Paracetamol pack sizes likely to be reduced: TGA

The Therapeutic Goods Administration (TGA) has announced an ‘interim’ decision to cut the size of paracetamol packets available in Australia.
 
If the move is approved, it will reduce the maximum pack size in supermarkets to 16 tablets, down from 20, while pharmacies will be allowed a maximum pack size of 32 tablets or capsules – a reduction from the current limit of 100.
 
‘The changes to maximum pack sizes and packaging of paracetamol are intended to minimise the incidence and harm from intentional paracetamol self-poisoning while also maintaining appropriate access to paracetamol for the treatment of pain,’ the TGA explains on its website.
 
Under another suggested amendment, packs on sale in supermarkets and pharmacies would also need to be in blister packaging.
 
The decision comes after the publication of an independent report, commissioned by the TGA in September last year, which considered existing access controls for paracetamol and the risks of self-harm from misuse.
 
The TGA subsequently sought feedback on suggested changes to the Poisons Standard, and the issue was then considered in November by the Advisory Committee on Medicines Scheduling.
 
In its submission, the RACGP said it supported placing all modified release paracetamol under Schedule 4, but did not favour restricting over-the-counter general paracetamol sales to adults only.
 
However, under the decision published this week, modified release tablets or capsules containing 665 mg or less paracetamol will remain under Schedule 3.
 
The TGA’s interim decision also supports a slightly larger pack size than was advocated for in the college submission, which suggested that 10 tablets or capsules should be the maximum available on general sale.
 
Professor Mark Morgan, Chair of the RACGP Expert Committee – Quality Care (REC–QC), believes reducing access to paracetamol will cut risks.
 
‘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.’
 
According to the TGA, there are 225 people hospitalised and around 50 deaths in Australia annually due to paracetamol overdoses.
 
While there will be no immediate changes – the decision is subject to a further consultation period until 3 March – the TGA is encouraging retailers to restrict sales to a single pack, as well as asking consumers not to stockpile paracetamol in the home.
 
The TGA advises that a final decision is due in April this year.
 
‘The proposals in the interim decision are not final, and no changes will occur until after a public consultation is held and all submissions have been considered,’ the TGA states.
 
If the change is approved, the TGA says the implementation would occur in late 2024 or early 2025.
 
Feedback on the interim decision can be made via the TGA Consultation Hub website.
 
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