alexa Does the Requirement of Readability Testing Improve Package Leaflets? Evaluation of the 100 Most Frequently Prescribed Drugs in Germany Marketed before 2005 and First Time in 2007 or After
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Research Article

Does the Requirement of Readability Testing Improve Package Leaflets? Evaluation of the 100 Most Frequently Prescribed Drugs in Germany Marketed before 2005 and First Time in 2007 or After

Beate Beime1 and Klaus Menges2*

1Diapharm Clinical Management GmbH, Oldenburg, Germany

2Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany

*Corresponding Author:
Klaus Menges
Federal Institute for Drugs and Medical Devices
Kurt-Georg Kiesinger Allee 3, D-53175 Bonn, Germany
Tel: +49 228 207 3458
Fax: +49 228 207 3567
E-mail: [email protected]

Received date: December 27, 2011; Accepted date: June 08, 2012; Published date: June 12, 2012

Citation: Beime B, Menges K (2012) Does the Requirement of Readability Testing Improve Package Leaflets? Evaluation of the 100 Most Frequently Prescribed Drugs in Germany Marketed before 2005 and First Time in 2007 or After. Pharmaceut Reg Affairs 1:102. doi:10.4172/2167-7689.1000102

Copyright: © 2012 Beime B, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Objectives: Based on the “Action Plan 2008/2009 for Improving Drug Therapy Safety” issued by the German Federal Ministry of Health, the Federal Institute for Drugs and Medical Devices (BfArM) has launched a study on the effect of readability user tests on the quality of Package Leaflets (PLs).

Methods: Based on recommendations from the EU Readability Guideline, a criteria catalogue for the analysis of PLs has been set up, serving as surrogate parameters for readability of statements within the PL. 100 of the most frequently prescribed medicinal products in Germany were selected and their readability analyzed. The study was blinded.

Results: This study shows that merely 44% of the 100 most frequently prescribed medicinal products in Germany have PLs with a “normal” or better readability. PLs on the market since 2007 show a trend towards improvement when compared with products marketed before 2005. This effect was even more pronounced with the 23 PLs tested as required.
Conclusions: The new European legislation in force by the end of 2005 induced a trend towards better usable PLs. On the average, however, this effect is barely recognisable. Only new products on the market need to be tested in regard to readability. Simultaneously, the text extent increased – a considerable effect against the intended improvement.

Practice Implications: Apart from text required to be short as possible, of short sentences, simple and clearly written, other legal requirements influence the length of PLs: These conflicts cannot be resolved as long as the entire SmPC needs to be mentioned in the PL due to Medicinal Product Act and liability provisions Nowadays, other (technical) solutions should be legally confirmed to present the content of a PL with a good design in different ways according to the need of each of different user groups.

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