TGA flags possible amendments to paracetamol Poisons Standard

In May 2022, the Therapeutic Goods Administration (TGA) launched an independent review into whether paracetamol scheduling should be tightened.
 
The review, conducted by a panel with expertise in pharmacology, toxicology and mental health, was commissioned in response to ‘the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets’.
 
The resulting report, released this week, details concerns – particularly from impacted families and healthcare professionals – regarding the number of poisonings and deliberate overdoses from over-the-counter paracetamol.
 
Commissioned to provide an overview of discussions related to potential scheduling changes, including access and purchasing controls, it warns that ‘healthcare professional oversight’ is limited in some settings where the medicine can be bought, such as supermarkets and convenience stores.
 
And while the TGA states that there are no current changes to how paracetamol can be purchased, the Advisory Committee on Medicines Scheduling is calling for broader consultation on possible options to amend the Poisons Standard.
 
The month-long process, in which members of the public have opportunity to comment on a range of options, will be open until 14 October.
 
Following public consultation, the selected delegate – a senior medical officer at the TGA – will decide on ‘one or a combination of options as part of their interim decision’, the regulatory body has confirmed.
 
According to the report, recent Australian data suggests that paracetamol overdose is increasing and each year leads to around nine people per million being hospitalised with liver injury and two deaths per million – equivalent to 50 lives lost. 
 
It also says that increasing rates of intentional self-poisoning and misuse in the community is ‘significantly overrepresented’ among adolescents, young adults and females.
 
Professor Helen Christensen, Black Dog Institute Board Director and co-author of the new report, said the review highlights the serious risks of self-poisoning from paracetamol, which many people may be unaware of.
 
‘Self-harming with paracetamol tends to be impulsive, with young people taking what is readily available in the home, and often as a first attempt,’ she said.
 
‘It is … very important that parents and the public are educated to store medicines such as paracetamol safely, and not keep too much around the home where it is easily accessible.
 
‘The panel recommended restricting packet size and introducing age restrictions while purchasing paracetamol in supermarkets, so we welcome the TGA’s decision to consult on possible amendments to the Poisons Standard.’
 
The TGA report also details other possible outcomes should paracetamol purchasing controls or restrictions be put in place, including the potential for deliberate self-poisoning with other medicines.
 
Speaking to newsGP earlier this year, Dr Marguerite Tracy, a member of the RACGP Expert Committee – Quality Care, said it is appropriate to conduct regular reviews on the scheduling and availability of ‘any medication available in Australia’.
 
‘[T]here are many unregulated sources of information [on paracetamol] available to the population which may also contribute to overuse, misuse and deliberate overdose,’ she said.
 
‘GPs always have a role in the safe use of medications … they prescribe and recommend paracetamol, and this [review] provides an opportunity for education about total daily recommended doses, the issue of multiple paracetamol-containing preparations, and encouraging people to ask the pharmacist when they purchase other products about interactions with prescribed medications.’
 
The TGA is also hosting a webinar on Friday 16 September to outline the expert panel’s key findings, and answer stakeholders’ questions about possible options for changing access or purchasing controls through the Poisons Standard.
 
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