Template: shortcomings

Some shortcomings of the QRD-template

The current QRD-template is at many points in conflict with the principles of information design. There are four main reasons:

  1. The Template does not distinguish between different types of users. It assumes that ‘all users are identical, read in an identical way, and understand information in an identical way’.
  2. The Template is not ‘action centered’. It does not provide any advice on different types of actions that people have to undertake when they handle medicines. And the Template ignores the contexts.
  3. The Template does not provide criteria that can be measured.
  4. The Template does not support alternative approaches.

A detailed analysis of Version 7 of the template (dated June 2008) can be downloaded here (pdf, 58 pages). This review draws the following conclusions:

“The current version of the template is highly problematic. It is not very useful as an example nor as a process.

  • 271 comments indicate that the QRD-template cannot accommodate the varied needs of different groups of patients.
  • 13 statements indicate that the QRD-template fits poortly into a document development processes of Marketing Authorization holders.

European Directive 2004/27/EC states in article 63,2 that ‘The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals’.

The 2008 review concludes that the use of the QRD-template is irreconcilable with the legal requirements of article 63,2 of Directive 2004/27/EC.”