December 2, 2022

The RACGP postpones the calendar of modified-release paracetamol

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The college also supports a proposal for smaller packaging, but does not favor restricting over-the-counter sales to adults only.

The college supports an initiative to prevent people from buying multiple packs of paracetamol.


The RACGP supports a proposed amendment to the poisons standard that would move modified-release paracetamol to Schedule 4.


However, he is not pushing for sales of the standard form of paracetamol – the world’s most widely available over-the-counter painkiller – to be subject to stricter age restrictions.


That’s the position outlined in the college’s submission to the Therapeutic Goods Administration (TGA), which last month opened its proposed amendments to the Poisons Standard for Paracetamol for consultation.


The RACGP noted that effective, evidence-based pain relief can be an important part of treatment and help patients have a good quality of life, but stressed that it advocates the safe and appropriate use medication “at any time”.


The college confirmed its support for reducing the size of paracetamol packs at general outlets to 10 x 500mg tablets/capsules or five individually wrapped sachets.


However, the college said “additional information” was needed to support a proposal to tighten age restrictions on paracetamol sales.


“Restricting the purchase of paracetamol to those under 18 would be detrimental to people suffering from acute pain, such as headaches, menstrual pain or flu-like symptoms,” the document states.


The college also backed a move to stop people buying multiple packs.


“Allowing the purchase of two packs of 10 tablets is reasonable and will reduce the tendency to keep large stocks at home,” the college says.


Professor Mark Morgan, chair of the RACGP Expert Committee – Quality Care (REC-QC), said restricting global access to paracetamol would reduce overdose deaths and harms.


“We don’t know by how much, but evidence from overseas shows it could be as much as a 50% reduction,” he told the ABC.


He said the most important recommendation backed by the college is to push to prescribe only modified-release paracetamol.


In the brief, the college describes regular paracetamol as “more appropriate” for acute pain.


“There is overuse of modified-release paracetamol for conditions for which there is insufficient evidence of benefit, such as osteoarthritis and back pain,” the submission states.


“In addition, the treatment of an overdose of modified-release paracetamol is more difficult than normal paracetamol. This is due to the particular pharmacodynamics of modified-release paracetamol.


Other jurisdictions have much stricter 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 in a million people to be hospitalized each year for liver damage, with around 50 Australian lives lost by overdose each year.


While supporting the proposal to reduce packaging sizes, the RACGP warned against a possible knock-on effect on prices.


“The potential cost increase due to a reduction in package size should be considered for patients in lower socioeconomic status groups,” the college said.


“This can be a problem for patients who regularly take paracetamol, so measures should be put in place to ensure affordability.”


The brief also emphasized that reducing access should only be part of one approach.


“It is important to note that preventing overdoses and suicide requires a multi-targeted approach, beyond changes in access to medicines,” the document states.


“This includes additional support and funding for GPs to provide and guide youth mental health care, particularly for at-risk populations, including people from LGBTIQA+ and Aboriginal and Torres Strait Islander communities.


“This should also include an increased number of affordable psychologist and psychiatrist services that young people can access.”


The RACGP consultation and submission follows an independent report commissioned by the TGA exploring the risks of self-harm under current paracetamol access controls.


The TGA says the report was prompted by concerns about poisonings and deliberate overdoses of paracetamol purchased at retail outlets.


“The review confirmed from multiple sources that there has been an increase in rates of intentional self-poisoning with paracetamol over the past decade in Australia,” the report said.


However, the report also highlighted the rarity of serious incidents relative to the volume of paracetamol used, calculating that there are around three hospitalizations for liver damage and less than one death per million units of paracetamol sold.


Submissions to the TGA’s proposed changes closed last week.


Amendments and submissions are due to be considered at a meeting of the Advisory Committee on Medication Planning (ACMS) next month (November).



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paracetamol Poisons Standard TGA Therapeutic Goods Administration


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