The Therapeutic Goods Administration (TGA), Australia, has decided to reduce the maximum pack size for various paracetamol products with effect from February 1, 2025.
Each year in Australia, around 225 people are hospitalised with liver injury and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults. The change in pack size aims to reduce the harm from intentional overdose.
While the decision was published in May 2023, the TGA recently further outlined temporary labelling exemptions for paracetamol. “To assist industry in transitioning to the upcoming paracetamol scheduling changes, and to facilitate pharmacy’s ability to supply these products, we are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine (Schedule 2) and Pharmacist Only medicine (Schedule 3) products,” it said in late-November.
The final decision on changing the scheduling of certain paracetamol products would reduce the maximum size of packs available for general sale (for example, at supermarkets and convenience stores) from 20 to 16 tablets or capsules; reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (namely ‘pharmacy medicine’ packs) from 100 to 50 tablets or capsules; and make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist.
The final decision to change the scheduling of paracetamol in the Poisons Standard was made following consultations in February-March 2023.
It takes into account an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose, inputs from the Advisory Committee on Medicines Scheduling, and submissions following rounds of consultations with individuals and organisations representing consumers, healthcare practitioners and industry.
(Source: TGA)
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