Who are the users?
If the current legislation needs to be followed, and it is obligatory to write and design package leaflets that ‘enable the users to act appropriately’ than it is necessary to define accurately who these users are.
And this differs according to the type of medicine and the context …
As an example the difference between a simple, over-the-counter, painkiller like ibuprofen and an insulin pen. Both are governed by the same legislation, the same template, and the same Readability guideline. Both must consider other guidelines, and other legislation too. But the ‘users’ of information about ibuprofen and insulin vary considerably.
For ibuprofen, it is likely that a consumer (not really a ‘patient’) visits a pharmacy or chemist. The consumer selects a package or asks an assistant to select a package. The tablets/capsules are taken home, used when needed, and stored in a drawer or medicine cupboard. There are – if all goes well – only two ‘users’. In case of a family, there might be several people using the same medicine.
For insulin, the situation is very different. There are major differences between ‘first time users’ and ‘experienced users’. Diabetic patients will receive a training by a diabetic nurse or a pharmacist. Patients will have had contact with specialist doctors and general practitioners. Their families (partners, parents, children), close friends, and colleagues will be informed. ‘Users’ of information about insulin consists of a substantial number of different types of users. And patients will continuously learn more about their situation and adjust their activities accordingly.
In contrast with ibuprofen, it is unlikely that a patient only has one brief conversation with a single healthcare provider. It is also unlikely that more people in a family share insulin. And it is unlikely that a diabetic patient does not learn by experience how to live with diabetes.
The current construction of legislation, guidelines, and template ignores these differences between different users. Every user, regardless of the type of medicine, experience, or situation receives a very similar printed leaflet.
The principles of good information design start from the idea that the characteristics of users vary substantially, and that 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 who the users are’. 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. After an evaluation of this, it might be possible to provide some provisional guidelines.
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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 MAHs and the Regulatory Authorities – need to be interviewed and observed to find out how these documents are currently used.