The Therapeutic Goods Administration (TGA) has published an independent report that it commissioned from a panel of experts asked to consider the risks of self-harm from intentional paracetamol misuse in relation to the current access controls for paracetamol.
Independent Expert Panel Report
On 9 May 2022, the TGA announced it had commissioned the expert report. The review is now completed, and the panel’s report is available below:
- Independent expert report on the risks of intentional self-poisoning with paracetamol
- Paracetamol report questions and answers
Terms of Reference
The panel was tasked with providing a critical analysis of:
- the incidence of overdosing reports, emergency department presentations, hospital admissions, adverse health outcomes and deaths attributable to paracetamol in Australia, with a particular focus on the contribution of paracetamol sourced by general retail sale. Where possible comparisons were to be made to other pain relief medicines that are available without a prescription.
- medicine overdosing behaviour, based on a systematic review of available published data, and
- the balance of benefits and risks of current access to paracetamol on the Australian market, and the possible outcomes in the community of changes to general sale access to paracetamol, including deliberate self-poisoning with other medicines.
The panel was to give regard to relevant published international findings related to paracetamol misuse and access controls, and the extent to which paracetamol is used in Australia generally.
The panel is not a decision making or approval body, and its role was to provide a publicly available report for consideration by the Advisory Committee for Medicines Scheduling and a Delegate of the Secretary of the Department of Health who is responsible for decisions about medicines scheduling.
Panel members
Professor Nick Buckley
Professor Nick Buckley is a Professor of Clinical Pharmacology at the University of Sydney and a practicing clinical toxicologist consulting at the Royal Prince Alfred Hospital and through all the Poisons Centres in Australia. He is highly experienced in guideline development, systematic reviews, clinical epidemiology, and research design. Professor Buckley has been involved with writing the Australian paracetamol poisoning guidelines since their inception and chairs the Australian Therapeutic Guidelines Toxicology and Toxinology writing group. He is also chair of the Australian Medicines Handbook (AMH) Editorial Advisory Board.
Professor Alison Calear
Professor Alison Calear is Co-Head of the Centre for Mental Health Research at the Australian National University and works in the areas of youth mental health, e-health and the prevention and early intervention of anxiety, depression, and suicide. She heads the Prevention, Promotion and Educational Systems research unit and is currently leading the development of a resource to assist parents to better recognise and respond to suicide risk and psychological distress in their children.
Professor Helen Christensen
Professor Helen Christensen is a mental health researcher and international leader in the use of technology to both detect poor mental health and to deliver quality evidence-based therapies. Her current research focuses on the effective integration of websites, apps, sensors, social media and Smartphone tools into large-scale prevention and intervention programs for anxiety, depression, and suicide. Professor Christensen is Scientia Professor of Mental Health at UNSW Sydney and a Board Director of the Black Dog Institute.
Consultation
The TGA is consulting on possible amendments to the Poisons Standard in relation to the panel’s recommendations. Public submissions are being received until 14 October 2022, following the standard process for consultation on possible amendments to the Poisons Standard. Further information is available here.
Contact details
For enquiries regarding the report or to contact the panel please email Paracetamol.Review@Health.gov.au.