Monitoring of Drug Utilization and Safety

Monitoring of Drug Utilization and Safety Unit

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

    Articles with peer-review

  • 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
  • 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.
    https://doi.org/10.1111/bcp.14564
  • 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.
    https://doi.org/10.1371/journal.pone.0253336
  • 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
  • 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.
    https://doi.org/10.2147/CLEP.S222888
  • 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.
    https://doi.org/10.1080/14740338.2020.1798928
  • 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.
    https://doi.org/10.1016/j.jad.2019.02.010
  • 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.
    https://doi.org/10.2147/CLEP.S173667
  • 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.
    https://doi.org/10.1007/s40264-019-00837-y
    https://repository.publisso.de/resource/frl%3A6416489

Current projects

Staff

Amann, Ute Anna-Maria, PD Dr.
Tel.: +49 (0)421 218-56873
Fax: +49 (0)421 218-56941
amann(at)leibniz-bips.de

Princk, Christina
Tel.: +49 (0)421 218-56869
Fax: +49 (0)421 218-56941
princk(at)leibniz-bips.de

Reinold, Jonas
Tel.: +49 (0)421 218-56868
Fax: +49 (0)421 218-56941
reinold(at)leibniz-bips.de

Schäfer, Wiebke
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

Voß, Annemarie
Tel.: +49 (0)421 218-56866
Fax: +49 (0)421 218-56941
avoss(at)leibniz-bips.de