New restrictions on paracetamol sales took effect on 1 February 2025, limiting pack sizes in non-pharmacy retailers, and changing how the medication is accessed in pharmacies.
The changes aim to reduce the risk of intentional overdose, which, according to the TGA, results in around 225 hospitilisations and 50 deaths per year in Australia.
What do the changes mean for pharmacies?Â
While the new rules largely relate to non-pharmacy retailers including supermarkets, petrol stations and convenience stores, pharmacies must also prepare for new pack size restrictions and blister packaging requirements.
As outlined by the TGA, the changes pertaining to pharmacies are as follows:
- The maximum pack size for unsupervised sales in pharmacies (Pharmacy Medicine) is now reduced from 100 to 50 tablets or capsules in most jurisdictions.
- Larger pack sizes of up to 100 tablets or capsules are now required to be Pharmacist Only Medicines, requiring supervision of a pharmacist.
- Paracetamol tablets and capsules sold in pharmacies must now be in blister packaging.
The TGA also states: “It’s important to note that some states and territories may have different restrictions.
“For example, in pharmacies in Queensland and Western Australia paracetamol-containing products in pack sizes larger than 16 capsules or tablets are stored behind the counter.
“However, packets of up to 50 capsules or tablets can be purchased without needing to consult a pharmacist.”
Writing for The Conversation, Natasa Gisev, clinical pharmacist and Scientia Associate Professor at the National Drug and Alcohol Research Centre, UNSW Sydney and Ria Hopkins, Postdoctoral Research Fellow, National Drug and Alcohol Research Centre, UNSW Sydney, state:
“Several paracetamol products are not affected by these changes.
“These include children’s products, slow-release formulations (for example, “osteo” products), and products already behind the pharmacy counter or only available via prescription,” they write.
Impact on non-pharmacy retailersÂ
As mentioned earlier, the current changes largely affect non-pharmacy retailers, including supermarkets, petrol stations and convenience stores.
Supermarkets, petrol stations and convenience stores will now be required to:
- Limit paracetamol to 16-tablet packs.
- Run down stocks of 20-tablet packs before 1 February, as selling these larger packs becomes illegal after this date.
Non-pharmacy retailers are also encouraged to limit sales of paracetamol to one pack per transaction.
Additionally, the TGA states:
“These restrictions cover paracetamol products and combination products, such as cold and flu medicines that contain paracetamol.
“Any paracetamol tablets and capsules for general sale will also be required to be in blister packaging.”
Pharmacists’ role in patient education
Dr Kate Wang, Senior Lecturer and Pharmacist at RMIT highlights the critical role of pharmacists in ensuring safe paracetamol use.
“The changes to scheduling and packaging of paracetamol presents an opportunity for pharmacists to engage in a discussion with patients to make them aware of the benefits and risks,” she says.
“These conversations can help pharmacists to assess whether patients are taking other medications containing paracetamol, or if they have pre-existing liver conditions that necessitate caution in its use.”
While the changes may add to pharmacists’ workload, Dr Wang stresses the importance of maintaining safe medication practices.
“There may be concerns around an increased workload for pharmacists, who already often face significant workloads,” she says.
“However, pharmacists are the medication experts in frontline healthcare.
“Addressing staff workload concerns should be approached separately without compromising safe practices and patient-centred care.”
For more information and to stay informed about all the latest regulatory updates, visit: ‘Comply with paracetamol pack size changes’.Â
