Jane Teather and David Dickinson

Development of the Yellow Card information package

For over forty years, the Yellow Card Scheme for reporting possible side effects of medicines has been the cornerstone of medicines safety monitoring in the UK. Since 2005, as a pilot scheme, it has accepted reports directly from members of the public; these currently represent about 10% of the total received. To date, around 7000 reports have been received from members of the public. These reports are seen as particularly important, as the pilot scheme demonstrated that they are at least equivalent in completeness and relevance to those from healthcare professionals. These reports may also be more effective in highlighting the impact of side effects on everyday activities.

However, independent research showed that public awareness of the scheme was only around 1%. The Yellow Card Scheme was therefore reviewed, in order to raise its profile and to promote a redesigned online reporting form.

Online reporting is to be encouraged, but is not available to everyone; also, people need to be aware of what ‘Yellow Card’ is about before they consider making a report, online or otherwise. The online Yellow Card reporting form therefore needs to be supported by an information package that raises awareness and gives people information about, and options for, making a Yellow Card report. These materials have initially been made available through community pharmacies.

The MHRA (Medicines and Healthcare products Regulatory Agency in the UK) asked Consumation, an information design consultancy specialising in usability-tested information about medicines and healthcare, to design and develop this information package. We agreed that it would consist of:

a poster to be displayed in the pharmacy

a credit-card-sized information leaflet (the ‘information card’), available in the pharmacy and included in the bag with prescribed and other medicines, to raise initial awareness of the Yellow Card Scheme

a leaflet explaining the Yellow Card Scheme in more detail – why reporting of side effects is important, the alternative methods for doing so, and where to get more information

integrated with the leaflet, a paper form and reply-paid envelope

a leaflet addressed to pharmacists.

As part of the development process, the draft Yellow Card information card, leaflet and paper form underwent diagnostic usability testing, in the form of in-depth interviews during which respondents were questioned about the scheme and observed completing hypothetical reports. The procedure was based on the diagnostic testing methods developed by the Communication Research Institute of Australia, and now widely used in developing effective information about medicines. Based on the results of these tests, we made a number of amendments.

In this presentation, we will summarise the background then describe the process of design and testing, focusing especially on how the feedback from interviews was used as the basis for changes to improve effectiveness and usability.

Jane Teather is an information designer with a background in biomedical science. Since 1991, she has run her own London-based information design consultancy, JET Documentation Services. Working with Consumation, a consultancy specialising in healthcare-related information design, she writes, designs, illustrates and tests information about medicines. She is a Life Fellow of the Communication Research Institute.