The Pharmaceutical Journal
Vol 275 No 7359 p105
23 July 2005

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News summary

PILs “need to communicate risks more clearly”

Patient information leaflets (PILs) need to communicate the risks associated with medicines more clearly, according to a Committee on Safety of Medicines working group. They also need to be more readable, both in terms of type-size and their use of language.

The working group’s report (PDF 590K), published this week, says that risk perception is a personal matter that is not always subject to logical thinking and that information on side effects, and other warnings required to be included in PILs by law, can alarm patients. It suggests that negative messages should be balanced by positive statements about a medicine’s potential benefits.

It adds that users generally favour a statistical approach to communicating risk and like to see it expressed numerically. It warns that current EU guidelines on what is meant by “very rare” (less than 1 in 10,000) or “uncommon” (between 1 in 100 and 1 in 1,000) correspond to lower levels of risk than the levels people believe they describe. The report includes guidance on how medicines manufacturers can improve the usability of the PILs they produce.

Recommendations include:

· simple language
· short sentences
· simple punctuation
· 12 point serif fonts
· no more than six bullet points

The working group also suggests that leaflets should be made available in formats suitable for blind or partially sighted people, including audio recordings. The CSM Patient Information Working Group was set up in 2003 in response to concerns that PILs did not meet patients’ needs.