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TGA confirms reduced paracetamol pack sizes
The changes, due to come into effect from February 2025, are aimed at reducing Australian overdose and death numbers.
All paracetamol tablets and capsules are now required to be sold in blister packaging.
The Therapeutic Goods Administration (TGA) has confirmed it will reduce the maximum size of paracetamol packs available in pharmacies, supermarkets and convenience stores.
From 1 February 2025, new restrictions on paracetamol will:
- reduce the maximum size of packs available for general sale (eg supermarkets and convenience stores) from 20 to 16 tablets or capsules
- halve the maximum size of packs available in pharmacies without the supervision of a pharmacist (ie ‘Pharmacy Only’ packs) from 100 to 50 tablets or capsules
- make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist.
The decision,
originally flagged in September 2022, is aimed at reducing the number of people who die (50) or are hospitalised (225) due to intentional paracetamol overdose in Australia each year, for which the rates are highest among adolescents and young adults
Access to liquid, modified-release and Schedule 4 (Prescription Only) paracetamol is not affected by the changes, while the originally signalled pharmacy reduction to 32-tablet pack sizes has been watered down since the
interim decision was announced in February.
In addition to smaller maximum pack sizes, paracetamol tablets and capsules for both general and Pharmacy Only sale will now also be required to be in blister packaging.
Likewise, the maximum size of Pharmacy Only packs of individually wrapped powders or sachets of granules containing paracetamol will be reduced in line with tablet and capsule packs.
The final decision to change the scheduling of paracetamol in the Poisons Standard was made following consultation in February and March 2023. According to the TGA, it carefully considered the feedback resulting from this consultation, and balanced the need for some restrictions to pack sizes while ensuring continued access to larger packs for those people who need regular pain relief.
The regulator said its determination takes into account:
Professor Mark Morgan, Chair of the RACGP Expert Committee – Quality Care (REC–QC), previously expressed support for restricting access to large quantities of paracetamol, which he believes will reduce the risk of harm.
‘Overall restricting access to paracetamol would reduce deaths and harms from overdose,’
he said last October.
‘We don’t know to what extent, but evidence from overseas shows it could be as high as a 50% reduction.’
The RACGP
has also backed smaller pack sizes, but said that there should be no difference between regulations on packs in supermarkets and those in pharmacies, except when sold under the supervision of a pharmacist.
To further minimise the harm from paracetamol overdose, the TGA is encouraging retailers to restrict sales to a single pack at a time, and has
asked consumers to appropriately store the medication in their home and not stockpile large quantities.
More information on the changes is available on the
TGA website.
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pack sizes paracetamol Poisons Standard TGA Therapeutic Goods Administration
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