The exposure of the population to pharmaceuticals is very dynamic. For example, new drugs are constantly approved, marketing authorizations are expanded, new contraindications are announced or there are trends in the utilization of certain drugs of concern from a public health point of view. Many of the research questions arising in this context can only be addressed on the basis of large health databases reflecting the actual healthcare situation and with the necessary expertise in the analysis of these data.
In this context, the unit is working on pharmacoepidemiological questions in the field of monitoring drug utilization and safety in Germany using the Pharmacoepidemiological Research Database (GePaRD). An important area is the conduct of observational studies on the utilization and safety of new drugs after market approval, which are required by regulatory authorities (e.g., the European Medicines Agency, short EMA). These so-called PAS studies (Post Approval Safety Studies) are mostly conducted with international partners with databases from other countries, in particular involving partners from the SIGMA consortium, of which BIPS has been a member since 2020. In addition, the unit responds to public health-relevant topics arising from current trends in the field of drug utilization and safety in Germany.
"Current projects" provides examples of some of the projects carried out by the unit. Information on ongoing PAS studies can be found here.
Selected Publications
- Scholle O, Rasmussen L, Reilev M, Viebrock J, Haug U. Comparative analysis of outpatient antibiotic prescribing in early life: A population-based study across birth cohorts in Denmark and Germany. Infectious Diseases and Therapy. 2024;13(2):299-312.
https://doi.org/10.1007/s40121-024-00916-3 - Reilev M, Jensen PB, Ranch LS, Egenberg A, Furu K, Gembert K, Hägg D, Haug U, Karlstad Ø, Reutfors J, Schäfer W, Schwarz S, Smits E, Holthuis E, Herings R, Trifirò G, Kirchmayer U, Cesare Rosa A, Belleudi V, Gini R, Støvring Henrik, Hallas J. Methodology of the brodalumab assessment of hazards: A multicentre observational safety (BRAHMS) study. BMJ Open. 2023;13:e066057.
https://doi.org/10.1136/bmjopen-2022-066057 - Platzbecker K, Müller-Fielitz H, Foraita R, Koepp MJ, Voss A, Pflock R, Linder R, Pigeot I, Schink T, Schwaninger M. In atrial fibrillation epilepsy risk differs between oral anticoagulants: Active comparator, nested case control study. Europace. 2023;25(5):euad087.
https://doi.org/10.1093/europace/euad087 - Willame C, Dodd C, Duran C, Elbers R, Gini R, Bartolini C, Paoletti O, Wang L, Ehrenstein V, Kahlert J, Haug U, Schink T, Diez-Domingo J, Mira-Iglesias A, Carreras JJ, Vergara-Hernández C, Giaquinto C, Barbieri E, Stona L, Huerta C, Martin-Perez M, Garcia-Poza P, de Burgos A, Martinez-Gonzalez M, Bryant V, Villalobos F, Pallejà-Millán M, Aragon M, Carreras JJ, Souverein P, Thurin N, Weibel D, Klungel O, Sturkenboom MCJM. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - An ACCESS cohort study. Vaccine. 2023;41(1):251-262.
https://doi.org/10.1016/j.vaccine.2022.11.031 - Voss A, Smits E, Swart KM, Balabanova Y, Brobert G, Suzart-Woischnik K, Herings R, Schink T, Haug U. Time trends in patient characteristics of new rivaroxaban users with atrial fibrillation in Germany and the Netherlands. Drugs - Real World Outcomes. 2023;10(2):215-224.
https://doi.org/10.1007/s40801-022-00350-2 - García Rodríguez LA, Ruigómez A, Schink T, Voss A, Smits E, Swart KM, Balabanova Y, Suzart-Woischnik K, Brobert G, Herings R. Safety and effectiveness of rivaroxaban for prevention of stroke in patients with nonvalvular atrial fibrillation: Analysis of routine clinical data from four countries. Expert Opinion on Drug Safety. 2023;22(6):493-500.
https://doi.org/10.1080/14740338.2023.2181334 - Schink T, Princk C, Braitmaier M, Haug U. Use of combined oral contraceptives and risk of venous thromboembolism in young women: A nested case-control analysis using German claims data. BJOG: An International Journal of Obstetrics & Gynaecology. 2022;129(13):2107-2116.
https://doi.org/10.1111/1471-0528.17268 - Schäfer W, Reinders T, Schink T. Second dose of measles-mumps-rubella-varicella vaccine (MMRV) and the risk of febrile convulsions. Vaccine. 2022;40(14):2168-2172.
https://doi.org/10.1016/j.vaccine.2022.02.072
https://repository.publisso.de/resource/frl:6432144 - Rivero-Ferrer E, Olesen M, Plana E, Aguado J, Saigi-Morgui N, Rubino A, Daoud S, Lei A, Perez-Gutthan S, Schink T, Kristiansen N, Hallas J, Pottegård A, Rebordosa C. Characteristics of new users of aclidinium bromide, aclidinium/formoterol, and other COPD medications in the United Kingdom, Denmark, and Germany. Clinical Drug Investigation. 2022;42(4):319-331.
https://doi.org/10.1007/s40261-022-01120-2 - Scholle O, Asendorf M, Buck C, Grill S, Jones C, Kollhorst B, Riedel O, Schüz B, Haug U. Regional variations in outpatient antibiotic prescribing in Germany: A small area analysis based on claims data. Antibiotics. 2022;11(7):836.
https://doi.org/10.3390/antibiotics11070836 - Fortuny J, von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G, Timmer A, Dress J, Blin P, Droz-Perroteau C, Ehrenstein V, Franzoni C, Herings R, Kollhorst B, Moore N, Odsbu I, Perez-Gutthan S, Schink T, Rascher K, Rasouliyan L, Rothman KJ, Saigi-Morgui N, Schaller M, Smits L, Forstner M, Intravenous Iron Consortium, Benichou J, Bircher AJ, Garbe E, Rampton D, Gutierrez L. Use of intravenous iron and risk of anaphylaxis: A multinational observational post-authorisation safety study in Europe. Pharmacoepidemiology and Drug Safety. 2021;30(10):1447-1457.
https://dx.doi.org/10.1002/pds.5319 - Scholle O, Kollhorst B, Haug U. Are prescribers not aware of cardiovascular contraindications for diclofenac? A claims data analysis. Journal of Internal Medicine. 2020;287(2):171-179.
https://doi.org/10.1111/joim.12990 - Gilsenan A, Fortuny J, Cainzos-Achirica M, Cantero OF, Flynn RW, García Rodríguez LA, Harding A, Kollhorst B, Karlsson P, Linnér L, MacDonald TM, Odsbu I, Plana E, Ruigómez A, Schink T, Ziemiecki R, Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: A multinational population-based cohort study. Drug Safety. 2019;42(10):1179-1190.
https://doi.org/10.1007/s40264-019-00835-0 - Reinold J, Viebrock J, Haug U. Verschreibung von parenteralen Eisen(III)-Präparaten in der ambulanten Arzneimittelversorgung in Deutschland. Bulletin zur Arzneimittelsicherheit - Informationen aus BfArM und PEI. 2023;4:4-9.
https://www.bfarm.de/DE/Aktuelles/Publikationen/Bulletin/Ausgaben/_node.html - Schink T, Princk C, Haug U. Risiko venöser Thromboembolien bei Einnahme von kombinierten hormonalen Kontrazeptiva. Bulletin zur Arzneimittelsicherheit - Informationen aus BfArM und PEI. 2021;2:13-16.
https://www.bfarm.de/DE/Aktuelles/Publikationen/Bulletin/Ausgaben/_node.html
Articles with peer review
Articles without 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.
- Development of prescribing patterns for combined hormonal contraceptives in Germany after Dear Doctor Letters (Rote-Hand-Briefe) in December 2018 and September 2021
- Further development, optimization and application of an algorithm for the detection of severe adverse drug reactions on the basis of claims data
- PAS-study for alemtuzumab
- PAS-study for Brodalumab
- PAS-study for eliglustat
- PAS-study for Entresto® (sacubitril/valsartan)
- PAS-study for galcanezumab
- PAS-study for romosozumab
- PAS-study for solriamfetol
- PAS-study for tralokinumab
- PAS-study for upadacitinib
- Study to analyze regional differences in antibiotic prescriptions
- Superthyroidism: Health care overuse in thyroid diseases in Germany
- Use of opioid-containing drugs in Germany
- Use of parenteral Iron-(III)-products in Germany
- Utilization of drugs containing testosterone in Germany
Staff
Reinold, Jonas, Dr.
Tel.: +49 (0)421 218-56868
Fax: +49 (0)421 218-56941
reinold(at)leibniz-bips.de
Schäfer, Wiebke, Dr.
Tel.: +49 (0)421 218-56887
Fax: +49 (0)421 218-56821
wschaefer(at)leibniz-bips.de
Scholle, Oliver, Dr.
Tel.: +49 (0)421 218-56878
Fax: +49 (0)421 218-56941
scholle(at)leibniz-bips.de
Strutz, Uwe
Tel.: +49 (0)421 218-56864
Fax: +49 (0)421 218-56821
strutz(at)leibniz-bips.de
Thiel, Anne
Tel.: +49 (0)421 218-56863
Fax: +49 (0)421 218-56821
thiel(at)leibniz-bips.de
Jonas Reinold
Head of Unit
Contact:
Dr. rer. nat. Jonas Reinold
Tel: +49 (0)421 218-56868
Fax: +49 (0)421 218-56941