Paracetamol questions and answers
The TGA commissioned a report on the risks of self-harm from intentional paracetamol misuse. Below are some answers to anticipated questions that consumers, healthcare professionals and industry may have with respect to the expert report and follow-up actions.
Access to paracetamol products
This review looked at the risks of self-harm from intentional paracetamol misuse in relation to the current access controls for paracetamol.
No. There have currently been no changes to how paracetamol can be purchased from supermarkets, pharmacies, or convenience stores.
The major risk from paracetamol poisoning is acute liver toxicity.
Paracetamol is the most widely used pain relief medicine in the world that is available without a prescription. While paracetamol has well established safety and toxicity profiles, given the wide use there will be accidental and deliberate paracetamol poisoning in the community, in both adults and children. All medicines have risks if misused and paracetamol is no exception.
Take paracetamol at the recommended dosage as indicated on the packaging and do not exceed the overall maximum daily dose. Many cold and flu medications also contain paracetamol and care should be taken to ensure that you don’t accidently take more paracetamol than you should. Always speak to your doctor or pharmacist if you are unsure and for more information.
Call the Poisons Information Centre immediately on 131 126 if you or someone you know may have made an error with any medicine.
It is best practice to keep only what you need in your medicine cupboard at home.
Ensure that any expired packets of paracetamol are disposed of safely. Expired packets can be returned to your pharmacy for safe disposal.
The independent expert panel report
The TGA was aware of concerns, particularly from impacted families and healthcare professionals, regarding the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets and sought expert advice on whether current access restrictions are appropriate.
The expert panel consisted of Professor Nick Buckley a clinical toxicologist, Professor Alison Calear Co-Head of the Centre for Mental Health Research at the Australian National University and Professor Helen Christensen a mental health researcher.
Yes, you will have an opportunity to comment on the recommendations made in the report when the pre-meeting public notice is published, and the public consultation opens on the consultation hub here.
The review confirmed that 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 females being significantly overrepresented.
The expert report is available at: https://www.tga.gov.au/resources/publication/publications/independent-expert-panel-report
Actions following the report
The report was considered by the ACMS in August 2022 and advised that it would be beneficial for the TGA to consult widely in the context on possible options to amend the Poisons Standard.
A pre-meeting public notice will be published and the standard process for consultation will commence for a period of a month. Members of the public will have the opportunity to comment on a range of options rather than a single option. These options are exclusive of one another and following the public consultation the Delegate may choose one or a combination of options as part of their interim decision.
The will also be hosting a webinar to highlight the expert panel’s key findings in the report, and answer stakeholders’ questions about possible options for changing access or purchasing controls through the Poisons Standard in response to the expert panel’s recommendations. The findings of the report and the advice of the Advisory Committee on Medicine Scheduling (ACMS) will be considered further by the TGA, who will determine what amendments to the Poisons Standard or other actions should be proposed.
The public will have two opportunities to provide submissions on possible amendments to the Poisons Standard. One when the pre-meeting public notice is published and second when the Delegate makes an interim decision.
The Delegate is a senior medical officer at the Therapeutic Goods Administration (TGA) acting as a Delegate of the Secretary of the Department of Health and Aged Care.
Paracetamol is a medication that is widely used throughout the community. Although the outcomes from paracetamol overdoses are tragic, they are extremely rare when considering the volume of paracetamol sold in the community each year.
If potential changes to accessing paracetamol are considered by the TGA, it is important that the public have an opportunity to provide feedback.