Drug Safety Unit
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:
- Utilization and safety of medications during pregnancy
- Use and risks of antidepressants and antipsychotics particularly in the elderly
- Utilization, effectivity, and safety of direct oral anticoagulants (DOAC)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. The BMJ. 2016;354: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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Articles with peer-review
Only currently running projects or those that ended less than a year ago will be shown. The entries are sorted alphabetically.
- A multisite collaborative research program of observational studies to monitor the utilization and safety of dulaglutide in the EU
- Cohort study of the relative incidence of major cardiovascular events (MACE) among patients initiating prucalopride versus a matched comparator cohort
- Drug utilization post-authorization safety study on aclidinium bromide
- Non-interventional post-authorization multi-database safety to characterize the risk of angioedema and other specific safety events of interest in association with use of Entresto® (sacubitril/valsartan) in audit patients with heart failure
- Post-authorization safety study (PASS) investigating the bleeding risk in patients treated with rivaroxaban
- Post-authorization safety study (PASS) on extrapyramidal symptoms in patients treated with Abilify Maintena® in Germany
- Post-authorization safety study (PASS) on roflumilast
- Post-authorization safety study (PASS) on the risk of severe hypersensitivity reactions in patients treated with intravenous iron
- Post-authorization safety study on agomelatine and the risk of hospitalization for acute liver injury
- Studying drug safety during pregnancy based on routine data in Germany
- Use of routine data for pharmacovigilance in Germany: Method development and initial applications
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