What you need to know about the paracetamol regulation changes

From February, pack sizes of paracetamol sold in pharmacies will change. Here’s what pharmacists need to know.

Come Saturday (1 February 2025), paracetamol in packs containing 50-100 tablets or capsules will shift to Schedule 3 following the final decision on paracetamol access controls made by the Therapeutic Goods Administration (TGA) in 2023.

The aim is to reduce the volume of paracetamol kept in people’s homes to prevent harm from intentional overdose. Each year, around 225 Australians are hospitalised with liver injury and 50 Australians die from paracetamol overdose. The highest rates of intentional overdose are among adolescents and young adults – particularly females.

Pharmacists can help to reduce the amount of surplus paracetamol available in homes by being ‘champions for the change’, said Peter Guthrey MPS, PSA Senior Pharmacist – Strategic Policy.

‘While pharmacists know paracetamol is very safe when taken at recommended doses, we also know the devastating impact of intentional or unintentional overdose.

‘On Friday, PSA will be releasing the next edition of our flagship medicine safety report series which contains concerning data on the use of medicines, including paracetamol, in children and adolescents.’

‘The data on intentional overdose involving paracetamol is alarming … Scheduling changes are not the full solution, but are a strategy which could make a positive difference if it changes the patterns of paracetamol supply.’

Other countries have gone much further than Australia in limiting access to paracetamol, through measures such as scheduling and limiting pack purchases,’ he said.

What are the changes?

The TGA’s decision includes changes to both pack sizes and packaging. The new regulations affect pain relief products containing paracetamol as the sole active ingredient and cold and flu medicines containing paracetamol in combination with other ingredients.

Access to liquid, modified release and Prescription Only paracetamol is not affected by the changes.

How should pharmacists respond to requests?

The new regulations will require some logistical changes, including relocating affected paracetamol products so they are stored out of public access, as well as making room behind the counter for Pharmacist Only paracetamol packs. 

But the biggest change for pharmacists is to consider how their team should respond to requests for paracetamol products, said Mr Guthrey.

All pharmacy staff must be clear on the reason for the regulatory changes, and prepared to communicate this to patients. And pharmacy assistants should know to discourage the purchase of multiple packs of Pharmacy medicines, unless the patient has first been referred to the pharmacist.

For patients who use paracetamol to manage their chronic condition, pharmacists should base conversations on clinical need, rather than the number of times a patient presents to the pharmacy for paracetamol.

What labelling is required?

In Queensland, where a patient’s name is required by regulation on Pharmacist Only medicines, Pharmacist Only packs of paracetamol will need the same information. 

The TGA has issued 12-month exemptions for product sponsors to allow the supply of paracetamol products affected by the change in existing packaging until current stock is depleted. 

This means pharmacies can store and supply their remaining stock after 1 February 2025, without the need for repackaging or over-labelling. The supply of these products will need to be in accordance with their new Schedule (despite the labelling). 

Similarly, updated paracetamol products in packaging compliant with the new scheduling can already be supplied under this exemption ahead of the changes taking effect.

What should a Pharmacist Only paracetamol consultation look like?

As with any Pharmacist Only medicine, pharmacists have a professional and legal obligation to establish a therapeutic need and determine whether prescribing larger packs of paracetamol will be safe. 

‘Where a patient has ongoing therapeutic needs for paracetamol, this should be fairly quick and easy to establish,’ said Mr Guthrey.

 ‘This is important to reinforce with patients and pharmacy staff – treatment guidelines have not changed, and patients with ongoing needs must not be disadvantaged by this change.

‘What may be more complex is handling requests for the supply of larger packs on the grounds of “convenience” or “value”.’  

In these cases, considering the volume of paracetamol required to meet a patient’s therapeutic need will be important. 

‘One difference between Pharmacy medicines and Pharmacist Only medicines in a number of states and territories is the requirement to prescribe in relation to treatment of an individual patient,’ he said. ‘This can include advance provision, but therapeutic need must be established.’