December 9, 2022

The TGA is considering restrictions on paracetamol due to poisonings – but what does this mean for consumers?

Paracetamol is the most widely used pain medicine in Australia, with 65 million packs sold nationwide in 2021. It is available everywhere from toilet vending machines, convenience stores, supermarkets and pharmacies.

The Therapeutic Goods Administration (TGA) is currently launching a public consultation on access to paracetamol in the community due to concerns about poisonings, particularly among young people.

What is paracetamol and what is it used for?

Paracetamol (commonly marketed as Panadol, Panamax, or Dymadon) is a drug used to treat pain and reduce fever.

Outside pharmacies, paracetamol is available in boxes of up to 20 tablets (or capsules), while pharmacies stock up to 100 tablets and a range of formulations including liquids and suppositories. The wide availability and low cost of paracetamol make it a convenient option for people who want to treat pain themselves without a doctor’s appointment or a prescription.

At therapeutic doses, paracetamol is considered safe for most people, with few side effects when used as directed.

However, it can be dangerous in high doses, causing acute liver toxicity which, in severe cases, can lead to death. Although there are treatments to reverse a paracetamol overdose, they must be given within 2 to 8 hours to be most effective.

Read more: How do painkillers actually kill pain? From ibuprofen to fentanyl, it’s about addressing pain where it is

Why is the TGA reviewing access to paracetamol?

The TGA is concerned about the harms of paracetamol poisoning, particularly intentional overdoses in young people, which have been seen in Australia as well as overseas. In response, the TGA requested an independent expert report to support its review of access to paracetamol.

The report found that between 2007 and 2020 there were 40 to 50 deaths each year in Australia from paracetamol poisoning. From 2009 to 2017, hospitalizations due to paracetamol poisoning increased from 8,617 to 11,697. They fell to 8,723 in 2019-2020.

About 80% of these admissions were due to intentional self-poisoning, with young people between the ages of 10 and 24 accounting for 40-50% of these incidents. Youth hospitalizations due to intentional overdoses of any drug also increased during this period. Calls to Australian Poison Information Centers about self-poisoning involving paracetamol have also increased over the past decade.

It is important to note that the number of harmful events is small compared to the amount of paracetamol sold in Australia. For every million packs of paracetamol sold, there were 100 hospitalizations for intentional self-poisoning, three hospitalizations for liver damage and less than one death. And in recent years, admissions of unintentional and intentional self-poisoning per million packets of paracetamol sold have declined.

More paracetamol implicated in intentional self-poisoning was already in the house.

Read more: Australia has a paracetamol poisoning problem. This is what we should do to reduce the damage

How could access to paracetamol change?

The expert panel made several recommendations, including:

  • limit the size of packaging
  • introduce purchase limits
  • requiring a prescription to purchase higher quantities and modified-release products (such as Panadol Osteo)
  • requiring a prescription for those under 18.

Additional measures being considered include changes to the packaging and presentation of paracetamol in stores. Currently, there are no recommendations to make all paracetamol products prescription only or to restrict their sale to pharmacies only.

Many of these strategies aim to reduce potential harm by limiting the amount of paracetamol available. Changing pack sizes available outside pharmacies would bring Australia in line with countries like Denmark, Ireland and the UK. These countries have for many years had restricted pack sizes (maximum 10-16 tablets) for sale outside pharmacies and have seen a reduction in hospitalizations and deaths. Poisonings among people aged 10 to 17 also fell in Denmark after age restrictions were introduced in 2011.

The expert report revealed that most cases of auto-intoxication involve drugs already present in the home. The benefits of these measures may therefore be limited. But limiting package sizes can help reduce the overall amount of medicine available at home and the risk of fatal poisoning.

The expert panel also recommended better follow-up care after self-poisoning events. Developing preventative strategies and increasing mental health support are key to addressing the drivers of intentional self-intoxication more broadly.

Read more: One in three people with chronic pain have difficulty accessing current prescriptions for opioids

And then ?

Immediate access to paracetamol makes it easy for people to self-treat their pain at minimal cost and without seeing a medical professional. Reduced availability of paracetamol may prompt people to switch to other pain relievers, such as ibuprofen, which has its own risks and may not be suitable for everyone.

While it is important to limit the harm from paracetamol poisoning, the TGA will at the same time ensure that paracetamol remains accessible to those who need it. By keeping paracetamol on supermarket and pharmacy shelves in reduced packaging, the TGA will aim to strike a balance between accessibility and safety.

The biggest potential impact for people with chronic pain would be to reduce the larger packs currently available only in pharmacies (such as those containing 50-100 tablets) and make modified-release paracetamol products only on arrangement. The expert report notes that at 665 mg, the modified-release formulation in particular is linked to higher overdoses. As these products are currently only available in pharmacies, authorities should show how these changes would significantly reduce harm, without overburdening sufferers.

The TGA is waiting for feedback until mid-October to guide its decision. After that, the TGA’s Expert Advisory Board will consider whether to amend the Poisons Standard to change access to paracetamol. For now, paracetamol is available as usual.

If this article has caused you any problems, or if you are concerned about someone you know, call Lifeline on 13 11 14.