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). A particular focus of the unit is on drug exposure during pregnancy. Recently, we have completed the 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.
Moreover, we investigate chronic use of drugs in children as well as in vulnerable adult populations such as persons with mental disorders.
"Current projects" provides examples of some of the projects carried out by the unit.
Selected Publications
- Princk C, Kollhorst B, Haug U. Use of leflunomide among girls and women of childbearing age and occurrence of leflunomide-exposed pregnancies in Germany. Reproductive Toxicology. 2024;125:108573.
https://doi.org/10.1016/j.reprotox.2024.108573 - Reinold J, Kollhorst B, Wentzell N, Platzbecker K, Haug U. Use of isotretinoin among girls and women of childbearing age and occurrence of isotretinoin-exposed pregnancies in Germany: A population-based study. PLoS Medicine. 2024;21(1):e1004339.
https://doi.org/10.1371/journal.pmed.1004339 - Reinold J, Kollhorst B, Temme HL, Wentzell N, Haug U. Use of acitretin among girls and women of childbearing age and occurrence of acitretin-exposed pregnancies in Germany. Clinical Drug Investigation. 2023;43(11):865-872.
https://doi.org/10.1007/s40261-023-01314-2 - Wentzell N, Kollhorst B, Reinold J, Haug U. Use of methotrexate in girls and women of childbearing age, occurrence of methotrexate-exposed pregnancies and their outcomes in Germany: A claims data analysis. Clinical Drug Investigation. 2023;43(2):109-117.
https://doi.org/10.1007/s40261-022-01227-6 - Amann U, Wentzell N, Kollhorst B, Haug U. Prescribing of endothelin receptor antagonists and riociguat in women of childbearing age in a large German claims database study. Reproductive Toxicology. 2023;119:108415.
https://doi.org/10.1016/j.reprotox.2023.108415
https://repository.publisso.de/resource/frl:6452989 - Platzbecker K, Wentzell N, Kollhorst B, Haug U. Fingolimod, teriflunomide and cladribine for the treatment of multiple sclerosis in women of childbearing age: Description of drug utilization and exposed pregnancies in Germany. Multiple Sclerosis and Related Disorders. 2022;67:104184.
https://doi.org/10.1016/j.msard.2022.104184
https://repository.publisso.de/resource/frl:6435355 - 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.
https://doi.org/10.1016/j.eplepsyres.2021.106838
https://repository.publisso.de/resource/frl:6431122 - 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.
https://doi.org/10.1016/j.reprotox.2021.04.005
https://repository.publisso.de/resource/frl%3A6428346 - 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.
https://doi.org/10.1016/j.schres.2020.03.048 - 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.
https://doi.org/10.3389/fpubh.2020.00350 - 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.
https://doi.org/10.1002/pds.4588
https://repository.publisso.de/resource/frl%3A6417552 - 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.
https://doi.org/10.1007/s00103-018-2768-1
Articles with peer review
Current Projects
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
- Women of childbearing age with inflammatory rheumatic disease: Characterizing patterns of care with a special focus on pregnancies
Staff
Riedel, Oliver, PD Dr.
Tel.: +49 (0)421 218-56883
Fax: +49 (0)421 218-56941
riedel(at)leibniz-bips.de
Schink, Tania, Dr.
Tel.: +49 (0)421 218-56865
Fax: +49 (0)421 218-56941
schink(at)leibniz-bips.de
Wentzell, Nadine
Tel.: +49 (0)421 218-56879
Fax: +49 (0)421 218-56941
wentzell(at)leibniz-bips.de
Ulrike Haug
Temp. Head
Contact:
Prof. Dr. Ulrike Haug
Tel: +49 (0)421 218-56862
Fax: +49 (0)421 218-56821
Email:
haug(at)leibniz-bips.de