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Paracetamol pack sizes should be reduced further: RACGP


Anastasia Tsirtsakis


13/03/2023 11:47:39 AM

The college has also renewed its calls for the TGA to up-schedule all modified release paracetamol to prescription-only.

A woman’s hands holding paracetamol tablets.
The RACGP is also recommending that the TGA up-schedule modified release paracetamol to prescription-only.

The RACGP has backed the Therapeutic Goods Administration’s (TGA) interim decision to reduce pack sizes of paracetamol, but says to truly make an impact the medicines regulator should consider reducing them further.
 
The matter was raised in a letter addressed to the TGA’s Advisory Committee on Medicines Scheduling (ACMS) by RACGP President Dr Nicole Higgins, who said the proposed change is ‘unlikely to significantly impact the harms from overdose of paracetamol’.
 
‘Given that overdoses mostly occur from available stockpiles in the home, the small reduction in pack size is unlikely to reduce the incidence of paracetamol overdoses in Australia,’ she wrote. 
 
‘The RACGP recommends pack sizes be reduced further to make an impact on stockpiled medications.’  
 
In Australia, around 225 people are hospitalised and about 50 people die as a result of paracetamol overdoses each year.
 
Though the latest data does not indicate a rise in recent years, an increase of misuse has been noted, with rates highest among adolescents and young adults.
 
In response, the TGA announced an interim decision on 3 February, following the release of an independent expert report, to reduce the maximum pack sizes for various paracetamol products sold in supermarkets and pharmacies.
 
If the move goes ahead, the Poisons Standard would be amended to reduce the maximum size of packs available for general sale from 20 to 16 tablets or capsules.
 
It would also see a reduction in the maximum size of packs available in pharmacies without supervision of a pharmacist from 100 down to 32 tablets or capsules. Pack sizes of up to 100 tablets or capsules would only be available under the supervision of a pharmacist.
 
However, the RACGP disagrees with differing front-of-store pack sizes between pharmacies and supermarkets.
 
‘Given that non-pharmacist staff are unable to provide advice on the use of medications, this setting is not any safer than supermarkets or other convenience stores where paracetamol is sold,’ Dr Higgins wrote in the college’s feedback. 
 
Meanwhile, Dr Higgins also took the opportunity to renew calls recommending that the TGA up-schedule all modified release paracetamol to prescription-only, in line with advice outlined in the college’s October submission which was part of the initial public consultation.
 
‘For acute pain, normal paracetamol is more appropriate,’ she wrote.
 
‘There is an overuse of modified release paracetamol for conditions for which there is insufficient evidence of benefit, such as osteoarthritis and back pain.
 
‘Additionally, treating overdose from modified release paracetamol is more difficult than normal paracetamol. This [is] due to the particular pharmacodynamics of modified release paracetamol.’
 
If the TGA’s interim decision goes ahead, there will also be a requirement for packs of paracetamol on general sale and those sold only by a pharmacist to be in blister packaging to help deter misuse.
 
Further to that, the TGA is encouraging retailers to restrict sales to a single pack at a time, and is also urging consumers to avoid stockpiling paracetamol in the home and to ensure the medication is appropriately stored.
 
As part of the RACGP’s feedback, Dr Higgins also recommended that ‘further support should be provided for GPs’ who undertake chronic pain consultations and medication reviews for patients who are taking pain medications.
 
‘[This is] to ensure these medications are being used safely and to identify opportunities for deprescribing and non-drug interventions,’ she wrote.
 
Following its interim decision, the TGA’s public consultation closed on 3 March.
 
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