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Health
31 January 2025

New Paracetamol Sales Rules To Curb Overdoses

Australia implements significant restrictions on paracetamol sales to address rising overdose incidents.

A significant change is set to reshape the way Australians purchase one of the nation's most popular pain relievers, paracetamol. Starting February 1, 2025, new regulations will limit the number of paracetamol tablets available for sale outside pharmacies, aiming to combat the rising incidences of overdose and liver damage associated with its misuse.

The Therapeutic Goods Administration (TGA) announced these changes after reviewing alarming statistics highlighting the toll paracetamol misuse takes on public health. Annually, approximately 50 people die from paracetamol overdoses, with around 225 hospitalizations linked to liver injuries. This does not include the countless instances of intentional overdoses among adolescents and young adults, which have been on the rise.

Dr. Kate Wang, a pharmacy expert from RMIT, shares her insights on the issue, stating, "It can cause hepatotoxicity, which is injury to the liver. […] acute liver failure and even irreversible liver injury requiring liver transplantation." The statistics are sobering: between 2007 and 2020, around 40 to 50 deaths annually were attributed to paracetamol poisoning.

Effective immediately, packs sold outside pharmacies will now be limited to just 16 tablets or capsules, down from the previous maximum of 20. Larger packs, which contain up to 100 tablets, will only be available behind the pharmacy counter and under pharmacist supervision. This decision follows international trends, as many countries have already adopted similar measures to curb the risks associated with paracetamol.

Dr. Wang emphasizes the importance of being aware of the risks, noting, "The accessibility of paracetamol increases the risk of overdose, particularly as it is found in many over-the-counter cold and flu medications. These changes provide pharmacists with opportunities to engage with patients, discussing benefits and risks associated with the drug." Such conversations could help identify patients at risk due to pre-existing liver conditions or concurrent medications.

Citation from The Guardian notes the expert review commissioned by the TGA, which found deliberate overdoses primarily among those aged 10 to 24. Mixed responses during the public consultation highlighted the need to balance safety and accessibility, particularly for those with chronic pain who may find it difficult to obtain adequate supplies due to travel or financial restrictions.

Interestingly, not all paracetamol products are impacted by these changes. Children's formulations and certain slow-release medications will remain exempt from the new regulations. The goal here is to mitigate risks without unnecessarily hindering access to those who legitimately require paracetamol for pain management.

According to Dr. Rose Cairns, one of the authors of the paracetamol overdose report, "These changes just bring us in line with many other countries which have these smaller pack sizes as the default because it has been shown to be effective." This consistency with international standards is expected to prevent many overdose incidents.

Monika Boogs, Chief Executive of Painaustralia, welcomes the new regulations as important safety measures but acknowledges concerns from consumers reliant on paracetamol for managing chronic pain. “While Painaustralia understands the reason for the changes, many pain consumers who rely on paracetamol have expressed concerns about the cost. And for regional and rural consumers, accessing medication can be complicated,” she stated.

The regulations will allow pharmacies to maintain larger stock levels, but consumers will need to seek the pharmacist's assistance to purchase those larger quantities. This balance aims to promote safe use without disrupting access to necessary medications.

Despite the need for caution, health authorities stress the overall safety of paracetamol when used appropriately. The TGA reassures the public, stating, "The overall safety profile of paracetamol has not changed." The regulation changes aim to minimize risks associated with misuse, especially as more individuals take this common medication for various ailments.

To help manage this transition, many companies are already updating their packaging to comply with the new regulations. This proactive step is likely to avoid any supply chain interruptions. People are encouraged to reach out to their pharmacists to discuss their individual needs, especially those who find themselves using paracetamol regularly.

On top of these regulatory changes, the TGA advocates for retailers, including supermarkets and convenience stores, to self-impose additional buying limits on paracetamol products. This act of caution can help avert tragic outcomes linked to overdoses.

The new paracetamol purchasing rules emerge as an important step toward safeguarding public health by mitigating risks associated with overdose incidents, particularly among the youth. Supply will remain stable and accessible, encouraging responsible use and consultation with healthcare professionals.

While these regulatory changes may bring about challenges for some, stakeholders believe they are necessary steps to protect the health of Australians. Pharmacists remain central to the process, offering guidance and support for medication use as these new rules come to fruition.