Changes are coming into effect from February 1 about how paracetamol is sold in Australia.

This mainly affects pack sizes of paracetamol sold outside pharmacies and how paracetamol is accessed in pharmacies.

The changes, announced by Australia’s drug regulator, are in line with moves internationally to reduce the harms of liver toxicity and the risk of overdose.

However, there are no new safety concerns when paracetamol is used as directed. And children’s products are not affected.

What is paracetamol?

Paracetamol is commonly sold under brand names such as Panadol, Dymadon and Panamax. It’s used to treat mild pain and fever for short periods or can be prescribed for chronic (long-term) pain.

Millions of packs of this cheap and accessible medicine are sold in Australia every year.

Small packs (up to 20 tablets) have been available from supermarkets and other retailers such as petrol stations. Larger packs (up to 100 tablets) are only available from pharmacies.

Paracetamol is relatively safe when used as directed. However, at higher-than-recommended doses, it can cause liver toxicity. In severe cases and when left untreated, this can be lethal.

Why are the rules changing?

In 2022, we wrote about how the Therapeutic Goods Administration (TGA) was considering changes to paracetamol access because of an increase in people going to hospital with paracetamol poisoning.

An expert review it commissioned found there were about 40–50 deaths every year from paracetamol poisoning between 2007 and 2020. Between 2009–10 and 2016–17, hospital admissions for this increased (from 8,617 to 11,697), before reducing in 2019–20 (8,723). Most admissions were due to intentional self-poisonings, and about half of these were among people aged ten to 24.

After the report, the TGA consulted with the public to work out how to prevent paracetamol poisonings.

Options included reducing pack sizes, limiting how many packs could be bought at once, moving larger packs behind the pharmacy counter and restricting access by age.

Responses were mixed. Although responses supported the need to prevent poisonings, there were concerns about how changes might affect:

• people with chronic pain, especially those in regional areas, where it may be harder to access pharmacies and, therefore, larger packs
• people on limited incomes, if certain products were made prescription-only.

Although deaths from paracetamol poisoning are tragic and preventable, they are rare considering how much paracetamol Australians use. There is less than one death due to poisoning for every million packs sold.

Because of this, it was important the TGA addressed concerns about poisonings while making sure Australians still had easy access to this essential medicine.

So what’s changing?

The key changes being introduced relate to new rules about the pack sizes that can be sold outside pharmacies, and the location of products sold in pharmacies.

From February 1, packs sold in supermarkets and places other than pharmacies will reduce from a maximum 20 tablets to 16 tablets per pack. These changes bring Australia in line with other countries. These include the United Kingdom, which restricted supermarket packs to 16 tablets in 1998, and saw reductions in poisonings.

In all jurisdictions except Queensland and Western Australia, packs sold in pharmacies larger than 50 tablets will move behind the pharmacy counter and can only be sold under pharmacist supervision. In Queensland and WA, products containing more than 16 tablets will only be available from behind the pharmacy counter and sold under pharmacist supervision.

In all jurisdictions, any packs containing more than 50 tablets will need to be sold in blister packs, rather than bottles.

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.

What else do I need to know?

These changes have been introduced to reduce the risk of poisonings from people exceeding recommended doses. The overall safety profile of paracetamol has not changed.

Paracetamol is still available from all current locations and there are no plans to make it prescription-only or remove it from supermarkets altogether. Many companies have already been updating their packaging to ensure there are no gaps in supply.

The reduction in pack sizes of paracetamol available in supermarkets means a pack of 16 tablets will now last two days instead of two-and-a-half days if taken at the maximum dose (two tablets, four times a day). Anyone in pain that does not improve after short-term use should speak to their pharmacist or GP.

For people who use paracetamol regularly for chronic pain, it is more cost-effective to continue buying larger packs from pharmacies. As larger packs (50+ tablets) need to be kept out of sight, you will need to ask at the pharmacy counter. Pharmacists know that for many people it’s appropriate to use paracetamol daily for chronic pain.

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

This article is republished from The Conversation under a Creative Commons license. Read the original article.