Australia’s smoking cessation landscape is undergoing significant changes. The government’s proactive stance aims to address health concerns while maintaining accessibility to therapeutic products for smoking cessation. This means significant changes have been occurring for prescribers, pharmacists and healthcare providers, ensuring quality patient care.
Key Points
- New regulations have banned the importation of non-therapeutic vaping products and ended the personal importation scheme.
- Healthcare providers can now access streamlined pathways for dispensing therapeutic smoking cessation products.
An overview of the new regulations
Australia continues to tighten regulations to address escalating health concerns surrounding recreational vaping products. Since 1 January 2024, measures have included bans on disposable product imports and the facilitation of streamlined pathways for therapeutic smoking cessation prescriptions by healthcare providers.
The most recent legislation update on 1 October 2024, means patients 18 years or older can purchase smoking cessation products with a nicotine concentration of 20 mg/mL or less from Australian pharmacies without a prescription, provided a pharmacist deems it clinically appropriate. This marks the reclassification of some products from Schedule 4 (prescription only) to Schedule 3 (pharmacist only).
There are continued prescription requirements for people under 18 years old and for products with a concentration of 20 mg/mL or more.
These changes highlight Australia’s commitment to tightening regulations, underscoring the need for healthcare professionals to understand and adapt to evolving standards. Crucially, these reforms aim to strike a balance between safeguarding public health and ensuring continued access to therapeutic products for smoking cessation.
To read the updated regulations in full, click here.
Let’s dive into how these reforms will impact healthcare professionals navigating these evolving regulations.
Moving from the black market to compliant smoking cessation products
With an estimated 450,000 people expected to change from illegal to legal channels, healthcare professionals anticipate up to one million additional patients seeking smoking cessation products within the coming year (source).
This will likely lead to an increase in the supply of smoking cessation products through pharmacies, providing options for those seeking support.
Regulatory compliance requirements for pharmacies
Dispensing smoking cessation products involves navigating several key regulations to ensure both safety and compliance.
Pharmacists can dispense these products through the Special Access Scheme Category C (SAS C). Retail sales outside pharmacies are prohibited, placing a significant responsibility on pharmacists to follow these guidelines meticulously.
Pharmacists sourcing smoking cessation products need to verify compliance with TGO 110, maintain accurate records and may require an import license from the Office of Drug Control. Advertising smoking cessation products is restricted to ensure prescriptions were clinically appropriate.
Compliance with state and territory regulations, including proper licensing and sales restrictions, is crucial. Safe storage to prevent accidental poisoning, especially in children, and reporting any adverse effects were also key responsibilities. This regulatory framework highlights the essential role pharmacists played in the safe use of smoking cessation products.
For more detailed information, you can visit the TGA’s guidance for pharmacists on smoking cessation products.
Patient education and support
With these regulatory changes, healthcare professionals will play a pivotal role in educating patients about the evolving landscape of smoking cessation regulations. Clear communication regarding the availability of therapeutic products, changes in importation rules, and alternatives for smoking cessation will empower patients to make informed decisions about their health.
With the new pathways for prescribing therapeutic products and the emphasis on compliance with updated standards, prescribers and pharmacists play a crucial role in supporting individuals in smoking cessation.
For healthcare professionals seeking therapeutic products to support their patients, Canview has introduced a new product category with prescription-only smoking cessation products.
For more information about the upcoming changes and how this affects your pharmacy or practice, read our blog on smoking cessation frequently asked questions.