Which actions do the users want to perform?
The principles of good information design start from the perspective of ‘the user’.
The main ‘user of medicines’ is a patient who needs to take a medicine, or a combination of medicines. There are several main actions that apply to all medicines, but the relevance of these actions can vary substantially depending on the situation, context, experience, urgency, and risks.
An initial provisional list of actions for some medicines would look like:
- considering to take a medicine (balancing benefits and inconveniences)
- planning to take a medicine (integrating it into a daily pattern)
- preparing to take a medicine (finding the box, opening it, taking a dose out of the inner packaging)
- taking a medicine (actually swallowing, adding a patch, injecting insulin, inhaling, etc.)
- storing a medicine.
An Ishikawa-diagram provides an alternative visualisation of these actions. (Example from Notenboom, 2017, p 40):
Each of these actions needs to be enabled. None of these can be taken for granted: all need information, warnings, instructions, and advice. Each can be further subdivided into smaller and more specific actions.
It is not only patients who need to be enabled to act appropriately. There are many other users who handle medicines and need information.
As an example, an anaesthetist who needs to select a particular medicine during a surgery needs specific information. This action of ‘selection’ differs from the ‘selection’ of exactly the same medicine by a hospital pharmacist who needs to check if stocks are sufficient. Providing a package leaflet might not be the most appropriate way to enable all these different actions by different people.
The principles of good information design start from the idea that different actions need different types of support. The actions differ, and the users who execute these actions differ. It is essential to provide different types of information, on different levels of detail, in different formats to increase the probability that users can access and understand information.
Before this principle can be applied to the development of information about medicines, it is essential to ‘establish which actions need to be executed’. 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.
As a first step, it is essential to establish what ‘best practice’ is for different types of medicines and situations. This requires ‘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 tests ‘for all medicines’ in ‘all situations’, but let’s start with the most error-prone and most risky actions first. (Vincristine? Aerosol confusion? Forgetting oral contraceptives?)
After an evaluation of these benchmark tests, it might be possible to provide some provisional guidelines on how to record, describe, and enable specific actions.
Again, ‘best practice’ needs to be established for each action. At a later stage, the information can be collected in a ‘central database’ in which suggestions and evidence are stored. From the perspective of a user, it is not beneficial that every Marketing Authorization Holder can divert from best practice, and modify instructions, warnings, and advice about specific actions. If an action is identical for different medicines, the instruction should be identical.
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This principle needs to be applied to the development of Guidelines and templates too. The different users of the Guidelines and templates – primarily the Marketing Authorization Holders and the Regulatory Authorities – need to be interviewed and observed to find out which actions need to be supported by these documents.