Studying drug safety during pregnancy based on routine data in Germany


Examining the safety of drug use during pregnancy based on claims data in Germany

Pregnant women need drug treatment if an untreated illness were to endanger the mother or unborn child. However, the possible consequences of drug intake during pregnancy are quite uncertain. This is especially the case with newer active ingredients, but there are also many unanswered questions regarding the use of commonly used drugs. Often, there is a lack of studies assessing the risk of drug intake during pregnancy.
Based on insurance data, the project aims to examine the safety of drug therapy during pregnancy. Experts from clinical, epidemiological and statistical fields work closely together in a research group to pool their competences. Initially, the project develops suitable scientific methods to use insurance data for the respective research questions. For example, the start of pregnancy, the duration of drug intake and the existence of health problems in newborns need to be estimated as accurately as possible on the basis of the claims data. In pilot evaluations, the methodology is subsequently applied to specific, exemplary drug groups. It is checked for consistency and plausibility and, if necessary, optimized.
If successful, the results could help to prevent serious health risks in children. Furthermore, if assumed risks were not confirmed, the unnecessary discontinuation of essential medicines could be avoided. From a health economics perspective, minimizing risks for mother and child is also of great importance.

Funding period

Begin:   February 2017
End:   October 2020


  • The Federal Joint Committee (G-BA)


Prof. Dr. sc. hum. Ulrike Haug


Poster: “Prescribing valproate to girls and women of childbearing age in Germany: Analysis of trends based on claims data” (2018 conference of the International Society for Pharmacoepidemiology (ISPE))

Poster: “Information on the expected delivery date in German claims data: Assessing its potential to estimate the beginning of pregnancy” (2018 conference of the International Society for Pharmacoepidemiology (ISPE))