Creation of a Dictionary of Medical and Lay Terms for Use in the Preparation of Patient Information Leaflets *

Abstract

The institution of a regulatory requirement for patient-oriented labeling in the European Union—the User Package Leaflet (Patient Information Leaflet)—engendered the need to prepare accurate and comprehensible labeling for many marketed products in a number of therapy areas within a short timeframe. In order to ensure the quality and consistency of “translation” of the medically-sophisticated Summary of Product Characteristics into the corresponding consumer-oriented leaflets, the authors prepared a “dictionary” of scientific and medical terms and their acceptable lay equivalents. Consistency in the language of the leaflets and reduced preparation time were achieved after implementation of the dictionary at headquarters and in European subsidiary offices.