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.
- 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.
- Schäfer W, Reinders T, Riedel O, Haug U. How often are antidepressants prescribed off-label among older adults in Germany? A claims data analysis. British Journal of Clinical Pharmacology. 2021;87(4):1778-1789.
- Reinold J, Braitmaier M, Riedel O, Haug U. Anticholinergic burden: First comprehensive analysis using claims data shows large variation by age and sex. PLOS ONE. 2021;16(6):e0253336.
- Pisa F, Reinold J, Kollhorst B, Haug U, Schink T. Individual antidepressants and the risk of fractures in older adults: A new user active comparator study. Clinical Epidemiology. 2020;12:667-678.
- García Rodríguez LA, Wallander M-A, Friberg L, Ruigómez A, Schink T, Bezemer I, Herings R, Shakir S, Evans A, Davies M, Suzart-Woischnik K, Vora P, Balabanova Y, Soriano-Gabarró M, Brobert G. Rationale and design of a European epidemiological post-authorization safety study (PASS) program: Rivaroxaban use in routine clinical practice. Expert Opinion on Drug Safety. 2020;19(11):1513-1520.
- 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.
- Schäfer W, Princk C, Kollhorst B, Schink T. Antidepressants and the risk of hemorrhagic stroke in the elderly: A nested case-control study. Drug Safety. 2019;42(9):1081-1089.
- Forns J, Pottegård A, Reinders T, Poblador-Plou B, Morros R, Brandt L, Cainzos-Achirica M, Hellfritzsch M, Schink T, Prados-Torres A, Giner-Soriano M, Hägg D, Hallas J, Cortés J, Jacquot E, Deltour N, Perez-Gutthan S, Pladevall M, Reutfors J. Antidepressant use in Denmark, Germany, Spain, and Sweden between 2009 and 2014: Incidence and comorbidities of antidepressant initiators. Journal of Affective Disorders. 2019;249:242-252.
- Pisa F, Reinold J, Kollhorst B, Haug U, Schink T. Antidepressants and the risk of traumatic brain injury in the elderly: Differences between individual agents. Clinical Epidemiology. 2019;11:185-196.
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.
- Further development, optimization and application of an algorithm for the detection of severe adverse drug reactions on the basis of claims data
- Study to analyze regional differences in antibiotic prescriptions
- Superthyroidism: Health care overuse in thyroid diseases in Germany
- Use of combined oral contraceptives and risk of venous thromboembolism
- Use of opioid-containing drugs in Germany
- Use of parenteral Iron-(III)-products in Germany
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