Vial Thierry, Gouraud Aurore, Bernard Nathalie
Therapie. 2014 Jan-Feb;69(1):31-8. doi: 10.2515/therapie/2014013. Epub 2014 Apr 4.
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 pharmacovigilance 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.
孕期或育龄期女性用药的风险评估及建议是药物警戒的一项重要任务。作为一个药物信息资源，法国地区药物警戒中心网络参与在孕期提供个性化风险评估及个体化咨询。它还必须确保对已联系的暴露于药物的妊娠进行系统性随访。为确保统一的数据收集和随访，里昂药物警戒中心于1984年建立了一个专用数据库，该数据库后来供其他18个中心使用。该网络定期使用该数据库的前瞻性数据进行国家级描述性或比较性合作研究，或参与由欧洲致畸学信息服务网络发起的研究，以便提供关于孕妇药物暴露安全性概况的信息。本文描述了该数据库的特点及使用示例。
