Can you hear me? Increasing the patient voice in Consumer Medicine Information
Patients are being heard and consulted increasingly across the spectrum of medicine development and medicine use in the community. The patient voice has an important role in, for instance:
designing clinical trials
co-authoring scientific publication of trial results
reporting study findings in plain language summaries (PLS)
designing apps and patient programs.
Written medicine information needs patient voices, too.
How Consumer Medicine Information is produced
In Australia, Consumer Medicine Information (CMI) is the most reliable written information for prescription medicines. These leaflets help you to use your medicine safely and effectively.
CMI is written by the pharmaceutical companies that make the medicines. They know the most about the products they make – all the benefits, and all the risks. They use CMI to communicate that knowledge to the patient.
Your doctor may give you the CMI when they first prescribe your medicine. More likely, your pharmacist will give you the CMI when they hand over your medicine at the pharmacy. You can also access CMI from a variety of trusted sites online:
National Prescribing Service (NPS) Medicine Finder
MedSearch app.
How can we make CMI better?
Over the last decade or so, pharmacists, the Therapeutic Goods Administration (TGA), drug companies and communications experts have been researching how to improve the design of CMI. The aim has been to make it easier for both consumers and healthcare professionals to use it.
Driving the research was Parisa Aslani, Professor in Medicines Use Optimisation at the University of Sydney. She says:
Pharmacists have always thought that the information was too long, too detailed, too hard for people to understand. Too much on side effects and not enough on benefits. So when people read this information all they’re thinking is ‘I’m going to get those side effects, therefore I don’t want to take the medication’, or ‘I need to go back and talk to the pharmacist about all of this information that they’ve given me’. And so, people have been reluctant to use it.
Throughout the CMI redesign project, researchers tested each version of the new design with real patients and consumers. To do this, they used something called ‘usability testing’*. This is a process that engages patients or consumers in the design and content, helping to identify which elements work and which don’t.
And so, in July 2019, the TGA announced that they had successfully concluded the development of an improved CMI format, including one page of information “highlights”.
And consumer voices and input have been critical to the development of this new CMI design, which is now being rolled out.
Increasing the patient voice through ongoing usability testing
But how can we continue to ensure that patients and consumers have a voice in written medicine information?
Through ongoing and regular usability testing.
Not only is usability testing important for CMI design, it’s also valuable in improving CMI content. In fact, it’s so valuable that the European Medicines Agency has made mandatory the user testing of patient information leaflets (like CMI) for new medicines.
CMI usability testing is also valuable for the CMI writer. During usability testing, if you are a CMI writer you may discover things like:
content which made perfect sense to you doesn’t make perfect sense to a consumer
some information is hard to find and there’s probably a more logical place to put it
your language isn’t direct enough
your language is too direct.
Most importantly, a CMI writer will discover that people love having a voice in the production of CMI. Consumers and writers alike leave the testing interview more empowered and informed.
So we need to keep user-testing CMI: not only to ensure that it performs well and meets regulatory standards, but so that patients and consumers have a bigger voice in its creation.
*Usability testing is done as per the guidance in Writing about medicines for people: Usability Guidelines for Consumer Medicine Information, 3rd Edition.
Sally Bathgate is a freelance health and medical writer with a decade of experience in research and the pharmaceutical industry in Australia.