‘Information designers transform and present an intended message to suit the purposes, skills, experience, preferences, and circumstances of the intended users. Engagement with users, including an iterative approach of design, testing, and modification based on their input, delivers results that are tailored to people’s needs.’ [page xi in Information Design: research and practice‘, 2017]

The intended message of package leaflets and medicine packaging is to make the ‘safe and correct use of medicines’ possible. The intended users are patients, nurses, pharmacists, … Information designers design, test, and modify information about medicines to suit people who handle medicines.

The current legislation (2004/27/EU) includes the phrase ‘written and designed to be clear and understandable, enabling the users to act appropriately’ (article 63). This phrase – enabling the users to act appropriately – is an excellent starting point because it accurately maps onto the definition of information design.

This phrase requires the answer to four questions that can lead both the development as well as the assessment of the quality of information about medicines.

Starting point: answer four questions

In order to develop information that really ‘enables the users to act appropriately‘, it is necessary to answer four questions:

Question 1: Who are the users? What are the main characteristics? Are there different groups of users? Are these groups homogeneous or do they need to be subdivided because they have different needs?

To answer question 1, it is essential to contact people directly and observe, ask, and interview them to find out what the real problems and issues are. [This includes an inventory of all the people who are involved: production, marketing, sales, regulatory, … and it includes all the people who handle medicine packaging and package inserts: patients, wholesalers, pharmacists, nurses, doctors, family-members, …] Without this analysis it is not possible to determine project-boundaries, nor is it possible to determine priorities. [How to do this? Click on: ‘A design approach’.]


Question 2: Which actions do these users want to perform? Which actions are most error-prone and pose the highest risks? Do different users execute different actions?

To answer question 2, observation studies and interviews are used. This will reveal what the most relevant/risky actions are. These actions need to be benchmarked to make sure there is a real issue and to provide a baseline measure. Without this selection and without benchmark test results it is not possible to gauge changes nor performance. [How to do this? Click on: ‘A design approach’.]


Question 3: What is appropriate for each action? And who can decide what appropriate is in a specific context? What are the factors that influence this judgement?

To answer question 3, it is necessary to set performance levels. These are negotiable, but the test results will be used as a comparative indicator for subsequent tests. Without agreed performance levels, it is not possible to determine if a prototype is successful or not. [How to do this? Click on: ‘A design approach’.]


Question 4: How can the actions of users be enabled? What are the different approaches that lead to achieve ‘an appropriate level’?.

To answer question 4, a combination of writing, designing and testing skills are essential to make and improve prototypes. Please note that ‘enabling’ might require a combination of analogue and digital materials in both verbal and visual formats. Without designing/writing/testing cycles, it is not possible to develop prototypes that can be tested. [How to do this? Click on: ‘A design approach’.]


Answering these four questions is standard information design practice. And this is exactly the way in which most designers work. It is for example described in detail in the ‘Human factors and usability Engineering guideline’ by the MHRA (2017). Although the terminology might differ, the process and approach is identical: “start from the perspective of the people who need to act”. Many Quality Improvement processes and Usability studies apply a very similar approach too. This extends the process from ‘information only to actual use and incorporates actions like ‘opening a package, ‘storing medicines, and ‘disposing medicines.

It should be noted that this ‘information design approach of answering four questions is only part of a larger process where production, implementation, legal reviews, and commercial reviews need to be considered as well.

Starting point to control information: the same four groups

The answers to the four questions lead to four different sets of criteria. These criteria can be checked and controlled.

  1. Is it clear who the users are? Who is included, who is excluded? [How to check this? Click on: ‘A design approach’. ]
  2. How are the actions selected? What is the current level of performance? [How to check this? Click on: ‘A design approach’. ]
  3. How are the criteria for each action determined? [How to check this? Click on: ‘A design approach’. ]
  4. Do the prototypes/models/designs achieve the agreed level of performance? [How to check this? Click on: ‘A design approach’. ]

It is clear from the outset that a ‘standardized design process or a ‘uniform step-by-step protocol is unlikely to lead to adherence to the current legislation. There are too many differences between medicines, between patients, between situations, and preferences to assume that ‘one size fits all.

In stead, ‘principles of good information design suggest a range of approaches to answer the four questions. The consequences of this approach are described in the section ‘A design approach . This describes how the Legislation, Guidelines, and Template might need to be modified to include the principles of good information design.