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Clarification of Terminology in Drug Safety

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Abstract

Nomenclature surrounding drug safety needs to be clear and unambiguous, so that patients, prescribers, manufacturers, and regulators can all understand each other. In particular, it needs to make it clear how adverse events and drug therapy are related to one another, how they are best classified, and their frequency, intensity and seriousness.

In this article, we therefore discuss and define terms used in the field of drug safety, particularly terms that are sometimes misunderstood or misused, including medicinal product, pharmaceutical formulation, excipient, adverse event (or experience) and adverse drug reaction (or effect). We also discuss terms used to define the seriousness, intensity, and risk of adverse reactions, and their classification.

Instead of creating definitions from scratch, as is commonly done, we have taken the novel approach of critically examining definitions that have been proposed or widely used and have formulated new or modified definitions based on a logical appraisal of their merits and demerits. We hope that these definitions will lead to discussion that will allow a corpus of satisfactory definitions to be widely agreed.

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Acknowledgements

No sources of funding were used to assist in the preparation of this study. The authors have no conflicts of interest that are directly relevant to the content of this study.

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  1. University Department of Clinical Pharmacology, Radcliffe Infirmary, Woodstock Road, Oxford, OX2 6HE, UK

    Jeffrey K. Aronson

  2. West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham, UK

    Robin E. Ferner

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Correspondence to Jeffrey K. Aronson.

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Aronson, J.K., Ferner, R.E. Clarification of Terminology in Drug Safety. Drug-Safety 28, 851–870 (2005). https://doi.org/10.2165/00002018-200528100-00003

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