title: 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.
authors.affiliation: King's Centre for Risk Management, King's College London, Strand, London, WC2R 2LS, UK. dominic.way@kcl.ac.uk.
authors.forename: Dominic
authors.identifier: 0000-0002-0581-640X
authors.initials: D
authors.lastname: Way
authors.affiliation: MINES ParisTech, Research Center on Risk and Crisis, rue Claude Daunesse, B.P 207, 06904, Sophia Antipolis Cedex, France.
authors.forename: Hortense
authors.initials: H
authors.lastname: Blazsin
authors.affiliation: King's Centre for Risk Management, King's College London, Strand, London, WC2R 2LS, UK.
authors.forename: Ragnar
authors.initials: R
authors.lastname: Löfstedt
authors.affiliation: Department of Technology and Society Studies, Maastricht University, Grote Gracht 76, 6211 SZ, Maastricht, The Netherlands.
authors.forename: Frederic
authors.initials: F
authors.lastname: Bouder
mesh_terms: D003142:Communication; D004348:Drug Labeling; D004349:Drug Packaging; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D018570:Risk Assessment / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations