In 2019, researchers called for access to Australia’s most commonly used painkiller, paracetamol, to be restricted.

As we reported then, this was because of a serious increase in people hospitalised with paracetamol poisoning.

This week, the Therapeutic Goods Administration (TGA) published a final decision to reduce the maximum size of packs for various paracetamol products.

In supermarkets and convenience stores, the maximum packets of paracetamol will shrink from 20 to 16 tablets.

In pharmacies, maximum packets have been halved, from 100 to 50 tablets.

The changes will take place on February 1, 2025.

Poisoning cases soar

Paracetamol poisoning cases have increased by 44.3 per cent since 2007-08 – and the number of cases of toxic liver diseases due to paracetamol overdose has more than doubled, according to a paper published in 2019.

And more than 20 per cent of overdoses were intentional, mainly among older people.

The research, led by Dr Rose Cairns, senior poisons specialist at the New South Wales Poisons Information Centre, found that:

• There were 95,668 admissions with paracetamol poisoning diagnoses (2007-08 to 2016-17)
• Toxic liver disease was documented for 1816 of these patients; the annual number increased by 108 per cent during the study period – or 7.7 per cent per year
• Most paracetamol overdoses – about 70 per cent – involved women
• The NSWPIC database included 22,997 reports of intentional overdose with paracetamol
• The annual number of intentional overdoses increased by 77 per cent during the study period
• The median number of tablets consumed by Australians increased from 15 in 2004 to 20 in 2017
• 126 in-hospital deaths were recorded, and 205 deaths (in and out of hospital)
• The median age was 53 years in cases of fatal overdoses, perhaps reflecting greater suicidal intent in overdoses by older people or the presence of other conditions that increased the risk of liver injury.

“Paracetamol is the leading cause of acute liver injury in Australia and in recent years we have seen increasing deliberate overdoses with paracetamol, particularly in young girls,” Dr Cairns said.

“Reducing pack sizes for paracetamol is an evidence-based approach to reduce harm from these poisonings. Limiting unnecessary stockpiles of paracetamol in Australian homes can prevent accidental and intentional poisonings.”

Overdoses

Associate Professor Sam Alfred is head of the Toxicology Unit at the Royal Adelaide Hospital.

“Paracetamol is the most commonly ingested drug in overdose taken with the intention of self-harm. It is also commonly ingested by individuals unaware of the considerable risks associated with supratherapeutic doses,” Dr Alfred said.

“In both scenarios, the available dose is a significant determinant of outcome, and it is likely the TGA’s decision to reduce this risk through a reduction in the immediately accessible amount of paracetamol will improve outcomes following overdoses and save lives.”

Add in alcohol

Elena Schneider-Futschik is a pharmacist by training and leads the Respiratory Pharmacology Lab at the University of Melbourne.

“Paracetamol is used to treat fevers and pain. When used as directed, paracetamol is safe and effective. Higher doses however lead to toxicity, including liver failure (which could even result in the need for a liver transplant). In countries where paracetamol access is not restricted, paracetamol poisonings is the foremost cause of acute liver failure,” Ms Schneider-Futschik said.

“Overdose is often related to high-dose recreational use or in consumption with alcohol. When the body breaks down paracetamol, it does via liver enzymes and produces a toxic intermediate metabolite (which the body needs to get rid of). Overdosing will cause over-production of the toxic intermediate. But also, alcohol interferes with this pathway, exposing the liver to this toxic intermediate causing permanent liver damage.”

Dr Tin Fei Sim is a senior lecturer with the Curtin Medical School at Curtin University.

“Each year in Australia, approximately 250,000 hospital admissions are a result of medicine misadventure, of which 225 people are hospitalised and 50 people die from paracetamol overdose,” Dr Fei Sim said.

“As a community, we need to work on improving education on the risks of paracetamol and medicine misadventure. Consideration must be given to wraparound measures that will help improve communication and public awareness about the issues, increase health literacy of individuals and family members, and facilitate timely access to acute pain relief.

“During the pandemic, we also noticed a shortage of paracetamol, and a reduction in pack size or the amount that any person will have on hand at one time, will go a long way to avoid medicine shortages enabling everyone who needs paracetamol to have access to it when they need it.”