This article is part of a special feature on packaging that was published in the May issue of PTE Digital, available at http://www.pharmtech.com/ptedigital0511.
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.
Dk Theo Rayner, professor of pharmacy practice at the University of Leeds, and director of Luto Research Ltd.
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.