In response to concerns about increased prevalence of intentional paracetamol self-poisoning, especially among young women, the Therapeutic Goods Administration (TGA) is undertaking work to explore whether it should change paracetamol accessibility in Australia.

This FlagPost will briefly discuss:

• the Poisons Standard
• why enhanced regulations are being considered
• how changes could be achieved
• next steps.

Poisons Standard

In Australia, medicines are classified into Schedules which determine how freely they are available to the public. The Schedules are published in the Poisons Standard, which is provided for in section 52D of the Therapeutic Goods Act 1989 (the Act) and implemented through state and territory legislation. Subsection 52D(2) of the Act allows the Secretary of the Department of Health and Aged Care to amend the current Poisons Standard. While an instrument made by the Secretary under subsection 52D(2) is a legislative instrument for the purposes of the Legislation Act 2003, it is not subject to disallowance.

In exercising this power, the Secretary is required to take certain matters into account, including:

• risks and benefits of the substance
• toxicity of the substance
• potential for abuse of the substance.

The Secretary may seek advice from different committees, including the Advisory Committee on Medicines Scheduling (ACMS) from which the Secretary must have regard to any recommendations, and needs to comply with any relevant guidelines from the Australian Health Ministers’ Advisory Council and its subcommittee.

The same active ingredient can be listed under different Schedules based on the specific medication — for example, concentration (strength), packet size or modified release tablets (sometimes called slow release or extended release paracetamol). Paracetamol is currently listed in 3 Schedules — Schedules 2, 3 and 4 (plus Appendices F and H) of the Poisons Standard — and is also available as an unscheduled product. As an example, supermarkets can sell packets of up to 20 paracetamol tablets as they are unscheduled but for a packet of 100 tablets, a person would need to go to the pharmacy as these are listed in Schedule 2 (pharmacy medicine).

Why are enhanced regulations being considered?

There have been growing concerns that intentional paracetamol poisoning has been increasing, especially in young people. In response to these concerns, the TGA engaged independent experts to review, analyse and discuss potential changes that could be made to paracetamol access and whether changes would be warranted. The expert panel provided its report to the TGA in August 2022. While the report notes that there are limitations with the Australian data, it made a number of findings, including:

• there has been a significant increase in intentional self-poisoning in people aged 10–19 years world-wide in the last decade
• paracetamol is the most common medicine used in overdoses in young people in Australia, at around 50% (p. 2)
• based on data from the NSW Poisons Information Centre (PIC) the annual rate of intentional self-poisoning events is estimated to have doubled since 2011 and tripled for people aged under 20 years (p. 3)
  • the greatest proportion of cases is in adolescents and young people, with females being disproportionately represented
• treatment for paracetamol overdose is very effective, and acute liver injury and death are therefore rare, estimated at about 9 hospitalisations and 2 deaths per million population (p. 3)
• the key risk factors for severe liver toxicity and death (late presentation, use of high doses and modified release paracetamol) have not changed, with each occurring in approximately 5–10% of overdoses (p. 3)
• additional information obtained by NSW PIC showed that the majority of cases were suicide attempts with most of these being impulsive and using paracetamol already in the house (pp. 53–54).

In providing their recommendations, the authors state that restricting access to highly toxic agents is an effective suicide prevention approach and restrictions to moderately toxic medicines like paracetamol may prevent some suicide deaths. However, this needs to be balanced alongside the widespread (appropriate) use of paracetamol. As such, the authors identify 4 access restriction and harm minimisation options, including packet size and modified release restrictions, and 3 non-medication recommendations, including expanding support for aftercare following intentional self-poisoning (pp. 123–126).

How could restrictions be introduced?

In a consultation paper released in September 2022, the TGA identified 6 overarching options for amending the Poisons Standard, which could be used in isolation or in combination:

• require solid dose paracetamol, such as tablets, to only be available in blister packs rather than, for example, bottles
• reduce the maximum paracetamol pack size available for sale
• restrict purchases of multiple packs
• no longer permit display and self-selection of paracetamol in non-pharmacy outlets
• introduce age restrictions (18 years and over)
• reschedule modified release paracetamol from Schedule 3 (pharmacist only medicine) to Schedule 4 (prescription only medicine) (sometimes known as up-scheduling), without changes to the maximum package size (pp. 9–22).

The consultation paper noted that neither the TGA nor the Delegate of the Secretary, who has proposed amending the Poisons Standard, had formed a view on which option may be implemented or preferred.

Concerns about the impacts of restricted access

In response to the options identified in the TGA consultation paper, some stakeholders have expressed concerns about the potential impact of further restrictions to paracetamol. Some organisations have released their submissions to the TGA, raising issues including:

• imposing an age restriction would not respect the autonomy of young people, especially people who live with chronic pain and would need people over 18 years to purchase paracetamol on their behalf
• up-scheduling paracetamol to prescription only has the potential to disadvantage vulnerable people due to costs associated with GP appointments for prescriptions
• introducing a requirement for paracetamol to be purchased from behind the counter would require supports for people with intellectual disability to adjust to the new process and ensure access
• restrictions may disproportionately impact people living in rural and remote communities, people with existing medication access issues, and people dependent on a carer
• limiting access may cause stress and anxiety for people with chronic pain.

Next steps: feedback on the interim decision

The options set out in the consultation paper, and any submissions received, were due to be considered at the November 2022 ACMS meeting.

Another opportunity to provide feedback to the TGA will be made available when the interim decision is released, anticipated in February 2023 (p. 28).