This is a repository copy of Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/93951/ Version: Accepted Version Article: Tong, V, Raynor, DK and Aslani, P (2014) Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. International Journal of Clinical Pharmacy, 36 (5). pp. 865-872. ISSN 2210-7703 https://doi.org/10.1007/s11096-014-9975-0 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. 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Consumers obtain this information from health care professionals such as pharmacists [1-3], 8 product labels [4, 5] and written medicine information leaflets (WMI) [1, 6]. 9 Consumers use OTC labels (medicine information provided on the packaging) and WMI (leaflets provided 10 with medicines, also referred to as Patient Information Leaflets) to further their understanding about a 11 [7], with similar 12 information highly valued by consumers before starting an OTC medicine [1]. Consequently, OTC labels and 13 WMI must deliver medicine information in an understandable manner. 14 Design and comprehensibility factors influence the degree to which medicine information is fit for purpose, 15 and thus, are critical considerations in OTC label and WMI development. Various strategies have been 16 implemented to ensure the quality of medicine information, such as OTC label standardisation in the 17 United States (U.S.) [8] and mandatory consumer testing of all WMI in the European Union [9] to ensure 18 usability. Similarly, a recent consultation paper published by the Therapeutic Goods Administration has 19 proposed the introduction of a standardised OTC medicine label format in Australia [10]. This indicates that 20 existing OTC labels may not be satisfactory and require improvements to better support safe and 21 appropriate use. Due to increasing consumer self-management, a better understanding of specific factors 22 such as design and comprehensibility in relation to OTC medicines information is critical to help ensure that 23 future optimisation strategies address previously identified deficits and incorporate evidence-based 24 recommendations. 25 Page 1 of 16 26 Aim of the review 27 The aim of the review was to undertake an in-depth exploration of studies that have evaluated design 28 and/or comprehensibility of OTC labels and WMI. 29 Methods 30 A narrative literature review was conducted using Medline, Embase, PubMed and International 31 Pharmaceutical Abstracts database searches to identify relevant original research pertaining to OTC WMI 32 and/or labels from 1987 to 2013. Relevant key terms and subject headings included: patient education, 33 drug labelling, medicine information, health information, package insert, patient information leaflet, label, 34 product label, packaging, over the counter medicine, over-the-counter, OTC, non-prescription drugs, 35 readability, design, comprehension, understanding. Key author and reference list searching was also 36 conducted to identify additional studies that met the inclusion criteria and key terms. T 37 (sourced primarily from government or organisation publications) was also searched for relevant 38 publications. 39 Studies were included if OTC label or WMI comprehensibility and/or design aspects were evaluated. OTC 40 labels and WMI included any labels or WMI currently available for an OTC product or developed specifically 41 for research. Articles were excluded if they: were written in a language other than English; primarily 42 examined pictograph understanding and use in OTC labels or WMI; examined consumer interpretation of 43 OTC treatment benefits or harm only; explored consumer opinions on comprehensibility and/or design 44 aspects alone; or if the study findings did not explicitly refer to OTC labels or WMI. Studies that fell within 45 any of these categories were outside the scope of this review. 46 Specific study aspects that were extracted and reviewed for all included articles were: medicine 47 information sources that were the subject of evaluation by the study authors (OTC labels, WMI or both), 48 whether the evaluation primarily involved researchers or consumers, study objectives, study sample and 49 sample size, study design, tools utilised and relevant outcome measures, key study findings relevant to the 50 review aim and data generalisability. These study aspects were reviewed by one researcher, and a second 51 researcher reviewed a proportion of the articles for accuracy of inclusion and review. Page 2 of 16 52 Results 53 A total of 35 studies were included in the review, which explored OTC medicine information design and/or 54 comprehensibility through either researcher-orientated (n=8) or consumer-based (n=27) studies. Consumer 55 comprehensibility studies were diverse in design with respect to participant demographics, sample size, 56 questionnaire length and item types, amongst other study design factors. Study conclusions highlighted 57 poor to adequate consumer understanding. Design influenced OTC label and WMI performance and 58 generally improved consumer-related outcomes measured. Tables 1 and 2 highlight the studies included in 59 the review. Further details regarding key study design aspects and findings can be found in the 60 supplementary tables available as electronic material. 61 [INSERT TABLE 1] 62 [INSERT TABLE 2] 63 Researcher evaluation of OTC labels or WMI 64 a. Comprehensibility 65 Comprehensibility evaluation was solely conducted by researchers in 5 identified studies (1 study explored 66 OTC labels; 4 remaining studies examined OTC WMI). A wide range of reading grade levels were 67 ascertained to be required to read OTC labels [11]. Poor OTC WMI readability was determined by 68 researchers using readability formulae [12-15]. For instance, mean reported reading grade levels 69 determined using the Simplified Measure of Gobbledygook ranged between 10.5 [15] and 12.7 [12]. 70 Consumers therefore required near completion of a secondary level of education to adequately 71 comprehend information contained in WMI. 72 b. Design 73 Most OTC WMI utilised bullet points and headings [18], identified as elements of good information design 74 by the author. However, in some WMI, deviation from good information design principles was evident 75 through the use of small font size and a single column format with lengthy sentences [18]. Other 76 unfavourable design characteristics identified in the studies included: 77 use of all upper case lettering for parts of OTC labels [16] and WMI [18]; Page 3 of 16 78 minimal use of bullet points in indications and warning sections in OTC labels [17]; 79 lack of bolding (for emphasis) of OTC label warnings information [16] and indications [17]; 80 hyphenation of precautions/warnings information in OTC labels [16, 17]; 81 consistent use of small font size for warnings information and indications on OTC labels, despite 82 increases in packaging size [16] 83 Impact on measured consumer-related outcomes 84 a. Study design and outcome measures of consumer-orientated studies 85 A range of study designs have been used to ascertain the impact of OTC medicine information on 86 consumer-related outcomes. Sampling frames differed, ranging from mainly younger [20, 26, 33, 36, 39- 87 41], older [27, 42, 43, 45], or both younger and older consumers [29, 31, 37]. Other studies attempted to 88 include demographically diverse participants [24, 25, 34, 44]. Aside from age, specific consumer samples of 89 females [25, 26] and parents/caregivers [22, 28], reflective of the target consumer population, were 90 recruited to test OTC labels for an emergency contraceptive and OTC paediatric products, respectively. 91 Overall, sample sizes varied considerably between studies of various designs, ranging from less than 100 92 consumers [23, 29, 33, 37, 39, 41- 43, 45], between 100 and 500 consumers (inclusive) [20, 22, 24, 26, 28, 93 30, 31, 36, 38, 40, 44], to larger sample sizes exceeding 500 consumers [8, 19, 21, 25, 32, 34]. 94 OTC labels or WMI studies exploring comprehensibility aspects measured specific consumer-related 95 outcomes, such as the ability to locate