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Paracetamol: changes to pack size

26 August 2013

The maximum paracetamol pack size to be sold in Australian retailers other than in pharmacies is going to change from twenty-five to twenty and will be fully implemented by 1 September 2013.

Why is the pack size being reduced?

Paracetamol can cause serious liver damage if taken in high doses.

The decision to decrease the pack size was made after considering the risks of different pack sizes in Australia. It is expected that this decision will result in fewer people requiring medical intervention following a paracetamol overdose.

Will the pack price change?

The pack price is a commercial decision. The TGA has no role in determining pack price.

When will it become illegal to sell larger packs?

It will become illegal for any retailer other than a pharmacy or licensed person authorised by their State or Territory to sell paracetamol packs containing more than twenty 500 mg tablets/capsules/caplets on 1 September 2013.

Will the pack sizes available in pharmacies change?

The larger paracetamol pack sizes available in pharmacies will not change. However, the smaller packs in pharmacies may contain 20 tablets instead of 24 tablets.

Why are pack sizes different in pharmacies?

The availability of medicines to the public is controlled by 'scheduling'. The higher the risks involved with a medicine, the higher the controls for that medicine. Medicines that are available in retailers other than pharmacies are known as 'unscheduled'.

When a medicine can cause harm at high doses, it is often placed in different schedules, depending on pack size. This is the case with paracetamol.

Paracetamol is unscheduled when labelled appropriately and sold in small pack sizes, which means that as long as the conditions are met, it is available from any retailer that wishes to stock it.

The description of the scheduling of paracetamol, found in the Poisons Standard, has been amended so that unscheduled paracetamol must be in a primary pack containing not more than 20 tablets or capsules. This decision was published in May 2012 and will be registered on the Federal Register of Legislative Instruments before the effective date of 1 September 2013.

What evidence made the TGA make this decision?

When making this decision, much information and evidence was considered, including the following:

  • Approximately 8000 patients per year are treated in Australia for paracetamol overdose taken as deliberate self-harm, usually without suicidal intent.
  • Self-harm is usually impulsive, and is not the same as deliberate suicidal intent.
  • In Australia, the median dose taken in an overdose is 12 g (one packet), while the mean ingestion was 12.5 g.
  • The pack size seems to be linked to the amount of paracetamol consumed in an overdose.
  • The current pack size was decided in the 1970s. The decision was based on the need to provide a three day supply; it was not decided on safety grounds.
  • Clinicians have been concerned with paracetamol overdose for a long time, but it was easier to measure deaths and admissions to liver units than monitor the overdose cases that were successfully mitigated.
  • Treatment for paracetamol overdose usually occurs in Australian hospitals when 10 g (20 tablets) has been consumed.

How does this decision compare with international decisions?

New Zealand currently restricts pack size to twenty.

The New Zealand Medicines Classification Committee considered increasing pack size to 25 in April 2011. The committee decided that increasing the pack size would be contrary to the spirit of the New Zealand Suicide Prevention Strategy. The committee also considered ingestion of over 12 g paracetamol (24 tablets) to increase the risk of harm and intervention compared to 10 g (20 tablets), even though the risk of death was much the same.

In the UK, the paracetamol pack sizes have been reduced, and there has been a corresponding reduction in paracetamol-related:

  • deaths
  • hospital admissions
  • liver transplants.

How do I find out more information?

The original decision was published on the TGA website in Section 2.1.7 of the Reasons for scheduling Delegate's final decisions, May 2012 - ACCS/ACMS consideration.

The Poisons Standard contains decisions regarding access to medicines and poisons as recommendations to States and Territories. The Poisons Standard is implemented through relevant State and Territory legislation. To discuss the implementation of this decision, please contact the Drugs and poisons unit in your state or territory.