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Sunday, February 9, 2025

Paracetamol Restrictions Updated Amid Rising Self-Harm Rates

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Starting 1 February 2025, new restrictions on the sale of paracetamol will be enforced across Australia in response to persistently high rates of self-harm, particularly among young women and girls. The changes, spearheaded by the Therapeutic Goods Administration (TGA), aim to reduce the risk of paracetamol overdoses by limiting the availability of larger pack sizes.

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Under the updated regulations, paracetamol pack sizes available outside of pharmacies will be reduced from 20 tablets to 16. Pharmacies will also adjust their offerings, limiting front-of-counter pack sizes from 100 to 50 tablets. Retailers like supermarkets are being encouraged to sell only one pack per transaction. These measures, though significant, will not affect liquid paracetamol formulations or modified release (MR) paracetamol, which had already been restricted in previous years.

Dr. Rose Cairns, a lecturer in poisons and pharmacology at the University of Sydney and director of research at the NSW Poisons Information Centre, emphasized the necessity of these changes. “Paracetamol is the leading cause of acute liver injury in Australia and many other countries,” she explained, noting that paracetamol overdoses have been particularly prevalent among young women over the past decade.

Rising Self-Harm Rates

Dr. Cairns highlighted a worrying trend: “We’re seeing a more than doubling in the number of paracetamol overdoses in young women in the past decade.” Her 2024 study found that girls and young women accounted for 64% of self-poisonings. The COVID-19 pandemic exacerbated these issues, with self-poisoning rates in young women increasing by 37% compared to an 11% rise among young men.

This alarming pattern aligns with global data, where young women are three times more likely to self-harm than young men. Paracetamol, due to its widespread availability and perception as a harmless drug, has become a common means of overdose, leading to acute liver failure and, in severe cases, death.

Expert Insights

Associate Professor Angela Chiew, a clinical toxicologist at Prince of Wales Hospital, explained the toxic threshold of paracetamol. “The toxic dose is 10g or 200mg/kg—whichever is less. By reducing the readily available amount from 20 tablets (10g) to 16 tablets (8g), we’re aiming to minimize harm,” she said.

A/Prof. Chiew underscored the critical window for administering the antidote, acetylcysteine (NAC), to prevent liver damage and potential fatalities. The reduced pack sizes are a preventive measure aimed at lowering the risk of massive overdoses.

Global Precedents and Impacts

Australia’s move to restrict paracetamol access follows similar measures in other countries. The UK, for instance, implemented restrictions in 1998, leading to a notable reduction in paracetamol-related overdoses and deaths. Dr. Cairns mentioned that many European countries either have similar restrictions or even stricter controls, which have proven effective in harm reduction.

In Australia, the 2020 reclassification of MR paracetamol to Schedule 3, requiring pharmacist intervention, did not significantly decrease poisonings but did shift overdose patterns toward less harmful alternatives like ibuprofen. This suggests that availability and accessibility significantly influence overdose behavior.

Balancing Access and Safety

While the restrictions aim to reduce overdoses, maintaining access to paracetamol for legitimate medical use remains crucial. “Paracetamol will still be available in supermarkets, convenience stores, and pharmacies,” Dr. Cairns reassured. “The key is that the larger packs will require a conversation with a pharmacist.”

Dr. Cairns also pointed out that new blister packaging for paracetamol could further mitigate impulsive overdoses by slowing the process of consuming large quantities of tablets. “Most self-poisoning is impulsive, and the time taken to pop out a tablet reduces the amount taken,” she said.

Addressing Mental Health

The underlying issue of rising self-harm rates, particularly among young women, points to broader mental health challenges. Dr. Cairns noted that many individuals who die by suicide may not have a diagnosed mental illness, highlighting the impulsive nature of these acts. “The means available often determine whether someone survives or dies after a poisoning event,” she added.

Resistance and Public Perception

The new restrictions have faced some opposition, primarily from those concerned about accessibility. However, Dr. Cairns emphasized that the changes are a balanced approach to reducing harm without limiting access for those who need the medication for legitimate pain management.

She also acknowledged concerns about potential price increases due to reduced pack sizes—a phenomenon sometimes referred to as “shrinkflation.” However, she hoped that drug companies would not exploit these changes for financial gain.

Looking Forward

As Australia aligns with international best practices in paracetamol regulation, the focus will remain on monitoring the effectiveness of these measures in reducing self-harm rates. Researchers like Dr. Cairns are optimistic that the restrictions will lead to fewer overdoses and better outcomes for individuals at risk.

The TGA’s proactive approach reflects a commitment to public health, aiming to strike a delicate balance between accessibility and safety. The coming months will reveal the impact of these changes on public health and whether they can significantly curb the concerning trends in self-harm among Australia’s youth.

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