TGA considers major restrictions on paracetamol


Paracetamol purchase limits would be introduced and modified-release formulations of the drug would become prescription-only under reforms being considered by the TGA.

A draft plan outlined by the regulator last week would also see the introduction of pack size limits for the analgesic as well a ban on purchases by anyone under 18 without a script.

It comes after the medicines watchdog published an independent report 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).

Based on data from the NSW Poisons Information Centre, the review found around 10% of cases involved modified modified-release (MR) paracetamol, identified as a key risk factor due to the increased likelihood of severe consequences such as liver failure.

“Prescription-only scheduling would be expected to reduce casual use of this more dangerous product and therefore overdose,” said the authors led by clinical toxicologist Professor Nick Buckley of the University of Sydney.

They pointed out that despite the availability of very effective treatments, there was still a substantial morbidity burden of paracetamol overdose in Australia, with 2-5% of cases resulting in acute liver failure and 0.2-0.5% in death.

Beyond that, Australia was found to be an outlier internationally in allowing unlimited quantities of paracetamol to be purchased without a script at pharmacies or supermarkets. New Zealand, the UK and the EU were among multiple jurisdictions where restrictions were in place, they said.

A result of this was that large numbers of tablets were often readily at hand in the home, a problem because self-harm with paracetamol tended to be impulsive, the authors said.

“People are taking what is readily available in the home and for most people, particularly young people, this is paracetamol as they don’t have access to other medications, such as prescription drugs,” they added.

Other recommendations included calls for education campaigns on the harms associated with paracetamol overdose as well as on safe storage of medicines in the home.

However, the report found the biggest impact was likely to come from MR paracetamol being made S4 (prescription only), followed by smaller pack size limits and pack number limits for products sold in retail environments.

“Both would be likely to reduce the number of grams of paracetamol routinely held in homes and thus the numbers of very large overdoses taken in impulsive self-poisonings,” the authors said.

They also said all paracetamol should be sold in blister packs, which were slower open to open than other forms of packaging and could thus reduce the likelihood of harm from impulsive attempts at self-harm.

The TGA consultation is open until October 14 (link here).

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