|Title: ||Patient-friendly medication information: Package inserts as a case in point|
|Authors: ||Wermuth, Cornelia|
|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
Bazerman, C. (1981). What written knowledge does: Three examples of academic discourse. Philosophy of the Social Sciences, 11, 361-387.
Berg-Schmitt, J. (2003). Wissenstransfer Arzneimittel. Untersuchungen zu Packungsbeilagen. (Dissertation). Universität Trier.
Berry, D. (2004). Patient information leaflets and provision of written information. (S. H. Payne, Red.) Risk, Communication and Health Psychology, 99-101.
Bhatia, V. K. (2004). Worlds of Written Discourse. London : Continuum.
Dawkins, R. (2009). The Oxford Book of Modern Science Writing. Oxford: Oxford University Press.
Dickinson, D. R. (2003). What information do patients need about medicines? British Medical Journal, 327, 861.
European Medicines Agency. (2009). Guideline On The Readability Of The Labelling And Package Leaflet Of Medicinal Products For Human Use .
European Medicines Agency. (2009). A Guideline On Summary Of Product Characteristics (SmPC).
Fuchs, J. E. ( 2009.). Patientengerechte Arzneimittelinformation in Packungsbeilagen. Diskussion und Bewertung der wesentlichen Änderungen in der aktuellen „Readability Guideline“ . Pharm. Ind., 71(7), 1094–1100.
Gonschorek, C. N. (1996). Beipackzettel: Eine kontrastiv-textologische Untersuchung von Beipackzetteln am Beispiel der Situation in Deutschland und Frankreich. (Masterthesis). Hildesheim.
Howes, L. M., Roberta, J., Kelty, S. F., Kemp, N., & Kirkbride, P. K. (2014). The readability of expert reports for non-scientist report-users: Reports of DNA analysis. Forensic Science International, 237, 7–18.
Hyland, K. (2004). Disciplinary Discourses: Social Interactions in Academic Writing. Ann Arbor, MI: University of Michigan Press.
www.ema.eu. (2014, June 12). Accessed 12 June 2014 at http://www.ema.europa.eu/ema
|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