The Pharmaceutical Journal
Vol 269 No 7214 p338
7 September 2002

This article
Reprint
Photocopy

World Congress of Pharmacy and Pharmaceutical Sciences 2002 summary

How to provide patient-friendly information on paper and on the internet

The way forward for the provision and sourcing of patient-friendly information — on labels, in leaflets and on the internet — was outlined by two speakers at a symposium on 2 September.

Jane Nicholson: patient information leaflets not always easy to understand

Discussing patient-friendly labelling, Jane Nicholson (Bristol-Myers Squibb, United Kingdom), said that although there is no substitute for reading a medicine label, improving the design of that label could lead to a reduction in medication errors. Manufacturers who use the same livery with the same colours and the same text size positioned on a same-sized carton are setting up an accident waiting to happen, she warned.

There are many ways that labelling can be improved. Mrs Nicholson recommended the use of sans serif type faces because they are easier to read. She also recommended using upper and lower case lettering because part of reading was the recognition of word shapes, and these are lost when capital letters are used. However, she added that a limited use of capital letters could be helpful when products had similar names, eg, vinBLASTine and vinCRISTine. Bold type is useful for emphasis. Abbreviations should never be used.

The use of colour is important, too, she said. Critical information could be given in red, but designers need to be careful to ensure that there is a maximum contrast between text and background. For instance, red type can be hard to read on a blue background.

For maximum safety, certain text is crucial, she said. The label must contain the product's registered name followed by the generic name, the strength of the drug, its route of administration and dosage instructions. Special warnings should appear in as large a font as possible and should not be broken up by such things as graphics or logos. She added that, for easy viewing, the full name, strength and, if appropriate, route of administration should appear on three non-opposing pack faces.

Turning to patient information leaflets, Mrs Nicholson said that these frequently do a poor job of providing information to the patient in a way that is easy to understand. Leaflets produced by manufacturers are usually based on legally approved text which must be converted into lay language with the result that, rather than being informed, patients are often overwhelmed by the information available. In some countries, a third party, rather than the company, produces the leaflet and its content is not reviewed by the regulatory agency.

Leaflets should be tested among a group of 20 patients to assess their user-friendliness, said Mrs Nicholson. That testing involves asking each patient, after they have read the leaflet, the name of the product and 14 safety-related questions. She drew attention to a European guideline which suggests that 16 of these 20 patients should be able to answer all the questions correctly.

Finally, on the subject of patient information on the internet, Mrs Nicholson said that much of what was available really constituted advertising and was of variable quality and limited usefulness. However, no one could stop people looking at such sites if they wanted to.

She told the congress that, for patient sites on the internet to be valuable, they need to contain:

• The identity of the company and the sponsor of the website

• Health education information, such as methods of disease prevention, screening advice, and information on public health

• Balanced and accurate patient information on products marketed by the company, to include the registered text of patient information leaflets

• The summary of product characteristics

• Links to other websites, such as patient groups, medical research and professional bodies

She added that all websites should be subjected to internal company scientific review. Preapproval by regulatory authorities is not necessary, but national authorities should monitor such websites' contents.

Mrs Nicholson said that, in conjunction with the advice of health professionals, patient-friendly labelling in and on the pack, and on the internet, helps to inform patients. "Well-informed patients are more likely to adhere to prescribed medication, with safer, more successful outcomes and more efficient use of health care resources," she concluded.

Dr Andrew Herxheimer (UK Cochrane Centre) focused on the sources and quality of health information.

He agreed with Mrs Nicholson that the internet was a major source of health information but that quality was often variable. He described to the congress the "Discern" criteria. This is a brief questionnaire which provides users with a valid and reliable way of assessing the quality of information on treatment choices. Pharmacists can view the questionnaire at www.discern.org.uk. According to Discern, a good publication should fulfil several criteria. It should have explicit aims and it should achieve them. It should be relevant to consumers, make sources of information explicit and be balanced and unbiased. It should describe how treatment works and outline its risks and benefits. It should refer to areas of uncertainty and describe what might happen if treatment is stopped. It should also make clear that there may be more than one possible treatment choice and should provide support for decision making that is shared between the patient and the health professional.

However, for patients, having access to information is only half the job. "The other half is knowing how to use it and understanding that judgements must be made," said Dr Herxheimer. Patients need information and the knowledge to be able to evaluate it. To aid that in future, he suggested that basic concepts about medicines should be taught in schools.

Patients need different kinds of information in order to make decisions at different stages of medicine choice. First they need to decide whether they need a medicine at all. Then, if they do, they need information on how to use it, for how long and with what precautions. Such information often comes from written sources, but is more useful to patients if it can be explained or elaborated upon during conversation with a health professional, including the pharmacist.

In conclusion, Dr Herxheimer said that he believed that information as a rule is best obtained from independent professional sources that disclose how and from what primary sources their information is assembled.