Sorry, but they won’t work.

Suddenly, the Therapeutic Goods Administration (TGA) is an expert in typography and information design. The TGA has proposed a new set of guidelines for medicine labelling, to replace the evidence-based approach in TGO69A, the current regulation and the ASMI Code of Practice. If implemented, the new guidelines will result in more medication errors and a gradual deterioration of medicine labelling usability in Australia.

I can make this claim because we at CRI have designed, redesigned, tested and retested many medicine labels with hundreds of consumers over the past thirty years. We have just published a free summary of our work. The evidence from our testing—much of it in the public domain and all of it available to TGA—shows repeatedly that the TGA’s proposal will not work.

The reasons are complex, but easily stated. TGA has assembled a list of requirements. The list is based on a misreading or misunderstanding of the research and a total lack of sensitivity about how consumers read, digest, and use information. This list is not a guide to designing labels. It’s a shopping list of permitted ingredients, but with no recipe and no cooking guide.

TGA wants the pharmaceutical industry to use this shopping list to cook up medicine packaging that consumers will be expected to swallow. Faced with the unappetising, uneatable, and indigestible mess, most consumers will decline the invitation and expose themselves to the risks of medication error.

Here is an item from the shopping list of requirements:

Required information on labels must be: …

  • …in text size not less than the equivalent of 6 point Arial, unless specified elsewhere in TGO 79 section (7)(2)(d).
‘Best Practice’ Label

TGA 'Best Practice' LabelBefore the typographers and information designers among you who know about document usability start to squirm, laugh, or cry, let me assure you that this is serious. This label, in contrast to TGO69A and the ASMI Code of Practice, is totally without any performance requirements or testing data, and is the TGA’s idea of best practice to protect consumers from medicine errors. As I said, an unappetising, uneatable, and indigestible mess.

We would love to help TGA avoid this disaster. We would give our time pro-bono if we thought it would make any difference. But if need be, we will fight them all the way.

For once I agree with our Prime Minister, Tony Abbott, who on another matter earlier today was quoted as saying that:

…the regulation of medicines (by the TGA) is a thicket of complexity, bureaucracy and corporate self-interest.

It need not be so.