Are you prepared for the paracetamol regulation changes?

At the end of this month, new pack sizes will start to arrive in pharmacies – ahead of the impending scheduling change of paracetamol.

From 1 February 2025, pack sizes of paracetamol will change, with larger quantities (50 plus in most jurisdictions) shifting to Schedule 3 following the final decision on paracetamol access controls made by the Therapeutic Goods Administration (TGA) on 3 May 2023.

Why are the changes occurring?

In short, the TGA changes aim to reduce the volume of paracetamol which is kept in people’s homes.

Paracetamol is frequently involved in self-poisoning cases worldwide. Due to concerns around rising cases of paracetamol poisoning in Australia, the TGA commissioned an independent review into the risks of intentional self-poisoning with paracetamol.

The harm caused by paracetamol is commonly perceived as low, given its safety at therapeutic doses, widespread use and broad availability, said Peter Guthrey MPS, PSA Senior Pharmacist – strategic policy.

‘However, paracetamol is still overrepresented in poisoning events – both intentional and unintentional,’ he said.

Around 225 Australians are hospitalised with liver injury and 50 Australians die from paracetamol overdose every year –  with intentional overdose highest in female adolescents and young adults.

Given paracetamol is a commonly used medicine in Australia, with people likely having multiple packs at home, along with several different medicines containing paracetamol – reducing access through smaller pack sizes was a key focus of action, said Kay Sorimachi MPS, PSA Manager Policy and Regulatory Affairs.

‘The access route is multifactorial, but the TGA’s report focused on the fact that it’s not that people go out and say, “I’m going to buy 100 tablets and take all of them,” but really it’s what they had access to at the time,’ she said.

What’s occurring internationally?

The availability and regulation of paracetamol varies significantly across countries, but those with stricter regulations generally report lower incidences of severe poisoning. 

In many European countries, including France, Germany, and Italy, paracetamol is not available in supermarkets and is only available in pharmacies, with much tighter pack size limits than Australia. For example, France limits pharmacy sales to 8 g per pack, while Germany only allows up to 10 g. 

Modified-release (MR) paracetamol is generally unavailable in most European nations, contrasting with its availability in countries such as  Australia and New Zealand.

In countries such as the USA and Canada, there are fewer restrictions on paracetamol sales, with larger pack sizes available outside pharmacies. However, similar to  Australia, the USA has reported rising cases of paracetamol-related poisonings – particularly among adolescents.

Will the changes work?

If the findings following the UK’s legislation on paracetamol pack sizes is anything to go by, size matters. Since the legislation was implemented, there was an average reduction of 17 deaths (43%) in England and Wales from paracetamol poisoning per quarter.

Change 1: Pack sizes will shrink

The TGA’s final decision involves reducing pack sizes; key changes include:

• reducing the maximum pack size for general sale (unscheduled) in supermarkets and convenience stores from 20 to 16 tablets or capsules (8 grams).
• reducing the maximum pack size for Pharmacy medicine (S2) sale from:
  • 100 to 50 tablets or capsules
  • 50 to 25 individually wrapped powders or sachets of granules
• pack sizes up to 100 tablets or capsules will remain available without a prescription but must be prescribed by pharmacists as Pharmacist Only medicines (Schedule 3). 
• Bulk bottle packs (100 + tablets) available now for purchase will not be permitted after 1 February, which could impact patients with dexterity issues who have chronic conditions.

The reforms affect pain relief products containing paracetamol as the sole active ingredient and cold and flu medicines containing paracetamol in combination with other ingredients. 

Change 2: Bottles banished, blisters better

Paracetamol tablets and capsules for both general and Pharmacy Only sale will also be required to be in blister or strip packaging.

Bottles containing up to 100 tablets will be permitted to be a Pharmacist Only medicine (Schedule 3), however pharmacists will need to carefully consider patient safety when prescribing these products. 

What are pharmacists’ workflow considerations?

With larger packs of paracetamol being up-scheduled, patients may need to request ‘Pharmacist Only’ paracetamol more frequently. 

For pharmacists, the transition from Schedule 2 to Schedule 3 can be quite significant, said Ms Sorimachi. 

‘Pharmacists will need to prepare for where you place it in the pharmacy and behind the counter to accommodate the range of paracetamol products, which take up a lot of space,’ she said.

‘So there are workflow considerations around the best place to store [these products] in the pharmacy and still be meeting the legal obligations.’

Pharmacies are required to ensure these medicines are stored according to Schedule 3 location regulations by the implementation date.

The legislation will also vary across Australia.

‘Queensland and Western Australia have stricter S2 criteria, allowing for smaller pack sizes,’ said Ms Sorimachi.

In these jurisdictions, S2 pack sizes are limited to 16 tablets/capsules, whereas throughout the rest of Australia, patients can access up to 50 per pack over the counter in pharmacies.

What medicine safety messages should pharmacists be relaying?

Pharmacists’ language should already be starting to change regarding paracetamol, said Mr Guthrey. 

‘We should be identifying with patients that bottles will be less available, and that there is an important safety reason for this,’ he said. ‘We should be taking the time now to offer alternative options to people with dexterity limitations – for example a dose administration aid (DAA) – ahead of the access changes in February.’

Equally, pharmacists should actively be discouraging stockpiling of the bottles or small pack sizes, as this increases the risk of harm from poisoning events. 

The TGA has requested all retailers, including pharmacies, limit pack sales of paracetamol to one pack unit at a time. 

How should patient counselling change?

Ahead of the TGA’s final decision, a key concern in Australia was the strong pushback from patient groups, said Ms Sorimachi.

‘Even the pharmacy profession was initially divided, because they understood that for chronic conditions such as arthritis, people rely on [paracetamol], and smaller packs mean that they may have to purchase more frequently to meet their chronic needs,’ she said.

Before the reforms come into effect next year, pharmacists should start communicating with patients that there will be changes to what they can purchase at the pharmacy.

‘There will need to be greater interaction with patients, starting now, about what they can anticipate next February,’ said Ms Sorimachi.

There are also concerns that patients who rely on paracetamol to manage their chronic condition will need to come into the pharmacy more frequently, placing them at risk of stigma.

‘The pack size change is to prevent harm in the younger female group, which has had the highest incidence of harm,’ she said. ‘But the regulation change will impact everyone – not just people who were subject to greater potential for harm.’

It’s therefore important to base conversations with patients on clinical need rather than the number of times they present to the pharmacy for paracetamol.

‘You don’t want to treat people with suspicion,’ said Ms Sorimachi. ‘There’s always that balance of making sure it’s a therapeutic conversation.’ 

Pharmacists should start talking to patients now, as well as encourage periodic review of long-term paracetamol use, said Mr Guthrey.

‘Now is also the right time to talk with pharmacy staff about these changes, and provide examples of how to communicate with patients regarding the reason and impact of the upcoming changes.’