About this guideline

This guideline applies to all healthcare professionals who support people wishing to quit smoking. It is intended to be relevant to the wider primary care setting, and is not limited to general practice. This is reflected in the multidisciplinary composition of the guideline development Expert Advisory Group.

A focussed update was undertaken to provide guidance about the rescheduling of nicotine e-liquids. Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 (TGO 110) came into effect on 1 October 2021.

Changes to the regulation of nicotine as of 1st October 2021

A revised recommendation and additional practice points were added in response to TGO 110. These are provided in the Summary of recommendations below and further information about prescribing nicotine vaping products is provided in Pharmacotherapy for smoking cessation – Electronic cigarettes and nicotine vaping products

With funding from the Commonwealth Department of Health, the Royal Australian College of General Practitioners was commissioned to develop an evidence-based guidance to support health professionals who may choose to prescribe nicotine vaping products (NVPs) as a quitting aid.

Guideline development for NVPs followed the GRADE (Grading of Recommendations Assessment, Development and Evaluation). The National Centre for Epidemiology and Population Health (NCEPH) at the Australian National University (ANU) was commissioned by the Australian Department of Health to undertake a program of research on electronic cigarettes in the Australian context. This work formed the basis of the evidence reviews and technical support to revise the RACGP GRADE recommendation on e-cigarettes / NVPs.

An expert advisory group (EAG) was assembled to specifically review updated evidence on the efficacy and safety of prescribing NVPs and to examine the practicalities of prescribing them for smoking cessation in the new regulatory environment.

The RACGP commissioned the Joanna Briggs Institute (JBI) and the JBI Adelaide GRADE Centre to assist with revising this guideline for the second edition.

Using GRADE to develop this guideline required JBI and the JBI Adelaide GRADE Centre to conduct an evidence review that resulted in a GRADE ‘Summary of findings’ table. This table is a summarised representation of the major findings, along with a rating of the certainty in the evidence.

The ‘Summary of findings’ table was incorporated into the evidence-to-decision framework. The Expert Advisory Group then worked to move from the evidence to making practice recommendations, ensuring all important aspects related to making structured recommendations were considered. This resulted in transparent and practice-based recommendations.

Adapting the previous guideline recommendations to GRADE

The GRADE process allows guidelines to be developed by adopting existing guideline recommendations from others, adapting existing recommendations to suit a new context and creating new recommendations.¹

The GRADE process is a resource-intensive process to create guideline recommendations. Therefore, where appropriate, existing guideline recommendations were retained and converted to the GRADE format.

The guideline recommendations from the first edition were based on the National Health and Medical Research Council (NHMRC) classification system. The NHMRC system classifies the quality of the evidence as follows:²

Level I – Evidence obtained from systematic review of relevant randomised controlled trials

Level II – Evidence obtained from one or more well-designed, randomised controlled trials

Level III – Evidence obtained from well-designed, non-randomised controlled trials,or from well-designed cohort or case control studies

Level IV – Evidence obtained from case series, either post-test or pre-test and post-test

Level V – Opinions of respected authorities based on clinical experience, descriptive studies, reports of expert committees

No evidence – No evidence was found relevant to general practice on the issue being considered

The strength of the recommendations for the first edition were based on the US Preventive Services Task Force (USPSTF) guide:³

A – There is good evidence to support the recommendation
B – There is fair evidence to support the recommendation
C – There is poor evidence regarding the inclusion, or exclusion of the recommendation but recommendations may be made on other grounds.

The Expert Advisory Group reviewed the guideline recommendations from the first edition for redundancy, relevance and the strength of evidence. The strength of these recommendations, based on the USPSTF guide, were then converted to the equivalent GRADE strength of evidence format through consensus on a case-by-case basis (Table 1).

Table 1

Comparison of USPSTF and GRADE recommendation descriptors
 

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New smoking cessation questions and recommendations

Since the minor update in 2014, the field of smoking cessation has moved forward. It now includes more sophisticated pharmacology, technology in the form of quitting apps, and controversial nicotine delivery modalities such as electronic cigarettes (ie e-cigarettes).

New topics identified by the Expert Advisory Group included questions on:

• combinations and dosage of pharmacotherapies
• relapse prevention
• use of nicotine replacement therapy (NRT) during pregnancy
• nicotine containing e-cigarettes as a cessation aid.

Clinical questions on these topics were formulated as PICO (patient, intervention, comparator, outcome) questions, which were subjected to the GRADE process.

The prioritised clinical questions were:

• Is combination NRT (ie patch and oral form) more effective than patch alone? If so, is this effective for all people who smoke or only for those who are more nicotine dependent?
• Is the combination of varenicline and NRT more effective than varenicline alone? If so, is this effective for all people who smoke or only for those who are more nicotine dependent?
• Does adding any further course of NRT (any form) reduce relapse in people who have quit smoking at the completion of a standard course of NRT?
• Does adding any further course of varenicline (>12 weeks) reduce relapse in people who have quit smoking at the completion of a standard course of varenicline (ie 12 weeks)?
• Is it safe and effective for pregnant women who smoke to use NRT rather than no NRT?
• Are nicotine-containing e-cigarettes more effective than NRT for smoking cessation?

Explanation for GRADE levels of evidence and strength of recommendations

The GRADE process classifies the quality of the evidence (certainty) into one of four scores:

1. High: very confident that the true effect lies close to that of the estimated effect.
2. Moderate: moderately confident in the estimated effect. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
3. Low: confidence in the estimated effect is limited. The true effect may be substantially different from the estimated effect.
4. Very low: very little confidence in the estimated effect. The true effect is likely to be substantially different from the estimated effect.

The GRADE process classifies the strength of a recommendation into one of three scores:

1. Strong recommendation for (or against) the intervention.
2. Weak recommendation for (or against) the intervention.
3. Conditional recommendation for either the intervention or comparison.

The role of health professionals

Recommendation 1 – All people who smoke should be offered brief advice to quit smoking.
Strong recommendation, high certainty

Recommendation 2 – A system for identifying all people who smoke and documenting tobacco use should be used in every practice or healthcare service.
Strong recommendation, high certainty

Recommendation 3 – Offer brief smoking cessation advice in routine consultations
and appointments, whenever possible.
Strong recommendation, high certainty

Recommendation 4 – Offer follow-up to all people who are attempting to quit smoking.
Strong recommendation, high certainty

Pharmacotherapy for smoking cessation

Recommendation 5 – In the absence of contraindications, pharmacotherapy (nicotine replacement therapy, varenicline or bupropion) is an effective aid when accompanied by behavioural support, and should be recommended to all people who smoke who have evidence of nicotine dependence. Choice of pharmacotherapy is based on efficacy, clinical suitability and patient preference.
Strong recommendation, high certainty

Recommendation 6 – Combination nicotine replacement therapy (NRT) (ie patch and oral form) accompanied by behavioural support is more effective than NRT monotherapy accompanied by behavioural support, and should be recommended to people who smoke who have evidence of nicotine dependence.
Strong recommendation, moderate certainty

Recommendation 7 – For people who have stopped smoking at the end of a standard course of nicotine replacement therapy (NRT), clinicians may consider recommending an additional course of NRT to reduce relapse.
Conditional recommendation for intervention, low certainty

Recommendation 8 –

Recommendation 9 – For women who are pregnant and unable to quit smoking with behavioural support alone, clinicians might recommend nicotine replacement therapy (NRT), compared with no NRT. Behavioural support and monitoring should also be provided.
Conditional recommendation for intervention, low certainty

Recommendation 10 – Varenicline should be recommended to people who smoke and who have been assessed as clinically suitable for this medication;it should be provided in combination with behavioural support.
Strong recommendation, high certainty

Recommendation 11 – For people who have abstained from smoking after a standard course of varenicline in combination with behavioural support, clinicians may consider a further course of varenicline to reduce relapse.
Conditional recommendation for intervention, low certainty

Recommendation 12 – For people who are attempting to quit smoking using varenicline accompanied by behavioural support, clinicians might recommend the use of varenicline in combination with nicotine replacement therapy, compared with varenicline alone.
Conditional recommendation for intervention, moderate certainty

Recommendation 13 – Bupropion sustained release should be recommended to people who smoke and who have been assessed as clinically suitable for this medication; it should be provided in combination with behavioural support. Bupropion is less effective than either varenicline or combination nicotine replacement therapy.
Strong recommendation, high certainty

Recommendation 14 – Nortriptyline should be considered as a second-line smoking cessation pharmacotherapy agent because of its adverse effects profile.
Strong recommendation, moderate certainty

Recommendation 15 – For people who have tried to achieve smoking cessation with first-line therapy (combination of behavioural support and TGA-approved pharmacotherapy) but failed and are still motivated to quit smoking, NVPs may be a reasonable intervention to recommend along with behavioural support. However, this needs to be preceded by an evidence-informed shared-decision making process, whereby the patient is aware of the following caveats:

• Due to the lack of available evidence, the long-term health effects of NVPs are unknown.
• NVPs are not registered therapeutic goods in Australia and therefore their safety, efficacy and quality have not been established.
• There is a lack of uniformity in vaping devices and NVPs, which increases the uncertainties associated with their use.
• To maximise possible benefit and minimise risk of harms, dual use should be avoided and long-term use should be minimised.
• It is important for the patient to return for regular review and monitoring.

Conditional recommendation for intervention, low certainty

Practice points – NVPs are unapproved products and it is valid and reasonable for medical practitioners to choose not to prescribe them.
Overseas nicotine vaping products are not required to meet all of the TGO 110 requirements for safety.
To minimise risk of harms, the EAG recommends the following measures for prescribers:

1. Recommend NVPs in closed systems and avoid open systems – to minimise the risk of poisoning, addition of toxic/illegal substances and contamination. High concentration disposable nicotine salt pod devices should also be avoided due to environmental waste and safety concerns, including high risk of diversion.
2. Use the Authorised Prescriber and Special Access Scheme prescribing pathways instead of the Personal Importation Scheme – to minimise the risk of the patient accessing NVPs that do not comply with the minimum safety and quality TGO 110 labelling and packaging requirements. In addition, the prescriber can supply the prescription directly to the patient’s nominated pharmacy and/or endorse it “For Local Supply Only”.
3. Avoid prescribing free-base nicotine at concentrations over 20 mg/mL. The two trials showing NVP efficacy used a concentration of ≤20 mg/mL free-base nicotine.
   Although they are the most widely available closed system option, there is currently no clinical trial evidence of efficacy for smoking cessation with nicotine salt products.
   Nicotine e-liquid concentrations of 100 mg/mL are not necessary and should not be prescribed. The risks of poisoning through skin contact and accidental ingestion are far greater where patients choose to dilute their own e-liquids.
4. Limit the quantity of nicotine vaping products per prescription to a maximum of 3 months’ supply. Consider aligning the duration of supply with the timing of follow-up.
5. Where possible, avoid flavours or limit to tobacco flavour.
6. Provide follow-up and behavioural support

Behavioural and advice-based support for smoking cessation

Recommendation 16 – Referral to telephone call-back counselling services should be offered to all people who smoke.
Strong recommendation, high certainty