Readability of Package Leaflets According to Age and Level of Education
Thomas Paech1, Birgit Ihnken1, Dr. Klaus Menges2, and Dr. Thomas Dobmeyer1
YES Pharmaceutical Development Services GmbH1, Friedrichsdorf (Germany), and Bundesinstitut für Arzneimittel und
Medizinprodukte (BfArM)2, Bonn (Germany)
The readability tests introduced by the European Union in 2005 are intended to enhance the readability of package leaflets. Since this time the content and structure of package leaflets has clearly improved. Nevertheless in readability tests it happens again and again that test readers have to search for a long time for information or cannot find or understand them at all. The aim of the present study was to determine the influence of various parameters, such as age and level of education, on the understanding of package leaflets in a meaningful collective. In addition, it was intended to investigate which sections of the package leaflet caused the test readers particular problems, and where a need for improvement in the drafting of package leaflets existed.
The demographic data from 529 subjects, who have participated in readability tests with the company YES, were used as the basis. These data, together with data on education, occupation, use of medicinal products and sources of information used by the test readers, were collected with the aid of data entry forms and entered in a database. Subjects aged between 17 and 78 years with varying levels of education and professional training were included in the analysis. It appeared that especially elderly people and test readers with a low level of academic education had particular difficulty in finding and understanding medical information in package leaflets. Shortcomings came to light in matters of particular relevance to safety, such as contraindications, special care or interactions. Therefore devising readable package leaflets, specifically addressed as far as possible to the target patients, remains an important issue; at present the patients’ needs in this regard are being met only in part. Alternative media such as television, magazines or the internet could be used to enhance the knowledge of basic medical terms in the general population as long as consumer advertising ist not linked with the medical information. The role of doctors and pharmacists in communicating information to patients that they can understand should also be reinforced.