Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology is a scientific discipline that bridges pharmacology and epidemiology. It studies the effects of drugs in humans and carries out risk-benefit assessments of drugs in patients.

The Department of Clinical Pharmacology and Toxicology engages in drug safety research in all phases of drug development. Pharmacoepidemiology analyzes the post-marketing safety of drugs using statistical approaches in appropriate databases. This allows quantitative evaluation of the severity of a safety signal that emerges from routine patient care, pharmacovigilance, health authority communications or the published literature. The aim of pharmacoepidemiology in the setting of an academic hospital is to identify drug-related safety issues, assess the true risk and thereby improve patient safety.

Selected publications from our department

  • Jödicke AM, Curkovic I, Zellweger U, Tomka IT, Neuer T, Kullak-Ublick GA, Roos M, Egbring M. Analysis of drug-drug interactions in Swiss claims data using tizanidine and ciprofloxacin as a prototypical contraindicated combination. Ann Pharmacother 2018 May 1. doi: 10.1177/1060028018775914
  • Kullak-Ublick GA, Andrade RJ, Merz M, End P, Benesic A, Gerbes AL, Aithal GP. Drug-induced liver injury: recent advances in diagnosis and risk assessment. Gut 2017; 66: 1154-1164
  • Kullak-Ublick GA, Merz M, Griffel L, Kaplowitz N, Watkins PB. Liver safety assessment in special populations (hepatitis B, C, and oncology trials). Drug Saf 2014; 37 Suppl. 1: S57-62
  • Merz M, Lee KR, Kullak-Ublick GA, Brueckner A, Watkins PB. Methodology to assess clinical liver safety data. Drug Saf 2014; 37 Suppl 1: S33-45
  • Church RJ, Kullak-Ublick GA, Aubrecht J, Bonkovsky HL, Chalasani N, Fontana RJ, Goepfert JC, Hackman F, King NMP, Kirby S, Kirby P, Marcinak J, Ormarsdottir S, Schomaker SJ, Schuppe-Koistinen I, Wolenski F, Arber N, Merz M, Sauer JM, Andrade RJ, van Bömmel F, Poynard T, Watkins PB. Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury: An international collaborative effort. Hepatology 2018 Jan 22. doi: 10.1002/hep.29802
  • Jödicke A, Dahmke H, Damke B, Schäublin M, Kullak-Ublick GA, Weiler S. Severe injection site reactions after subcutaneous administration of Sayana: a retrospective, post-marketing analysis of WHO and Swiss spontaneous pharmacovigilance reports. Swiss Med Wkly 2017 Jun 21;147:w14432. doi: 10.4414/smw.2017.14432
  • Meli M, Rauber-Lüthy C, Hoffmann-Walbeck P, Reinecke HJ, Prasa D, Stedtler U, Färber E, Genser D, Kupferschmidt H, Kullak-Ublick GA, Ceschi A. Atypical antipsychotic poisoning in young children: a multicentre analysis of poisons centres data. Eur J Pediatr 2014; 173: 743-50
  • Mwinyi J, Vokinger K, Jetter A, Breitenstein U, Hiller C, Kullak-Ublick GA, Trojan A. Impact of variable CYP genotypes on breast cancer relapse in patients undergoing adjuvant tamoxifen therapy. Cancer Chemother Pharmacol 2014; 73: 1181-8
  • Gutscher K, Rauber-Lüthy C, Haller M, Braun M, Kupferschmidt H, Kullak-Ublick GA, Ceschi A. Patterns of toxicity and factors influencing severity in acute adult trimipramine poisoning. Br J Clin Pharmacol 2013; 75: 227-235
  • Curkovic I, Rentsch KM, Frei P, Fried M, Rogler G, Kullak-Ublick GA, Jetter A. Low allopurinol doses are sufficient to optimize azathioprine therapy in inflammatory bowel disease patients with inadequate thiopurine metabolite concentrations. Eur J Clin Pharmacol 2013; 69: 1521-31
  • Curkovic I, Egbring M, Kullak-Ublick GA. Risks of inflammatory bowel disease treatment with glucocorticosteroids and aminosalicylates. Dig Dis 2013; 31(3-4): 368-73
  • Goltz L, Kullak-Ublick GA, Kirch W. Potentially inappropriate prescribing for elderly outpatients in Germany: a retrospective claims data analysis. Int J Clin Pharmacol Ther 2012; 50: 185-194