Should paracetamol be up scheduled?

The most commonly used over-the-counter pain-relief medicine in Australia is responsible for a steady rise in overdose rates.
 
Despite clear usage guidelines and most healthcare professionals assuming patients know how to use paracetamol, some misunderstandings about the drug’s safety – as well as its easy accessibility – are contributing to misuse and accidental or intentional overdose.
 
In 2018–19, non-opioid analgesics, including paracetamol, made up 11% of drug-related hospitalisations. More specifically, a 2019 study revealed that paracetamol-related hospital admissions in Australia increased by 3.8% per year between 2007–08 and 2016–17, prompting experts to call for a reduction in pack sizes.
 
Although paracetamol has dosage guidelines and Poisons Standard restrictions to pack sizes and strength sold on the Australian market, there are currently no applications to update these restrictions.
 
But the ongoing growth in paracetamol-related harms has prompted the Therapeutic Goods Administration (TGA) to commission an independent report on whether access to the medicine needs to be tightened.
 
The regulatory body cites concerns regarding ‘the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets’.
 
Dr Marguerite Tracy, a member of the RACGP Expert Committee – Quality Care, supports the review.
 
‘It is appropriate for the TGA to review the schedule and availability of any medication available in Australia,’ she told newsGP.
 
‘We have always known that paracetamol can be harmful above therapeutic/recommended doses – and rarely even within recommended doses in special circumstances, [such as] children, [people who are] very lean, or fasting.
 
‘There is increasing complexity with paracetamol included with other analgesics – ibuprofen, caffeine, codeine – and in cold and flu preparations which could lead to inadvertent consumption above recommended dosing.
 
‘In addition, there are many unregulated sources of information available to the population which may also contribute to overuse, misuse and deliberate overdose.’
 
The TGA review will cover analyses of overdose reports, emergency department presentations, hospital admissions, adverse health outcomes and deaths attributable to paracetamol.
 
This will include a particular focus on ‘the contribution of paracetamol sourced by general retail sale’ in Australia, with comparisons to other available over-the-counter pain-relief medicines.
 
A similar review into codeine resulted in the drug being up-scheduled in 2018, which subsequently led to a significant drop in its use and contribution to overdose rates.
 
Dr Tracy believes one solution to reduce harm from paracetamol misuse is to follow the lead of purchasing controls in parts of Europe.
 
‘Pharmacy-only sales have been shown to be effective in other countries [such as] Sweden, and restricting the age of sale to 18 years or older in Denmark has reduced paracetamol poisonings,’ she said. 
 
‘Restricting pack sizes, access points, age of purchase have all been shown in other countries to reduce the rate of presentations of poisoning from paracetamol.’ 
 
But, like the review into restricting codeine, Dr Tracy cautions that the impact on reduced harms from overdose needs to be evaluated against potential harms in terms of pain management.
 
GlaxoSmithKline, the pharmaceutical supplier of Panadol in Australia, does not support a regulatory overhaul of paracetamol, citing a current lack of evidence around misuse, but is in favour of a potential restriction to how many packs could be purchased at non-pharmacy sites.
 
The TGA review will also forecast the benefits and risks of current access to paracetamol, and possible outcomes in the community of changes to purchasing access, including ‘deliberate self-poisoning with other medicines and impacts on access to effective pain relief’.
 
Given that paracetamol is often recommended as first-line therapy for pain management, Dr Tracy said healthcare professionals have a valuable role in educating of the potential risks of misuse and overdose as part of supporting patient health literacy and the quality use of medicines.
 
‘GPs always have a role in the safe use of medications,’ she said.
 
‘GPs prescribe and recommend paracetamol, and this 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. 
 
‘In addition, GPs also manage mental health issues; careful discussion about the risks and benefits of medications, including paracetamol are frequently undertaken.’ 
 
The review will also examine relevant international findings related to paracetamol misuse and access controls, and the extent to which paracetamol is used in Australia generally.
 
‘One of the outcomes of the review may be a change in scheduling or could include other recommendations to minimise inadvertent and deliberate dosing above recommended therapeutic dosing,’ Dr Tracy said. 
 
The TGA report will be produced by a panel of independent experts and published in July 2022.
 
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