Paracetamol pack sizes would be reduced and retailers would be ‘encouraged’ to impose purchase limits under plans released by the TGA.

In an interim decision published last week, the regulator also announced it would push ahead with plans to introduce mandatory blister packaging for all paracetamol to limit overdose risk.

If they go ahead, the changes would amend the Poisons Standard (which provides regulatory controls over medicine availability) to:

• 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 supervision of a pharmacist (i.e. “Pharmacy Only” packs) from 100 to 32 tablets or capsules
• make other pack sizes of up to 100 tablets or capsules only available under the supervision of a pharmacist (‘Pharmacist Only’ medicines).

It comes after the TGA released a report last September warning almost 1400 children aged 10-14 and more than 2600 of those aged 15-19 were deliberately self-harming with paracetamol each year (link here).

The authors, led by University of Sydney clinical toxicologist Professor Nick Buckley argued for major restrictions in response, including a ban on purchases by anyone aged under 18 without a prescription and restrictions on the sale of modified release (MR) preparations.

However, in its official response, the regulator stressed any move needed to “balance the benefits of paracetamol as an effective and widely used analgesic” with the risks from intentional misuse.

“The introduction or tightening of any restrictions on access to paracetamol through scheduling has the potential to impact upon the significant benefits of paracetamol for individuals and public health,” it said.

“Although appropriate access to paracetamol as a safe and effective option in pain and febrile conditions is essential, I consider that some change to access to paracetamol under the Poisons Standard is required and justified as part of a broader strategy to reduce the relatively small but devastating consequences of severe paracetamol overdoses.”

And while the review had identified MR paracetamol as a key risk factor due to the increased likelihood of severe consequences like liver failure, additional restrictions were not required, the TGA said (link here).

This reflected the fact that the bulk of buyers were osteoarthritis patients aged above 55, while a number of peak bodies including Painaustralia had come out against such a move, according to the decision.

It added: “Insufficient time has lapsed since MR preparations were up-scheduled to Schedule 3 on 1 June 2020, especially considering its potential to disproportionately impact access in the context of chronic pain management.”

“At this point in time, I do not believe there is adequate evidence to support the further upscheduling of MR paracetamol on balance with the considerable burden to suffers of chronic pain, especially in the rural areas.”

The TGA advises that a final decision is due in April this year, with implementation likely to occur in late 2024 or early 2025 if approved.