Unit Drug Safety

The Drug Safety unit studies drug and vaccine safety after approval. Clinical studies prior to the market release of new drugs often do not detect certain risks because they test for a relatively short period of time on a limited patient collective, e.g. mostly excluding children, pregnant women or elderly people. However, rare drug risks can often only be detected in long-term trials with large, heterogeneous populations which include these special patient groups as well as patients with previous and accompanying ailments or co-medications.

To investigate the safety and efficacy of medicinal products, the unit uses secondary data, in particular that of the Pharmacoepidemiological Research Database (GePaRD).

The unit covers a wide spectrum of research questions from the area of drug and vaccine safety. A particular focus is on the following areas:

Selected publications

    Articles with peer-review

  • Trifirò G, de Ridder M, Sultana J, Oteri A, Rijnbeek P, Pecchioli S, Mazzaglia G, Bezemer I, Garbe E, Schink T, Poluzzi E, Frøslev T, Molokhia M, Diemberger I, Sturkenboom MCJM. Use of azithromycin and risk of ventricular arrhythmia. Canadian Medical Association Journal. 2017;189(15):E560-E568.
    http://dx.doi.org/10.1503/cmaj.160355
  • Jobski K, Schmedt N, Kollhorst B, Krappweis J, Schink T, Garbe E. Characteristics and drug use patterns of older antidepressant initiators in Germany. European Journal of Clinical Pharmacology. 2017;73(1):105-113.
    http://dx.doi.org/10.1007/s00228-016-2145-7
  • Schmedt N, Kollhorst B, Enders D, Jobski K, Krappweis J, Garbe E, Schink T. Comparative risk of death in older adults treated with antipsychotics: A population-based cohort study. European Neuropsychopharmacology. 2016;26(9):1390-1400.
    http://dx.doi.org/10.1016/j.euroneuro.2016.07.006
  • Douros A, Jobski K, Kollhorst B, Schink T, Garbe E. Risk of venous thromboembolism in cancer patients treated with epoetins or blood transfusions. British Journal of Clinical Pharmacology. 2016;82(3):839-848.
    http://dx.doi.org/10.1111/bcp.13019
  • Schmedt N, Jobski K, Kollhorst B, Krappweis J, Schink T, Rüther E, Garbe E. Treatment patterns and characteristics of older antipsychotic users in Germany. International Clinical Psychopharmacology. 2016;31(3):159-169.
    http://dx.doi.org/10.1097/YIC.0000000000000119
  • Arfè A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff VE, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom MCJM, Corrao G, on behalf of the SOS project consortium. Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: Nested case-control study. British Medical Journal. 2016;354:i4857.
    http://dx.doi.org/10.1136/bmj.i4857
  • Schink T, Behr S, Thöne K, Bricout H, Garbe E. Risk of stroke after herpes zoster - Evidence from a German self-controlled case-series study. PLOS ONE. 2016;11(11):e0166554.
    http://dx.doi.org/10.1371/journal.pone.0166554
  • Swart E, Bitzer EM, Gothe H, Harling M, Hoffmann F, Horenkamp-Sonntag D, Maier B, March S, Petzold T, Röhrig R, Rommel A, Schink T, Wagner C, Wobbe S, Schmitt JM. STandardisierte BerichtsROutine für Sekundärdaten Analysen (STROSA) - ein konsentierter Berichtsstandard für Deutschland, Version 2. Das Gesundheitswesen. 2016;78(Suppl. 1):e145-e160.
    http://dx.doi.org/10.1055/s-0042-108647
  • Holstiege J, Enders D, Schink T, Innocenti F, Oteri A, Bezemer I, Lapi F, Kaguelidou F, Poluzzi E, Puccini A, Ulrichsen SP, Sturkenboom MCJM, Trifirò G, Garbe E. Trends in paediatric macrolide use in five European countries - A population-based study. European Journal of Clinical Pharmacology. 2015;71(8):991-999.
    http://dx.doi.org/10.1007/s00228-015-1870-7
  • Jobski K, Kollhorst B, Schink T, Garbe E. The risk of opioid intoxications or related events and the effect of alcohol-related disorders: A retrospective cohort study in German patients treated with high-potency opioid analgesics. Drug Safety. 2015;38(9):811-822.
    http://dx.doi.org/10.1007/s40264-015-0312-x
  • Jobski K, Enders D, Amann U, Suzart K, Wallander M-A, Schink T, Garbe E. Use of rivaroxaban in Germany: A database drug utilization study of a drug started in hospital. European Journal of Clinical Pharmacology. 2014;70(8):975-981.
    http://dx.doi.org/10.1007/s00228-014-1697-7
  • Schink T, Holstiege J, Kowalzik F, Zepp F, Garbe E. Risk of febrile convulsions after MMRV vaccination in comparison to MMR or MMR+V vaccination. Vaccine. 2014;32(6):645-650.
    http://dx.doi.org/10.1016/j.vaccine.2013.12.011
  • Holstiege J, Schink T, Molokhia M, Mazzaglia G, Innocenti F, Oteri A, Bezemer I, Poluzzi E, Puccini A, Ulrichsen SP, Sturkenboom MCJM, Trifirò G, Garbe E. Systemic antibiotic prescribing to paediatric outpatients in 5 European countries: A population-based cohort study. BMC Pediatrics. 2014;14:174.
    http://dx.doi.org/10.1186/1471-2431-14-174
  • Valkhoff VE, Schade R, 't Jong GW, Romio S, Schuemie M, Arfè A, Garbe E, Herings R, Lucchi S, Picelli G, Schink T, Straatman H, Villa M, Kuipers EJ, Sturkenboom MCJM, on behalf of the SOS project consortium. Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries. What size of data platforms and which study designs do we need to assess safety issues? The SOS project. BMC Pediatrics. 2013;13:192.
    http://dx.doi.org/10.1186/1471-2431-13-192
  • Schmedt N, Garbe E. Antipsychotic drug use and the risk of venous thromboembolism in elderly patients with dementia. Journal of Clinical Psychopharmacology. 2013;33(6):753-758.
    http://dx.doi.org/10.1097/JCP.0b013e3182a412d5
  • Amann U, Schmedt N, Garbe E. Prescribing of potentially inappropriate medications for the elderly: An analysis based on the PRISCUS list. Deutsches Ärzteblatt International. 2012;109(5):69-75.
    http://dx.doi.org/10.3238/arztebl.2012.0069

Current projects

Staff

Pisa, Federica, Dr.
Tel.: +49 (0)421 218-56869
Fax: +49 (0)421 218-56941
pisa(at)leibniz-bips.de

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

Schink, Tania, Dr.
Tel.: +49 (0)421 218-56865
Fax: +49 (0)421 218-56941
schink(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

Wentzell, Nadine
Tel.: +49 (0)421 218-56879
Fax: +49 (0)421 218-56941
wentzell(at)leibniz-bips.de

Witzleb, Anna Julia
Tel.: +49 (0)421 218-56843
Fax: +49 (0)421 218-56941
witzleb(at)leibniz-bips.de