New medicine labels to promote safer use for consumers

New consumer labels on medicines are being introduced to provide simpler instructions and to address safety concerns for people with allergies and reduce accidental overdose.

Page last updated: 05 September 2016

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3 September 2016

New consumer labels on medicines are being introduced to provide simpler instructions and to address safety concerns for people with allergies and reduce accidental overdose.

Minister for Health Sussan Ley announced today that from September 2016 new regulations would be introduced to improve information about medicines on labels.

“Regulations for medicine labels in Australia have not been updated for more than 15 years and are not aligned with international practices. The current labelling can lead to poor medicine use and a number of medicine safety concerns,” Minister Ley said.

“The new medicine labelling requirements will give Australian consumers clearer and more meaningful information about the medicines they buy and will provide Australian consumers with the clarity they deserve.

“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.

"These changes will also require that a space must be included for pharmacists to apply dispensing labels to prescription medicines.”

Ms Ley said the medicine label changes will gradually appear on prescription medicines as well as medicines bought at pharmacists or in 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 said.

Ms Ley said the changes have been initiated following extensive industry, health care professional and public consultations over the past five years by the Therapeutic Goods Administration (TGA) which identified safety concerns with the current labelling of medicines.

These included:

    • Lack of awareness of the active ingredients within 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 use or identifying advisory statements such as contraindications; and
    • The potential for administration of the wrong medicine arising from similarities in medicine names and branding.
As a result two new Therapeutic Goods Orders for medicine labels – one for prescription medicines and the other for non-prescription medicines – have been developed and will come into effect in September 2016.

The head of the TGA, Professor John Skerritt, said improved medicine labels will assist in the quality use of medicines.

“New minimum text heights requirements for the names and quantities of active ingredients will improve the readability of labels for higher risk medicines,” Professor Skerritt said.

“To allow easier identification by both consumers and medical practitioners, this information must also be placed adjacent to or below the name of the medicine.

“Critical health information to ensure safe use of the medicine must be formatted in tables for high risk medicines that are purchased directly by consumers. This also assists in making the information easy to identify and read.”

Information for consumers and health professionals can be found on the TGA website.

Media contact:
Randal Markey, 0417 318 620 (Minister Ley)
Kay McNiece, 0412 132 585 (TGA)


Case Histories:


Example:

A patient collects their prescription medicine from the pharmacist. The pharmacist explains how to use the medicine and that the dosage instructions given by the doctor are on the dispensing label for them to follow.

When the patient takes the medicine home, they don’t realise that it needs to be stored in the fridge. The dispensing label could not be applied without covering important information and the storage conditions included on the carton are no longer visible.

The patient stores the medicine at room temperature and after 3 days it is no longer as effective in treating his condition.

Under the new labelling rules:

The new labelling requirements include a dedicated 70x30 millimetres space that must be on prescription medicines. This means that the dispensing label can be more easily applied without covering other important information printed on the box.

With the new label design, the patient can see the storage conditions below the dispensing label and puts the medicine in the fridge. Proper storage keeps the medicine effective over the entire treatment course.

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Example:

Jane is allergic to eggs. She usually buys the same medication every month but was recently offered a different brand in her health food store.

Under the new labelling rules:

More allergens, such as eggs, have to be disclosed on medicine packaging. Jane and her health care provider are quickly able to see that the new medication contains egg products and therefore is not an appropriate choice for her circumstances.

Because of the new labelling rules Jane can make a more informed and appropriate choice for her health.

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Example:

Doris, an elderly 86 year old Australian, is suffering from failing eyesight. Doris is having difficultly knowing what is contained in her medicine and requires a magnifying glass to read the information on the label. Doris also takes a number of medicines simultaneously.

The active ingredient is in small writing, and for each medicine, Doris needs to look in a different spot on the label to find the active ingredient.

Doris takes her medicines to her GP who realises that she has multiple generic brands of the same medicine. He explains the difference between the medicine name and the name of the active ingredient but is concerned that that she might not remember this in future and may accidently take too much of a particular treatment.

Under the new labelling rules:

Once the new labelling requirements apply, her medicine comes in a newly designed carton.

Her GP points out that the active ingredient is immediately under the medicine name, in larger print and more readable.

Because the active ingredient is always in the same place Doris can now easily recognise the ingredients in her different medicines and is less likely to take extra doses.

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