An Analysis and Evaluation of the Development of the QRD Human Product Information Template used in Package Leaflets

Abstract

Package leaflets of medicines distributed within the European Union must reflect the QRD template. Since the first edition of the QRD template from 1996, thirteen revisions have followed. During development the QRD template update published in 2011, headings and mandatory texts underwent major changes based on information gained from user testing and feedback from various sources. The methods and resulting data used to create these amendments remain unpublished.<br /> This study analysed the development of the QRD template from its initial version to the present day and addressed the problem of insufficient data regarding its readability and use. A comparison of content and structure of templates of non-EU countries to the QRD template was also carried out.<br /> The English QRD template text intended for package leaflets of centralised approved OTC medicines was analysed regarding the number of words, and content of information contained in each section. In addition, a written readability test was carried out using package leaflets with QRD templates 7.3.1, QRD template 8 and a model template using three enalapril texts: German BfArM sample text, and a shortened German version of the BfArM sample text and its English translation. Every participant tested all three templates with a 6 month time gap in a cross-over procedure. An internet search was used to identify package leaflet templates available in English and German; the content and structure of these templates were analysed including the relevant directives and guidelines. To investigate how widely the QRD template is implemented in the practice, package leaflets for centralised approved medicines were downloaded from the EMA website three times with a year between each download. <br /> During development of the QRD template up to the present day, the number of words has increased from initially less than 100 to over 800. The continuous updating has led to wide-ranging structural and content changes in the template as well as altering the wording of many headings and standard statements. A total of 241 people from Germany and England participated in the readability test. For the short leaflet text, participants provided significantly more correct answers with the model template compared to both QRD templates. For the long BfArM sample text tested in Germany, participants provided a comparable numbers of correct answers with QRD template 8 and the model template, but significantly less when QRD template 7.3.1 had been used. Information contained in the sections for contraindications, precautions and possible side effects caused the most problems with regard to locatability and comprehensibility. Analysis of the package leaflets for centralised procedures showed that up to nearly 40 % of the text used in package leaflets can come from the QRD template.<br /> The continuous updating of the QRD template can be seen as positive as improvements have been found in general headings and standard sentences. Further optimisation is however still possible by reducing the length of the text and rewording the description of side effect frequencies.