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Research conducted in the UK by the University of Leeds and Luto Research shows that many commonly-used phrases on medicine labels are easily misunderstood.
Editor's Note: This article is part of a special feature on packaging that was published in the May issue of PTE Digital.
Research conducted in the UK by the University of Leeds and Luto Research shows that many commonly-used phrases on medicine labels are easily misunderstood, which is why the latest version of the UK's British National Formulary (a drugs bible used by doctors, nurses, pharmacists and other health professionals) will feature revised, simplified language and phrases.
Pharmaceutical Technology Europe caught up with DK Theo Raynor in an interview to find out more...
What labelling changes are being recommended in the UK?
The labelling changes being recommended relate to the 30 or so "cautionary and advisory labels" that pharmacists use when labelling prescription medicines. These include wordings such as "Avoid alcoholic drink" and "This may cause drowsiness", which have remained unchanged for 30 years. The BNF asked Luto Research and the University of Leeds to user test the labels with members of the public to determine whether they were understandable.
We used nearly 200 people in three rounds of testing. In one-to-one interviews, people were asked to explain, in their own words, the meaning of each label's wording. After each round, the performance of each label was assessed and if there were problems, the label was re-written and re-tested. A number of labels were re-written in this way. For instance, "Avoid alcoholic drink" became " Do not drink alcohol while taking this medicine"; "Take with or after food" became "Take with or just after food or a meal"; and "May cause drowsiness" became "This medicine may make you sleepy".
The philosophy behind this testing and the changes is that many of the wordings used technical language rather than everyday language, which can be confusing. It is important to take into account everyone who takes medicines, including those who are not proficient readers.
On-package instructions are often more widely read then leaflets accompanying a medicinal product. Do you think that there is more that pharmaceutical manufacturers should do in the area of on-package labelling?
This research related to the labels that pharmacists prepare and apply to prescribed medicines whenever they are dispensed. One key issues for pharmacists, however, is where do they apply the label on the original pack? There needs to be a space large enough to accommodate the label without obscuring information that is on the pack. In particular, the label should not be placed over a barcode because this often shows through the label and makes it more difficult to read.
For OTC medicines, pharmacists usually don't apply a label. In these instances, branding and marketing can adversely affect the information on a pack. This is especially important when the need for a leaflet is waived because all the information is already present on the package.
Why do you think many patients overlook product leaflets?
Many patients do fail to take notice of the leaflet. This is partly because of the nature of the leaflet: thin paper folded multiple times inside the box. The new EU-wide legal requirement for user testing of packaged leaflets, however, means that the content and layout of leaflets, as well as the print size, is now much improved. We hope, these changes will mean that people will start to take more notice of the leaflets.
For the record, our research in the UK, which was conducted in the early 2000s before user testing was in place, showed that around 70% of people read some or all of the package leaflet when they received a medicine for the first time. For a long-term medicines, however, 60% of people said they never or rarely looked at the leaflet after the first time. Health professionals play an important role in drawing people's attention to the package leaflet and the important information that it contains.
The labelling changes have been proposed to clarify important information. Do you think there is any benefit in doing the same for leaflets provided by pharmaceutical manufacturers?
In fact, the process we've applied to label wordings actually brings them up to speed with package leaflets, which have already been user tested — rather than the other way round. The UK is one of the few EU countries that have retrospectively applied legislation mandating leaflet user-testing. New leaflets have been tested since 2005, but the UK also implemented a requirement for user-testing of older leaflets, completed in 2008.
Some packaging companies have devised packaging that displays essential information on the outer packaging and ensures that product leaflets cannot be separated and lost. Do you think is a positive development?
There are advantages and disadvantages. You are right that leaflets may be lost or discarded, but incorporating the information into the packaging itself can lead to compromises in terms of how the information is laid out, as well as print size. Our testing has shown that in some cases, people aren't even aware of leaflets that can be opened up from the pack; for instance, some labels can be peeled back to reveal the leaflet, but some people don't realise this. Additionally, people who have problems manipulating things, typically older people, can find it difficult to actually open these leaflets and read all of the information while it is attached to the packaging.
The bottom line is that the information with a medicine pack can make the difference between a medicine being used safely and effectively, and a medicine that does not work to best effect or even causes harm. The only way of ensuring if the information works is to test it with real people – such as through user testing. Can people find and understand the key information for safe and effective use?