Abstract
Current regulatory guidelines related to pharmaceutical risk minimization put most emphasis on risk communication and control of the use of drugs. Little, if any, consideration is given to those aspects of an adverse drug reaction that ultimately determine whether the risk can be minimized. However, this limited scope is unfortunate and could prevent risk minimization activities from improving drug use safety. This article attempts to present an overview of possible elements of pharmaceutical risk minimization and to place these in a framework. The promotion of drug safety through risk communication and control of use should be advanced, with more attention to actionable and evidence-based guidance relating to the ‘pretreatment evaluation’, and in particular the ‘on-treatment management’ of the patient.
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Notes
1Following new US legislation, this plan may in future be referred to as a ‘Risk Evaluation and Mitigation Strategy’ (REMS)
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No sources of funding were used to assist in the preparation of this review, and the author has no conflicts of interest that are directly relevant to the content of this review.
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Callréus, T. On Pharmaceutical Risk Minimization. Drug-Safety 31, 737–742 (2008). https://doi.org/10.2165/00002018-200831090-00002
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DOI: https://doi.org/10.2165/00002018-200831090-00002