By Melissa Blewitt

Changes to how paracetamol is sold in Australia are now in place.
In 2023, the Therapeutic Goods Administration (TGA) announced its decision to alter the way some paracetamol containing products were to be sold and packaged in Australia. These changes came into effect on Saturday, 1 February.
The new regulations apply to all paracetamol and paracetamol combination products.
Under the changes general sale pack sizes available from supermarkets or grocery stores will be reduced from 20 to 16 tablets, and Pharmacy Medicine packs will be limited to 50 tablets, with larger packs requiring pharmacist supervision (Pharmacist Only Medicine).
Several paracetamol products are not affected by these changes. These include children’s products, slow-release formulations (for example, “osteo” products), and products already behind the pharmacy counter or only available via prescription.
Shortis and Timmins Pharmacist Dave Rees has welcomed the changes, saying by limiting maximum pack sizes of paracetamol the community can have a discussion about promoting the safe use of medicines.
‘We can all have a conversation about the risks and benefits of these medicines – both in the pharmacy and at home,” he explained.
The changes have been introduced to reduce the risk of poisonings from people exceeding recommended doses. The overall safety profile of paracetamol has not changed.
Paracetamol is one of the medicines most frequently responsible for hospital admissions due to poisoning, a new report from the peak body for Australian pharmacists has found, with approximately 16 per cent of pharmaceutical poisoning hospital admissions in children under five years of age being attributed to paracetamol.
The Medicine safety: Children and adolescent care report released by the Pharmaceutical Society of Australia on 31 January, further reveals that an estimated 93 children present to Australia’s emergency departments each day due to medicine-related problems, with approximately 40 admitted to hospitals. At least half of these incidents are preventable.
As the peak body for all Australian pharmacists, PSA strongly supports the move which will reduce the risk of overdose and poisoning, but there is more to be done.
“The sobering reality is that we are leaving our kids vulnerable to harm, particularly when it comes to common medicines around the house,” PSA National President Associate Professor Fei Sim FPS said.
“By limiting the maximum pack sizes of paracetamol, we are opening the door to have a conversation about the risks and benefits of these medicines – both in the pharmacy and at home – and take steps as a community to promote the safe use of medicines.
“By involving pharmacists in the supply of larger paracetamol pack sizes, we strike the right balance between access and safety, giving pharmacists and pharmacy assistants the opportunity to help patients manage their pain effectively while reducing the risk of misuse and harm.
“As the peak body for all pharmacists in all areas of practice, PSA continues to advocate for pharmacists to be further empowered in their roles as medicine safety experts. This includes the recommendations PSA makes in our report, from implementing a national reporting system for medicine safety incidents, to increasing the availability of pharmacists in children’s hospital wards.
“It takes all of us, across health professions, communities and policymakers, to make a difference to the children and adolescents who rely on our care.”
PSA joined Assistant Minister for Health and Aged Care Ged Kearney at Westgarth Pharmacy in Melbourne to launch the report and discuss paracetamol changes.
“Each year in Australia around 225 people are hospitalised with liver injury and 50 people die from paracetamol overdose. To think of so many young lives lost is heartbreaking,” she stated.
“The TGA’s decision to limit the size of paracetamol packs struck a balance between protecting young Australians from harm while also ensuring those in pain can access the medicine. My thanks to the TGA for its sensible and measured decision, and to the pharmacists and retailers around the country who have responded so robustly.”
The Key findings from the Medicine safety: Children and adolescent care report include:
Medicine-related problems in children and adolescents cost the Australian economy at least $130 million annually.
An estimated 93 children present to Australia’s emergency departments each day due to medicine-related problems, with approximately 40 admitted to hospitals. At least half of these incidents are preventable.
Paracetamol is responsible for approximately 16 per cent of pharmaceutical poisoning hospital admissions in children under five years of age.
Poisoning by non-opioid analgesics, antipyretics or antirheumatics was the leading cause of admission, with paracetamol accounting for at least 85% of the cases within this group.