Rubrik: Arzneimittelwesen

    Prüfbarkeit der Lesbarkeit von Packungsbeilagen in einer öffentlichen Apotheke

    Testing of the Readability of Package Inserts at a Community Pharmacy

    Rolf Brockmeyer a, Ludwig Steindl a, Ilsabé Behrens b, Sabine Gnekow b, Frank Verheyen c, and Martin Schulz c

    Bayer Vital GmbH a, Leverkusen; Adler-Apotheke b, Hamburg; Center for Drug Information and Pharmacy Practice (ZAPP) of the Federal Union of German Associations of Pharmacists (ABDA) c, Eschborn (Germany)

    The comprehensibility of package inserts is still being highlighted as a key concern by patients and consumer organisations. The German Drug Law (AMG) requires that patient information should be generally intelligible, in German and in easily legible print. In the runup to a decentralised marketing authorisation procedure, Bayer Vital investigated the readability of package inserts in conjunction with the Center for Drug Information and Pharmacy Practice (ZAPP) of the Federal Union of German Associations of Pharmacists (ABDA) and the Adler Pharmacy in Hamburg.
    The European Commission Guideline of 29. 9. 1998 entitled „A guideline on the readability of the label and package leaflet of medicinal products for human use“ served as a basis for the planning and conduct of the readability test. Content-related aspects of the Guidelines on the Design of Package Inserts issued by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) on 17. 8. 1994 were also taken into account. The questions tested the extent to which the text and format of the package insert influence a patient’s ability to understand the content of the principal sections and to locate information after a single reading. The test involved a package insert that reflected in terms of format the template required for use with the centralised procedure by the EMEA (European Agency for the Evaluation of Medicinal Products).
    The involvement of patients in the development of the package insert would appear to be a good idea in future too. This is ultimately the only way of determining whether the message is getting through.

    Key words Community pharmacy · Guideline on label and package leaf-let readability · Package insert · Patient


    © ECV- Editio Cantor Verlag (Germany) 2001