When pharmacists receive a script for NVPs, they must establish which special access pathway the clinician has prescribed. In particular, the pharmacist should check the script for a SAS Authority number (starting with either MAP, MB or MC) plus supporting documentation.

If the pharmacist is not provided with evidence of any of the above, and the patient is not pregnant or below 16 years of age, they may assume that the script is issued under SAS-C and may submit the TGA notification on behalf of the prescriber, allowing the pharmacist to dispense immediately.

Please see Practical Considerations (Scripts for NVPs as unlicensed medicines) for more detailed information about the dispensing process.

The process to validating a script is as follows:

Using the TGA’s SAS Portal to validate prescribing authority

The TGA operates a portal (SAS Portal) for the prescribing and dispensing of unlicensed medicines under the SAS pathways. The SAS Portal allows practitioners to seek online approvals and file notifications depending on which SAS pathway they choose to prescribe through.

For pharmacists, the SAS Portal provides a tool to validate the authority under which a prescriber has issued the script. Pharmacists can use the validation tool within the SAS Portal to check the status of the SAS/AP submission and associated information associated with a script.

Further, where a script is presented without a valid SAS/AP authority, pharmacists can also submit SAS-C notifications via the SAS Portal on behalf of the prescriber, following which, they are able to immediately dispense the prescribed NVP to the patient.

How to register and access the SAS Portal

After following the link above:

• Create a user profile on the SAS and AP online system via the ‘Register now’ button.
• When creating your user profile, select ‘healthcare practitioner’ as the profile and complete the requested details (including your AHPRA number and pharmacy details).
• This will permit you to use the prescription validation tool.

How to use the SAS Portal to check and validate the SAS authority for NVP scripts

• Log in to the SAS Portal and select ‘SAS/AP Submission Validation’ from the top menu bar.
• Enter the Authorisation or Notification reference number set out in the patient’s script and select “search”.
• The system will display the details associated with the submission number allowing the pharmacist 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. In such a case, the TGA’s guidelines allow pharmacists to lodge an SAS-C notification on behalf of the prescriber through the TGA’s SAS Portal.

Before submitting an SAS-C notification, confirm with the patient that they are neither (i) pregnant nor (ii) under the age of 16 years.

If the patient is either, contact the prescribing practitioner directly and inform them that they should submit an SAS-B application to the TGA, and send you a copy of the approval letter before you will dispense.

How to file an SAS-C Notification

1. Log in to the SAS Portal and select ‘SAS dashboard’ from the top menu bar
2. Click the ‘New SAS Application’ green button on right side of the SAS dashboard
3. Enter the following information:

Informing prescribers that you have filed an SAS-C notification on their behalf

It is best practice to inform prescribers when you have filed an SAS-C notification on behalf of their patient. Set out below is a template email, which can be incorporated into your dispensing software.

Dear [Title and Name of prescriber],

[title and name of patient] presented a prescription issued by you for [insert name of product], a nicotine vaping product, to our pharmacy on [date].

The prescription did not indicate the authority under which it was issued, and [I / Our pharmacist ] was unable to validate it through the TGA’s SAS/AP Submission Validation tool.

Consequently, [I / Our pharmacist ] lodged an SAS-C notification on your behalf and dispensed the prescribed medication to the patient, as per your prescription, in accordance with the TGA’s guidance.

May I kindly recommend that you include your SAS/AP authority number on future prescriptions and, if you are an Authorised Prescriber of NVPs, provide the patient with a copy of the Authorised Prescriber approval letter issued by the TGA.

Reporting requirements when dispensing NVPs

• Wholesalers | Sponsors are required to submit 6-monthly reports to the TGA for the supply of NVPs. You should seek guidance from your wholesaler to clarify their reporting requirements when supplying NVPs.
• Pharmacists must report any adverse events (AE) to the TGA via its AE reporting site.

Non-brand-specific or generic prescriptions

Patients may occasionally present with a script that is not brand-specific or stipulates a quantity of e-liquid that differs from what you would expect for a closed-system NVP. This may manifest as large quantities of liquid (up to 1,000ml) or lower-concentration liquids for use in open-system/refillable NVPs.

You should note that the RACGP’s Smoking Cessation Guidelines recommend that patients be prescribed closed-system NVPs for, among other things, the following reasons:

• Reduced risk of accidental ingestion (by third-parties) or self-exposure to a nicotine overdose;
• Prevents incorrect dilution concerning dosing; and
• Prevents any contamination or consumption of potentially toxic or illegal substances.

If the script presented is for a closed-system NVP but fails to specify the brand, you should ensure that the concentration is specified and not set out as a range.

If a patient presents a generic script with no determined concentration, or a wide range of permitted concentrations (such as 0-50mg/mL), you should either:

• Contact the prescribing doctor to specify the nicotine concentration in the prescription;
• Refer your patient to a local established AP, who is more experienced in prescribing NVPs; or
• If there are no locally established APs, you can refer your patient to a dedicated smoking cessation service.