The international Institute for Information Design (IIID) makes the following recommendations.
Development of the European Legislation
Legislation. The legislation of article 65 (3): ‘Design and write information to enable the users to act appropriately‘ provides a very good starting point. This legislation needs to be enforced.
The International Institute for Information Design (IIID) endorses the six recommendations of the European Commission. In summary, IIID agrees that it is important:
- to put more focus on improving the package leaflet
- to include principles of good information design
- to improve the input from patients
- to make best practice examples available
- to explore the use of electronic media
- to investigate the use of a key information section
The consequences of the integration of information design principles
If ‘principles of good information design’ must be applied – as it is suggested by the European Commission and the European Medicines Agency than it is important to reformulate the recommendations. The main reason is that the recommendations focus on the perspectives of Marketing Authorisation Holders and Regulatory Authorities. This focus is in conflict with the principles of good information design.
The main focus should be on the activities of people to make sure that ‘people can use medicines safely and effectively’. It is essential to put ‘the activities of users’ in the center and not the ‘activities of MAHs or the authorities’.
An information design approach would reformulate the recommendations as follows:
- make sure that all users are enabled to handle medicines safely and effectively.
- make sure that the development of information leads to desired outcomes.
- involve all stakeholders (yes, patients should come first, but many other groups of people handle medicines too: they must be involved and cannot be ignored.).
- [Making best practice examples available is only part of the development process. It is not really interesting for users.] There are many other issues that would improve the development process, such as the use of a standardised vocabulary, standardised translations, and the use of xml.
- [Exploring the use of electronic media is already mentioned in point 2 and point 3. It is an unavoidable consequence if information design principles are applied and if the involvement of patients increases.]
- [Investigate the use of a staged approach in which ‘not all information is supplied at all times’ is worthwhile. People can select the amount of information that they need and decide for themselves if they want the ‘key-points’ only, a more detailed description, or a full overview.
Development of European Guidelines for information for patients.
Based on the legislation, and considering the recommendations, the IIID recommends to introduce four activities for the development of every document. The IIID suggests ‘an effective approach’ to develop ‘effective, efficient, and attractive’ information.
This approach applies to package leaflets, outer packaging, guidelines, and templates. For all these documents, the same four questions must be answered:
1. Users. IIID recommends that it is essential for every document to ‘establish who the users are’. Before any information can be developed, it is first absolutely essential to get into contact with all the people who might use specific information. For most medicines, the number of different groups is very limited. This initial activity will lead to a list of different users.
As a first step, it is essential to establish what ‘best practice’ is. After an evaluation of this, it might be possible to provide some provisional guidelines.
2. Actions. IIID recommends that it is essential to ‘establish which actions need to be executed’. For each of the different users, there will be a list of actions. For most medicines this list of actions is very limited and only consists of a few items. And this is where a thorough scoping phase is necessary. There are many ways to observe and interview people, and these interviews will lead to fundamentally different insights into the use of specific medicines.
After the actions have been listed, it is essential to conduct ‘benchmark tests’. It is absolutely essential to have reliable data about the current performance of specific actions related to the use of medicines. It is not necessary to do these benchmark tests ‘for all medicines’ in ‘all situations’. Starting with the most error-prone and most risky actions seems most effective.
3. Appropriate. IIID recommends that it is essential to ‘establish acceptable performance levels’. And this is where a close cooperation between all the different users is necessary. It is likely that different stakeholders perceive the risk of errors and the risks of incorrect use in different ways. Through these dialogues of the different users, it is possible to set ‘acceptable performance levels’ for each action. Again, it is initially only necessary to set these levels for the most risky and potentially harmful actions.
4. Enable. IIID recommends that it is essential to allow for a design approach to develop prototypes. It must be possible to divert from the current templates and guidelines when the information effectively enables users to act appropriately. Every possible way should be allowed to make sure that ‘users are enabled to act appropriately’.
It is clear that ‘information design’ only tackles one specific part within the development process of medicines. It only focuses on the usability of information. Other aspects, such as production requirements, costs, and corporate strategies, will determine if designs are actually produced and can reach patients, pharmacists, and healthcare professionals. These aspects must be included in usable guidelines too.