What would ‘a design approach’ look like?
The legislation (2004/27/EU, article 63) states that package leaflets must ‘enable the users to act appropriately‘. The principles of good information design suggest that it is necessary to find out who the users are, which actions need to be undertaken, what appropriate is for each action, and how each action can be enabled.
The following four questions need to be answered:
- Who are the users?
- Which actions do these users want to perform?
- What is ‘appropriate’?
- How can the actions of users be enabled?
In contrast with the current approach, the information design approach does not assume that ‘all users are identical for all medicines’. Information designers start from the principle that the characteristics of users vary and that this has a major effect on the design of information. Information designers base their decisions on the actual actions of people. There are many ways in which medicines can be obtained, need to be prepared, could be taken, and can be stored. These different ways of handling medicines are the starting point. A third starting point is that there is not a ‘single standard performance level for all actions and for all users’. What an ‘appropriate level’ is for some users, for some medicines, and for some actions might not be appropriate at all for other medicines. Appropriate performance levels vary accordingly. And the fourth starting point is that there are many ways to enable people to act appropriately. Just providing a printed and standardized leaflet inside a medicine box is unlikely to be effective. All sorts of combinations of printed, digital, written, visual, and aural information need to be developed in order to really ‘enable the users to act appropriately’.
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The development of Guidelines and templates should follow exactly the same principles of good information design. Guidelines should support both Marketing Authorisation Holders and the Regulatory Authorities to develop and check if information for patients really ‘enables the users to act appropriately’. To rephrase the aims of the legislation: ‘Guidance must enable Marketing Authorization Holders to develop usable information’ and ‘Guidance must enable Regulatory Authorities to check if information is usable’.