This is a repository copy of Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review.

BackgroundConsumer Medicine Information (CMI) is a brand‐specific and standardized source of written medicine information available in Australia for all prescription medicines. Side‐effect information is poorly presented in CMI and may not adequately address consumer information needs.ObjectiveTo explore consumer opinions on (i) the presentation of side‐effect information in existing Australian CMI leaflets and alternative study‐designed CMIs and (ii) side‐effect risk information and its impact on treatment decision making.DesignFuzzy trace, affect heuristic, frequency hypothesis and cognitive‐experiential theories were applied when revising existing CMI side‐effects sections. Together with good information design, functional linguistics and medicine information expertise, alternative ramipril and clopidogrel CMI versions were proposed. Focus groups were then conducted to address the study objectives.Participants and settingThree focus groups (n = 18) were conducted in Sydney, Australia. Mean consumer age was 58 years (range 50–65 years), with equal number of males and females.ResultsAll consumers preferred the alternative CMIs developed as part of the study, with unequivocal preference for the side‐effects presented in a simple tabular format, as it allowed quick and easy access to information. Consumer misunderstandings reflected literacy and numeracy issues inherent in consumer risk appraisal. Many preferred no numerical information and a large proportion preferred natural frequencies.ConclusionsOne single method of risk presentation in CMI is unable to cater for all consumers. Consumer misunderstandings are indicative of possible health literacy and numeracy factors that influence consumer risk appraisal, which should be explored further.

Background Over-the-counter (OTC) labels help support safe medication use by consumers. In 2012, the Australian Therapeutic Goods Administration (TGA) released a consultation paper proposing OTC label standardization to improve label quality via implementation of the Medicine Information Box (MIB) label. However, consumer opinions of the MIB and standardization of OTC labelling remain unexplored.Objective To explore consumer perspectives of OTC label standardization and the proposed MIB.Design Mock MIB labels were developed by the research team, guided by the TGA consultation paper, and used as interview stimulus material.Participants and setting Semi-structured interviews were conducted with 38 Australian and 39 UK adult participants. Participant perspectives on OTC label standardization, opinions on the MIB and perceived improvements were explored. All interviews were audiorecorded with permission, transcribed verbatim, and the content thematically analysed.Results Participants expressed a range of opinions towards OTC label standardization, from welcoming standardization to concern that important details may be overlooked. The MIB was generally positively received due to its perceived good information design and ease of navigation. Participants requested reordering of informationspecifically, for the active ingredient to be moved to a less prominent position. Suggested improvements centred on content and design changes, for example colour, pictograms, bolding.Conclusions Participants felt positively towards OTC label standardization and saw the MIB as a feasible standardized format to implement for OTC labels. Although they appreciated its good information design, they felt further improvements to its content and design are required to enhance its quality and usability. 948

No abstract

This is a repository copy of User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines.White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/102796/ Version: Accepted Version Article:Tong, V, Raynor, DK orcid.org/0000-0003-0306-5275 and Aslani, P (2017) User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines. ReuseUnless 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. TakedownIf 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.Page 1 of 23 User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines Abstract Background User testing evaluates written medicine information (WMI) usability by examining participant ability to find and understand information. It can also be an effective method to determine how consumers say they will act on information on an over-the-counter (OTC) label. ObjectiveTo examine reported behaviors regarding dosage and storage as a measure of a . Material and methods U OTCto find and understand key points of information using a 13-item questionnaire. Consumers were required to elaborate on their behavior in regard to 2 additional questions: 1) when they would take diclofenac if they had constant back pain from 8am (dosage-related) and; 2) where they would store it in their home (storage-related). Responses were transcribed verbatim, and coded by 2 pharmacists. ResultsAppropriate dosing for constant back pain was reported by 29 consumers. However, dosing intervals shorter than the specified 8 hours were often reported (n=19), due to adjusting intervals to accommodate up to the maximum of 8 tablets in 24 hours, desire for pain relief, and/or Page 2 of 23 pragmatic dosing (e.g. around bedtime). Only 29 consumers stated completely appropriate storage location examples (e.g. medicine cabinet). ConclusionsConsumers may act inappropriately on OTC label information about dosage and/or storage, which could potentially adversely impact medicine use. User testing can contribute to the development of high quality WMI and help identify where label wordings are inappropriate for the health literacy levels of consumers. Key wordsHealth literacy; user testing; drug labeling; non-pres...