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

AbstractThis 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 rev iewed 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 evi dence 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 conv eying 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 pa per 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.

Source: Drug Safety - October 13, 2016 Category: Drugs & Pharmacology Source Type: research