[Terappel: description of a computerised database and examples of studies]

Area of Science:

• Pharmacovigilance and Drug Safety
• Reproductive Toxicology
• Public Health

Context:

• The use of medications during pregnancy necessitates careful risk assessment and counseling.
• Pharmacovigilance centers play a crucial role in providing individualized guidance to pregnant women and those of childbearing age.
• Systematic follow-up of drug-exposed pregnancies is essential for monitoring safety.

Purpose:

• To describe the characteristics and utilization of a dedicated database for managing pharmacovigilance data related to pregnancy.
• To highlight the role of the French regional pharmacovigilance centers network in providing personalized risk assessment and counseling.
• To explain how prospective data from the database supports national and international collaborative studies on drug safety in pregnancy.

Summary:

• A centralized database, established in 1984 by the Lyon pharmacovigilance center and now utilized by 18 centers, facilitates harmonized data collection and follow-up for drug-exposed pregnancies.
• This database supports the French pharmacovigilance network in conducting descriptive and comparative studies on medication safety during gestation.
• Data from this resource is also leveraged for studies initiated by the European Network of Teratology Information Services (ENTIS).

Impact:

• Enhances the safety profile of drug exposure information for pregnant women through collaborative research.
• Improves the quality and consistency of pharmacovigilance data collection and follow-up across multiple centers.
• Provides a valuable resource for personalized risk assessment and counseling, ultimately contributing to better maternal and fetal health outcomes.