Paracetamol, a staple of most Australian medicine cabinets, could soon be much harder to buy as the country’s regulator mulls the dangers of the common painkiller.
Australia’s Therapeutic Goods Administration (TGA) met this week to consider limiting the sale of paracetamol products after an increasing number of poisonings and deliberate overdoses.
And while limiting paracetamol pack sizes has some support, experts are considering whether to make paracetamols available only to over 18-year-olds or by prescription.
A ruling on future access to paracetamol has yet to be made, but medical experts warn any decision needs to strike a balance between safety and access.
Isn’t paracetamol safe?
Paracetamol is typically used to treat symptoms including pain, fever, colds and flu.
It is found in brand-name products, such as Panadol and Chemist Own, as well as supermarket or pharmacy home-brand medicines. The drug, from whatever brand and in whatever form it comes in, is often considered a staple in households worldwide.
But paracetamol is the number one pharmaceutical that Australian poisons centres receive calls regarding, with the annual number of poisoning cases increasing by 44 per cent from 2007-’08 to 2016-’17.
In that 10-year period, there were 95,000 paracetamol-related hospitalisations, and 200 deaths from paracetamol poisoning in Australia.
Fei Sim, national president at the Pharmaceutical Society of Australia, told The New Daily paracetamol is one of the safest painkillers worldwide, but it comes with risk just like any other medicine.
This is especially the case for people with poor liver function, as the drug needs to be broken down by the liver. If it’s not, it can build up and cause liver toxicity, which can potentially turn fatal.
Liver toxicity can also occur if people take an incorrect dose – either by accident, or deliberately.
A reported commissioned by the TGA and released in August confirmed there were increasing rates of intentional self-poisoning with paracetamol in the last decade in Australia, with the greatest proportion of cases in adolescents, young adults and women. It accounts for about 50 per cent of overdoses in young Australians.
These findings have pushed the TGA to review how the drug is sold in Australia.
What changes are the TGA proposing?
The TGA report recommended four main changes for consideration:
- limiting pack sizes
- introducing purchase limits
- requiring a prescription to purchase higher dose and modified-release products (such as those used to treat osteoarthritis)
- requiring a prescription for purchases by people under 18.
Angela Chiew, clinical toxicologist at the NSW Poison’s Information Centre and the Prince of Wales Hospital, said limiting pack sizes is a good idea.
“You can buy 100 tablets at the pharmacy and not have to speak to a pharmacist,” Dr Chiew said.
“You can go to a supermarket, and even though the pack sizes are restricted to 20, I can go in and buy five packets, and nobody will stop me. And I could do that as a teenager, unfortunately.”
The codeine model?
However, both Dr Chiew and Dr Sim stand against TGA’s proposal to ‘upschedule’ paracetamol, which means people would need to get prescriptions to access the drug, similar to what was done to codeine in 2018.
This is of particular concern to people with issues like chronic pain, who sometimes rely on paracetamol just to get on with day-to-day life.
Dr Sim says while the healthcare system has a responsibility to prevent harm, that responsibility goes both ways: Trying to reduce paracetamol poisoning while making sure medicine is still accessible to those who need it.
“The key here is access to essential medicines,” she said.
“If people can’t access paracetamol as an essential analgesic to manage their condition, then their condition is not well-managed, and … that will reduce their quality of life.
“It’s a fine balance between ensuring medicine safety, but still enabling access to medicine, [and] access to paracetamol.”
While making people get a prescription for paracetamol is “too extreme” and would clog an already overwhelmed national GP system, making the drug only available for purchase from pharmacies could be a neat solution, Dr Sim said.
This would mean that while Australians won’t be able to pick up their basic supply with their weekly shop, they would still be able to buy it without a prescription after a quick chat with a local pharmacist.
This has been the case for modified-release paracetamol since June 2020.
“That is the fine balance,” Dr Sim said.
“We have the health professional there to provide clinical governance and safety checks to make sure that the paracetamol can be used safely but at the same time it is still very easily accessible because you can simply walk into a pharmacy, have that consultation, and then have your medication.”
Focus on mental health
While the regulation of medicine is important, Dr Sim said if the final goal is to protect Australians then restricting sales of paracetamol is just a quick bandaid over a larger problem.
She said the “elephant in the room” – mental health – needs to be acknowledged.
Australian Bureau of Statistics data shows one in six Australians have experienced suicidal thoughts or behaviours in their lifetime, and more than two in five have had a mental health disorder.
“The conversation should not just be about regulating medicines,” Dr Sim said, “it should also be about access to mental health care, really bolstering systems that we have in place to support people affected by … mental illnesses.”
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