Comprehensibility of the package leaflets of all medicinal products for human use: A questionnaire survey about the use of symbols and pictograms

Directive 92/27EEC establishes that the package leaflet is a document, whic h must be included in the package of medicinal products for human use in EU countries. This informative leaflet is directed at the users and it must g ive full and comprehensible information. The Law suggests the use of symbol s but it does not give advice about the subjects to be represented. In orde r to evaluate the attitude of patients towards package leaflets provided wi th symbols, we planned a survey interviewing 1004 patients in pharmacies. T he data suggest that Italian patients usually read the package leaflet but they neither understand it easily nor find the needed information readily. Most respondents (74.3%) considered the use of symbols helpful in finding t he needed information. We proposed five symbols for each heading (therapeut ic indications, side effects, paediatric use, contraindications, use in pre gnancy) and asked to select which symbol could be used. In the case of 'sid e effects', 'paediatric use', 'use in pregnancy' and 'dose', most of the re spondents chose the same symbol. In the case of 'therapeutic indications' a nd 'contraindications' there was no uniformity in the answers. The choice d epends greatly on education, age and employment of respondents. (C) 2000 Ac ademic Press.