Role of pharmacies in supplying NVPs

The pharmacy channel plays a central role in the NVP framework. In addition to distributing, stocking and dispensing, the channel also acts in an important quality control capacity, evaluating which NVPs are suitable for therapeutic use.

Prescribers will look to ensure that their local pharmacy:

• Holds sufficient stock to dispense to patients immediately, and
• Is trained and capable of providing initial and ongoing support to patients.

Please see Module 13: Questions you need to ask before prescribing an NVP brand, to understand issues that you (and prescribers) may wish to consider when choosing which NVPs to dispense (and prescribe).

The role of pharmacists in the NVP supply chain

In addition to distributing, stocking and dispensing therapeutic NVPs, the pharmacy channel plays a central role in ensuring that more than four million nicotine dependent Australians are properly educated about how NVPs, when used appropriately, can act as an important smoking cessation tool.

Further, as all NVPs are unlicensed, the pharmacy channel also acts in an important quality control role, evaluating which NVPs are suitable for therapeutic use.

In particular, pharmacists have four key roles:

Educate

• Trusted first point of contact for health issues
• Enquire to understand patient’s smoking history and associated underlying medical conditions
• Explain alternative cessation therapies
• Distinguish between illicit and therapeutic NVPs

Direct

Access remains a key barrier for nicotine dependent Australians seeking NVPs

Pharmacists can direct patients to:

• Local prescribers of NVPs; or
• Appropriate telehealth platforms

Supply

• Immediate access to compliant NVPs is key to successful adherence
• Established supply chain through CSO wholesalers, with appropriate access, quality control and support infrastructure
• Ongoing script management is key to successful treatment
• Financial constraints may require staged supply

Support

• Ongoing behavioural support improves likelihood of success
• Pharmacists are likely to have 25 – 50 points of contact with patients during their treatment
• Two step approach: (i) stabilised smoking cessation before (ii) attempting nicotine abstinence, requires structured support

Scripts for NVPs as unlicensed medicines

All scripts for NVPs must be prescribed under one of the TGA’s three special access pathways for unlicensed medicines:

Authorised Prescriber Scheme (AP)

• 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, and Nurse Practitioners.
• Prescribers must notify the TGA for each script.
• Pharmacists may notify the TGA on behalf of prescribers and dispense immediately.

While most doctors will register as APs of nicotine, under the TGA’s streamlined registration process, others may elect to prescribe using SAS-B or SAS-C.

Reading a prescription for NVPs

Sample Rx (Insert Sample)

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.