Terappel: Description of a Computerised Database and Examples of Studies

Risk assessment and recommendations regarding the use of medicines during pregnancy or in women of childbearing age is an important task of pharmacovigilance. As a drug information resource, the network of French regional phannacovigilance centres is involved in providing a personalized risk assessment and individualized counselling during pregnancy. It must also ensure systematic follow-up of exposed pregnancies for which it has been contacted. To ensure harmonized data collection and follow-up,a dedicated database was set-up in 1984 by the Lyon pharmacovigilance centre, which was later made available to 18 other centres. Prospective data from this database is regularly used by the network for descriptive or comparative collaborative studies at the national level or by participating to studies initiated by the European Network of Teratology Information Services in order to provide information on the safety profile of drug exposure in pregnant women. The characteristics of this database and examples of utilization are described in this article.