Around 50 Australians die from an overdose of the common painkiller each year.
An amendment to the Poisons Standard could see limits placed on how much over-the-counter paracetamol can be sold to consumers in one transaction, as the TGA attempts to curb misuse of the drug.
The regulator is currently taking community feedback on a range of recommendations made by an independent expert panel tasked with looking into the risks of intentional self-poisoning with paracetamol.
Overdoses of the drug can be effectively and safely reversed, but only if the patient presents within four to eight hours and has only overdosed by a moderate – i.e. no more than 30g – amount.
The independent panel found that acute liver injury or failure occurred in up to 5% of paracetamol overdoses and 0.5% of overdoses resulted in death.
In real terms, this equates to about nine hospitalisations with liver injury and two deaths per million people per year.
Slow-release paracetamol, which is stronger and generally used for chronic pain, was associated with higher rates of liver injury.
Paracetamol overdoses account for up to 50% of poisoning admissions in adolescents, and overall admissions from overdoses of the painkiller far outweigh the total number of admissions due to poisoning with other NSAIDs.
Most self-poisonings were impulsive and used paracetamol which was already available in the home.
It was uncommon for people to people to go out and buy the drug with the specific intent of using it for suicide.
Paracetamol overdoses have broadly risen over the last decade, reaching a peak of about 12000 admissions in 2017.
Adolescent girls and young women drove the biggest increase, with females aged between 10 and 24 accounting for two thirds of admissions.
Given those findings, the panel made seven recommendations:
- Reducing the pack size available in supermarkets and in pharmacies without the advice of a pharmacist
- Limiting the number of packs that can be purchased in one transaction to reduce home stockpiles
- Making modified-release paracetamol prescription-only
- Restricting over-the-counter purchase of paracetamol to people aged 18 and older
- Improving communication around the potential harms of paracetamol
- Maintaining and expanding follow-up care and support after self-harm
- Increasing awareness about safer storage of medicines.
The recommendations were welcomed by the Black Dog Institute, whose board director, Professor Helen Christensen, was on the independent panel.
Professor Christensen was particularly concerned with the finding that self-harm with paracetamol was increasingly common among young women.
“The review found that self-harming with paracetamol tends to be impulsive, with young people taking what is readily available in the home, and often as a first attempt,” Professor Christensen said.
“This is very concerning, especially for parents who may be unaware of the risk of substances like paracetamol.
“The panel recommended restricting packet size and introducing age restrictions while purchasing paracetamol in supermarkets and so we welcome the TGA’s decision to consult on possible amendments to the Poisons Standard.”
Another panel expert, Professor Alison Calear, said that while it was important to introduce measures which would help prevent paracetamol misuse, it was also vital to address the causes of self-harm behaviour.
“It is critical that we find out through new research with young people why they are self-poisoning, in order to prevent more attempts and deaths and hear from them ways we can address the problem,” Professor Calear said.
“It is particularly important this research be conducted with young women.”
The TGA consultation is open until October 14.
