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It is hoped that a reduction in the maximum packet size of immediate release paracetamol will reduce the harm from intentional overdose, but have the changes gone far enough?
The Therapeutic Goods Administration (TGA) has recently finalised their decision regarding paracetamol packet size limits.
From February 2025, the maximum size packet available for general sale outside of pharmacies will drop from 20 to 16 tablets, and the maximum size packet available in pharmacies without the supervision of a pharmacist will halve from 100 to 50 tablets.
Packets of up to 100 tablets will now be upscheduled to pharmacist only medicines, requiring pharmacist supervision for these purchases. Although there is no requirement to limit sales to a single packet, the TGA has encouraged retailers to consider this.
Even though this announcement does not affect the current scheduling of modified release paracetamol, it follows the upscheduling of modified release paracetamol preparations to pharmacist only in June 2020. All decisions were made in an attempt to combat the increasing harms of intentional paracetamol overdose.
Annually, paracetamol overdose kills 50 people in Australia, and a further 225 people are admitted to hospital. According to the TGA, the rates of intentional overdose are highest among adolescents and young adults; however, the reduction in maximum packet sizes is expected to reduce harm across all age groups, which the TGA says “frequently involves impulsive ingestion of the entire contents of whatever pack is available in the home”.
Dr Rose Cairns, researcher and senior Lecturer at Sydney University’s School of Pharmacy, welcomes the change.
“I think this is a positive move and I really hope it will reduce harm from intentional overdose with paracetamol. Paracetamol toxicity is dose-dependent and anything we can do to reduce sizes of overdoses should improve outcomes,” Dr Cairns told InSight+.
Dr Cairns, who recently published a research letter in The Medical Journal of Australia that found there was no significant reduction in intentional overdose using modified release paracetamol since it was upscheduled to pharmacist only medicine, believes the TGA could have gone further to reduce potential harms of paracetamol.
“I would have liked to see imposed limits on the number of packs that can be purchased in one transaction, which was one of the options that was not taken up,” Dr Cairns said.
“In addition, given the ongoing harms from modified release paracetamol, I was hoping to see a change there, which didn’t happen — modified release paracetamol remains Schedule 3 (ie, behind the pharmacist’s counter). Modified release paracetamol is more likely to result in liver injury than immediate release paracetamol, and has been banned in some countries as a result.”
A spokesperson for the TGA told InSight+. that Dr Cairn’s research was taken into consideration when finalising the recommendation, but “the Delegate considered that it is premature to again up-schedule these preparations, noting the influence of factors such as COVID-19 lockdowns and potential stockpiling of these products on the incidence of overdose”.
However, Dr Cairn’s believes that a change would now be apparent. “In my opinion if there was going to be an impact, we would have seen it by now. Previous successful rescheduling has caused a pretty immediate shift in poisonings. Based on our data, there is a case for making it Schedule 4 [prescription only medicine].”
The TGA stands firm, reporting that “modified-release formulations are not affected by this decision and no changes to access restrictions are currently proposed.”
Some have voiced concerns over current restrictions causing a barrier for people who need access to paracetamol; however, by international standards, current restrictions are moderate.
“The pack sizes in Australia will still be larger than those available in the United Kingdom and most of continental Europe, so I don’t think these changes should be seen as harsh or controversial,” Dr Cairns said. “The UK experience has showed that reducing paracetamol pack sizes can reduce harm including liver injury and deaths. I think this treads the fine line of trying to minimise harm from paracetamol while still maintaining access to it for people who need it for pain and fever management.”
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Has the TGA set a timetable to review whether this change is justified? For example, after a year has there been a measurable reduction in overdoses? Based on the results, should purchase limits be reduced again, or should the package sizes be allowed to return to the previous size?
Given the dangers surrounding Paracetamol ingestion it is valid to ask: How effective is paracetamol for pain?
Lately there has been a spate of studies that address this question and it seems surprising that before this “household” usage became so widespread that there weren’t more studies done.
You can find these studies easily by Googling: How effective is paracetamol for pain.
The articles published in the BMJ, Cochrane, The Lancet and others are useful.