Independent review of paracetamol overdose

The Therapeutic Goods Administration (TGA) has published an independent expert report examining the incidence of serious injury and death from intentional paracetamol overdose, and will now consult widely on the recommendations including possible options to amend the Poisons Standard.

The independent report was commissioned by the TGA and led by Professors Nicholas Buckley (University of Sydney and NSW Poisons Information Centre), Alison Calear (Centre for Mental Health Research, Australian National University) and Helen Christensen (Black Dog Institute, University of New South Wales), with expertise in pharmacology, toxicology and mental health.

The report was commissioned to examine the rate of serious injury and death from intentional paracetamol overdose, and to understand whether the current access controls for purchasing paracetamol products are appropriate, particularly in younger more vulnerable groups in the community. In addition, the report assessed whether if stricter controls on access to paracetamol were implemented, individuals would likely seek other means for self-harm, however assessment of the international literature and experience of the authors suggested that this was not likely. 

The report found that the rates of intentional paracetamol overdose were highest among adolescents and young adults, and more common among females, further highlighting the need to develop targeted interventions to help younger people.  Survival rates from a paracetamol overdose are excellent, but only where medical treatment is sought within 2-6 hours after ingestion. If treatment is delayed after ingesting high doses of paracetamol, there is a risk of serious liver injury, and sometimes death. Treatment of overdose is also more challenging following ingestion of modified release paracetamol than immediate release paracetamol.

Recent data shows that each year in Australia, paracetamol overdose leads to around nine people per million hospitalised with liver injury and two deaths per million – or about 50 Australian lives lost.  While hospitalisation and death rates have not increased in recent years, there is a concerning increase of misuse in the community.

The report also found that both impulsive and planned paracetamol overdose occur at similar rates, with impulsive acts often using paracetamol already present in the home. Furthermore, it was found that when purchasing paracetamol, consumers generally favour the largest pack size available, and that these larger pack sizes are more frequently used in overdose cases.

The panel made seven recommendations to help reduce the harms from intentional paracetamol overdose:

1. reducing the size of packs of paracetamol sold in supermarkets and convenience stores, and in pharmacies without the advice of a pharmacist
2. limiting the number of packs of paracetamol products that can be purchased in one transaction to 1 or 2 packs to reduce home stockpiles of paracetamol
3. making modified-release paracetamol, which is designed for long-term use rather than for acute pain, available only with a prescription
4. restricting the purchasing of paracetamol without a prescription to individuals aged 18 years and older
5. improving the communication around the potential harms from paracetamol
6. maintaining and expanding follow-up care and support after self-harm
7. increasing awareness about safer storage of medicines and reducing stockpiling of unwanted medicines.

The report was considered by the Advisory Committee on Medicines Scheduling (ACMS) in August 2022. The ACMS advised that it would be beneficial for the TGA to consult widely in the context of possible options to amend the Poisons Standard.

This consultation is here - external site and is open until 14 October 2022. It follows the standard process for consultation on possible amendments to the Poisons Standard, with the exception that a range of options rather than a single option is put forward.