International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names

No, health professionals are not necessarily familiar with the proposed sole ingredient names. The following were considered significantly different from their existing names and are therefore unfamiliar to some members:

- Calcitonin salmon acetate - asparaginase
- doxycycline hyclate - dosulepin hydrochloride
- formoterol fumarate dihydrate - estropipate
- pentoxifylline -hydroxycarbamide
- asparaginase -tetracaine hydrochloride
- alimemazine tartrate - mercaptamine

Our members believe it is likely some consumers will be unfamiliar with the new ingredient names, particularly those that differ markedly from the existing names. ACN suggests implementing awareness activities, such as including a QR code sticker on medication packages with a link to the relevant TGA webpage during the dual labelling period, or a printed leaflet provided by the pharmacist at the time of dispensation.

ACN suggests continuing dual labelling of the ingredients below from table 1, for a further 12 months beyond the dual labelling period:

- Calcitonin salmon acetate
- doxycycline hyclate
- formoterol fumarate dihydrate
- pentoxifylline

ACN members consider this necessary to promote consumer safety and ensure all consumers affected by the change will have the opportunity to become aware of the change.

ACN recommends maintaining the dual label for mercaptamine for a further 12 months as the scope of its therapeutic usage and handling is critical and is at higher risk of causing serious adverse outcomes.

ACN members suggest that although health care providers will not require a dual label as these ingredient names will be familiar, all of these ingredients should remain dual labelled to ensure direct consumers have more time to become familiar.

ACN recommends extending the dual labelling for Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) for another 12 months as it is very commonly still prescribed as BCG.

This question is beyond our direct remit, however ACN suggest that the extension of dual labelling could give the providers and consumers more time to become familiar with the proposed sole ingredient names. Otherwise, successful familiarisation and public awareness strategies will be entirely reliant on proactive and engaged pharmacists and other health care providers.

ACN believes the way information is displayed is essential to the safe and quality use of medicines. It is critical the active ingredient is prominently displayed using appropriate placement and font size. [See Australian Government, Department of Health, July 2019. Medicine labels guidance on TGO 91 and TGO 92\. https://www.tga.gov.au/sites/default/files/medicine-labels-guidance-tgo-91-and-tgo-92.pdf]

ACN recommends including the old name in the product description to ensure it is searchable using generic terms, for up to three years. While health care professionals new to the system will easily adapt to the change, it is likely more senior health care providers may need more time to become familiar and adapt their practices beyond the transition period.

ACN supports all efforts to streamline and optimise health care delivery. However, any innovation must be responsive to the needs of the health workforce and consumers. ACN suggests the transition should be as user friendly and person-centred as possible to ensure maximum benefit and to avoid confusion. Educational resources for pharmacists and other health care providers must be made available, as well as public awareness strategies for different consumer groups.

ACN supports the proposal to implement a transition period for medicine labels to be updated with the sole ingredient names to reflect international best practice. This will also assist health practitioners to identify emerging issues in the medical literature and other communication channels. This will reduce the cost burden on manufacturers that currently produce different labels for the same medicines in different markets.

ACN supports the proposal to implement a transition period for medicine labels to be updated with the sole ingredient names to reflect international best practice. This will also assist health practitioners to identify emerging issues in the medical literature and other communication channels. This will reduce the cost burden on manufacturers that currently produce different labels for the same medicines in different markets.

Yes, ACN recommends updating PI/CMI of affected medicines and of other medicines that refer to the dual labelled ingredients during the transition phase. PI/CMI is a critical part of medication registration and ensuring consumers are provided accurate information about the safe use of medications.

1 year should be sufficient, provided appropriate, tailored awareness strategies for different health care providers and consumer groups are implemented.

Not applicable.

ACN agrees with the proposal for sponsors to request updated labels and/or PI/CMI documents to reflect the updated sole name according to the existing legislation and process as PI and CMI as it would facilitate clear communication between consumers, health professionals, software vendors and medicine sponsors and support the transition phase.

ACN is aware some medicine ingredient names in Australia are outdated and differ from the same medicines internationally. This can be confusing for consumers and health care professionals who travel internationally, health care professionals who qualified or practiced overseas or people who access medicine information online. ACN appreciates the TGA’s commitment to align ingredient names in Australia with international naming practices. ACN supports this initiative, provided the change is user-friendly, as labelling has a significant impact on the safe and quality use of medicines. ACN members suggested continuing dual labelling for at least another 12 months, as much of the transition period was during the COVID-19 pandemic and as such may not have been appropriately practiced in health facilities as required.