Title: Patient-friendly medication information: Package inserts as a case in point
Authors: Wermuth, Cornelia
Verplaetse, Heidi
Issue Date: Dec-2014
Conference: Théories & Réalités en Traduction et Rédaction edition:3 location:Université de Bretagne Occidentale (Brest) date:11-12 décembre 2014
Abstract: Patient-friendly medication information: package inserts as a case in point
The European Union authorization of medicinal products, following the European Medicines Agency guidelines (2009), prescribes package inserts, which are intended to provide understandable and legible scientific information for patients on safe usage of medicines (Fuchs 2009). The informational content of these inserts is derived from the scientific description of a medicinal product’s properties and the conditions attached to its use called Summary of Product Characteristics (SmPC). This is a highly specialized document, which is written by and for healthcare professionals. In this paper we aim to investigate how the specialized medical knowledge provided in SmPCs is summarized, re-organized and reformulated in package inserts in order to reach a wider non-specialized group of readers. The following issues will be considered:
(1) What are the formal (cf. sentence / paragraph length), stylistic (voice) and linguistic features of SmPCs and package inserts? The latter includes syntactic and terminological questions (technical vs. lay terms, definitions, use of symbols etc.)
(2) Which strategies are adopted in the process of rewriting the scientific contents and language of SmPCs into a patient-accessible format?
(3) Which language- and culture-specific differences exist between English, French and German patient inserts concerning the transfer of scientific medical information to non-specialists: what kind of knowledge is presupposed vs. what kind of (additional) knowledge is realized linguistically and/or added?
The investigation is conducted by means of a (partially contrastive) corpus analysis. The corpus is taken from the EMA (European Medicines Agency) database and consists of a set of SmPCs in the source language English and the package leaflets derived thereof in English, French and German. The study aims to chart the general and language-specific features of package inserts in order to gain better insight into the strengths and weaknesses of the current strategies adopted in the popularized discourse of authorized medicines across Europe.
Science communication, popularization medical discourse, medical meaning and knowledge, package inserts, explanation strategies
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Publication status: published
KU Leuven publication type: IMa
Appears in Collections:Multimodality, Interaction and Discourse, Campus Sint-Andries Antwerp
Linguistics Research Unit - miscellaneous
Translation and Technology, Campus Sint-Andries Antwerp
Translation Studies Research Unit - miscellaneous

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