As with all smoking cessation therapies, using a combination of product education and patient counselling will yield the best outcomes.

Formulating a treatment plan should be a collaborative process between GP and patient, with the setting and reviewing of goals ongoing. The duration of treatment and decisions about when patients should attempt abstinence should be decided and reevaluated jointly and as clinically indicated.

GPs should establish firm expectations that patients should not continue to smoke after an agreed period. Dual-use provides no benefit to the patient.

Patient selection

A central requirement of the AP scheme and current RACGP guidelines is that patients should have attempted previously to quit using existing licensed therapies.

These previous treatment failures are likely to be true of most patients who have smoked long-term.

Patient and product considerations regarding safety and efficacy

For patients new to NVPs, closed systems will almost always be the appropriate intervention.

GPs can ensure adequate dosage by prescribing the manufacturer’s recommended dosage for smoking cessation and evaluating its tolerability in patients.

Patient education and informed consent

Obtaining and recording informed consent is required by the TGA.

In line with best practice, quality clinical documentation is essential. It is prudent from a medico-legal perspective to document the clinical rationale for prescribing an unregistered NVP.

Clinicians should inform patients that the TGA has not currently evaluated any NVPs for inclusion on the ARTG.

Maximising outcomes with clinical education

Liber’s experience has shown that when patients understand the following points, they are most likely to adhere to treatment:

• They should not expect to use the product like a cigarette.
• They should use the product as often as required to ease cravings and withdrawal symptoms.
• They should use the product as and when needed to not return to smoking.
• They should not smoke at all.

The first point is crucial. Nicovape® Q (or any NVP) is not used in a cigarette-like intensive fashion. The typical pattern of use is a ‘grazing’ pattern. When patients are told this upfront, they can confidently settle into the typical usage pattern.

Clinicians should also give patients accurate information about the relative risks of smoking and non-smoked nicotine treatments.

Specifically:

• NVPs are a safer alternative to smoking;
• No amount of smoking is safe;
• Even one cigarette per day can cause smoking-related disease; and
• Nicotine, while dependence causing, is not the harmful component of cigarette smoke and, when used absent of smoking, is not measurably associated with disease outcomes.

Additional behavioural guidance may include the following:

• Ensure to use the product in situations where they would ordinarily smoke;
• If possible, avoid going into smoking shelters (and other smoking areas) to use the product;
• Ensure they have sufficient replacement cartridges available to them at any time; and
• Keep batteries charged, perhaps consider purchasing additional backup batteries.

Titrating down ahead of abstinence

There is no clear evidence that underpins which strategy is best to lower nicotine before a quit attempt or if such titration is likely to increase the probability of successful abstinence.

Possible methods for titrating nicotine in NVPs include using:

1. A lower nicotine concentration to limit the overall daily nicotine dosage. Patients will have to ensure they do not take additional compensatory puffs; or
2. A regular-concentration product with limits on the amount prescribed. Patients will have to moderate the number of puffs they take per day consciously.

Note that users can extract more nicotine from the aerosol by inhaling deeply and holding their breath. The Nicorette Quickmist is supplied only in one nicotine concentration, which offers a precedent for the second titration option.

Abstinence and relapse prevention

Nicotine abstinence is only possible when patients are ready to achieve it. It may be impossible for clinicians to determine if a patient is ready in advance. When a patient attempts abstinence, clinicians should assume that they will relapse.

Patients that successfully achieved smoking cessation with an NVP should have access to the same product on an ongoing basis in case of relapse.

Open system users and clinical considerations

A considerable number of Australian smokers used vaping products before the regulatory changes. Of these, an unknown proportion uses open systems for smoking cessation. Since 1 October 2021, GPs have had consultations with patients currently using open systems requesting a prescription of nicotine liquids.

While open systems pose avoidable risks, the benefits of prescribing e-liquid refills to patients who do not wish to use a closed system outweigh the risks of relapse to smoking.

It’s important to understand that while NVPs (open devices and e-liquids) must conform with TGO 110, they are not assessed for quality and safety by the TGA. GPs should consider the following:

• Prescribing e-liquids only if the patient has already stopped smoking entirely or has committed to doing so within a defined timeframe.
• Taking usage history to aid appropriate prescribing and understanding of usage, including:
  • E-liquid nicotine concentration and type used (freebase or nicotine salts);
  • Daily nicotine dosage (e-liquid concentration and the quantity consumed/day); and
  • The device name and power output. User-selected power settings.
• Ensuring written informed consent reflects that patients understand that:
  • They are electing to use open systems as a continuation of existing use;
  • Open systems have risks related to user choices or device performance.

Closed-system NVPs are the recommended format for prescription

As outlined by the Royal Australian College of General Practitioners’ (RACGP) Smoking Cessation Guidelines, prescribing closed-system NVPs is recommended to avoid the following risks:

• Inappropriate or incorrect dilution of liquid nicotine (the dilution process is not straightforward and relies on adequate product labelling);
• Intentional or accidental ingestion or exposure through skin or eyes; and
• Addition of potentially toxic or illegal substances, or contamination.