Communication of Medical Product Risk
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LEADING ARTICLE
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Communication of Medical Product Risk How Effective is Effective Enough? Stephen A. Goldman Stephen A. Goldman Consulting Services L.L.C., Morris Plains, New Jersey, USA
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 benefitrisk relationship of any individual medical product must also be part of the evaluative process.
1. Historical Perspective In recent years, there has been heightened concern about the safe use of such marketed medical products as prescription and non-prescription drugs, biological agents and medical devices. As a result,
the methods by which the relative benefit-risk relationship of medical products are assessed, monitored and acted upon have come under close scrutiny. Given the prominence of the US FDA’s position in innovative medical product risk management, an historical perspective on the FDA’s national and
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cooperative international initiatives regarding this critical public health issue is valuable. In 1998, under then Commissioner Dr Jane Henney, a Task Force was established to assess the system for managing risks associated with the use of FDA-approved medical products, with particular focus on the role of the FDA. The resulting May 1999 Report to the FDA Commissioner, ‘Managing the Risks from Medical Product Use: Creating a Risk Management Framework’,[1] was a landmark document that established the FDA’s phil
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