New Paracetamol Packaging Changes
By Dr Geraldine Moses Dec 24
Have you noticed the absence of paracetamol on supermarket shelves lately? This occurred due to implementation of new state and federal legislation regarding packaging and labelling of paracetamol with the intention to reduce the risk of harm from paracetamol overdose. These regulatory changes come into effect on 1st February 2025, but you may have noticed that some paracetamol manufacturers have already made the changes.
The Therapeutic Goods Administration (TGA) has long held concerns about rising cases of paracetamol poisoning in Australia, in both adults and children. Several years ago, the TGA commissioned an international review of accidental and intentional paracetamol poisoning which concluded that although availability and regulation of paracetamol varies significantly, in countries with stricter regulations of pack size and availability, severe harm from paracetamol poisoning is reported less frequently. At last, the TGA has finally been able to act upon these findings with new rules about paracetamol packaging and availability.
The main change to paracetamol pack sizes for general sale, which you may have already noticed, is that the number of dosage units will be reduced from 20x to 16x tablets per pack and larger quantities (50 plus in most jurisdictions) will be regulated as Schedule 3 medicines, only available on consultation with a pharmacist. In addition, from February 1ST, paracetamol will only be manufactured in blister packs. Bottles will no longer be permitted, as they make it too easy for a dangerous number of tablets to be consumed quickly. It remains to be seen whether this change negatively impacts patients with dexterity issues, such as those with arthritis, who often struggle to remove tablets from blister packs.
Will these changes work? Well, since legislation in the UK was implemented over a decade ago to reduce paracetamol pack size, there has been an average reduction of 17 deaths (43%) per quarter from paracetamol poisoning in England and Wales. In addition, registrations for liver transplantation due to paracetamol-induced hepatotoxicity reduced by 61%. https://www.nature.com/articles/nrgastro.2013.33
For further information, consult the TGA’s paracetamol hub at https://tinyurl.com/4an638rp
