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On 3 February 2023, the TGA announced the interim decision to amend the scheduling of paracetamol in the Poisons Standard. The decision has been made following an independent expert report regarding the risks of intentional self-poisoning with paracetamol, public consultation on possible options to amend the scheduling of paracetamol, and advice from the Advisory Committee on Medicines Scheduling (ACMS).
For further information about scheduling, see Scheduling of medicines & poisons.
Access to paracetamol
Has access to paracetamol changed?
No. A proposal, or interim decision, has been made to change the maximum size of paracetamol packs that can be purchased on general sale (e.g. from supermarkets) and in a pharmacy without the supervision of a pharmacist.
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.
How are paracetamol pack sizes and packaging proposed to change?
The interim decision would, if made final:
- reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules, with a requirement for blister packaging.
- reduce the maximum size of packs available in pharmacies without supervision of a pharmacist (Schedule 2 ‘Pharmacy Only’ medicine) from 100 to 32 tablets or capsules, with a requirement for blister packaging.
- make other pack sizes up to 100 tablets or capsules only available under the supervision of a pharmacist (Schedule 3 ‘Pharmacist Only’ medicine).
Schedule 3 ‘Pharmacist Only’ medicines are located behind the counter in pharmacies but a prescription from a doctor or other healthcare practitioner is not required to purchase them.
What are the reasons for the proposed changes to paracetamol pack sizes and packaging?
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.
A detailed explanation of the reasons for the decision can be read in the Notice of interim decisions to amend (or not amend) the current Poisons Standard.
The interim decision follows the Independent expert report on the risks of intentional self-poisoning with paracetamol that confirmed that paracetamol was used in an increasing number of intentional self-poisonings, particularly in adolescent and young adult women. The report made recommendations for changing access to paracetamol to minimise the harm from intentional paracetamol overdoses.
What is the basis for reducing pack sizes to minimise intentional self-poisoning?
The Independent expert report on the risks of intentional self-poisoning with paracetamol reported that the largest pack sizes of paracetamol available from either general retail or pharmacies are frequently consumed in intentional self-poisoning. Reducing the maximum size of packs is therefore intended to reduce the dose of paracetamol that is consumed during intentional overdose. The report found reductions in the size of packs in other countries has been associated with reduced harm from self-poisoning.
Is paracetamol safe?
Paracetamol is the most widely used pain relief medicine in the world that is available without a prescription. While paracetamol has well established safety and toxicity profiles, given the wide use there will be accidental and deliberate paracetamol poisoning in the community, in both adults and children. All medicines have risks if misused and paracetamol is no exception.
How do I make sure that I use paracetamol safely?
Take paracetamol at the recommended dosage as indicated on the packaging and do not exceed the overall maximum daily dose. Many cold and flu medications also contain paracetamol and care should be taken to ensure that you don’t accidently take more paracetamol than you should. Always speak to your doctor or pharmacist if you are unsure and for more information.
Call the Poisons Information Centre immediately on ;131 126 if you or someone you know may have made an error taking any medicine or taken an overdose.
It is best practice to keep only what you need in your medicine cupboard at home.
Ensure that any expired packets of paracetamol are disposed of safely. Expired packets can be returned to your pharmacy for safe disposal.
Actions following the interim decision
What happens after an interim decision is made?
A second round of public consultation regarding this interim decision is now open on the TGA Consultation Hub. The consultation is open for one month and will close on 3 March 2023.
All submissions received will be considered before a final decision is made and published on the TGA website.
The final decision is anticipated to be made later this year.
Will I get to have a say on the proposed changes?
Yes, anyone can have their say on the interim decision by making a submission to the public consultation.
When will the scheduling changes take effect?
Once a final decision is made, there will be a period of time before the changes will come into effect. As no final decision has been made, an exact implementation date has not been finalised. However, if a scheduling change is determined we anticipate the implementation would occur in late 2024 or early 2025.
If paracetamol causes so much harm, why has the TGA not restricted access already?
Paracetamol is safe and effective for most people when taken at the recommended dose. It is widely used throughout the community. If potential changes to accessing paracetamol are considered by the TGA, it is important that the public have an opportunity to provide feedback.
Although the outcomes from paracetamol overdoses can be tragic if not treated early, they are extremely rare when considering the volume of paracetamol sold in the community each year.
Who is the Delegate?
The Delegate is the decision-maker for amendments to the Poisons Standard. The Delegate is a senior medical officer at the Therapeutic Goods Administration (TGA) acting as a Delegate of the Secretary of the Department of Health and Aged Care.