An analysis of patient information leaflets supplied with medicines sold by pharmacists in the United Kingdom

The primary aim of this exploratory study was to analyse the design factors contributing to the reading ease and comprehension of medicinal information leaflets. Good practice guidelines on general typography and layout were chosen from the literature and compared with European Commission guidelines on preparing package leaflets. The suitability of the guidelines for evaluating package inserts was investigated using leaflets accompanying thirteen different medicines available from pharmacies. With minor revision, the design recommendations were appropriate for developing over the counter medicinal leaflets. There was general agreement that simplicity is the key to good information design. It was concluded that the design of readable medicinal package inserts is a complex, process. Consumer participation is essential and advice from a professional designer highly desirable. Acknowledgements The author is grateful to Sheila Patel for supply of the patient information leaflets and to Eileen Milner and Rosemary McGuinness of the University of North London. Introduction Patients are being encouraged by recent government initiatives to take greater personal responsibility, in partnership with appropriate professionals, for health care decisions (Department of Health, 1997a; 2000). Consumer choice has increased in the last decade with legislative action allowing a wider range of more potent medicines previously only available on prescription being reclassified for sale in pharmacies (Blenkinsopp & Bradley, 1996). Access to high quality information is essential if these drugs are to be used safely and effectively without clinical supervision. Since 1998 all UK medicinal products, whether dispensed by a pharmacist or bought over the counter, have to be supplied with an authorised patient information leaflet (European Commission, 1992; Medicines Control Agency, 1998a). Manufacturers need to compile leaflets that comply with this legislation, fit into the drug packaging and are understood by a general population with diverse abilities and needs (Griffin & Griffin, 1996). The few studies that have evaluated the quality of medicinal package inserts (Bradley, 1994; Wong, 1999) have used readability formulae as assessment tools but these are limited in their scope for improving the quality and value of information leaflets (Redish, 1981). Information design not only improves the presentation of a document, it is also instrumental in attracting, motivating and promoting the understanding of the reader (Orna & Stevens, 1991). In this exploratory study good practice design guidelines have been compiled from the literature and used to assess a sample of patient information leaflets (PIL) supplied with over the counter (OTC) medicines in the United Kingdom. As far as is known this is the first study to investigate the design of OTC medicinal package inserts. Methodology Guidelines on information design from the literature were pooled and areas of consensus and dissimilarity identified. A set of evaluated guidelines was compiled and compared to: • the guideline on the readability of the package leaflet produced by the European Commission (1998) • a sample of current OTC medicinal information leaflets. Literature searches Between October 1998 and February 1999, searches were made using MEDLINE, PsycLIT, LISA Plus, Science Citation Index of BIDS and the Internet. Free text and subject heading searches were conducted covering: medicines, patient information leaflets, health education, information and product design, communication, guidelines, evaluation studies, patient satisfaction and quality indicators. Investigation of hyperlinks and the reference sections of articles from initial results gave additional sources. Guidelines based on research evidence, the psychology of reading and the practice of graphic designers were selected. Wherever possible the original source of the guidelines was traced so that agreement amongst authors was not spurious. Patient information leaflets Leaflets accompanying products whose legal status had changed from prescription only to pharmacy sale since 1993 were chosen for analysis. The starting date was selected as the time when the Medicines Control Agency (MCA) introduced a new structured annual timetable to expedite the reclassification of prescription only medicines (Department of Health, 1994). The products containing single active substances were identified from the Chief Medical Officer’s Annual Reports (Department of Health, 1994; 1995; 1996; 1997b; 1998) supported by information from the MCA (1997, 1998b) and its advisers (Lawson, 1996). Package inserts were obtained from a retail pharmacist, photocopied and details, such as size and colour that did not show on the photocopies, recorded. Leaflet characteristics The leaflets were assessed as follows: 1) linear measurements were made by eye to the nearest 0.5mm using a millimetre rule; 2) transparency was registered when print from the reverse side showed through the leaflet; 3) type size was estimated from the text occupying the majority of the leaflet. Measurement was made in millimetres, from the top of an ascender of a letter to the bottom of a descender in one line, and converted to ‘points’ (1mm is approximately equivalent to 3 points); and 4) typefaces were identified by comparison to typographic encyclopaedias (Jaspert, 1970; V & M Typographic, 1974). Information Design Guidelines Good design practice identified from the literature originated from a range of organisations and researchers with differing backgrounds and interests: Association of the British Pharmaceutical Association (1990); Basic Skills Agency (1999); Hartley (1994, 1998, 1999); National Information Forum (1996); Orna and Stevens (1995); Plain English Campaign (1998); Raynor (1992); Royal National Institute for the Blind (1997); and Stone (1992). The benchmark criteria shown in Table 1 were formulated with the general reader in mind, as OTC medicines are available to all members of the public. In particular, the advice of the Basic Skills Agency (1999) and the Royal National Institute for the Blind (1997) was heeded to include visually impaired and older people and those with reading difficulties. Simplicity, clarity and the importance of planned spacing are emphasised in the literature. The choice and orientation of page size and the inclusion of illustrations will determine many of the subsequent design decisions (Hartley, 1999). However, once the format, spacing (between headings, paragraphs and lines) and typographic or colour cues have been chosen they must be used consistently throughout the leaflet (Hartley, 1994; Orna & Stevens, 1995). Significant differences between authors were only revealed in two areas: type size and justification of text. Table 1: Good practice guidelines on patient leaflet design and typography