Submission to the TGA about Medicine Labelling

CPSA welcomes the opportunity to again provide feedback as part of the TGA consultation on medicine labelling, having provided comment on the labelling and packaging of medicines review in August 2012. CPSA is very pleased that a number of the issues we raised and proposals we supported in that submission have been incorporated including the medicine information box with standardised information; dispensing label space to avoid important information being covered up; the increase in minimum font sizes; blister strip labelling requirements; and clearly having the active ingredient prominent on the packaging.

Older people are among the largest demographic taking medicines on a regular basis, and are more likely to be taking more than one medication. For this reason it is essential that active ingredients, warnings and dosage are clearly marked and able to be read and comprehended by people who may have failing eyesight or limited literacy and English language skills. At present, the print on packaging and medicine inserts is far too small for many people, particularly older people, to read.

Option 1: ‘No change’ leaves medicine users at risk as outlined in the regulatory impact statement.

Option 2: ‘Provide best practice guidelines in line with most current evidence’ is insufficient to bring about any lasting change. Experience tells us that universal adoption of voluntary best practice guidelines is extremely unlikely, with the lack of universality negating some of the benefits to users of medicines that may take up the voluntary recommendations as there is no standardisation.

For these reasons CPSA is very supportive of the proposals outlined under Option 3: ‘Introduction of a new Therapeutic Goods Order’ being implemented. It is only through mandating new requirements that the positive proposed changed will eventuate. Medicine information is vital consumer safety information which needs to be clearly conveyed. For this reason CPSA would like to see the shorter transition period of two years chosen. Any longer timeframe will be to the detriment of patient health. This shorter timeframe will not place undue regulatory burden on industry, particularly given that it is estimated that more than half of medicine labels for products in Australia are changed every 2.9 years. Furthermore, the estimated costs quoted in the regulation impact statement ($1937 per product for pre-production for a medium level label change and $1290 for the production costs[1]) are very low, particularly when you factor in what big business pharmaceutical companies are.

Some additional concerns which CPSA believes should be addressed as part of the new Therapeutic Goods Order include having a requirement that the active ingredients have equal prominence with the brand name, both in size and location.

CPSA would also like to see the medical name be highlighted first and foremost, over the brand name. This would minimise confusion for patients and medical staff and go some way to addressing the problem raised in the regulation paper that the increased use of generic medicines is causing confusion as packaging is different in colour, shape and trade name.

CPSA also calls for it to be clearly specified that all important information be put in a dark colour that is easily legible on a light background. Light coloured text is particularly illegible for those with poor eye sight.

1. Australian Government, Department of Health , Therapeutic Goods Administration (2014) Regulation impact statement: General requirements for labels for medicines, p. 28.