Understanding smoking cessation product legislation changes
The Australian government has implemented substantial changes to therapeutic vaping product regulations, effective from 1 July 2024, with more changes implemented 1 October 2024. These changes to smoking cessation product legislation will see restrictions on flavours, concentrations and mandated plain packaging. Additionally, certain therapeutic products are set to be reclassified from a Schedule 4 (prescription only) to a Schedule 3 (pharmacist only) drug.
These changes aim to address public health concerns, particularly the rising use of unregulated smoking cessation products among young people. As healthcare providers, it is essential to stay informed about these legislative updates to effectively support and guide your patients.
Key legislation changes from 1 July 2024
Regulation as Therapeutic Goods
From 1 July 2024, smoking cessation vape products will be classified and regulated as therapeutic goods. This classification restricts their sale exclusively to pharmacies, under the oversight of the Therapeutic Goods Administration (TGA). The primary objective of this regulation is to ensure that smoking cessation therapies are accessed appropriately for nicotine dependence management, thereby aligning their availability with their intended therapeutic use. Patients will still need a prescription from a licensed healthcare provider to purchase nicotine or zero nicotine smoking cessation products from a pharmacy.
Restriction on flavour, concentration and packaging
Flavours have been restricted to mint, menthol and tobacco. The transitional arrangements that allowed the supply of other flavours will end. The maximum nicotine concentration limit is 100mg/ml. (base form or equivalent base form concentration). All smoking cessation products must come in plain pharmaceutical packaging.
Key legislation changes from October 1, 2024
Access to smoking cessation products without a prescription through pharmacies
From 1 October 2024, smoking cessation products with a nicotine concentration of 20mg/mL or less will be available from Australian pharmacies to patients 18 years or over without a prescription, provided a pharmacist deems it clinically appropriate. This downgrades smoking cessation products from a Schedule 4 (prescription only) to a Schedule 3 (pharmacist only) drug.
Continued prescription requirements for minors and high concentrates
Smoking cessation products for patients under 18 years old and/or with a nicotine concentration exceeding 20 mg/mL will remain available by prescription from a medical or nurse practitioner, subject to state and territory laws. In some jurisdictions, laws prohibit the supply of any smoking cessation product to individuals under 18. This ongoing requirement ensures that minors receive appropriate medical guidance and supervision when using smoking cessation products.
Impact on prescribers
From now until 1 October, Australian prescribers could see an increase in patients seeking a prescription for smoking cessation therapies, as the new laws prohibit the sale of any form of smoking cessation product from non-pharmacy settings. Prescribers must ensure the smoking cessation products they recommend adhere to new standards, including limitations on flavours, nicotine concentrations and packaging. Prescribers will need to stay up to date with the latest regulations and product details to ensure they provide safe and effective patient care.
Clear communication with pharmacists is necessary to ensure accurate dispensing of prescribed products and prompt resolution of any issues related to dosing or product compliance This collaborative approach aims to maximise the effectiveness of smoking cessation products as a therapeutic tool while minimising potential health risks associated with improper use.
Impact on pharmacies
The changes from 1 October will significantly impact pharmacist roles, positioning them as a key healthcare provider in smoking cessation efforts. Additionally, pharmacists will face increased responsibilities in verifying product compliance, managing inventory and advising patients on appropriate dosing and usage. Pharmacists will need to discuss dosage and other options for managing nicotine dependence with patients. Patients can only purchase a month’s supply of smoking cessation therapeutics at once and must provide identification.
For more information about smoking cessation legislation changes, click here.
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