Utilization and safety of medications during pregnancy

Taking medication during pregnancy can seriously impact the development and health of the child. On the other hand, mother and child can also be harmed if necessary treatments are interrupted during pregnancy, for example, in the case of epilepsy or depression. Weighing the benefit of medicines against possible (long-term) risks requires information on the risk of individual active substances or classes of active substances during pregnancy.

Due to the size and the population-based information they contain, databases based on billing data from statutory health insurance providers such as the Pharmacoepidemiological Research Database (GePaRD) are well-suited for studies on drug utilization and safety during pregnancy.

Therefore, this research area covers the following areas:

  • Methodical work, inter alia, the development of algorithms for the valid detection of pregnancies as well as the correct estimation of the start of gestation,
  • The description drug utilization before, during and after pregnancy, also compared to non - pregnant women as well as
  • The investigation of the (long-term) safety of individual drugs or classes of active substances during pregnancy


Third party funding

Studying drug safety during pregnancy based on routine data in Germany (AMTS in utero) in cooperation with Wissenschaftliches Institut der Techniker Krankenkasse für Nutzen und Effizienz im Gesundheitswesen (WINEG) and  Institut für Klinische Pharmakologie und Toxikologie at Charité / Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Embryotox), Funding body: GBA

Selected Publications

  • Mikolajczyk R T, Schmedt N, Zhang J, Lindemann C, Langner I & Garbe, E. (2013). Regional variation in caesarean deliveries in Germany and its causes. BMC pregnancy and childbirth, 13(1), 99. https://doi.org/10.1186/1471-2393-13-99.
  • Mikolajczyk R T, Kraut A A & Garbe E. (2013). Evaluation of pregnancy outcome records in the German Pharmacoepidemiological Research Database (GePaRD). Pharmacoepidemiology and drug safety, 22(8), 873-880. https://doi.org/10.1002/pds.3467.
  • Garbe E, Suling M, Kloss S, Lindemann C & Schmid U. (2011). Linkage of mother–baby pairs in the German Pharmacoepidemiological Research Database. Pharmacoepidemiology and drug safety, 20(3), 258-264. https://doi.org/10.1002/pds.2038.


Selected presentations

  • Wentzell N, Schink T. Indikatoren zur Abbildbarkeit von Schwangerschaftsverläufen in deutschen Krankenkassendaten am Beispiel der deutschen pharmakoepidemiologischen Forschungsdatenbank (GePaRD). Methodenworkshop der Arbeitsgruppe Erhebung und Nutzung von Sekundärdaten (AGENS), 3.-4. März 2016, München.
  • Reinold J, Wentzell N, Schink T. Identification, adaptation and comparison of algorithms to estimate the beginning of pregnancy in the German Pharmacoepidemiological Research Database (GePaRD). Congress "Health - Exploring Complexity: An Interdisciplinary Systems Approach (HEC2016)." Joint Annual Meeting of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS), the German Society for Epidemiology (DGEpi), the International Epidemiological Association - European Region (IEA-EEF) and the European Federation for Medical Informatics Association (EFMI), 28 August-2 September 2016, Munich.