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

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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.

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Notes

  1. Pharmaceutical regulation in the US and at the FDA had a somewhat different historical evolution [62]. For example, thalidomide was not put on the US market due to safety concerns, although it did have global ramifications (see Carpenter [64]).

  2. This is despite thalidomide being one of the cases discussed in the more than 100 case studies analysis of events that produced ‘social shocks’ and public alarm in the mid-1970s (see Lawless [38]).

  3. Unofficial sources might include discussions among friends, unsubstantiated claims in the mass media or on social media, etc.

  4. The final decision rests with the European Commission, and therefore EMA committees provide an ‘opinion’.

  5. To be clear, although regulators also communicate to other actors such as healthcare professionals, the focus audience of this paper is patients.

  6. The authors would like to thank two anonymous reviewers for providing helpful comments on distinctions between conveying knowledge and changing beliefs.

  7.  At the time of writing, these frameworks were under review by the FDA and EMA, respectively.

  8.  Indeed, written information tools also seek to provide factual information to patients in order to change their beliefs (e.g. to inform patient decisions over whether to take a medicine or not) [see Sect. 5.1].

  9.  In the EU, risk minimisation tools are also referred to under the umbrella term ‘risk minimisation activities’.

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Acknowledgments

This paper was initially written after two of the authors presented at the joint PCWP (Patients’ and Consumers’ Organisations) and HCPWP (Healthcare Professionals’ Organisations) meeting on ‘Communication and Information on Medicines’ held at the EMA on 2 March 2016. The authors are grateful to EMA staff for organising the event, including Juan Garcia-Burgos, Isabelle Moulon, Ivana Silva, and Malika Holleyman, as well as all patient and doctor group attendees who provided comments and discussion at the meeting that helped inform the paper. We are also grateful to the following individuals who have provided us with materials, discussed their views on communication tools with us personally, or commented on earlier drafts of this review: Baruch Fischhoff, David Haerry, Lisa Schwartz, and Steven Woloshin. In spite of this advice, any errors remain our own.

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Authors and Affiliations

  1. King’s Centre for Risk Management, King’s College London, Strand, London, WC2R 2LS, UK

    Dominic Way & Ragnar Löfstedt

  2. MINES ParisTech, Research Center on Risk and Crisis, rue Claude Daunesse, B.P 207, 06904, Sophia Antipolis Cedex, France

    Hortense Blazsin

  3. Department of Technology and Society Studies, Maastricht University, Grote Gracht 76, 6211 SZ, Maastricht, The Netherlands

    Frederic Bouder

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  1. Dominic Way
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Correspondence to Dominic Way.

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Funding for writing this article was supported by Biogen Idec., who had no involvement and no role in designing, writing, or researching the paper, which was undertaken independently by the authors.

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Dominic Way, Hortense Blazsin, Ragnar Löfstedt and Frederic Bouder have no conflicts of interest that are directly relevant to the content of this study.

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Way, D., Blazsin, H., Löfstedt, R. et al. Pharmaceutical Benefit–Risk Communication Tools: A Review of the Literature. Drug Saf 40, 15–36 (2017). https://doi.org/10.1007/s40264-016-0466-1

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