Ley on medicine label changes


Health Minister reveals safety concerns that prompted the changes

In early August, the AJP reported that medicine labels in Australia were to change for the first time in 15 years – a rollout which began on 31 August.

Minister for Health Sussan Ley reminds pharmacists that these changes will affect the way dispensing labels are applied to prescription medicines.

“Under the changes, consumers will be able to easily identify the active ingredients in medicines because they will be more prominent and also placed in a consistent location on the label.

“In addition, to protect people with serious allergies, substances from crustaceans, fish, eggs, soya, milk and tree nuts must now be declared for all types of medicines,” says Ley.

She says the medicine label changes will gradually appear on prescription medicines as well as medicines bought at pharmacies or other retail outlets.

“Many higher risk over-the-counter medicines will be required to include a health information panel, with details of active ingredients, uses, warnings and directions for use.

“This will provide consistency so consumers can find important information about their medicines,” she says.

The changes have been initiated following five years’ worth of industry and public consultations by the TGA, which identified safety concerns with the labelling of medicines.

Ley says these concerns included:

  • lack of awareness of the active ingredients in medicines, leading to accidental overdose when taking multiple medicines at once, as well as dispensing errors;
  • poor readability of medicine labels due to inconsistent placement of information, the use of complex language and legibility issues;
  • poor outcomes associated with taking a medicine due to difficulties in following directions for us or identifying advisory statements such as contraindications; and,
  • the potential for administration of the wrong medicine arising from similarities in medicine names and branding.

Pharmacists are also reminded that the TGA is changing some medicine ingredient names to align with the International Harmonisation of Ingredient Names (IHIN) labelling reform work, which commenced in April 2016.

The four-year transition period for these changes started in April this year and will end in April 2020. Dual labelling will continue until April 2023.

Read more:

Australia’s medicine labels to change for first time in 15 years

TGA reminds pharmacists about ingredient names update

Non-prescription labelling reformed

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