Pharmacoepidemiology

In the last decades, we have witnessed a tremendous progress in the medical sciences that has led to the development of a great number of new powerful pharmaceuticals. These new medicines enable us to provide much better medical care, but occasionally they will cause harm and give rise to serious adverse reactions that were unexpected from preclinical studies or premarketing clinical trials. Moreover, their effectiveness compared to long-established treatments is sometimes unclear. Against this background, pharmacoepidemiology has developed as a scientific discipline at the interface between clinical pharmacology and epidemiology (cf. chapter Clinical Epidemiology and Evidence-Based Health Care of this handbook). Pharmacoepidemiology can be defined as the application of epidemiological knowledge, methods, and reasoning to the study of the effects and uses of drugs in human populations (Porta M, Hartzema AG, Tilson HH, Pharmacoepidemiology. The fundamentals, Harvey Whitney, Cincinnati, 1997). The application of epidemiological methods – that is, the use of nonexperimental observational techniques – the epidemiological perspective with an emphasis on investigations in large unselected populations and long-term studies, the public health approach, and the philosophy of epidemiology are all extended to the scope of clinical pharmacology, that is, the study of the effects of pharmaceuticals in humans.

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Author information

Authors and Affiliations

1. Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen, Germany Edeltraut Garbe
2. Faculty of Human and Health Sciences, University of Bremen, Bremen, Germany Edeltraut Garbe
3. Division of Clinical Epidemiology, Department of Medicine, McGill University, Montreal, QC, Canada Samy Suissa & Antonios Douros
4. Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada Samy Suissa & Antonios Douros

1. Edeltraut Garbe