Prescription Requirements and Nicotine Content Limits - What’s changing on 1 October 2024.
With yet again more regulation changes right around the corner on how pharmacies in Australia dispense vaping products, pharmacists will face new challenges and responsibilities over the next few months. These modifications, affecting prescription requirements, dosage regulations, and the overall role of pharmacists, are crucial for ensuring compliance and patient safety. Here is an overview of the main changes that will take effect from 1 October.
Changes in Prescription Requirements
Until 30 September 2024, patients need to speak with a medical or nurse practitioner to:
- get a prescription to buy vapes containing nicotine, and
- access zero-nicotine vapes
From 1 October 2024, however, therapeutic vapes with a nicotine concentration of 20mg/mL or less will be available in pharmacies to patients 18 years or over without a prescription. A pharmacist will need to be satisfied it is clinically appropriate, and meet several other conditions, to supply a vape to a patient without a prescription. These changes will help facilitate patient access while maintaining appropriate controls and protections.
Despite the increased accessibility of therapeutic vapes, they remain unapproved therapeutic goods. As such, all therapeutic vapes for patients under 18 years old and/or containing a nicotine concentration higher than 20 mg/mL will remain available only with a prescription from a medical or nurse practitioner, in accordance with state and territory regulations.
Practitioners can prescribe these vapes using the following pathways.
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Authorised Prescriber (AP) Scheme: This pathway is available only to medical practitioners who can prescribe unapproved therapeutic vaping substances for patients over 16 years of age without requiring individual patient approval. The AP status is valid for five years, with mandatory six-monthly reporting of patient numbers to the TGA.
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Special Access Scheme C (SAS C): Both medical and nurse practitioners can use this notification-based system, which allows immediate access to vapes for patients aged 16 and over. Pharmacists must verify that a SAS C notification has been submitted within 28 days of supply.
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Special Access Scheme B (SAS B): This pathway is used for individual patient access where other categories are not applicable. Approval from the TGA is required before the prescription.
Changes in Dosage Regulations
The dosage regulations under the Therapeutic Goods (Standard for Therapeutic Vaping Goods) Order 2021 (TGO 110) remain stringent. Therapeutic vapes must adhere to a maximum nicotine concentration of 100 mg/mL. However, as mentioned above, only vapes with nicotine concentrations of 20 mg/mL or less will be available without a prescription. Pharmacists must ensure that the products they dispense meet these concentration limits and are listed on the TGA's notified list. More information on List of Notified Vapes below.
Changes in the Role of Pharmacists
Pharmacists are now pivotal in the safe dispensing of therapeutic vapes. They must:
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Assess Clinical Appropriateness: Evaluate whether the vape is suitable for the patient, considering alternative cessation methods and potential health risks.
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Compliance with State and Territory Laws: Ensure that dispensing aligns with local regulations, which may impose additional requirements, such as licensing and advertising restrictions.
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Submit SAS C Notifications: While prescribers usually handle this, pharmacists can submit SAS C notifications on behalf of the prescriber and must retain these records in the patient’s medical file.
List of Notified Vapes
Pharmacists must only dispense therapeutic vapes listed on the TGA's notified list. This list includes details on the product type, nicotine form, flavour, and concentration. It is crucial to check this list regularly as only notified vapes are lawful for supply.
View the current List of Notified Vapes including those supplied by Vapelabs.
Tools for Pharmacists
To support compliance and effective patient care, pharmacists should utilise the following tools:
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TGA SAS and AP Online System: This portal allows for the submission of SAS C notifications and AP applications. Pharmacists should familiarise themselves with this system to ensure efficient processing of prescriptions.
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TGA’s Guidance Documents: These provide comprehensive details on product standards (TGO 110). Staying updated with these documents will help pharmacists navigate the regulatory landscape.
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MBS Items: Various Medicare Benefits Schedule (MBS) items are available to support smoking cessation consultations. Pharmacists should guide patients to practitioners who are familiar with the appropriate MBS items.
Having trouble navigating the current market and regulatory changes?
Book your free training session with our Nicotine Vaping Product specialists. Our team of experts is committed to assisting Australian pharmacies by providing tailored training sessions on NVP products or onboarding assistance.
