THE TGA has published an interim decision to reduce the maximum pack sizes for various paracetamol products.
Each year in Australia around 225 people are hospitalised and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults, the TGA has reported.
The interim decision proposes to amend the Poisons Standard to reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules; reduce the maximum size of 'Pharmacy Only' packs from 100 to 32 tablets or capsules; and making other pack sizes of up to 100 tablets or capsules 'Pharmacist Only' medicines.
Packs of paracetamol on general sale and 'Pharmacy Only' sale would also be required to be in blister packaging to deter overdose from ingesting large numbers of tablets or capsules, the TGA explained.
To further minimise the harm from paracetamol overdose, the TGA said it is encouraging retailers such as supermarkets to restrict sales to a single pack at a time.
The TGA is also requesting consumers to not stockpile paracetamol at home and to appropriately store paracetamol and other medicines.
The decision follows an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose.
The decision by the TGA took into account responses to the initial public consultation in Sep-Oct 2022 and advice from the Advisory Committee on Medicines Scheduling.
The TGA said the decision strikes a balance between minimising the incidence and harm from intentional self-poisoning and access to paracetamol for the treatment of acute and chronic pain.
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