Comply with Paracetamol Changes From February 1
February 2, 2025
Paracetamol Access Changes
In response to the high rates of paracetamol-related harm in Australia, including intentional overdoses leading to severe liver injury and fatalities, significant regulatory changes have been introduced. As a medical professional, it is crucial to understand these changes, their implications, and the steps needed to ensure compliance ahead of their implementation on 1 February 2025.
Why These Changes Have Been Made
Each year in Australia, approximately 225 people are hospitalised with liver injuries caused by paracetamol overdose, and around 50 lives are lost. Adolescents and young adults are particularly at risk, with intentional overdoses contributing significantly to these statistics.
On 3 May 2023, the Therapeutic Goods Administration (TGA) announced changes to the way paracetamol products are sold to reduce the risk of intentional overdoses. This decision was informed by an independent expert report on the incidence of serious injury and death from paracetamol overdose, recommendations from the Advisory Committee on Medicines Scheduling (ACMS), and feedback from extensive consultations with individuals and organisations representing consumers, healthcare practitioners, and industry stakeholders.
Overview of the 2025 Changes
The new guidelines primarily focus on limiting pack sizes and ensuring blister packaging for paracetamol products. Here’s what these changes mean for different sectors. From 1 February 2025, non-pharmacy retailers such as supermarkets, petrol stations, and convenience stores can only sell packs containing 16 tablets or capsules. Retailers with stock of larger packs (e.g., 20-tablet packs) must run down these stocks or return them to wholesalers before the implementation date. Selling larger packs after this date will be illegal. Paracetamol tablets and capsules must be sold in blister packaging, and retailers are now encouraged to limit sales to a single pack per customer to further reduce the risk of misuse. Pharmacies must also prepare for stricter regulations, including a reduction in pack sizes. The maximum size of unsupervised ‘Pharmacy Medicine’ packs will decrease from 100 to 50 tablets or capsules in most jurisdictions. Packs containing up to 100 tablets or capsules will be available only under the supervision of a pharmacist (‘Pharmacist Only Medicines’). All paracetamol tablets and capsules must again be in blister packaging. This applies to pharmacy and non-pharmacy retailers alike.
Pack sizes for individually wrapped powders or sachets of granules will also be reduced in line with tablet and capsule packs. Liquid, modified-release, and prescription-only paracetamol are not going to be affected by these changes.
State-Specific Restrictions
In Queensland and Western Australia, customers must consult a pharmacist to purchase packs larger than 16 tablets or capsules. Pharmacy Medicine (Schedule 2) and Pharmacist Only Medicine (Schedule 3) products can be stored and supplied with non-compliant signal words for 12 months after 1 February 2025. This measure ensures stock can be distributed without repacking or over-labelling. Pharmacies can also supply newly labelled Pharmacist Only products before 1 February 2025 under a temporary exemption. This exemption ends when the new Poisons Standard comes into effect.
Implications for Medical Professionals
The changes to paracetamol access and packaging carry significant implications for medical professionals, who play a crucial role in ensuring the safe and effective use of this widely available medication. As the February 2025 compliance deadline approaches, healthcare providers must engage with patients, retailers, and pharmacies to support the transition and improve patient safety.
One of the primary responsibilities for medical professionals is to educate patients on the safe use of paracetamol. This includes reinforcing the importance of adhering to proper dosage guidelines, understanding the risks of misuse, and securely storing paracetamol to prevent access by vulnerable individuals, such as children or those at risk of intentional self-harm. These conversations should also highlight the new packaging and pack size limitations, fostering awareness of how these measures aim to reduce harm.
Collaboration with non-pharmacy retailers, such as supermarkets and convenience stores, is another critical aspect of adapting to the new regulations. Medical professionals can provide guidance to these retailers on the safe sale of paracetamol, particularly regarding the transition to smaller pack sizes and the requirement for blister packaging. By offering expertise, healthcare providers can help ensure retailers understand their responsibilities and comply effectively.
Monitoring patient safety remains a top priority. Medical professionals should remain vigilant for signs of paracetamol misuse, whether accidental or intentional, and provide timely interventions. This includes offering mental health support or referring patients to appropriate services, particularly those in high-risk groups such as adolescents and young adults. Identifying patterns of misuse early can prevent severe outcomes and save lives.
Lastly, medical professionals have a role in advocating for compliance within pharmacies. Supporting pharmacists in understanding and implementing the new restrictions—such as changes to pack sizes and classification under the Poisons Standard—will help ensure a smooth transition. Clear communication and education about these requirements will enable pharmacies to integrate the new guidelines into their workflows without disrupting patient care.
Education is Paramount
The 2025 changes to paracetamol access and packaging serve as a reminder of the dual nature of many common medications. While paracetamol remains a cornerstone of pain management and fever reduction, its potential for harm—particularly in cases of misuse—cannot be overlooked. Medical professionals are uniquely positioned to act as stewards of safe medication use, balancing accessibility with vigilance.
This evolving landscape underscores the need to regularly review the safety, accessibility, and education surrounding common drugs like paracetamol; especially their access to those without the proper knowledge around misuse. What may appear to be a harmless over-the-counter remedy can pose significant risks if misunderstood. Healthcare providers are responsible to ensure patients and the broader community are equipped with the knowledge and resources to use such medications safely.
By embracing a proactive approach—educating patients, collaborating with retailers, monitoring safety, and advocating for compliance—medical professionals can lead the way in minimising harm. Let us not underestimate the importance of reviewing and updating practices around even the most familiar medications. These efforts are essential to safeguarding public health and ensuring that accessible drugs remain as beneficial as intended.
The upcoming changes to paracetamol access are a crucial step toward reducing the incidence of harm associated with this widely used medication. By understanding the new guidelines and promoting compliance, medical professionals play a vital role in safeguarding public health. For more detailed guidance, visit the TGA website or consult local regulations specific to your state or territory.
