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New words for cautionary and advisory labels make them easily understood

A revised set of cautionary and advisory labels will be published in the new edition of the British National Formulary (March 2011). Emma Harris, staff editor, and Duncan Enright, publishing director, BNF Publications, explain how the changes came about

By Emma Harris and Duncan Enright

A revised set of cautionary and advisory labels will be published in the new edition of the British National Formulary (March 2011). Emma Harris, staff editor, and Duncan Enright, publishing director, BNF Publications, explain how the changes came about


It was in this journal almost 30 years ago that a contributor wrote: “We must take a hard look at the labelled instructions we use, as well as think very carefully about the wording and content of additional labels and patient information”. So, it seems highly appropriate that, when the British National Formulary decided to review again the current wording of labels on medicines, it turned to this contributor Theo Raynor, now professor of pharmacy practice at the University of Leeds and director of Luto Research, to direct a programme of user testing, resulting in recommendations for a revised set of cautionary and advisory labels.

Revision

The wording of the original cautionary and advisory labels was recommended by a working party of the Royal Pharmaceutical Society of Great Britain, and have been included in the BNF since 1985, with minor adjustments to the wording being made over time by the BNF’s Joint Formulary Committee.

Further improvements have now been sought through research carried out by Professor Raynor and the team at Luto Research, who have been engaged in user testing as a method of readability testing since the company was formed in 2005. Professor Raynor and his colleagues are leading authorities on the European legislative framework with respect to patient information for licensed medicines, and this strong research base has helped to enhance the clarity of information created for patients.

Professor Raynor has long been concerned about the phenomenon of patient non-compliance and the important factor of misinterpretation or misunderstanding of instructions.

“Most medicines,” he says, “do contain leaflets which provide detailed information for patients. However, the leaflet may get lost, which means that the label on the medicine plays a very important part in guiding people’s behaviour. It is vital, therefore, that wordings on labels are simple and straightforward.”

Readability testing

Luto undertook readability testing of the 32 cautionary and advisory labels for dispensed medicines (CALDM) from appendix 9 of the BNF. Most people see the CALDM on computer-generated printed labels, which are affixed to medicine packs. Depending on the medicines that they are taking, people often have to read multiple cautionary or advisory messages spread over several labels. Luto believes this could impact on a person’s ability to find and understand the information contained in these warnings and, therefore, selected a range of medicines to be represented in the testing in order to cover each one of the CALDM.

Participants in the research were all literate in English and covered a range of ages and educational abilities. They were asked to read and answer questions about medicines with several label wordings and medicines with single-label wordings. A group of paediatric medicines was also created and used for participants who were parents or carers of children. The questions were agreed by an expert panel consisting of pharmacists from Luto Research and the BNF.

Almost 200 lay participants were involved over three rounds of testing. The results from each round of testing were combined with good practice and research evidence to produce revised wordings that reflect current best practice in written medicines information for patients. Of the 32 labels, three existing wordings (labels 12, 17, and 29) worked well and are retained in the proposed revised wording for the new labels. The BNF now recommends improvements to the other 29 wordings and examples are given in the Panel (see PDF attachment for a higher resolution version of the Panel).

 

 

Although the wording of individual labels may have changed, the intended instruction of each of the numbered labels remains largely the same. The proposed changes include terminology that is better understood by patients. For example, user testing showed that, in label 1, the word “drowsiness” is not always readily understood and has been improved by using the wording “This medicine may make you sleepy”.

The recommended changes (see Panel for examples), following user testing, also produce more precise instructions, which present little opportunity for different interpretations. Thus, in label 4, the wording “Avoid alcoholic drink” is replaced with “Do not drink alcohol while taking this medicine”.

Luto’s testing showed that label wordings that can be incorporated in an appropriate position in the directions for dosage or administration (labels 21 to 28) did not generally work well. Separating these wordings into a discrete instruction worked better and this format has been adopted in the proposed wordings.

Conventional label styles were used for the first two rounds of testing. This was when most of the wording improvements were made and tested. In the third round, where the wordings were mostly only refined, a design-led label format recommended in the 2007 National Patient Safety Agency publication “Design for patient safety: a guide to the design of dispensed medicines” was used. This ensured that the revised wordings worked in this aspirational format, as well as in the conventional label style.

According to Nick Barber, professor of pharmacy practice at The School of Pharmacy, University of London: “When serious errors occur which cause harm to patients, it is often as a result of a series of minor failures at various stages. Therefore, in taking more care about the wording of detailed instructions, we can help improve the safety of medicines. With two million prescriptions being issued every day, a small percentage improvement through labels being more understandable could make a significant impact.”

It has never been easier to change labels on medicines given current computerised systems, and we therefore hope that the large pharmacy chains and independent pharmacies will adopt these recommendations, which appear in the new edition of the BNF (BNF 61, March 2011).

Citation: The Pharmaceutical Journal URI: 11070074

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Supplementary images

  • An example of the new recommended wording for label 2 cautionary and advisory label in the latest British National Formulary (March 2011)

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