Any Australian registered medical practitioner (including GPs) is eligible to apply to become an Authorised Prescriber (AP) for Nicotine Vaping Products (NVPs). The Therapeutic Goods Administration (TGA) SAS and AP Online System provides a streamlined application process to become an AP for unapproved NVPs.

Option 1: Register via the TGA online portal

If you have previously registered to use online services provided by the TGA, please use your existing login details and go to compliance.health.gov.au/sas/ to commence your application.

If you have not previously registered to use online services provided by the TGA, please go to the following link and create an account:

apps.tga.gov.au/portalaccounts/account/register/288580002

As part of the registration process, you will be required to provide the following information:

• A new unique username, password and email address (for the purposes of account registration); and
• Full name, health practitioner type, AHPRA registration number, and contact details.

Note: only medical practitioners are able to access the TGA online portal.

Option 2: Register via email or fax

The TGA also provides an application form (hard copy attached) that can be emailed or faxed directly to the TGA. The TGA will process the application and return the AP authorisation letter and MAP number to the practitioner.

The paper-based application form can be accessed here:

https://www.tga.gov.au/sites/default/files/nicotine-authorised-prescriber-scheme-application-form.pdf

Simply print the form, complete the required fields and send to the TGA at:

• Email: Authorised.Prescribers@health.gov.au
• Facsimile: 02 6203 1105 (TGA central fax number)

The TGA recommends submitting paper-based applications via email as this ensures the application goes directly to the appropriate department. Submitting applications via the central fax number may result in processing delays.

If you require assistance to complete the application form or require support, please contact the TGA’s SAS Helpline on 02 6289 4632.

Guidance for practitioners prescribing under the AP scheme

To ensure that AP reporting requirements can be met by the dispensing pharmacy and the product sponsor, and to facilitate the efficient dispensing of the product at the pharmacy, please note the following guidance:

• The practitioner’s MAP number (taken from the authorisation letter) must appear on the prescription.
• A copy of the practitioner’s AP authorisation letter must accompany the prescription. TGA regulations require that the product sponsor and pharmacy must have a copy of the AP authorisation to release the prescribed product to the patient.
  • The pharmacy will retain a copy of the authorisation letter on the patient’s file to facilitate repeat prescriptions.

The TGA requires several practice points to be observed as a part of the prescribing process for unapproved therapeutic goods (such as NVPs).

The practitioner should:

• Maintain good quality clinical notes that establish the rationale and justification for the prescription.
• Document an ‘informed consent’ that outlines the risks and benefits of the proposed treatment to the patient.
• Report any adverse reactions to the TGA.

Note: A schedule 4 drug can be prescribed by law for up to 12 months. However, in practice this period is usually less. The RACGP Smoking Cessation Guidelines provide specific guidance in this respect.

Sample prescription for Nicovape® Q

Initial prescription

Clinicians initially should prescribe one cartridge per day for all patients who qualify for treatment, regardless of the number of cigarettes that patients smoke. Patients should be provided with a prescription for three months’ supply of Nicovape® Q or Nicovape® Q SD (as the consultation determines).

• 4 x 7-packs (28 cartridges total) with one cartridge prescribed per day initial prescription with 2 x repeats; and
• Maximum one cartridge per day. During the follow-up consultation, clinicians should ask patients about the number of cartridges they consume per day and adjust, as necessary, the number of Nicovape® Q cartridges prescribed subsequently.

Sample RX

Instructions

1. Remind the patient that PBS does not cover NVPs.
2. The RACGP recommends that brand substitution should not be permitted.
3. TGO 110 limits NVP flavours to tobacco, menthol, or mint. In most cases, prescribers will allow patients to select their preferred flavour at their discretion.
4. The prescription will be issued with its corresponding SAS/AP authorisation reference number:
   • AP Scheme reference number
     • MAPYY/9999999
   • SAS-B reference number
     • MBYY/99999999
   • SAS-C notification number
     • MCYY/99999999
     • YY: Year Granted
5. Prescribers are encouraged to note a specific quantity per month here as a matter of best practice.
6. Noting the total number of cartridges per month and the cartridge volume of the recommended brand (cartridge volume varies across brands) is a mandatory prescribing requirement.
7. RACGP guidelines allow for prescriptions of up to 12 months.
8. Prescribers should specify the NVP device on the initial prescription as a matter of best practice. Note: This is mandatory in the Northern Territory, as pharmacists can only supply NVP devices under prescription.

Please ensure a copy of the Authorised Prescriber approval letter issued to you by the TGA is attached to the initial prescription. The dispensing pharmacist will retain the TGA approval letter on the patients’ file to facilitate repeat prescriptions and to comply with the TGA’s reporting requirements for supplying unapproved nicotine vaping products via the Special Access Scheme (SAS-B) or the Authorised Prescriber Scheme (APS).

Practical considerations

Ensuring prescriptions are valid

Pharmacists are required to confirm an authorisation to supply is in place prior to dispensing NVPs.

It is essential that prescriptions include the prescribing doctor’s Authorised Prescriber number or SAS approval or notification number.

This will allow the pharmacist to confirm the authorisation to supply via the TGA’s online SAS portal.

In addition, where possible, a paper copy of the AP or SAS approval/notification document should be given to the patient. The pharmacy will retain a copy of this on the patient’s file.

Where pharmacists or their wholesalers require a copy of the AP registration document, they may reach out directly to the prescribing doctor.

Doctor’s contact details on eRx prescriptions

Prescribers should ensure that any prescriptions issued through eRx contain clear contact information to allow contact if issues arise around the script.

Feedback indicates that pharmacists are frequently struggling to contact the prescribing doctor if they need additional information. Please ensure that your prescription contains clear contact information.

Patients’ concerns

Communicating with patients about the prescription

Doctors are currently consulting with large numbers of existing vapers, who often have preferences around the products they would like to continue using, which they have used historically.

Many patients will not understand the limitations the new framework imposes on their input in determining which NVP a doctor prescribes them.

Clear communication about the product you are prescribing and why you are prescribing it will help address your patients’ concerns. Your communication may include some, or all, of the following:

• “The RACGP guidelines recommend against prescribing open liquids”
• “The product I am prescribing has been assessed by myself and the pharmacy channel as appropriate for medical use as a smoking cessation therapy.“
• “The products I am prescribing are distributed by Australian sponsors, meet the required standards, have product recall and adverse event reporting infrastructures, and are adequately insured.”

Product strength is a concern for some vapers and is likely to be particularly concerning for those who use lower-concentration liquids in open systems. Explain:

• The product you prescribed the patient is designed to replicate the nicotine delivery of a cigarette and is optimised to reduce cravings.
• At the first review point, you will work with the patient to understand what is working for them and adjust the plan accordingly.
• Changes may be made to the amount of daily usage, the strength of the product offering or both.

Patients can fill their prescriptions in a way that works for them

It is unlikely that many patients will be willing or able to fill a month’s script in one go. People who smoke tend not to purchase bulk cigarettes and should not be expected to buy bulk cartridges. Liber has advised pharmacists to explain how patients may elect to have their prescription partially dispensed. In this instance:

• Patients will be given a revised eRx after partial dispensing.
• The original prescription becomes unusable, and the pharmacist will reissue an amended eRx.