Dispensing therapeutic vapes from 1 October 2024
From 1 October 2024, nicotine in therapeutic vapes for smoking cessation and the management of nicotine dependence will be classified as Schedule 3 substances. At this time, the SAS C rules will also be amended to allow pharmacists to supply nicotine and zero-nicotine vaping substances for smoking cessation or the management of nicotine dependence without a prescription from a medical or nurse practitioner in certain circumstances.
Following these changes, patients 18 years or over will no longer require a prescription or SAS/AP authorisation from a medical or nurse practitioner to access therapeutic vaping substances from Australian pharmacies. Instead, the pharmacist will submit the SAS C notification (see below).Â
Pharmacies that stock and supply therapeutic vapes will still need to comply with state and territory regulations relating to Schedule 3 substances, including, for example, that the vapes are kept behind the counter and are personally handed to the patient by the pharmacist. See state and territory regulation of vapes above.
Dispensing nicotine vapes without a prescription
The dispensing of vapes containing nicotine or a zero-nicotine vaping substance without a prescription must be in final dosage form for smoking cessation or the management of nicotine dependence.
The pharmacist must ensure:
supply is to persons aged 18 years or over, including requesting and sighting evidence of the patient’s identity and age
professional advice is provided to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines
contact details about smoking cessation support services are provided to the patient
the quantity of the goods does not exceed 1 month supply and is only supplied to the patient once in a month
that the nicotine concentration does not exceed 20 mg/mL.
Dispensing of vapes that do not meet these requirements will still require a prescription and SAS/AP authorisation from a doctor or nurse practitioner. This includes, for example, vapes with a nicotine concentration greater than 20mg/mL or patients under 18 years of age, which is also subject to state and territory requirements.
Conditions on supply of vapes without a prescription
Supply to persons without a prescription is conditional on the pharmacist:
informing the patient, or a parent or a guardian of the patient, that the vaping good is an unapproved therapeutic goodÂ
obtaining informed consent from the patient, or a parent or a guardian of the patient, before supplying the vape
supplying the vaping good in accordance with good pharmacy practice
providing professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines
providing contact details about smoking cessation support services to the patient.
If the pharmacist becomes aware that:
the patient has suffered an adverse event in relation to the vaping good, or
there is a defect in the vaping good,Â
the pharmacist must notify the TGA and the sponsor of the therapeutic good about the adverse event or the defect.
A SAS C notification must be made by the pharmacist within 28 days of supplying the vape to the patient. This will generally need to be done at the time of dispensing (see below).
Submitting a notification in the TGA’s SAS & AP online system when supplying vapes without a prescription after 1 October 2024
If a pharmacist determines that a vape can be supplied to a patient for smoking cessation or the management of nicotine dependence, the pharmacist will need to submit a notification under SAS C. The notification must be submitted to the TGA using the SAS & AP Online system.
To make submissions under SAS C, pharmacists must first create a profile in the online system. A notification must be made within 28 days of supplying the vape to the patient. However, unless the pharmacist is keeping separate records relating to the dispensing of therapeutic vapes, it will be necessary to lodge the notification at the time of dispensing to ensure relevant data can be submitted as required.
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