Lesbarkeitsprüfungen von Packungsbeilagen
Erfahrungen und Erfolge seit der Revision der europäischen Arzneimittelgesetzgebung im Jahr 2005
Dr. Klaus Menges
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn
Since the revision of the European Medicines Law in 2005 and the subsequent implementation in German law, the pharmaceutical enterprises have to perform a readability test for package leaflets in a marketing application procedure. Despite the long existing recommendations for the preparation of readable texts the goal has not been achieved yet that patients readily read package leaflets, that they can understand and act upon them. Even though time has been allowed for enforcing the new rules, it shows after the first 3 years that the test method „interview“ is performed with very differing quality, that the focus in the assessment and interpretation of results is too often on obtaining certain percentages and that it is to be feared that only an even more consistent application of the revised legislation will achieve the anticipated success for the patient. An – even though not representative – analysis of user test reports proves that definite quality specifications for the design, performance and evaluation of interviews would be sensible. Especially critical points in the evaluation by the authorities are the compilation of questions, the assessment of the performance of the respondents concerning search and reproduction of information as well as the calculation of scores. Frequently, inadequate mock-ups, quasi test prints of the package leaflet are used which do hardly match with the final print version.
pharmind 2008, Nr. 11, Seite 1332