The Pharmaceutical Journal
Vol 270 No 7253 p817
14 June 2003

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Meeting summaries  14 June

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Association of the European Self-Medication Industry (www.aesgp.be)

Make labels more user-friendly

Regulatory authorities should control medicines labelling and information leaflets on the basis of usefulness to patients, rather than perceived information requirements, the AESGP annual meeting heard.

In most countries, regulatory authorities specify what must appear and where and how it must be shown, said Yong Sook Kwok, co-chairwoman of the Medicines Labelling Group. But evidence shows that stipulating the content of labels fails to achieve intended outcomes of usability or quality of use of medicines.

"Often, too much emphasis is placed on what ought to be in the label and not enough thought is given to how labels are to be developed and their usefulness to the end-user," Mrs Kwok said. Instead, she advocated a performance-based approach to medicines labelling, which places the emphasis on actions that people are able to take after reading a label with information and the order in which it is presented based on research and not on what one group thinks people ought to know.

People need to be able easily to find the information they want on a label and to understand it, labels should be attractive, physically and socially appropriate (readable and acceptable), efficient (how long does it take to find information) and productive. People also need to feel that they are being shown due respect in terms of what they are being told and how, Mrs Kwok said.

Minimum standards need to be set for these criteria and labels should be written, tested and rewritten until they are met.

This approach is taken in Australia, where prototypes have been developed and put through iterative testing. Benchmarks that must be met are given in the panel.

"The European system is proven to fail to get the information across," Mrs Kwok said. The European model leaflet fails to meet many principles of good information design. In tests using the EU's testing method, only three out of 13 people could find and use information at the Australian benchmark levels. After rewriting, this rose to six out of 13, with another three being near the benchmark. EU leaflets perform so poorly because of their inflexible structure and content, such as a requirement to put contraindications under the heading "Before taking this medicine".

The Journal's attendance at the 39th annual meeting of the Association of the European Self-Medication Industry, held in Cannes, France, from 4 to 6 June was made possible by the Proprietary Association of Great Britain