Regulatorische Anforderungen und allgemeine Erfahrungen in der Umsetzung von Lesbarkeitstests bei Packungsbeilagen
Dr. Ulrike Hiemer, Dr. Editha Räuscher und Prof. Dr. Marion Schaefer
Consumer Health Care − Science and Services GmbH, Berlin, Charite´-Universitätsmedizin
A patient information leaflet (PIL) is one of the most important source of information for the patient next to the face-to-face counselling by physicians and pharmacists. However, the content and layout of PILs have to follow sophisticated legal regulations. As a consequence, PILs are often very comprehensive and difficult to read and understand by the patient. Current experience with mandatory user testing indicates that it not only increases the comprehensibility of PILs but also provides additional qualitative information. In addition, a clear and well structured PIL strengthens the trust of the patient in the product as well as the producer.
pharmind 2007, Nr. 11, Seite 1248