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 of drug utilization before, during and after pregnancy, also compared to women who are not pregnant
  • 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 Die Techniker (TK) and  Institut für Klinische Pharmakologie und Toxikologie at Charité / Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Embryotox), Funding body: GBA

Selected Publications

  • Wentzell N, Schink T, Haug U, Ulrich S, Niemeyer M, Mikolajczyk R. Optimizing an algorithm for the identification and classification of pregnancy outcomes in German claims data. Pharmacoepidemiol Drug Saf. 2018 Sep;27(9):1005-1010. https://doi.org/10.1002/pds.4588.
  • Wentzell N, Haug U, Schink T, Engel S, Liebentraut J, Linder R, Onken M, Schaefer C, Dathe K. Prescribing valproate to girls and women of childbearing age in Germany : Analysis of trends based on claims data. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Aug;61(8):1022-1029. https://doi.org/10.1007/s00103-018-2768-1.
  • 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, Haug U, Dathe K, Onken M, Schink T. Information on the expected delivery date in German claims data: Assessing its potential to estimate the beginning of pregnancy. 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), August 22-26, 2018, Prague, Czech Republic.