„The granting of a market authorization does not mean that there are no safety issues with a product. It means that, on present evidence, those that have been identified are considered to be outweighed by the benefits.“

This quote from P. Waller summarizes the essence of drug safety and implies the need for on ongoing evaluation of a drug’s safety profile. In fact, drug safety is not completed but only restarts after a drug’s regulatory approval and start of marketing, and is then also referred to as postmarketing safety.

The Section of Pharmacoepidemiology and Drug Safety conducts pharmaco-epidemiological research and evaluates drug safety in clinical practice. It is well integrated into many other activities related to drug safety at the Department of Clinical Pharmacology and Toxicology. These include the regional pharmacovigilance center, drug information services, clinical safety ward rounds at the University Hospital, education and training of medical students and practicing physicians, and clinical and basic research with a focus on drug transporters and pharmacogenetics.

Research and Services

We maintain various national and international research collaborations with academic groups, regulatory authorities and industry. We also provide a range of drug safety services, including:

       •  Formal pharmacoepidemiological studies (cohort and case-control studies) in large automated databases

       •   Drug utilization studies

       •   Disease epidemiology studies relevant for drug safety

       •  Retrospective and prospective hospital-based safety studies including evaluation and development of electronic drug prescription with clinical decision support

       •  Comprehensive evaluation of safety data from randomized clinical trials, pharmacovigilance systems and pharmacoepidemiological studies

       •  Independent drug safety expert reports

Data resources

We have first-hand research experience with a range of large automated medical records and claims databases suitable for pharmacoepidemiological research. These include the GPRD (UK), Henry Ford Health System (USA), Pharmetrics (USA), Thomson Medstat's MarketScan and Medicare (USA), and AMSP (CH/D/A).

Patient-level validation of electronic medical information

Patient-level validation can be an essential step for inclusion or exclusion of “cases” in pharmacoepidemiological studies. For that purpose we developed an html-based software solution named Phynx.

Phynx is a flexible and highly efficient tool for visualizing patient-level electronic medical data in chronological order. It is based on html format for platform independent viewing in a web browser. The original application was developed using data from the UK GPRD, but it can also use data from other sources.

Contact

PD Dr. med. Stefan Russmann
Head of Pharmacoepidemiology and Drug Safety
Clinical Pharmacologist and Toxicologist
Adjunct Associate Professor of Epidemiology, Boston University

e-mail: stefan.russmann@usz.ch
phone: +41 - 44 - 255 2067

Publication list S. Russmann - click for pdf download
(latest update: April 2012)

Publist_Russmann_04-2012.pdf 

 Selected publications

e-mail for reprint requests

  ·         Zorina OI, Haueis P, Semmler A, Marti I, Gonzenbach RR, Guzek M, Kullak-Ublick GA, Weller M, Russmann S.
Comparative Evaluation of the Drug Interaction Screening Programs MediQ and ID PHARMA CHECK in Neurological Inpatients
Pharmacoepidemiology and Drug Safety 2012, in press

 ·          Fritz D, Ceschi A, Curkovic I, Huber M, Egbring M, Kullak-Ublick GA, Russmann S.
Comparative Evaluation of Three Clinical Decision Support Systems: Prospective Screening for Medication Errors in 100 Medical Inpatients.
Eur J Clin Pharmacol 2012, Feb 29 [Epub ahead of print]

·           Haueis P, Greil W, Huber M, Grohmann R, Kullak-Ublick GA, Russmann S.
Evaluation of Drug Interactions in 84,607 Psychiatric Inpatients Using A Data Interface for Mass Analysis with Clinical Decision Support Software.
Clinical Pharmacology & Therapeutics 2011, Oct;90(4):588-96.

·           Gonzenbach RR, Teagtmeyer AB, Luft A, Russmann S.
Interaction between Fluoxetine and Clopidogrel after Acute Ischemic Stroke.
Lancet Neurology 2011 Jun; 10(6): 499-500

·           Russmann S, Jetter A, Kullak-Ublick GA
Pharmacogenetics of Drug-induced Liver Disease
Hepatology 2010, 52(2):748-61

·           Egbring M, Kullak-Ublick GA, Russmann S.
Phynx - An Open Source Software Solution Supporting Data Management and Web-based Patient-Level Data Review for Drug Safety Studies in the General Practice Research Database and Other Health Care Databases.
Pharmacoepidemiology and Drug Safety 2010 Jan; 19(1):38-44.

·           Motsko SP, Russmann S, Ming EE, Singh VP, Vendiola R, Jones JK.
Effectiveness of Rosuvastatin Compared to Other Statins for the Prevention of Cardiovascular Events - A Cohort Study in 395'039 Patients from Clinical Practice.
Pharmacoepidemiology and Drug Safety 2009 Dec; 18(12):1214-22.

·           Russmann S, Lamerato L, Motsko SP, Pezzullo J, Faber MD, Jones JK.
Risk of Impaired Renal Function After Colonoscopy: Risk of Further Decline in Renal Function After Use of Oral Sodium Phosphate or Polyethylene Glycol in Patients With a Preexisting Glomerular Filtration Rate Below 60 ml/min.
American Journal of Gastroenterology 2008 Nov, 103(11):2707-16.

·           Jick H, Kaye JA, Russmann S, Jick S.
NSAIDs and acute myocardial infarction in patients with no major risk factors.
Pharmacotherapy 2006; 26(10):1379-87.

·           Russmann S, Kaye JA, Jick SS, Jick H.
Risk of cholestatic liver disease associated with flucloxacillin and flucloxacillin prescribing habits in the UK: cohort study using data from the UK General Practice Research Database.
Br J Clin Pharmacol 2005;60(1):76-82.

·       Russmann S, Lauterburg BH, Helbling A.
Kava hepatotoxicity.
Ann Intern Med 2001;135(1):68-9.