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

  • 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
  • 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
  • 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
  • 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
  • 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
  • Tan EH, Robinson DE, Jödicke A, Mosseveld M, Bodkergaard K, Reyes C, Moayyeri A, Voss A, Marconi E, Lapi F, Reinold J, Verhamme K, Pedersen L, Braitmaier M, De Wilde M, Far Ruiz M, Aragón M, Bosco-Levy P, Lassalle R, Prieto-Alhambra D, Sanchez-Santos M. Drug utilization analysis of osteoporosis medications in seven European electronic health databases. Osteoporosis International. 2023;34(10):1771-1781.
    https://doi.org/10.1007/s00198-023-06837-0
  • 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
  • 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
  • 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
  • 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
  • Platzbecker K, Voss A, Reinold J, Elbrecht A, Biewener W, Prieto-Alhambra D, Jödicke A, Schink T. Validation of algorithms to identify acute myocardial infarction, stroke, and cardiovascular death in German health insurance data. Clinical Epidemiology. 2022;14:1351-1361.
    https://doi.org/10.2147/CLEP.S380314
  • de Sordi D, Kappen S, Otto-Sobotka F, Kulschewski A, Weyland A, Gutierrez L, Fortuny J, Reinold J, Schink T, Timmer A. Validity of hospital ICD-10-GM codes to identify anaphylaxis. Pharmacoepidemiology and Drug Safety. 2021;30(12):1643-1652.
    https://doi.org/10.1002/pds.5348
  • 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
  • Komen J, Pottegård A, Mantel-Teeuwisse A, Forslund T, Hjemdahl P, Wettermark B, Hellfritzsch M, Hallas J, Olesen M, Bennie M, Mueller T, Voss A, Schink T, Haug U, Kollhorst B, Karlstad Ø, Kjerpeseth LJ, Klungel O. Persistence and adherence to non-vitamin K antagonist oral anticoagulant treatment in patients with atrial fibrillation across five Western European countries. Europace. 2021;23(11):1722-1730.
    https://doi.org/10.1093/europace/euab091
  • 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
  • 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
  • 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
  • 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

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.

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:
Jonas Reinold
Tel: +49 (0)421 218-56868
Fax: +49 (0)421 218-56941

Email:
reinold(at)leibniz-bips.de