Talking About Harm and Benefit Information-The Challenges in Healthcare Practice This is a repository copy of Talking About Harm and Benefit Information-The Challenges in Healthcare Practice. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/93946/ Version: Accepted Version Proceedings Paper: Raynor, DK (2015) Talking About Harm and Benefit Information-The Challenges in Healthcare Practice. In: Drug Safety. 15th ISoP Annual Meeting “Cubism in Pharmacovigilance”, 27-30 Oct 2015, Prague, Czech Republic. Springer , p. 960. https://doi.org/10.1007/s40264-015-0346-0 eprints@whiterose.ac.uk https://eprints.whiterose.ac.uk/ Reuse Unless indicated otherwise, fulltext items are protected by copyright with all rights reserved. The copyright exception in section 29 of the Copyright, Designs and Patents Act 1988 allows the making of a single copy solely for the purpose of non-commercial research or private study within the limits of fair dealing. The publisher or other rights-holder may allow further reproduction and re-use of this version - refer to the White Rose Research Online record for this item. Where records identify the publisher as the copyright holder, users can verify any specific terms of use on the publisher’s website. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request. mailto:eprints@whiterose.ac.uk https://eprints.whiterose.ac.uk/ Session type Abstract submission Topic Benefit / Burden of pharmacovigilance (Pharmacoeconomics and Pharmacovigilance) Presentation preference Oral - invited Abstract title Talking about harm and benefit information – the challenges in healthcare practice Co-authors D.K. Raynor 1,2 . 1 University of Leeds Faculty of Medicine and Health, School of Healthcare - Pharmacy Practice, Leeds, United Kingdom. 2 Luto Research, n/a, Leeds, United Kingdom. Abstract text Effective pharmacovigilance increasingly depends on patients playing their part, but the ‘dialogue’ is impeded because of patients’ lack of knowledge of drug development and safety measures. However, the main barrier is the language we use, which is not the language of the man or woman in the street. Even many grass roots health professionals struggle to describe what ‘pharmacovigilance’ means – it is meaningless to patients. What words would they understand to describe the process? Equally we talk about benefit/risk, whereas what we mean is the chance of benefit and the risk of harm. Pharmacovigilance should allow the patient and prescriber to understand the benefit/harm balance for a medicine and decide if it is right for them – but we currently only given them numerical information about the risk of harm (‘affects less than 1 in 10 people’) – and nothing about the chance of benefit. This means a truly informed decision is not possible. So, how can we best describe numerically the chance of benefit, and where can we source that information? User testing of patient information leaflets is helping to make such leaflets fit-for- purpose, but wordings imposed by regulators are not tested. The wording associated with the Black Triangle initiative is a case in point: ‘Warning – this medicine is subject to additional monitoring’ means something quite different to some lay people – they think it means that they will have more tests or checks (monitoring) if they take the medicine. Equally the wordings recommended by PRAC appear less than ideal, and are un-tested. Finally, Risk Management Plan summaries are designed to inform lay people about how the plans for safe use of medicines have been developed and put into practice. But what does user testing of RMP Summaries show? Are they fit for purpose? This presentation will draw on academic research from the University of Leeds on describing benefit and harm information for patients, along with practical examples from user testing in practice by Luto Research, a spin out company of the University.