EXPERT REACTION: Paracetamol pack size to be reduced to tackle overdoses

Paracetamol is a safe medicine when used at the recommended doses, however, overdoses due to paracetamol have been rising. Rates of intentional paracetamol overdose are highest among adolescents and young adults, and more common among females. Intentional overdose in adolescents and young adults is frequently driven by what is available in the home, and therefore reducing maximum size of packs will likely reduce risk of intentional paracetamol doses. Medical treatment is need within 2 to 6 hours after the paracetamol overdose. If treatment is delayed after ingesting high doses of paracetamol, there is a risk of serious liver injury, and sometimes death. Thus it is best to keep smaller quantities in the house, particularly where households may have members at risk of self-harm.

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. 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. People might be concerned when they hear that restrictions are happening but they should be reassured that they will still be able to access paracetamol from supermarkets and pharmacies under these new rules.

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. In both scenarios 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 overdose and save lives.

Reducing pack sizes and making medicines prescription only have both repeatedly been proven effective methods to reduce severe poisonings.  However, all scheduling decisions are a trade off - in this case the TGA is making a trade off between providing easy access to an affordable pain killer for the whole population and trying to reduce the severity of the 7,000 paracetamol poisonings each year.  Currently around 200 people suffer severe liver injury and around 20 die each year, and poisons centre data continue to show rapidly rising rates of deliberate self-poisoning in young girl and women.

Each year in Australia around 225 people are hospitalised and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults.

In 2022, the TGA published a report that it had commissioned from a panel of independent experts asked to consider the risks of self-harm from intentional paracetamol misuse in relation to the current access controls for paracetamol. Based on that report and evidence from overseas (e.g. UK where access to paracetamol is more restricted), the decision has been made to reduce the size packs of paracetamol. I strongly support this decision as the use of paracetamol is often underestimated as it is so easily accessible in such large quantities.

Paracetamol is used to treat fevers and pain. When used as directed, paracetamol is safe and effective. Higher doses however led 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. 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 right off). 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.

Paracetamol is commonly used to manage different types of pain in the community. Although reducing harms from paracetamol poisoning is important, it is also important that a variety of options to treat pain continue to be available and easily accessible to those in need. This need for balance is highlighted in the TGA’s decision, which introduces some changes to the way paracetamol can be accessed, with added safety measures for accessing larger pack sizes which will remain available through community pharmacies.

While limiting deaths from paracetamol poisoning is important, these medicines are commonly used to manage pain in the community, and there is a need to ensure people living with pain are not adversely affected by new restrictions. The TGA’s decision appears to have taken into consideration the need to balance limiting harms from paracetamol while still ensuring these medicines remain accessible to Australians to manage pain.

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.

A multifaceted approach is required to ensure that patients have access to paracetamol to treat acute pain, but we must also be steadfast in our commitment to ensuring medicines are safe for all patients.
Health professionals including doctors and pharmacists must be the champions for medicine safety and reducing the amount of paracetamol kept in the home for possible misadventure.

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.

The need to achieve a balance between minimising incidence and harm from intentional and unintentional self-poisoning, and maintaining appropriate access to paracetamol – a safe and widely used analgesic.

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.