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Abstract
Comprehensive medicine information leaflets for patients are now mandatory across
the European Union. In 1997, the European Commission (EC) proposed a prescriptive
'model' for the leaflets and a method for consumer testing. This exploratory study
compared consumers' ability to use a leaflet based on the EC model leaflet and an
alternative leaflet based on best practice in information design (Mark II). The leaflets
were tested in two matched groups of 20 consumers, who were required to find, and
understand, 15 pieces of information in the leaflets. The target that each question
should be answered correctly by 16 out of 20 consumers, was achieved for three of
the 15 points in the EC leaflet, compared with eight in the Mark II leaflet. Open
questioning confirmed the problems with the EC leaflet, including a failure to understand
key concepts about medicine interactions and contraindications. This research demonstrates
the benefits of consumer testing, ensuring that leaflets are patient-orientated. A
rigid model leaflet would prevent these benefits from being utilised.