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Further restrictions on the sale of paracetamol will begin from 1 February. InSight+ spoke with a toxicology expert about the changes.
From 1 February 2025, packs of paracetamol will contain fewer tablets, both in pharmacies and in other places that paracetamol is sold. The TGA is also encouraging retailers such as supermarkets to restrict sales to a single pack at a time.
Paracetamol is the most common cause of liver poisoning in Australia, and in self-harm by poisoning (InSight+ wrote here about the changes). The new regulations are intended to reduce self-harm via poison for young people.
Rates of paracetamol poisoning in girls and young women are 2 to 3 times higher than for boys and young men.
Higher self-poisoning rates for girls and young women, compared to boys and young men
Dr Rose Cairns, a poisons and pharmacology lecturer at the University of Sydney and director of research at the NSW Poisons Information Centre, said that according to her research, there has been a marked increase in child and adolescent female self-poisonings over the last six years.
“Paracetamol is the leading cause of acute liver injury in Australia, and in many other countries,” said Dr Cairns.
Paracetamol is the drug most frequently taken in overdoses in Australia. Paracetamol is the most commonly used medicine in overdoses in young Australians.
The rates of self-harm by poisoning increased sharply during the COVID-19 pandemic restrictions but persisted when restrictions eased, said Dr Cairns.
“We’re seeing this increase in overdoses, and it’s particularly apparent in young people, teenagers, particularly young women. There’s been a more than doubling in the number of paracetamol overdoses in the past decade in that demographic,” she said.
Dr Cairns’ 2024 study looking at rates of self-harm in young people showed higher rates of poisoning for girls and young women, at 64% of self-poisonings documented.
During the COVID-19 pandemic, the increase in intentional poisonings in young people was just under 30%. Although for young men the increase was 11%, the rate for young women was more pronounced at 37%.
“It’s a lot more. For self-harm generally, young women outnumber young men three to one. With paracetamol, it might be an even bigger difference,” said Dr Cairns.
A 2019 report co-authored by Dr Cairns stated that while the gold standard treatment for paracetamol overdose is acetylcysteine, “adverse outcomes in patients with massive paracetamol overdoses, despite early administration of acetylcysteine, have recently been reported.”
Associate Professor Angela Chiew is a Staff Specialist in Clinical Toxicology & Emergency at the Medicine Prince of Wales Hospital and Clinical Toxicologist, NSW Poisons Information Centre.
“The changes in pack size are important as the toxic dose of paracetamol is 10 g or 200 mg/kg – whichever is less – so in most adults 10 g is a toxic dose that if taken over 24 hours can cause liver injury, potentially liver failure, the need for liver transplant and death if not treated with the antidote (NAC) in a certain time. Hence, by decreasing the amount readily available from 20 tablets (10g) to 16 (8g) as a means of harm minimisation,” said A/Prof. Chiew.
A persistent problem
Dr Cairns co-authored an expert report in 2022, commissioned by the Therapeutic Goods Administration (TGA), regarding intentional paracetamol poisoning, especially among young people.
“When the TGA report was written, there was approximately a tripling in paracetamol overdoses in teenage girls, in the decade before COVID. It was massive,” said Dr Cairns.
“The numbers were already rising pre-pandemic, then we saw this big spike with the pandemic, and things have settled somewhat since then but at a higher baseline than the pre-pandemic levels,” she said.
“With the increases in injury and overdose during COVID and then sort of calming down after COVID, I think that’s something we’re going to need to keep an eye on, research wise.
“And keeping in mind that it’s just so much more common in girls and young women versus boys and men.”
Small changes for significant results
Dr Cairns said that it is important to know that paracetamol will still be available, and that the new restrictions aim to address self-harm, while avoiding lack of access.
“Paracetamol will still be available in supermarkets, convenience stores, as well as pharmacies, but the pack sizes that are available outside of pharmacies have been reduced in size from 20 tablets to 16 tablets,” said Dr Cairns.
“In pharmacies, it’s going from 100 tablets to 50 in front-of-the-counter.”
“It’s not as though you can’t get those larger packs, but what people self-select is going to be a smaller pack size,” said Dr Cairns.
“It’s important also to mention that these changes aren’t affecting liquid paracetamol, such as is used for young kids, or modified release (MR) paracetamol, which has already been moved behind the pharmacist’s counter a few years ago,” said Dr Cairns.
“Paracetamol will also be in blister packs now, as that’s been shown in other studies to reduce the number of tablets people take. Again: the data shows most self-poisoning is impulsive, and the time taken to pop out a tablet reduces the amount taken,” she said.
“It’s something that won’t restrict access to people but might prevent harm.”
The UK restricted paracetamol in 1998
Dr Cairns said that similar restrictions on paracetamol to those now being introduced in Australia have been in place in other countries for decades.
“These changes bring us in line with a lot of other countries. A lot of countries in Europe don’t even allow non-pharmacy sales of paracetamol. The UK made similar restrictions to what we’re about to do, in 1998,” said Dr Cairns.
Dr Cairns said that while the United States and Russia, for example, have largely unrestricted paracetamol access, many countries in Europe have similar restrictions, based on the intention of reducing self-harm by poisoning.
“A lot of other countries have this kind of level of access or stricter, they’re still managing their pain fine,” she said.
In June 2020, the TGA modified restrictions of MR paracetamol to Schedule 3, meaning that MR paracetamol could only be purchased with involvement of a pharmacist.
MR paracetamol is not immediate release, and the researchers indicated that treating poisoning by MR paracetamol is more difficult than for IR (immediate release) paracetamol (the common form of paracetamol).
In a study co-authored by Dr Cairns looking at the MR paracetamol restrictions, the data did not show a reduction in the poisonings related to MR paracetamol, but also showed an increase in poisonings using other drugs, such as ibuprofen.
As the researchers wrote, “The increase in overdoses with ibuprofen and other over‐the‐counter analgesics may indicate that people were switching analgesics; as MR paracetamol is more toxic than non‐steroidal anti‐inflammatory drugs, this would be consistent with harm reduction.”
Dr Cairns said that data relating to UK statistics regarding paracetamol restrictions have been effective in harm minimisation.
“These risks are really in an overdose setting. Paracetamol is safe when taken as prescribed or according to the directions on the pack. I think there are a lot of misconceptions as to its safety — people often just assume that it cannot cause any harm because it’s so readily available. Like, how would something that you can get everywhere be so harmful? So, it does surprise some members of the public that it can cause toxicity and death if you overuse it,” said Dr Cairns.
A bigger mental health problem
As an epidemiologist, Dr Cairns said that mental health is a much larger problem than restrictions on the sale of paracetamol alone can relieve. She and her co-researchers are keen to look at what a difference these restrictions will make.
“While it’s hard to stop people from taking overdoses entirely, we hope that these changes will reduce the size of overdoses, which should improve outcomes”.
“The people who die by suicide don’t always have any diagnosed mental illness. And I think it’s tragic. There’s a lot of just impulsive suicides that happen,” said Dr Cairns.
“What determines whether someone dies or survives after a poisoning event is more dependent on the methods that they’ve used or the means available to them, rather than the actual level of intent,” she said.
Opposition to the changes
“Any change can be met with resistance, and that’s understandable,” said Dr Cairns.
“Opposition has mainly been around people not understanding what’s about to happen. Paracetamol will remain very accessible; people can get it from supermarkets, convenience stores, and from pharmacies. The large pack sizes will still be accessible, but you need to speak to a pharmacist,” she said.
“One other thing that’s interesting is that someone mentioned that they think it’s going to be an excuse for shrinkflation,” said Dr Cairns.
“That’s up to the drug companies, but recent experience with other things at the supermarket would indicate that that might happen. That was an interesting sort of side effect to this, which I had not considered. I hope it doesn’t happen,” she said.
Some states and territories may have different restrictions. For example, in pharmacies in Queensland and Western Australia consumers will need to speak to a pharmacist to purchase paracetamol-containing products in pack sizes larger than 16 capsules or tablets.
“Even if your pharmacy’s closed, you can still go and get some paracetamol if you need it,” said Dr Cairns.
The MJA paracetamol treatment guidelines can be accessed here.
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