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Gold Standards in Pharmacovigilance

The Use of Definitive Anecdotal Reports of Adverse Drug Reactions as Pure Gold and High-Grade Ore

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Abstract

Anecdotal reports of adverse drug reactions are generally regarded as being of poor evidential quality. This is especially relevant for postmarketing drug safety surveillance, which relies heavily on spontaneous anecdotal reports. The numerous limitations of spontaneous reports cannot be overemphasised, but there is another side to the story: these datasets also contain anecdotal reports that can be considered to describe definitive adverse reactions, without the need for further formal verification. We have previously defined four categories of such adverse reactions: (i) extracellular or intracellular tissue deposition of the drug or a metabolite; (ii) a specific anatomical location or pattern of injury; (iii) physiological dysfunction or direct tissue damage demonstrable by physicochemical testing; and (iv) infection, as a result of the administration of an infective agent as the therapeutic substance or because of demonstrable contamination. In this article, we discuss the implications of these definitive (‘between-the-eyes’) adverse effects for pharmacovigilance.

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Notes

  1. 1The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

We are grateful for the helpful comments of David Madigan, Robin Ferner, Paul Glasziou, Yoon Loke and Jan Vandenbroucke, who reviewed draft versions of the manuscript, and Andrew Bate, François Girardin and Sheila Weiss Smith, who refereed our original paper in the British Medical Journal.

Dr Hauben is an employee of Pfizer Inc. and owns stock and stock options in Pfizer and other pharmaceutical companies. The authors have no conflicts of interest that are directly relevant to the content of this manuscript. No funding was provided for the preparation of this review.

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Authors and Affiliations

  1. Risk Management Strategy, Pfizer Inc., 235 East 42nd Street, New York, New York, 10017, USA

    Manfred Hauben

  2. Department of Medicine, New York University School of Medicine, New York, New York, USA

    Manfred Hauben

  3. Department of Community and Preventive Medicine, New York Medical College, Valhalla, New York, USA

    Manfred Hauben

  4. Department of Pharmacology, New York Medical College, Valhalla, New York, USA

    Manfred Hauben

  5. Department of Clinical Pharmacology, Radcliffe Infirmary, Oxford, England

    Jeffrey K. Aronson

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  1. Manfred Hauben
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Correspondence to Manfred Hauben.

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Hauben, M., Aronson, J.K. Gold Standards in Pharmacovigilance. Drug-Safety 30, 645–655 (2007). https://doi.org/10.2165/00002018-200730080-00001

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