C Basic & Clinical Pharmacology & Toxicology 2006, 98, 235.Printed in Denmark . All rights reserved

Copyright C

ISSN 1742-7835

BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY SYMPOSIUM

May 27–28, 2005, Kolding, Denmark

Current Controversies in Pharmacoepidemiology

The Editor of BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, Professor Kim Brøsen, pro-posed a pharmacoepidemiological symposium to celebrate the Journal’s 60th anniversary. We, the under-signed, were given free hands to invite the World’s leading experts. The symposium was entitled ‘‘CurrentControversies in Pharmacoepidemiology’’ and held on May 27–28 2005 at Koldingfjord in Kolding, in thesouthern part of Denmark. We are happy to say that the symposium was a great success due to the manyvaluable contributions, to spirited discussions, and not least due to the generous funding and the practicalarrangement of the symposium by BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY.

Pharmacoepidemiology can be defined as the study of effects of and use of drugs in large populations. Itis the use of epidemiological methods to address issues from clinical pharmacology, usually questions aboutthe balance between beneficial and adverse effects of drugs. There is a tremendous public interest in pharm-acoepidemiogical scientific results. Among the controversies that have recently generated heated debateare the cardiac effects of non-steroidal antiinflammatory drugs and selective cyclooxygenase-2-inhibitors,gastrointestinal bleedings induced by paracetamol or selective serotonin reuptake-inhibitors, protective ef-fects of statins against fractures or dementia, cardiovascular or cancerogenic effects of hormone replace-ment therapy, to name a few. Several of these issues were covered in the symposium.

A pharmacoepidemiologist usually work with observational methods, comparing the outcomes be-tween users and non-users of drugs. Unlike in the clinical trial, users are not allocated randomly, butthey become users or non-users by their own and their prescribers’ decisions. Thereby, they are non-comparable by nature. The intellectual challenge of addressing and overcoming this lack of comparabilityis one of the most intriguing elements of the pharmacoepidemiologist’s work. Some examples of therecently developed techniques are presented in this issue.

The most important methodological development in pharmacoepidemiology during the past twentyyears has been the emergence of large population-based databases covering prescriptions and outcomesfor entire populations. One striking example is the British General Practitioners Research Database,which has complete capture of all general practitioner contacts for some 4 million persons since 1987.By using such data sources, it is possible with relatively low cost and relatively little delay to provide aqualified response to emergent safety issues. A number of examples are provided in the current issue ofthe Journal. We also present some examples of how prescription databases can be used to capture,describe and possibly intervene against problems with quality of prescribing.

This issue of the Journal reflects a natural development in the spectrum of pharmacological science.From originally thought of as being mainly a basic laboratory discipline, it has developed through therational clinical applicability of pharmacology and now looks at drug use in a society perspective.

We hope you will enjoy reading the papers.

Jesper Hallas Morten Andersen

Organizers