Avans University of Applied Sciences | Graphic - Design Research
Elewijt, Belgium

Karel van der Waarde studied Communication Design in Eindhoven, Leicester and Reading. In 1995, he started a design research consultancy in Belgium specializing in developing and testing visual information, with a specific focus on information about medicines for patients, doctors and pharmacists, both on paper and on screen. Since 2006, he is a professor in Visual Rhetoric. He is a Life-Fellow of the Communications Research Institute - CRI, Australia, a board member of the International Institute for Information Design - IIID, Austria and editorial board member of five academic journals.

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What Can We Learn From European Developments in the Last 20 Years?

Information is an essential factor of every medication. Without information, it is impossible to prescribe, dispense, prepare or take medicines. The provision of printed information about medicines for patients started in Europe in the 1980s for all the right intentions. Information about medicines must be 'full and comprehensible, clear and understandable, and it must enable users to act appropriately'. Although major changes are visible, some of them are of questionable quality. Patients, doctors, pharmacists, and nurses do not always receive information in a format that is optimally suitable for them in all circumstances.

Over the past 20 years, a complex system of laws, guidelines and advisories was put into place to help the pharmaceutical industry develop information. A detailed look at the processes involved in the development of visual information is used as a starting point. This analysis shows that the current regulatory framework ignores the professional knowledge of writers, designers and usability testers, and that it is based on a number of incorrect assumptions. Through the description of these assumptions, the provision of research data, and the suggestion of alternatives it is hoped that modifications to the regulatory process can be made.

The analysis of the approach and the design of alternatives exposes that the current regulatory process and results are not optimally suited to provide appropriate information to individual patients. It is necessary to

• regulate performance - and not the contents,
• consider all information sources together - not only the package leaflet,
• provide best practice examples,
• involve professional writers, designers and testers,
• start from practical use, and
• apply appropriate criteria.

These six proposals for improvement can be implemented without modifying the legislation, however they all require a shift towards 'enabling people to act appropriately.'

The requested shift needs to be reinforced through the use of proper arguments, research findings, and examples.

The fundamental problem is that motivations of the main stakeholders are different: patients care about their personal health, the pharmaceutical industry follows economic reasoning, and governments look at information from a legal perspective. Information about medicines clearly show that these three views - health, profit, and legal regulation - have little in common.
Lessons learned from the development of appropriate information display can be used for other regulatory areas, and also in different geographic locations.

Raynor, D.; Blenkinsopp, A.; Knapp, P.; Grime, J.; Nicolson, DJ.; Pollock, K.; Dorer, G.; Gilbody, S; Dickinson, D.; Maule, AJ; Spoor, P.; (2007). 'A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines', HTA Programme Report, Southampton: National Institute for Health Research

Sless, D. (2008). 'Measuring information design', Information Design Journal. 16(3). 250-258
Van der Waarde, K. (2008). 'Measuring the quality of information in medical package leaflets: harmful or helpful?', Information Design Journal. 16(3). 216-228
Van der Waarde, K. (2010). 'Visual communication for medicines: malignant assumptions and benign design?', Visible Language 44.1. pp 40-69.

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