gms | German Medical Science

11. Jahrestagung 2004 der GAA

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

30.09. bis 01.10.2004, Jena

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Relevance of the patient package insert for the drug treatment in ambulatory care patients: analysis of 77 patients' interviews

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  • corresponding author presenting/speaker M. Gulich - Dept. General Practice, University of Ulm
  • W. Knaus - Dept. General Practice, University of Ulm
  • Th. Breuning - Dept. General Practice, University of Ulm
  • U.-M. Schmidt - Dept. General Practice, University of Ulm
  • H.-P. Zeitler - Dept. General Practice, University of Ulm

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA) e.V.. 11. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie (GAA) e.V.. Jena, 30.09.-01.10.2004. Düsseldorf, Köln: German Medical Science; 2004. Doc04gaa32

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/gaa2004/04gaa32.shtml

Published: September 30, 2004

© 2004 Gulich et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Introduction

In Germany as in most European countries, it's a legal requirement to add a patient package insert to medications sold or distributed to the public. The package insert has to contain information about administration, indications, risks, contraindications and effects of drugs. Only sparse information is public available about (a) the use and (b) most of all the effect of the patient package insert as a constituent of drug treatment.

Methods

We interviewed patient who were prescribed first time a presumably continuing drug treatment at their homes. Semi structured interviews were centred around the drug and especially about the use of, the judgement about and the consequences of the patient package insert. Interviews were digitally recorded, transcribed and analytically coded.

Results

77 interviews are available for analysis. Reading of package inserts varies to a large degree intra- and interindividually. Individual patterns of use can be described. Package inserts usually seem to have only minor consequences as far as adherence to medication is concerned. The analysis of the data is continuing at present.

Discussion and Conclusion

The impact of patient package inserts might be less than expected. individual patterns of use of package inserts might be used to develop directed interventions to optimize drug treatment in ambulatory care by purposefully tailored package inserts.