Final decision on paracetamol access controls in the Poisons Standard – Question and Answers

No. The changes to the access restrictions on paracetamol medicines on general sale or in pharmacies through their scheduling in the Poisons Standard do not take effect until 1 February 2025.

No. Modified-release paracetamol products, which often have brand names that include ‘Osteo’, ‘MR’ or ‘XR’, are usually supplied for the treatment of osteoarthritis.

These products are currently ‘Pharmacist Only’ medicines, meaning they are available without a prescription but only with the supervision of a pharmacist. You can purchase these products only after it is checked by a pharmacist who will ask you some questions and give you advice to make sure it is safe and appropriate for you. These will continue to be available as they currently are.

Maximum pack sizes will reduce, and blister packaging will be mandated for some paracetamol products containing ‘immediate release’ paracetamol. Specifically, the final decision is to:

• reduce the maximum size of packs available for general sale (e.g. at 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 50 tablets or capsules
  • 50 to 25 sachets of powders or granules
• make other pack sizes of up to 100 tablets or capsules available without a prescription from a doctor but only under the supervision of a pharmacist (‘Pharmacist Only’ medicines).

These changes apply to products for pain relief containing paracetamol as the only active ingredient, and those for cold and flu that contain paracetamol along with other active ingredients.

Packs of paracetamol on general sale and Pharmacy Only sale will also be required to be in blister packaging.

All other products containing paracetamol including liquid preparations, modified-release formulations (e.g. ‘Osteo’, ‘XR’ or ‘MR’ type preparations for chronic pain) and Schedule 4 (Prescription Only) medicines are not affected by this decision.

No. Paracetamol products containing up to 100 tablets or capsules will continue to be available in pharmacies, but only with the oversight of a pharmacist. This means that the products will be displayed behind the counter where pharmacists process patient prescriptions, so that pharmacists can advise patients on the appropriateness of the product for their needs.

This decision does not implement the following options that were initially publicly consulted on:

• restrictions on the age of the person that can purchase paracetamol
• limits on the number of packs that can be purchased
• sales only from behind the counter in supermarkets and convenience stores
• modified-release paracetamol only available with a prescription from a doctor

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.

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.

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 final decisions to amend (or not amend) the current Poisons Standard.

The final 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.

The final decision differs from the interim decision published on 3 February 2023 in that it will:

• reduce Pharmacy Only pack sizes to 50 tablets or capsules (rather than 32) or 25 sachets of powders or granules (rather than 16)
• not change the size of packs of paracetamol powders or granules in sachets for general sale.

The Delegate varied the interim decision because they determined that this provides a more appropriate balance of the benefits and risks from paracetamol access. This was based on additional information from the public consultation in response to the interim decision, reconsideration of data from the Independent expert report on the risks of intentional self-poisoning with paracetamol, and additional data on the incidence of self-poisoning with sachet products.

The decision was made according to the criteria that must be considered under s 52E of the Therapeutic Goods Act 1989. These matters include the risks and benefits of the use of a substance, the purposes for which a substance is to be used, the substance's toxicity, dosage, formulation, labelling, packaging, presentation and any potential for abuse. It also includes the Scheduling Policy Framework.

The Delegate also considered advice from the Advisory Committee on Medicines Scheduling (ACMS), submissions from two rounds of public consultation, and the Independent expert report on the risks of intentional self-poisoning with paracetamol. The submissions on the public consultation about the interim decision are published on the TGA website at:

• Public consultation on proposed amendments to the Poisons Standard in relation to paracetamol prior to ACMS meeting in November 2022
• Public consultation on interim decision to amend the Poisons Standard in relation to paracetamol

Initial public consultation took place in September-October 2022. The TGA received 190 consultation submissions from the public prior to the Advisory Committee on Medicines Scheduling (ACMS) meeting in November 2022.

After advice was obtained from the ACMS at its meeting and the interim decision was published in February 2023, the public was invited to provide further comment between 3 February 2023 and 3 March 2023. A total of 201 consultation submissions were received.

Yes. The Delegate received submissions from individuals, and organisations representing consumers, healthcare practitioners and industry during the consultation rounds. Submissions received were both for, and against, the changes to paracetamol scheduling. All public submissions were considered by the Delegate in making the final decision.

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.

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.

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.

No. The Office of Impact Analysis (OIA) advised the TGA that a Regulatory Impact Analysis (RIA) is not required as the scheduling changes are unlikely to have more than a minor regulatory impact.

However, the Delegate considered the regulatory impacts of their decision, about which several submissions were received during the public consultation, in determining the date on which the scheduling changes will come into effect.

You may see an increase in the number of patients requesting ‘Pharmacist Only’
(Schedule 3) paracetamol products after 1 February 2025, when pack sizes larger than 50 tablets or capsules are up-scheduled.

As with all ‘Pharmacist Only’ (Schedule 3) medicines, pharmacies will need to ensure any up-scheduled medicines meet the relevant location requirements within the store by
1 February 2025.

From 1 February 2025, many of the paracetamol containing products in general sale and Schedule 2 (Pharmacy Only) will be affected by the scheduling decision where pack size is reduced and blister packs will be mandatory.

Depending on how sponsors decide to market and supply their products, they may need to change their product in relation to the:

• size of the pack (to decrease the number of tablets, capsules or sachets)
• packaging (to add blister packaging)
• labelling (e.g. to indicate it is ‘Pharmacist Only’ instead of ‘Pharmacy Only’, or contains a different number of tablets of capsules)
• inclusion of Product Information and Consumer Medicine Information documents
• registration of the product on the Australian Register of Therapeutic Goods (ARTG)

Further information about OTC medicine requirements are available on the TGA website at Supply a non-prescription medicine and Changing an OTC medicine: Paracetamol solid-dose products.

The Poisons Standard is implemented by states and territories under their legislation.

Whether existing retail stock of affected paracetamol products can continue to be supplied after 1 February 2025, such as through the relabelling of stock, is the decision of each state and territory.

The TGA anticipates providing more information about the arrangements in each state and territory in coming months.

In December 2022, the TGA ran a campaign across social media platforms to raise awareness of the risks of accidental and deliberate paracetamol poisoning and to promote safe use and storage.

The TGA will continue to publish educational information leading up to the implementation of the changes to maximum pack sizes to inform consumers of the risks of paracetamol and stockpiling of medicines in the home.