In our March 2019 Newsletter I made an announcement:
We have initiated an international program to transform medicine information for consumers around the world.
International consumer advocates, medicine information producers, and CRI Fellows are collaborating in this transformation.
With the support of our Donors, Members, and Volunteers from around the world, we are developing new international guidelines and model templates for consumer medicine information and labelling.
We expect this project to take three years.
1. If you want to find out why we need this initiative, read our latest blogs.
2. If you would like to be part of this initiative, contact us now.
Since then a steady stream of people and organisations around the world have expressed interest in joining us.
We welcome all!
Why are we doing this?
Those of you who read my blogs know of my frustration with the Australian medicine regulator, the Therapeutic Goods Administration (TGA).
Over the last three years we have observed with dismay and sadness the inexorable dismantling and abandonment of the principles of good information design that we introduced, first to Consumer Medicine Information (CMI).1Writing about Medicines for People, then to the labelling of Over-The-Counter (OTC) medicines.2Labelling code of practice for OTC medicine In their place TGA has reverted to information design methods that were out of date 30 years ago.
We used to work side by side with industry, consumer advocates and regulators, but we can no longer do so in Australia because the new regulations make it impossible for us to design medicine information to a high standard.
Our diagnostic testing repeatedly shows that OTC labelling conforming to these new regulations fail to meet the minimum usability standards that we had agreed with industry and consumers.
Consumers who say they are able to read English should be able to use the label as stand-alone information, without help, to:
- find at least 90% of what they look for on a label
- use appropriately at least 90% of what they find.
Specifically, consumers should be able to:
- quickly and easily make a choice about the appropriateness of this medicine for their needs, at the point of sale
- find and appropriately use instructions for using the medicine safely and effectively, at the point of use
- access further information, if they want to know
more about the medicine, at any point. 3 Page 8. labelling code of practice: designing usable non-prescription medicine labels for consumers
Testing designs following the new regulations shows a marked deterioration in labelling usability. This is unacceptable.
But we are not alone. No doubt the loss of funding affecting all governments nowadays has played its part in narrowing regulators’ focus. Our international Fellows and colleagues overseas are reporting similar frustrations with their own regulators, who seem more intent on harmonizing with each other than with their local populations of medicine users. They seem to have turned their backs on medicine users in favour of talking to each other.
We would be neglecting our core mission and responsibility if we let this deterioration continue. We have therefore decided to work in collaboration with industry, consumer advocates, information designers, researchers and charitable donors around the world to create, test, and validate model medicine information templates for OTC labelling and CMI.
There are useful precedents
There is always a lag between advanced research and practice, between discovery and use.
Such gaps are not unusual, as Nigel Cross (a leader in design research) recently observed:
It seems that it takes a generation, at least twenty-five years, maybe thirty years or more, for the things that perhaps seemed ‘ivory tower’ research projects and ideas to become embedded in practice.4Nigel Cross (2018) Developing design as a discipline, Journal of EngineeringDesign, 29:12, 691-708, DOI: 10.1080/09544828.2018.1537481
But in areas where life and wellbeing are at stake that gap needs to be as short as possible. Medicine is one such area—yet there is still a lag between discovery and final regulatory approval. 5Matthew Howes (2015) The Global Drug-Lag Problem: The Pulse on Global Trials
Industry and consumer advocates have had some success in getting regulators to speed up new drug approval processes without compromising efficacy and safety testing. But this is not enough. Medicines are information dependant products. Without high quality information for health professionals and patients there are risks of medicine misuse. Without quality information they are useless, potentially harmful, even fatal.
Of course, neither governments nor industry have an interest in confusing, harming or killing people. A generation ago in Australia the Baume Report described how inadequate medicine information was doing exactly that. It was this report that led to the introduction of the Quality Use of Medicines policy and our intensive research leading to the principles of good medicine information design. Now a generation later, these seem to have been forgotten by our regulators.
If however we can newly create and share models of good practice, we may also succeed in bringing pressure to bear on regulators to adopt regulations that enable good practice to be a matter of routine.
The risks associated with poor quality information are technically within our power to control. In 2004, in a keynote speech to an international conference on information design, I was able to say on behalf of the information design community:
…there is now no technical barrier to designing public documents to extremely high standards…(p24)
Sless, David. “Designing Public Documents.” Information Design Journal + Document Design Journal 12, no. 1 (2004): 24–35.
What sat behind that announcement were the standards we had developed and now routinely apply to research and development work on public document design projects: standards for gaining reader attention, and standards for engaging readers .
For whatever reasons, regulators are currently failing in their duty of care to ensure the quality of information over which they have jurisdiction. No one should have to use medicine information designed to standards that were obsolete thirty years ago.