Medicine information and labelling need mandatory diagnostic testing, with results available in the public domain. Too many examples of untested consumer medicine information on packaging, pack inserts, and leaflets are proliferating around the world. Globally, medicine regulators and the pharmaceutical industry have, unsurprisingly, resisted mandatory testing with results available in the public domain. I argue that untested medicine information is a health risk. The argument for testing consumer medicine information is clear-cut. Medicines are information-dependent products, and without testing, the usability of the medicine information is unknown.
There is abundant evidence that medicines can be harmful if misused. Equally there is abundant evidence of medicine misuse. While no direct evidence links unusable medicines information with harmful outcomes, no one has argued that medicine information is therefore unnecessary. If it were not even suspected as a contributing factor, why would medicine regulators around the world make medicine information a mandatory accompaniment with all medicines? Other than the obvious answer—that they are just making a token gesture to cover any legal liability that might follow—there is no justification for unusable medicine information.
As those of you who regularly read this blog will know, over the last thirty-plus years, our Institute and many other information design researchers and practitioners have been testing and developing methods for designing medicines information and labelling to a high standard. Occasionally, industry, consumer advocates, and even regulators have agreed to those standards. But no more. We are now at a tipping point. Over the last three years, in our routine testing of consumer medicine information (CMI) and medicine labelling, we have seen a marked deterioration.
Our routine work is done for industry and regulators and is, sadly, commercial-in-confidence, so we cannot publish our methods or findings. Our commercial-in-confidence findings clearly show that recent changes in labelling regulations lower the likelihood of consumers using labelling information effectively. Often information does not reach a minimum acceptable standard. In some cases, our findings suggest the possibility of serious and harmful misuse and the possibility of overdose. Yet neither industry nor the regulators have removed products from the market as a consequence of our adverse findings. And consumer advocates, who know nothing of these findings, are themselves contributors to the deterioration by insisting on changes that are not supported by evidence.
This is why I now believe there is a strong case that the data on CMI and labelling testing should be in the public domain and subject to peer review, like other medicine research. Without such public scrutiny there is an obvious and avoidable health risk.
Still doubtful? See my next blog for an example.