Vulnerable groups—such as pregnant women, children, older adults, or individuals with chronic conditions—are often excluded or underrepresented in clinical trials. Therefore, some questions about drug safety in these groups are initially left unresolved. Resulting uncertainties may lead to in inadequate drug therapy for these individuals. On the other hand, there is a risk of prescribing drugs associated with known or as yet unknown side effects in these individuals.
To expand the knowledge base in this important area, the unit addresses research questions regarding the drug utilization and safety in vulnerable groups using the Pharmacoepidemiological Research Database (GePaRD). These questions include chronic drug therapy in children and drug therapy in vulnerable groups in adulthood, for example, in individuals with psychiatric comorbidity. A particular focus of the unit is on drug exposure during pregnancy. In a recently concluded project funded by the Innovation Fund of the Federal Joint Committee, we have completed substantial methodological work to use GePaRD for this research. This includes the development of algorithms to identify and classify pregnancy endpoints, accurately estimate the onset of pregnancy, and link mothers to their children based on GePaRD.
"Current projects" provides examples of some of the projects carried out by the unit.
- Wentzell N, Haug U. Characterization of pregnancies among women with epilepsy using valproate before or during pregnancy - A longitudinal claims data analysis from Germany. Epilepsy Research. 2022;179:106838.
- Schäfer W, Wentzell N, Schink T, Haug U. Characterization of pregnancies exposed to St. John's wort and their outcomes: A claims data analysis. Reproductive Toxicology. 2021;102:90-97.
- Scholle O, Kollhorst B, Riedel O, Bachmann CJ. First-time users of ADHD medication among children and adolescents in Germany: An evaluation of adherence to prescribing guidelines based on claims data. Frontiers in Psychiatry. 2021;12:653093.
- Scholle O, Fegert JM, Kollhorst B, Öztürk E, Riedel O, Kölch M. Predictors for receiving medication and/or psychotherapy in children newly diagnosed with ADHD: A longitudinal population-based cohort study. Journal of Attention Disorders. 2020;24(2):255-264.
- Reutfors J, Cesta CE, Cohen JM, Bateman BT, Brauer R, Einarsdóttir K, Engeland A, Furu K, Gissler M, Havard A, Hernandez-Diaz S, Huybrechts KF, Karlstad Ø, Leinonen MK, Li J, Man KK, Pazzagli L, Schaffer A, Schink T, Wang Z, Yu Y, Zoega H, Bröms G. Antipsychotic drug use in pregnancy: A multinational study from ten countries. Schizophrenia Research. 2020;220:106-115.
- Schink T, Wentzell N, Dathe K, Onken M, Haug U. Estimating the beginning of pregnancy in German claims data: Development of an algorithm with a focus on the expected delivery date. Frontiers in Public Health. 2020;8:350.
- 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. Pharmacoepidemiology and Drug Safety. 2018;27(9):1005-1010.
- Wentzell N, Haug U, Schink T, Engel S, Liebentraut J, Linder R, Onken M, Schaefer C, Dathe K. Valproatverordnungen bei Mädchen und Frauen im gebärfähigen Alter in Deutschland: Untersuchung zeitlicher Trends basierend auf Versichertendaten. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 2018;61(8):1022-1029.
Articles with peer-review
Only currently running projects or those where publications are still in preparation or those that ended less than a year ago will be shown. The entries are sorted alphabetically.
- Cross-generational adverse drug effects
- Prescription behavior of HIV therapeutics in women of childbearing age and during pregnancy in Germany
- Prescription of teratogenic substances in women of childbearing age
- The use of MS-medications in girls and women of childbearing age and during pregnancy in Germany
- Use of Carbimazole, Thiamazole and Propylthiouracil during pregnancy in Germany