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Investigation of Pharmaceutical Drug Safety During Pregnancy Based on Routine Data in Germany
There is substantial uncertainty of the impact of drug use during pregnancy because clinical studies are not available, observational data are insufficient for many substances and preclinical results cannot be directly translated to humans. During the last decades, the German Embryotox institute at the Charité university hospital Berlin substantially improved the availability of pertinent risk information on drug use during pregnancy. Based on their observational studies, Embryotox contributed to signal detection, specification of known risks or confirmation of safety. Until now there is a lack in structure and standardized methods to use German routine data for studies on drug effects in pregnancy.
Aims of the project are therefore, (i) the establishment of a research consortium for the study of medication safety during pregnancy based on German routine data from statutory health insurance providers and by combining clinical and epidemiological expertise as well as sound experience in the use of routine data. Furthermore, (ii) the efficiency of methods and processes will be investigated with pilot studies on selected drugs that may affect the unborn child such as valproic acid, RAAS-inhibitors and immunomodulatory substances. Based on these pilot studies a continuous collaborative project will be established. Such a project will have substantial impact on the individual pregnant patient and the society.
Leibniz-Institut für Präventionsforschung und Epidemiologie (BIPS), Bremen; Wissenschaftliches Institut der Techniker Krankenkasse für Nutzen und Effizienz im Gesundheitswesen (WINEG), Charité – Universitätsmedizin Berlin, Institut für Klinische Pharmakologie und Toxikologie (Embryotox)