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

Abstract : This paper reviews the main tools for communicating benefit–risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. 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 goals are (i) sharing information (e.g. publishing clinical trial and adverse event data online); (ii) changing patients’ beliefs by conveying factual knowledge (e.g. patient information leaflets and the drugs facts box); and (iii) changing behaviour (e.g. patient alert cards and warning labels). The mental models approach and traffic-light labelling, developed outside the pharmaceutical context, are then examined. Ultimately, the paper provides a helicopter view of the variety of benefit–risk communication tools that are used, or could be used, by pharmaceutical regulators in the US and Europe.
Keywords : Medecine Risk
Type de document :
Article dans une revue
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https://hal-mines-paristech.archives-ouvertes.fr/hal-01411682
Contributeur : Magalie Prudon <>
Soumis le : mercredi 7 décembre 2016 - 16:21:44
Dernière modification le : lundi 12 novembre 2018 - 11:03:45

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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-01411682⟩

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