TGA compromises on paracetamol pack sizes

4 minute read

Consumers will be able to buy packs of 100 if a pharmacist hands it to them. Also, you can prescribe ivermectin off label again.

The TGA has softened its stance on paracetamol pack sizes in a final decision released today which looks likely to disappoint the RACGP. 

In an interim report released on 3 February, the TGA floated a plan to reduce the maximum size of paracetamol packs available off the shelf in pharmacies from 100 to 32 capsules or tablets. Today they changed that position to 50.  

It’s a win for the Australian and New Zealand College of Anaesthetists and a loss for the RACGP, who called for the TGA to further slash the pack size of paracetamol pills available off the shelf in pharmacies and to up-schedule modified-release paracetamol to prescription-only.  

The anaesthetists opposed that call, saying the RACGP proposal would make chronic pain treatments less accessible and lead to “further harms” from overuse of other medication. 

The TGA has also changed the date from which the restrictions will come, moving it out to 1 February 2025, rather than 1 June 2024, “to allow manufacturers and retail outlets sufficient time to adjust”. 

After reviewing more than 200 submissions from the consultation period the TGA has settled on the following new restrictions: 

  • reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules; 
  • reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (i.e. “Pharmacy Only” packs) from 100 to 50 tablets or capsules; and, 
  • make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist (“Pharmacist Only” medicines). 

“Paracetamol tablets and capsules for both general and Pharmacy Only sale will also be required to be in blister packaging. The maximum size of Pharmacy Only packs of individually wrapped powders or sachets of granules containing paracetamol will also be reduced in line with tablet and capsule packs,” the TGA said. 

“Access to liquid, modified-release and Schedule 4 (Prescription Only) paracetamol is not affected by this decision. 

“The decision takes into account: 

  • an independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose; 
  • advice received from the Advisory Committee on Medicines Scheduling (ACMS); and, 
  • submissions from two rounds of consultation from individuals, and organisations representing consumers, healthcare practitioners and industry.” 

The TGA final decision also includes two “encouragements” – one to retailers to restrict sales to a single pack per time, and one to consumers not to stockpile and to appropriately store paracetamol. 

“Each year in Australia around 225 people are hospitalised and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults. This decision aims to reduce the harm from intentional overdose,” the TGA said. 

In another decision announced today, the TGA has lifted restrictions on GPs prescribing ivermectin for off-label uses from 1 June 2023.  

Ivermectin for oral use is a prescription only (Schedule 4) medicine in the Poisons Standard. It is only approved by the TGA for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis), and scabies. 

The restrictions limiting off-label prescriptions to dermatologists, gastroenterologists and infectious diseases specialists was introduced in September 2021 because of concerns about consumers using ivermectin without health advice to treat covid, rather than approved treatments and vaccines.  

“There is sufficient evidence that the safety risks to individuals and public health is low when prescribed by a general practitioner in the current health climate,” the TGA said in their final decision. 

“This considers the evidence and awareness of medical practitioners about the risks and benefits of ivermectin, and the low potential for any shortages of ivermectin for its approved uses. Also, given the high rates of vaccination and hybrid immunity against covid in Australia, use of ivermectin by some individuals is unlikely to now compromise public health. 

“However, the TGA does not endorse off-label prescribing of ivermectin for the treatment or prevention of covid.” 

The RACGP has been contacted for comment on this story. 

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