital malformations, but also enables the detection of differential risks for rare malformations, thanks to the exceptional size of its dataset, which covers the entire French population.

EPI-PHARE’s work represents a major step forward in improving our understanding of the teratogenicity of medications and better protecting future generations.

About the EPI-MERES Registry

The National Mother-Child Registry (EPI-MERES), developed by EPI-PHARE using data from the SNDS, records all pregnancies that have occurred in France since 2010 and enables linkage with the children born from these pregnancies, allowing for the monitoring of their development and health status from birth. To date, EPI-MERES includes more than 14 million pregnancies and 10.7 million children (98% of births recorded by INSEE) followed up to 15 years after birth. This registry is an indispensable tool for research in perinatal pharmacoepidemiology, and is among the most promising in the world due to its size and the wealth of information it contains.