Pharmacist Information Hub
How to dispense S4 therapeutic vapes
Understanding the prescribing pathways
All scripts for therapeutic vapes must be prescribed under one of the TGA’s three special access pathways for unlicensed medicines:
Authorised Prescriber (AP) Scheme
- Preferred pathway for GPs likely to prescribe to multiple patients
- GPs are pre-approved for five years by the TGA to prescribe NVPs
- APs do not require further approvals or notifications to prescribe NVPs
Special Access Scheme B (SAS-B)
- Used for patients who have presented with complicating factors (below 16, pregnancy, comorbidities)
- Prescribers need approval from the TGA for each script
Special Access Scheme C (SAS-C)
- Used by GPs who are not APs, Nurse Practitioners and pharmacists supplying S3 vapes
- Prescribers must notify the TGA for each script
- Pharmacists may notify the TGA on behalf of prescribers and dispense immediately
Validating a prescription for S4 vapes
When pharmacists receive a script for therapeutic vapes, they must establish under which special access pathway the clinician has prescribed.
In particular, the pharmacist should check the script for an SAS Authority number (starting with either MAP, MB or MC) plus any supporting documentation.
Authorised Prescriber (AP) Scheme
e.g. MAPYY/01234567
Special Access Scheme B (SAS-B)
e.g. MBYY/01234567
Special Access Scheme C (SAS-C)
e.g. MCYY/01234567
Using the SAS Portal to validate a prescription
The TGA has created a new validation tool within its existing SAS Portal. Pharmacists can now use this tool to check information associated with a script.
- Log in to the SAS Portal and select ‘SAS/AP Submission Validation’ from the top menu bar
- Enter the Authorisation or Notification reference number on the patient’s script and select ‘Search’
- The validation tool will display the details associated with the reference number allowing you to validate that the prescription has been appropriately authorised
- Once verified, you can proceed to dispense immediately
Submitting an SAS-C notification when a script cannot be validated
If the script does not contain an authorisation number, the TGA’s validation tool will not be able to confirm the validity of the prescription.
If patient is neither pregnant nor below 16, pharmacists may assume that the script is issued under SAS-C.
The TGA’s guidelines allow pharmacists to lodge an SAS-C notification on behalf of the prescriber through the TGA’s SAS Portal, allowing you to dispense immediately. It is best practice to inform prescribers when you have filed an SAS-C notification on behalf of their patient.
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Important links
Therapeutic Goods Administration
Pharmaceutical Society of Australia
References
- PSA Professional Practice Standard 1: https://www.psa.org.au/practice-support-industry/pps/
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iNRT Healthcare is operated by Liber Pharmaceuticals for the purpose of furthering healthcare education regarding Nicotine Vaping Products (NVPs) within the Australian medical framework. Liber has no affiliation with the tobacco industry, their affiliates, or any organisations or individuals engaged in lobbying on their behalf.
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