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Communication of Medical Product Risk

How Effective is Effective Enough?

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Abstract

Ever-increasing attention is being paid worldwide to the safety of medical products, and the risks associated with their use. The integral role of risk communication in overall risk management is demonstrated by several recent market withdrawals of drugs, in which a perceived incapability of healthcare systems to manage well-characterised, avoidable risks was a significant factor.

With advances in clinical pharmacology, pharmacogenomics and pharmacoepidemiology expanding our knowledge of medical products, effective delivery of the latest safety-related information to health professionals and consumers becomes even more imperative. In this regard, it is important to evaluate whether current modes of risk communication lead to desired changes in relevant behaviours such as prescribing or drug monitoring, particularly in context with which achieved level of effectiveness is deemed acceptable. This is crucial, as there have been product-specific risk communication efforts that achieved a fair degree of success, yet were not seen as effective enough to prevent market withdrawal of the medical product in question.

In the service of improving public health through enhanced risk communication, it is essential to critically assess current methods, both as to results achieved (or not), and whether each method is applicable to the various types of risks associated with medical product use. Furthermore, just as combining methods may well improve overall risk communication, there are societal and psychological factors that must be considered in attempting to maximise effectiveness. However, in assessing risk communication effectiveness, the particular benefit-risk relationship of any individual medical product must also be part of the evaluative process.

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Acknowledgements

No funding was obtained from any source specific to the preparation of this manuscript. In the course of the author’s career in medical product safety, he has been a full-time employee of both the US Food and Drug Administration FDA) and Knoll Pharmaceutical Company (Abbott Laboratories), and acted as a consultant to pharmaceutical companies. During the author’s tenure at FDA, he served on the Task Force on Risk Management that is described in the manuscript.

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  1. Stephen A. Goldman Consulting Services L.L.C., 34 Arlington Avenue, Morris Plains, New Jersey, 07950, USA

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Correspondence to Stephen A. Goldman.

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Goldman, S.A. Communication of Medical Product Risk. Drug-Safety 27, 519–534 (2004). https://doi.org/10.2165/00002018-200427080-00005

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