TGA makes interim decision to reduce maximum paracetamol pack sizes

The Therapeutic Goods Administration (TGA) has today published an interim decision to reduce the maximum pack sizes for various paracetamol products.

The decision follows an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose. 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 interim decision proposes to amend the Poisons Standard (which provides regulatory controls over medicine availability) 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 packs available in pharmacies without supervision of a pharmacist (i.e. “Pharmacy Only” packs) from 100 to 32 tablets or capsules
• make other pack sizes of up to 100 tablets or capsules only available under the supervision of a pharmacist (‘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 decision took into account responses to the initial public consultation in September-October 2022 and advice from the Advisory Committee on Medicines Scheduling. It intends to strike a balance between minimising the incidence and harm from intentional self-poisoning and access to paracetamol for the treatment of acute and chronic pain.

To further minimise the harm from paracetamol overdose, the TGA is encouraging retailers such as supermarkets to restrict sales to a single pack at a time. The TGA is also encouraging consumers to not stockpile paracetamol in the home and to appropriately store paracetamol and other medicines.

The decision is an interim one, and is open to further public consultation until 3 March 2023 on the TGA Consultation Hub. All submissions will be considered before a final decision is made.

Additional information is available on the paracetamol questions and answers page.

Contact for members of the media:
Email: news@health.gov.au
Phone: 02 6289 7400