RACGP backs up-schedule for modified release paracetamol

The RACGP is supporting a proposed change to the Poisons Standard that would up-schedule modified release paracetamol to Schedule 4.
 
However, it is not pushing for sales of the standard form of paracetamol – the most widely available over-the-counter pain relief medicine in the world – to be subject to greater age restrictions.
 
That is the position outlined in the college’s submission to the Therapeutic Goods Administration (TGA), which last month opened up its proposed amendments to the Poisons Standard for paracetamol to consultation.
 
The RACGP noted that effective, evidence-based pain relief can be an important part of treatments and help patients have a good quality of life, but stressed it advocates for the safe and appropriate use of medicines ‘at all times’.
 
The college confirmed its support for the reduction of paracetamol package sizes in general retail outlets to 10 x 500 mg tablets/capsules, or five individually wrapped sachets.
 
However, the college said ‘additional information’ is needed to support a proposed move to tighten age restrictions on paracetamol sales.  
 
‘Restricting the purchase of paracetamol for people under 18 would be detrimental for those suffering from acute pain, such as headache, period pain or influenza-like symptoms,’ the submission reads.
 
The college also supported a move to stop people buying multiple packs.
 
‘Allowing the purchase of two packs of 10 tablets is reasonable and will reduce the tendency for large stockpiles to be kept in the home,’ the college states.  
 
Professor Mark Morgan, the Chair of RACGP Expert Committee – Quality Care (REC–QC), said that restricting overall access to paracetamol would reduce deaths and harms from overdose.
 
‘We don’t know to what extent, but evidence from overseas shows it could be as high as a 50% reduction,’ he told the ABC.
 
He said the most important recommendation supported by the college is the push to make modified release paracetamol prescription only.
 
In the submission, the college describes normal paracetamol as ‘more appropriate’ for acute pain.
 
‘There is an overuse of modified release paracetamol for conditions for which there is insufficient evidence of benefit, such as osteoarthritis and back pain,’ the submission states.
 
‘Additionally, treating overdose from modified release paracetamol is more difficult than normal paracetamol. This is due to the particular pharmacodynamics of modified release paracetamol.’
 
Other jurisdictions have significantly tighter restrictions on the use of modified release paracetamol, with the EU banning its marketing in late 2017.

According to data cited by the TGA, paracetamol causes around nine people per million to be hospitalised with liver injury each year, with about 50 Australian lives lost to overdoses annually.
 
While backing the proposed reduction in package sizes, the RACGP warned about a possible knock-on effect on prices.
 
‘The potential increase in cost from a reduction in pack size needs to be taken into consideration for patients in lower socioeconomic status groups,’ the college submission stated.
 
‘This may be an issue for patients who are taking paracetamol on a regular basis, so measures should be in place to ensure affordability.’
 
The submission also stressed that reducing access should only be part of an approach.
 
‘Importantly, overdose and suicide prevention require a multi-targeted approach, beyond changes to medication access,’ the submission reads.
 
‘This includes further support and funding for GPs to provide and refer for youth mental health care, particularly for at risk populations, including people in the LGBTIQA+ and Aboriginal and Torres Strait Islander communities.
 
‘This should also include increased numbers of affordable psychologist and psychiatrist services for young people to access.’
 
The consultation, and the RACGP’s submission, follows an independent report commissioned by the TGA probing the risks of self-harm under the current access controls for paracetamol.
 
The TGA says the report was prompted by concerns surrounding poisonings and deliberate overdoses from paracetamol bought in general retail outlets.
 
‘The review confirmed from several sources that there were increasing rates of intentional self-poisoning with paracetamol in the last decade in Australia,’ the report stated.
 
However, the report also underlined the infrequency of serious incidents compared to the volume of paracetamol used, calculating there are around three hospitalisations with liver injury and less than one death per million units of paracetamol sold.
 
Submissions to the TGA’s proposed amendments closed last week.
 
The amendments and submissions are due to be considered at a meeting of the Advisory Committee on Medicines Scheduling (ACMS) next month (November).
 
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paracetamol Poisons Standard TGA Therapeutic Goods Administration