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Pharmaceutical Benefit–Risk Communication Tools: A Review of the Literature

Abstract : This paper reviews the main tools used by pharmaceutical regulators for communicating benefit-risk medicines information to patients. Two highly successful tools from the environmental/technological and food safety fields - that could be usefully adapted to the pharmaceutical context - are also reviewed. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature. Three distinct goals are then made explicit before critically examining the evidence for and against tools developed in the US (e.g. at the Food and Drug Administration [FDA]) and Europe (e.g. at the European Medicines Agency [EMA]). These are sharing information (e.g. publishing clinical trial and adverse event data online), changing patients' beliefs (e.g. patient information leaflets and the drugs facts box), and changing behaviour (e.g. risk minimisation activities and warning labels). The two tools developed in other risk communication fields - the mental models approach and traffic light labelling - are then examined. Ultimately the paper provides a helicopter view and examination of the variety of benefit-risk communication tools that are used or could be used by pharmaceutical regulators in the US and Europe.
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Submitted on : Friday, December 23, 2016 - 12:00:06 PM
Last modification on : Wednesday, November 17, 2021 - 12:31:25 PM



Dominic Way, Hortense Blazsin, Ragnar Löfstedt, Frederic Bouder. Pharmaceutical Benefit–Risk Communication Tools: A Review of the Literature. Drug Safety, Springer Verlag, 2017, 40 (1), pp.15-36. ⟨10.1007/s40264-016-0466-1⟩. ⟨hal-01421940⟩



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