Professional practice guidelines for pharmacists: Nicotine dependence support

Relationship between the guidelines and professional practice standards

Professional practice standards are objective statements of the minimum performance expectations of professional behaviour of all pharmacists in Australia. Standards relate to the systems pharmacists should have in place for the delivery of a service and provide a benchmark against which performance can be assessed.

 

These guidelines provide practical guidance to support pharmacists to provide nicotine dependence support and meet the relevant standards (see Table 1. Professional practice standards relevant to providing nicotine dependence support). The health setting and context in which nicotine dependence support occurs will influence how the guidelines are applied to practice.

 

See Figure 1 for information about the relationship between documents that articulate, govern and guide pharmacist practice.

 

Figure 1. Guidance and regulation of pharmacist practice in Australia

Structure of the guidelines

These guidelines highlight relevant professional practice standards followed by a description of practical actions that contribute to the achievement of the standard (See Figure 2). In this way, the guidelines can be viewed as a ‘how to’ guide for providing nicotine dependence support according to the relevant standards.

 

Figure 2. Structure of the guidelines

 

While not specifically referred to in the body of these guidelines, the fundamental standards (Person-centred care, Responsibility and accountability, Collaborative practice) apply to all aspects of pharmacy practice, and pharmacists can refer to the professional practice standards for actions required to meet these fundamental standards. The principles of the fundamental standards are included within the relevant actions listed in these guidelines.

 

Scope of these guidelines

These guidelines are applicable to all practice settings in which pharmacists provide nicotine dependence support, including providing medicines available without a prescription. These guidelines focus on the management of nicotine dependence that may have developed as a result of smoking or vaping.

 

Nicotine dependence due to the use of other nicotine-containing products (e.g. nicotine pouches, heat-not-burn tobacco) is outside the scope of these guidelines as there is a lack of evidence to guide cessation of these products. Until evidence emerges, it may be reasonable to use the same strategies that are used for smoking cessation (e.g. brief advice, pharmacotherapy, multi-session behavioural intervention) to provide support to patients seeking to stop using other nicotine-containing products.

 

Specific information about general dispensing and compounding processes is covered by other guidelines, which are referred to in the relevant sections within these guidelines.

 

Legislative requirements are not addressed in detail in these guidelines due to the evolving nature. Information about legislation is correct at the time of publication. At all times, pharmacists must comply with relevant Commonwealth and state or territory legislation. No part of the guidelines should be interpreted as permitting a breach of the law or discouraging compliance with legal requirements.

 

Pharmacists are expected to apply professional judgement when applying these guidelines in practice. They will need to make risk–benefit assessments from time-to-time based on the best available information and current evidence. Records of assessments should be kept, and all significant decisions should be documented.

Tobacco smoking

Tobacco smoking remains the leading cause of preventable death and disability in Australia, contributing significantly to diseases such as cancer (especially lung cancer), chronic obstructive pulmonary disease (COPD) and cardiovascular disease.^1,2 Additionally, second-hand smoke exposure poses serious health risks, leading to cardiovascular and respiratory complications in adults and issues such as low birth weight and sudden infant death syndrome (SIDS) in infants.^2,7

 

Over the last three decades, smoking rates in Australia have declined. This success is attributed to effective public health strategies, including tax increases, comprehensive smoke-free laws, plain packaging and targeted social marketing campaigns. However, further declines in tobacco smoking are needed to meet the 2030 smoking targets set in the National Tobacco Strategy. While smoking has declined in the general population, some patient populations continue to experience higher smoking rates than the general population (e.g. Aboriginal and Torres Strait Islander peoples, people living with mental illness, people living in low socio-economic circumstances). The rise in vaping has also introduced new challenges to public health.^1–3

 

The health benefits of stopping smoking are widely recognised. See Appendix 2 Health benefits of stopping smoking.

 

Nicotine dependence and vaping

Recent trends indicate a significant increase in exclusive vaping and dual smoking and vaping, particularly among people under 35 years of age.² The highest prevalence of vaping among never-smokers is seen in adolescents and young adults.⁸ Use of nicotine-containing vapes by never-smokers can lead to nicotine dependence.⁹ Evidence suggests that people who vape are more likely to take up smoking than those who do not vape.¹⁰

 

Vaping-related risks and harms

Vaping exposes the user to a range of chemicals (e.g. flavours, solvents, humectants). These chemicals may be considered safe when ingested but may be harmful when inhaled.⁹

 

The long-term effects of exposure to vaping are unknown. Some of the harms associated with vaping that have been documented (mostly from short-term use) include⁸:

 

• adverse pregnancy and perinatal outcomes (e.g. preterm delivery, low birthweight)
• effects on adolescent brain development
• periodontitis

 

It is suspected that an increase in vaping is contributing to the increasing rate of a condition characterised by respiratory and gastrointestinal symptoms including cough, shortness of breath, nausea and vomiting. This condition is known as E-Cigarette or Vaping Associated Lung Injury (EVALI). Most cases of EVALI have been linked to e-liquids containing THC (tetrahydrocannabinol) or vitamin E acetate, substances often found in illicit or unregulated vaping products.⁸

 

Pharmacist role and requirements in providing nicotine dependence support

These guidelines provide practical guidance on how to achieve the professional practice standards as they apply to providing nicotine dependence support. Information about the clinical aspects of providing nicotine dependence support can be found in Appendix 1 Treatment guideline for pharmacists: nicotine dependence.

 

Providing support to a patient with nicotine dependence can vary based on the service delivery model of the pharmacy or health service and the education and training of the pharmacy or health service staff.

 

Regardless of the service delivery model of the pharmacy or health service, offer brief advice to all people who smoke or vape.

 

Ask, Advise, Help forms the basic structure for brief advice on smoking cessation³:

 

• Ask ‘Do you smoke?’ and record status.
• Advise all people who smoke to stop.
• Help by offering to arrange a referral and encouraging the use of behavioural interventions and appropriate pharmacotherapy.

 

Elements of Ask, Advise, Help are further developed in Patient assessment, Prescribing, Providing health information and Patient monitoring. See also Appendix 3 Brief advice.

 

Note: There is a lack of research that specifically addresses vaping cessation and dual smoking and vaping cessation. Until evidence emerges, it is reasonable to use the same strategies that are used for smoking cessation (e.g. brief advice, pharmacotherapy, multi-session behavioural intervention) to provide support to patients who are seeking to stop vaping.5 This may also apply to cessation of other nicotine-containing products (e.g. nicotine pouches, heat-not-burn tobacco).

The pharmacist delivers a service to improve health outcomes

 

 

 

 

 

 

A pharmacist in a senior clinical, managerial or organisational oversight role in the pharmacy or health service (e.g. community pharmacy owner, pharmacist manager, sole operator, director of pharmacy) has increased obligations to plan, resource, monitor and review the service.⁶

 

Quality systems are needed to deliver nicotine dependence support that is:

• safe and therapeutically appropriate for the patient
• consistent between different pharmacists
• aligned with evidence and scope of practice.

 

Actions required for service delivery are split into two categories:

• Those actions that apply to all pharmacists in an oversight role where nicotine dependence support is provided.
• Those actions that apply to all pharmacists providing nicotine dependence support.

 

Actions required

Pharmacist in an oversight role

Develop and maintain a standard operating procedure for providing nicotine dependence support, with a particular focus on:

• purpose and scope, including
  • the role of other health professionals and services involved in the provision of care
  • when to consult with or refer to other health professionals and services
• identifying patients who smoke and/or vape and documenting their use
• the nicotine dependence consultation (see Appendix 1 Treatment guideline for pharmacists: nicotine dependence), including
  • providing in-person nicotine dependence consultations with the patient in a private consultation area/room
  • gathering patient information, including screening for undiagnosed conditions if appropriate (see Screening, case-finding and risk assessment)
  • assessing patient needs
  • agreeing on a management plan (including obtaining informed consent for unapproved products)
  • discussing the agreed management plan
  • documenting the details of the consultation (including documenting informed consent if an unapproved product is supplied; see Appendix 4 Template written consent form for unapproved therapeutic vaping goods)
• roles and responsibilities of staff involved (e.g. how pharmacy support staff will support the pharmacist)
• professional indemnity insurance coverage (e.g. coverage for supply of unapproved products)
• managing conflicts of interest
• managing pharmacist autonomy (i.e. the pharmacist practises and promotes patient-centred care, including informing the patient when exercising the right to decline supply of a medicine to the patient).¹¹ See Prescribing.
• education, training and qualification of staff members
• health and safety risks and applicable mitigating measures, including risks associated with
  • storage, handling and disposal of therapeutic vaping goods (see Safe and secure handling of therapeutic goods)
  • declining supply (see Prescribing)
• advertising and promotion, including
  • how patients will be advised of the nicotine dependence support available, noting
    • advertising Schedule 4 (Prescription Only) medicines and therapeutic vaping goods to the public is prohibited^12,13
    • text-based signage can be used to alert patients if a type of pharmacotherapy is unavailable or not stocked by the pharmacy
  • quality assurance, including
    • frequency of routine reviews of standard operating procedures
    • processes for collecting, documenting and reviewing feedback
    • method for documenting near misses or incidents associated with providing nicotine dependence support.

 

Provide appropriate facilities for providing nicotine dependence support, including:

• a private consultation area/room for consultations with
  • appropriate space and furnishings to accommodate the pharmacist, the patient and a support person for the patient, if needed
  • adequate protection of pharmacist and patient privacy such that the area/room layout and separators (e.g. screens, walls, doors) prevent
    • conversations at normal speaking volumes being overheard by people outside the consultation area/room (test whether conversations at normal speaking volumes can be heard outside the consultation area before the consultation area is used by patients)
    • unauthorised access to computer screens and documentation, including when the consultation area/room is not in use
  • required technology (e.g. computers, software) for the nicotine dependence support being delivered
  • required reference material, including guidelines
  • appropriately maintained and calibrated equipment as required (e.g. blood pressure monitor).

 

Meet legislative requirements if importing, stocking or supplying unapproved therapeutic vaping goods:

• Pharmacies can hold stock of unapproved therapeutic vaping goods in anticipation of supply under the Authorised Prescriber (AP) scheme or Special Access Scheme (SAS).¹² See Appendix 5 Access to unapproved therapeutic vaping goods and Appendix 6 Vaping devices.
• The unapproved therapeutic vaping goods must be confirmed to be included on the Therapeutic Goods Administration (TGA) list of notified vapes¹²

• Australian sponsors of therapeutic vaping goods (see Vapes: information for sponsors, importers and manufacturers) are responsible for meeting import requirements, including^12,14
  • import licences and import permits
  • Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021 (TGO110)¹⁵ labelling, packaging and record-keeping requirements
  • reporting adverse events or device failures. See Vapes: information for sponsors, importers and manufacturers.
• Pharmacists are considered sponsors of therapeutic vaping goods if they¹²
  • import therapeutic vaping goods directly from an overseas supplier to supply to Australian patients
  • export therapeutic vaping goods from Australia (e.g. send the product to someone overseas)
  • extemporaneously compound therapeutic vaping goods. See Compounding.
• Legislation on the control of therapeutic vaping goods differs by state or territory.¹² See Appendix 5 Access to unapproved therapeutic vaping goods.

 

Review feedback from the community, patients and professional peers.

 

Use feedback to determine ways to improve service delivery.

 

Pharmacist providing nicotine dependence support

Provide brief advice on smoking and/or vaping cessation to all patients that is tailored to their needs. See Appendix 3 Brief advice.

 

Provide nicotine dependence support consultations according to standard operating procedures.

 

Meet legislative, organisational and professional requirements, including requirements for:

• evidence-based medicine and patient-centred care
• informed consent, including informed financial consent (e.g. costs associated with nicotine dependence support in the pharmacy (e.g. any private consultation fee, product costs) and if subsidised support options are available)
• obtaining and recording patient personal details required to safely supply a therapeutic good
• professional indemnity insurance coverage for supplying unapproved products
• unapproved product access pathways requirements, including
  • validating the AP or SAS approval or notification using the TGA online validation tool. An AP or SAS-B approval or SAS-C notification submitted to the TGA by a prescriber will generate a reference number to use for validation. The reference number should be provided with the prescription or can be obtained by contacting the prescriber¹²
  • submitting a notification for each supply of a therapeutic vaping good as a Schedule 3 medicine under SAS-C using the TGA SAS and AP online system.¹² Although SAS-C must be submitted with 28 days of supply, best practice is to submit SAS-C notifications on the day of supply to minimise reporting errors
• supply of therapeutic vaping goods (regardless of whether they are supplied with or without a prescription) directly to the patient or their carer (i.e. cannot be supplied to a third party unless they are the patient’s carer)
• supply of therapeutic vaping goods (regardless of whether they are supplied with or without a prescription) in final dosage form (i.e. no mixing or dilution of the vaping substance is required). See Compounding.

 

Maintain personal competence and recency of relevant experience, including:

• cultural safety
• patient populations that may require additional support (see Appendix 7 Patient populations that may require additional support), for example
  • Aboriginal and Torres Strait Islander peoples
  • people with a co-existing medical condition (e.g. cardiovascular disease, diabetes, mental illness, substance use disorder)
  • adolescents
  • people who are pregnant or breastfeeding
  • lesbian, gay, bisexual, transgender, intersex, queer, asexual and other sexually or gender diverse (LGBTIQA+) people
  • people living with a disability
  • people from culturally and linguistically diverse backgrounds.

 

Conduct consultations consistent with personal competence and scope of practice:

• Pharmacists with additional training in behavioural interventions for smoking cessation can provide multi-session behavioural support services.
• Pharmacists practising in certain states or territories who have fulfilled the requirements for the scope of practice in that state or territory can prescribe bupropion or varenicline.

 

Encourage the patient to engage in the decision-making process to the extent they wish to participate (note that this will differ between patients and possibly along an individual patient’s care journey).

 

Discuss with the patient relevant, evidence-informed information they need to make an informed decision.

 

Communicate relevant information about the nicotine dependence support being provided to the patient’s regular general practitioner or practice (if they have one) with the patient’s consent.

 

Document the details of the patient consultation in the patient’s clinical record according to legislative, professional and organisational requirements, including details about:

• patient personal details
• patient assessment
• management plan
• informed consent
• prescribing
• dispensing
• patient monitoring (including follow-up schedule)
• health advice provided.

The pharmacist promotes health and preventive strategies to help people to increase control over and improve their health.

 

 

 

 

 

 

Smoking and vaping cessation health promotion activities aim to increase awareness of the risks of smoking and vaping and the benefits of stopping. Delivering a health promotion activity over a defined period can assist pharmacists to open a conversation about smoking and vaping cessation with patients and learn more about the specific barriers to smoking and vaping cessation faced by their patient populations.

 

Advice from pharmacists to patients about stopping smoking helps people to stop. Both longer consultations (>10 minutes) and brief advice (up to 3 minutes) can be beneficial.^3,4 Written materials and other resources (e.g. videos, audio, websites) for patients may also be helpful to support smoking cessation.³

 

Actions required for health promotion apply to all pharmacists delivering smoking and vaping cessation health promotion activities.

 

Actions required

Plan the health promotion activity, including:

• setting specific, measurable, achievable, realistic and timely objectives for the health promotion activity according to organisational and professional requirements, for example,
  • to inform patients who smoke about the health impacts of continued smoking and the benefits of stopping smoking over a 2-week period
  • to provide parents of teenage children advice and written materials over a 3-month period to assist them to talk to their children about smoking
  • to run a fortnightly drop-in clinic for breastfeeding people and their infants to talk about the benefits of smoking cessation
• identifying resource requirements (e.g. team member roles and responsibilities, written materials)
• developing or ordering written materials (e.g. posters, brochures) to complement the health promotion activity
• identifying special professional indemnity insurance requirements (e.g. for holding health promotion activities off site, engaging external providers)
• informing team members (e.g. hold a staff meeting to discuss the health promotion activity and roles and responsibilities)
• engaging with external organisations or health professionals to support the activity (e.g. state-based smoking cessation organisations)
• developing evaluation processes (e.g. team member and patient surveys).

 

Conduct team member training according to the roles and responsibilities of each team member.

 

Deliver the health promotion activity, including:

• displaying promotional materials
• approaching patients in the target audience
• tailoring the information provided according to the needs of the individual
• providing written resources to complement the health promotion activity.

 

Evaluate the health promotion activity to determine if the objectives have been met. Determine what worked well, what could be improved and how it can be done differently next time.

The pharmacist provides safe and secure handling of therapeutic goods to enable access and safeguard the patient.

 

 

 

 

 

 

The safe and secure handling of pharmacotherapy used for nicotine dependence support involves the same processes as for other TGA-approved medicines. Follow the guidance outlined in the Professional Practice Standards.⁶

 

Nicotine is a hazardous substance¹⁶ and safe and secure handling of therapeutic vaping goods involves additional actions to meet legislative, professional and organisational requirements. See also Appendix 1 Treatment guideline for pharmacists: nicotine dependence.

 

Actions required for safe and secure handling of therapeutic goods apply to all pharmacists handling therapeutic vaping goods.

 

Actions required

Confirm the therapeutic vaping goods to be ordered are included in the TGA list of notified vapes.

 

Verify that therapeutic vaping goods ordered from a sponsor or wholesaler comply with the labelling, packaging, ingredient and record-keeping requirements outlined in the TGO110 prior to ordering.¹² See Service delivery.

 

Store therapeutic vaping goods in the dispensary out of the line of sight of the public.

 

Dispose of any containers with vaping liquid (e.g. cartridges, pods) or empty containers that may contain residual nicotine through the return of unwanted medicines (RUM) program.¹⁷

• Vaping devices cannot be disposed of in the RUM bin as they contain batteries that are a fire risk. Devices should be switched off and batteries removed prior to disposal in pharmacy waste. Contact local councils for advice on the disposal of vaping device batteries.¹⁷

The pharmacist prepares compounded medicines that are safe and appropriate for the patient.

 

 

 

 

 

 

Compounding pharmacotherapy for smoking cessation or nicotine dependence involves the same processes as compounding other medicines. Follow compounding guidelines outlined in the Pharmacy Board of Australia Guidelines on compounding of medicines¹⁸ and the Compounding section of Australian Pharmaceutical Formulary and Handbook.¹⁶

 

Therapeutic vaping goods must be supplied to the patient in the final dosage form (i.e. no mixing or dilution of the vaping substance is required). Mixing or dilution of a vaping substance (e.g. a prescriber recommends dilution of a free-base nicotine product that has concentration >20 mg/mL to avoid adverse effects) is considered compounding and therefore must be undertaken by a pharmacist with consent from the TGA. Some additional processes are required when compounding therapeutic vaping goods.

 

Actions required for compounding apply to all pharmacists compounding therapeutic vaping goods.

 

Actions required

Seek and be granted consent from the TGA to compound therapeutic vaping goods.¹²

 

Meet the requirements of TGO110 as an Australian sponsor of the therapeutic vaping good.¹² See Service delivery and Vapes: information for pharmacists.

The pharmacist assesses the person’s needs and determines appropriate management with them.

 

 

 

 

 

 

Patient assessment involves gathering and assessing information to inform the provision of nicotine dependence support.

 

Actions required for patient assessment apply to all pharmacists providing nicotine dependence support.

 

Actions required

Ask all patients if they smoke or vape when routinely gathering patient information (e.g. when a patient requests a Schedule 2 or 3 medicine, providing advice on managing a minor health condition, when a patient presents a prescription, providing immunisation services, prescribing a medicine). Nicotine use status can change over time. See Appendix 1 Treatment guideline for pharmacists: nicotine dependence and Appendix 3 Brief advice.

 

Record the patient’s use of nicotine-containing products in their clinical record according to legislative, organisational and professional requirements.

 

Gather patient information in a confidential, respectful, systematic and non-judgemental manner, consistent with the principles of cultural safety. See also Appendix 1 Treatment guideline for pharmacists: nicotine dependence.

 

Identify if any of the information gathered indicates an actual or potential medicine-related problem (e.g. medicine interaction) and take steps to address it.

 

Identify if any of the information gathered indicates a need for referral to another health professional. See Appendix 7 Patient populations that may require additional support.

The pharmacist judiciously and collaboratively prescribes therapeutic goods to treat the patient’s health needs safely and effectively

 

 

 

 

 

 

After establishing the patient’s needs, work with the patient to consider all options to develop the most appropriate management plan. Nicotine dependence can be a chronic, relapsing condition.³ Management plans should be tailored to the patient and their individual needs. For detailed clinical information about prescribing pharmacotherapy for nicotine dependence, see Appendix 1 Treatment guideline for pharmacists: nicotine dependence.

 

At the time of publishing this guideline, there were no therapeutic vaping goods in the Australian Register of Therapeutic Goods (ARTG). Therapeutic vaping goods not in the ARTG (and therefore unapproved products) can be accessed through the AP Scheme or the SAS.^12,19 Pharmacists prescribing unapproved therapeutic vaping goods as Schedule 3 (Pharmacist Only) medicines will need to use the SAS-C pathway.¹² See Appendix 5 Access to unapproved therapeutic vaping goods.

 

Actions required for prescribing apply to all pharmacists providing pharmacotherapy as part of nicotine dependence support.

 

Actions required

Offer pharmacotherapy to patients who are nicotine dependent based on the outcome of patient assessment.

 

Choose pharmacotherapy based on³:

• efficacy, including
  • evidence for pharmacotherapy options (e.g. first-line therapies are recommended based on established evidence)
  • TGA approval status of pharmacotherapy (i.e. unapproved products have not been assessed by the TGA for quality, safety, efficacy, performance)²⁰
• suitability for an individual patient, including:
  • current pharmacotherapy (if the patient wishes to continue using pharmacotherapy initiated previously)
  • level of nicotine dependence
  • impact of patient factors (e.g. contraindications, precautions, co-existing medical conditions) and medicine factors (e.g. potential adverse effects, drug interactions) on the safety of potential pharmacotherapy for the patient
  • cost, which can be a barrier to the continuation of pharmacotherapy (the Pharmaceutical Benefits Scheme (PBS) subsidises the use of some pharmacotherapies in certain situations.²¹ See pbs.gov.au)
• patient preference and goals, for example
  • available dosage forms
  • past experience with pharmacotherapy for smoking or vaping cessation, which may influence their preference
  • harm reduction (as opposed to complete cessation) may be an interim goal for some patients (however, complete nicotine cessation remains the ultimate goal).

 

See Appendix 1 Treatment guideline for pharmacists: nicotine dependence for detailed clinical guidance on pharmacotherapy options.

 

Consider avoiding products that are manufactured by the tobacco industry or companies with links to the tobacco industry.⁵

 

Discuss any reasons why the pharmacist is choosing to decline to prescribe the patient’s preferred pharmacotherapy (if applicable) with a focus on explaining:

• why the patient’s preferred pharmacotherapy is not the preferred option for the patient (e.g. therapeutic indication, contraindications, interactions, co-existing medical conditions) or not able to be prescribed (e.g. pharmacy does not stock the pharmacotherapy, the pharmacotherapy is unavailable)
• why another pharmacotherapy option is more suitable
• other options available to support the patient (e.g. referral to a medical practitioner or other service provider).

 

Discuss when the patient should be referred to a medical practitioner or other service provider for additional support.

 

Discuss an appropriate duration of therapy and plan for cessation of pharmacotherapy.

 

Offer follow-up advice and support to people trying to stop smoking and vaping within one week of them stopping. See Patient monitoring.

 

Record the agreed management plan in the patient’s clinical record.

The pharmacist facilitates the safe provision of a prescribed therapeutic good, according to a valid prescription or order, to treat a patient.

 

 

 

 

 

 

Dispensing pharmacotherapy for nicotine dependence support involves the same processes as dispensing other medicines. Follow the guidance outlined in the Dispensing practice guidelines.²²

 

Dispensing of therapeutic vaping goods involves additional actions to meet legislative, professional and organisational requirements. See also Appendix 1 Treatment guideline for pharmacists: nicotine dependence.

 

Actions required for dispensing apply to all pharmacists dispensing therapeutic vaping goods.

 

Actions required

Dispense therapeutic vaping goods that are prescribed by the pharmacist (under Schedule 3) using the same processes as dispensing Schedule 4 medicines.

 

Determine the safety and therapeutic effectiveness of the therapeutic vaping goods for the individual patient. This may include assessing:

• prior use of first-line pharmacotherapy
• prior use of therapeutic vaping goods
• presence of co-existing conditions or medicine interactions
• appropriateness of prescribed concentration, dose and quantity of vaping substance
• appropriateness of vaping device
• risk of poisoning associated with the vaping device (Open systems carry a higher risk of nicotine poisoning than closed systems and are not recommended.⁵ If an open system containing nicotine is prescribed, contact the prescriber to discuss the risks and alternative options)
• goals of therapy (i.e. smoking cessation or management of nicotine dependence)
• use of behavioural intervention by the patient.

 

Include dosing information for the therapeutic vaping goods on the dispensing label of therapeutic vaping goods.

 

Include the words ‘Do not swallow’ on the dispensing label of therapeutic vaping goods.

 

Use Cautionary Advisory Label 21 for all therapeutic vaping goods that contain nicotine to identify them as hazardous medicines.

 

Supply the therapeutic vaping goods directly to the patient or their carer (i.e. cannot be supplied to a third party unless they are the patient’s carer).

The pharmacist critically appraises information to provide accurate, evidence-based, trusted and reliable medicines and health information to meet the needs of the patient, group of people and members of the healthcare team.

 

 

 

 

 

Pharmacists can provide effective support to patients seeking to stop smoking.⁴ This can be in the form of brief advice when providing health information to patients about their medicines and management of medical conditions through to providing ongoing smoking cessation behavioural support.^3,4

 

There are some situations where smoking and vaping cessation care may be even more relevant. For example, when a patient³:

• has a medical condition related to tobacco or vaping use (e.g. periodontal health)
• has been diagnosed with a medical condition where treatment or outcome is affected by tobacco use or vaping (e.g. asthma)
• has been hospitalised or recently discharged from hospital
• is preparing for surgery
• is pregnant/planning pregnancy or has recently given birth.

 

Pharmacists also have an important role in the multidisciplinary team providing, information on medicines to other health professionals.

 

Actions required for providing health information are split into two categories:

• Those that apply to all pharmacists providing health information to patients about nicotine dependence support.
• Those that apply to all pharmacists providing medicines information to other health professionals relating to smoking cessation or management of nicotine dependence.

 

Actions required

Providing health information to patients

Tailor advice for each patient’s needs and experiences. See Appendix 1 Treatment guideline for pharmacists: nicotine dependence for detailed information.

 

Reinforce the management plan agreed to between the patient and prescriber (if the pharmacist providing health advice is not the prescriber). Confirm any changes to the management plan with the patient and the prescriber.

 

Advise patients that the chance of successfully stopping smoking is increased if behavioural support is used in combination with other treatments (e.g. pharmacotherapy).³

 

Document the information provided according to legislative, organisational and professional requirements.

 

Providing medicines information to other health professionals

Identify the information needs of the health professional.

 

Conduct a search of the literature and appraise the relevant information.

 

Tailor the medicines information provided according to the needs of the health professional.

 

Document the information provided according to legislative, organisational and professional requirements.

The pharmacist uses evidence-based screening, case-finding and risk assessment methods to identify people at increased risk of, or who may have, an undiagnosed health condition.

 

 

 

 

 

 

Consultations for nicotine dependence support provide an opportunity to identify if patients have, or are at risk of, undiagnosed health conditions.

 

Actions required for screening, case-finding and risk assessment apply to all pharmacists providing nicotine dependence support consultations.

 

Actions required

Offer screening, case-finding and risk assessment to patients during an initial nicotine dependence support consultation.

 

Use an appropriate, evidence-based tool or device to obtain objective information about the patient. Some chronic health conditions that are more common in people who smoke include cardiovascular disease, COPD, diabetes, mental health conditions and substance use.^2,72 Reputable, validated risk assessment tools that can be used to identify people at risk of these conditions include^16,23:

• Australian cardiovascular disease risk calculator (this may also involve measuring the patient’s blood pressure)
• COPD case finding in the community
• Australian type 2 diabetes risk assessment tool (AUSDRISK)
• Alcohol use disorder identification test – consumption tool (AUDIT-C)
• Anxiety and depression test (K10).

 

Obtain information about the patient’s immunisation history (e.g. from the patient or their health record).

 

Interpret and evaluate the risk assessment results in the context of the patient and the patient’s condition.

 

Discuss the findings (including limitations) with the patient.

 

Refer the patient to a relevant health professional as required based on the findings.

The pharmacist collaboratively monitors patient outcomes and supports patients to self-monitor their condition and prevent complications.

 

 

 

 

 

 

Relapse is common in the first few weeks after stopping smoking and may be related to the patient experiencing nicotine withdrawal.³

 

Review of patient progress and support provided by health professionals increases the likelihood of long-term abstinence. Follow-up should be offered to all people who are attempting to stop smoking and/or vaping.

 

Actions required for patient monitoring apply to all pharmacists providing nicotine dependence support.

 

Actions required

Schedule reviews of the patient according to the agreed management plan. See Prescribing and Appendix 1 Treatment guideline for pharmacists: nicotine dependence.

 

Discuss the patient’s smoking and vaping and treatments, such as pharmacotherapy and behavioural interventions.

 

Refer patients to a medical practitioner for additional advice and follow-up if required according to the agreed management plan.

 

Document the findings of the review according to legislative, organisational and professional requirements, including:

• the details of any changes made to the management plan
• reasons for any change/s
• ongoing management goals and plan.

This guideline focuses on the treatment of nicotine dependence that may have developed as a result of smoking or vaping.

 

There is a lack of research that specifically addresses vaping cessation. Until evidence emerges, it is reasonable to use the same strategies that are used for smoking cessation (e.g. brief advice, pharmacotherapy, multi-session behavioural intervention) to provide support to patients who are seeking to stop vaping.¹ This may also apply to cessation of other nicotine-containing products (e.g. nicotine pouches, heat-not-burn tobacco).

 

This guideline includes pharmacist management of nicotine dependence where prescribing of Schedule 4 (Prescription Only) bupropion and varenicline is within a pharmacist’s scope of practice. See state or territory legislation and protocols for specific requirements.

 

Obligations in relation to the supply of a medicine by a pharmacist include^2,3:

• complying with all appropriate standards, codes, guidelines and regulatory requirements
• respecting the patient’s privacy and maintaining confidentiality
• recommending treatment that is safe for the patient and appropriate for their needs
• advising the patient on management of their condition
• referring the patient to other healthcare practitioners, if necessary
• documenting the supply (or refusal), and associated referral and advice provided, in accordance with relevant organisational and professional requirements
• following up patients at risk.

 

The Code of Ethics for Pharmacists³ provides guidance on the ethical framework for the delivery of health services. The health and wellbeing of the patient is a pharmacist’s first priority.

 

The Professional Practice Standards (PPS)² recommend that pharmacists follow a systematic process for gathering patient information, assessing the patient’s condition(s), assessing potential management options and developing a management plan with the patient.

 

Poisons Standard schedules

Treatments for smoking and vaping cessation include medicines listed in multiple poisons schedules.⁴ See Table 1 for scheduling.

 

Table 1  Scheduling of treatments for smoking and vaping cessation

 

Therapeutic vaping goods

The sourcing, supply and dispensing of vapes (including vaping devices and vapes with a zero-nicotine substance) are subject to specific vaping legislation in addition to the general requirements for the supply of scheduled medicines. This includes:

• Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024⁵
• Therapeutic Goods (Medicines and OTG – Authorised Supply) Rules 2022⁶
• Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021⁷
• state and territory tobacco, smoking or e-cigarette legislation.⁸

 

Requirements for the supply of a therapeutic vaping substance without a prescription

​​​Therapeutic vaping substances (containing nicotine or a zero-nicotine substance) can only be supplied without a prescription when^4,5,6,8:

• supplied to patients ≥18 years
• the product is in the final dosage form (i.e. no mixing or dilution of the vaping substance is required)
• it is being used for smoking cessation or management of nicotine dependence
• evidence of the patient’s identity and age are sighted (cannot be supplied to a third party unless they are the patient’s carer)
• advice is provided to the patient on alternative management options and appropriate use of the product (see ‘Treatments’, ‘Management choice’ and ‘Using the treatments’)
• contact details for smoking cessation support services are provided (e.g. Quitline)
• the quantity supplied does not exceed the quantity that is reasonably required for a patient’s therapeutic use for 1 month and products are only supplied once a month (a smaller quantity can be supplied more frequently; e.g. a patient can be supplied with 7 days worth, four times in a month)
• the concentration of nicotine in the product is ≤20 mg/mL
• the patient is informed that vaping products are unapproved products
• informed consent is obtained from the patient for the use of an unapproved product (this can be written or verbal; see ‘Professional practice guidelines for pharmacists: Nicotine dependence support; Appendix 4‘ for sample template)
• supply is in accordance with good pharmacy practice (i.e. reputable and relevant guidelines are followed).

 

Additional requirements for the sourcing and supply of therapeutic vaping goods include the following:

• Therapeutic vaping goods are only available in pharmacies or pharmacy settings (e.g. aged care facilities, correctional facilities; subject to state and territory legislation), regardless of whether they contain nicotine or a zero-nicotine substance.⁸
• The dispensing of therapeutic vaping goods to patients <18 years is restricted in some jurisdictions even with a valid prescription (due to state and territory tobacco, smoking or e-cigarette legislation). See state or territory legislation and TGA fact sheet for specific restrictions.⁸
• The supply of therapeutic vaping goods by a pharmacist without a prescription may be restricted in some jurisdictions. See state or territory legislation and the PSA regulation hub.
• Some of the patient’s personal details will need to be obtained and recorded to satisfy legislative, organisational and professional requirements.
• A SAS-C notification must be submitted for each supply of a therapeutic vaping good (containing nicotine or a zero-nicotine substance) without a prescription.⁸ It must be submitted within 28 days of supplying the therapeutic vaping good; best practice is to submit it on the day of supply.⁸ See ‘Professional practice guidelines for pharmacists: Nicotine dependence support; Service delivery‘.
• All therapeutic vaping goods (including vaping substances containing nicotine or a zero-nicotine substance and vaping devices) must be supplied directly to the patient or their carer, regardless of whether they are supplied with or without a prescription.⁵ See ‘Professional practice guidelines for pharmacists: Nicotine dependence; Glossary‘ for details on who is considered a carer.
• Any vaping substance supplied by a pharmacist must be in final dosage form (i.e. no mixing or dilution of the vaping substance is required once supplied), regardless of whether it is supplied with or without a prescription.⁵
• See Table 2 for key requirements for the supply of therapeutic vaping goods depending on whether a medical or nurse practitioner or a pharmacist has prescribed them.

 

Table 2  Key requirements for the supply of therapeutic vaping goods

 

Health professional prescribing	Requirement	Therapeutic nicotine containing vaping substance	Therapeutic zero-nicotine vaping substance	Therapeutic vaping device (not packaged wit a vaping substance)
When prescribed by a medical or nurse practitioner	Must be on the TGA List of notified vapes	Yes	Yes	Yes
		Special access scheme (SAS) or Authorised prescriber (AP) authorisation required	Yes	Yes	No
		Pharmacist must validate the SAS or AP authorisation prior to dispensing (by contacting the prescriber or using the TGA's online validation tool)	Yes	Yes	No
When prescribed by a pharmacist	Must be on the TGA List of notified vapes	Yes	Yes	Yes
		Must comply with the requirements for supply of a therapeutic vaping substance without a prescription	Yes	Yes	No
		SAS-C notification required	Yes	Yes	No
		Pharmacist must independently determine whether it will be used for smoking cessation or managing nicotine dependence	Yes	Yes	Yes

Reference: TGA⁸

Gather patient information in a confidential, respectful and non-judgemental manner. Ask the patient about their history of smoking, vaping and use of other nicotine-containing products, previous cessation attempts, medical and lifestyle history, age, pregnancy or breastfeeding status, and current medicines.

 

Gather sufficient information to assess the safety and appropriateness of a medicine for the patient. Use additional sources of information (e.g. the patient’s My Health Record), as applicable.

 

Clinical features

Nicotine dependence is a chronic condition and relapse is common.^9,10

 

Assess the patient’s nicotine dependence by asking^1,9:

• How soon after waking do you have your first cigarette/vape?
• Have you had cravings for a cigarette/vape, urges to smoke/vape or withdrawal symptoms if you have tried to stop smoking/vaping?
• How many cigarettes do you smoke a day?*

 

​Symptoms of nicotine withdrawal include^1,9:

• cravings for nicotine
• anxiety
• depressed mood
• insomnia
• irritability, frustration, anger
• difficulty concentrating
• restlessness
• increased appetite.

 

Nicotine dependence is likely if a patient:

• smokes within 30 minutes of waking, smokes more than 10 cigarettes a day and has a history of withdrawal symptoms with previous attempts to stop smoking⁹
• vapes within 30 minutes of waking, experiences withdrawal symptoms when they can’t vape or has cravings to vape.^1,11

 

* The number of cigarettes smoked a day is not a reliable indicator of nicotine dependence. However, it can be used to guide dosing of NRT and nicotine vapes.^1,9

 

Attitudes and barriers to smoking and vaping cessation

Identify and consider the patient’s individual attitudes about smoking or vaping cessation and barriers they may be facing or have faced in previous attempts to stop smoking or vaping.^1,9

 

Beliefs or attitudes that can prevent an attempt at, or affect the success of, smoking or vaping cessation include⁹:

• I’m not addicted.
• I don’t need help to stop.
• I’m too addicted.
• I won’t benefit from stopping.
• I don’t have enough willpower or motivation to stop.
• I need nicotine to help me relax.
• I will put on weight if I stop.
• I won’t be able to spend time with my friends who smoke/vape.

 

Beliefs or attitudes that affect vaping cessation can differ from those of smoking cessation. Additional barriers to vaping cessation can include¹:

• belief that vaping is not harmful
• potential lower cost than smoking
• peer pressure
• fear of returning to tobacco smoking.

 

See ‘Non-pharmacological management’ for strategies to address the patient’s attitudes or barriers.

 

Particular patient populations may face additional barriers to ceasing smoking or vaping. Health advice and behavioural interventions should be tailored to their individual needs.^9,12 These population groups include^1,9,12:

• Aboriginal and Torres Strait Islander peoples
• people from culturally and linguistically diverse backgrounds
• lesbian, gay, bisexual, transgender, intersex, queer, asexual and other sexually or gender diverse (LGBTIQA+) people
• people living with a mental illness
• younger people.

 

See ‘Professional practice guidelines for pharmacists: Nicotine dependence support; Appendix 7‘ for strategies to overcome potential barriers in patient populations that may require additional support.

 

Medical, medicines and lifestyle history

Tobacco smoking can modify the physiological effects of some medicines. Patients taking affected medicines should be advised to stop smoking.¹³ These include^12,13:

• corticosteroids – reduced response to corticosteroids in patients with asthma
• oral contraceptives – increased risk of cardiovascular disease.

 

Medical conditions that can complicate smoking and/or vaping cessation interventions include⁹:

• cardiovascular disease
• diabetes
• mental illness
• substance use disorders
• pregnancy (see ‘Management in pregnancy and breastfeeding’).

 

The patient’s medical, medicines and lifestyle history, including hypersensitivity reactions will influence management choice (see ‘The need to refer’, ‘Treatments’ and ‘Formulation choice’).

 

The patients smoking or vaping history can influence the dose of nicotine replacement therapy (NRT) or vape (see ‘Using the treatments’). Ask the patient how many cigarettes they smoke a day and/or what their vape usage is (e.g. nicotine concentration used, whether it is nicotine free-base or salt, volume of vape liquid used per day).

 

If prescribing of Schedule 4 (Prescription Only) bupropion and varenicline is within a pharmacist’s scope of practice, take the patient’s blood pressure to screen for hypertension and have a baseline measurement.

 

Impact of smoking/vaping cessation on medicines

• CYP1A2 induction by tobacco smoke
  • Tobacco smoke contains aromatic hydrocarbons that induce cytochrome P450 isoenzymes, primarily 1A2 (CYP1A2) and can decrease concentrations of drugs that are metabolised by CYP1A2.^13,14
  • Smoking cessation can, therefore, increase concentrations of drugs metabolised by CYP1A2 if the same dose regimen is maintained.
    • For medicines metabolised by CYP1A2 that have a wide therapeutic index, the impact of smoking cessation may not be clinically significant.
    • For some medicines metabolised by CYP1A2 (e.g. clozapine, erlotinib, olanzapine, pirfenidone, theophylline, warfarin), monitoring and dose adjustment may be required (see ‘The need to refer’).^13,15
    • Caffeine is metabolised by CYP1A2 – intake should be reduced when stopping smoking. Maintaining pre-cessation caffeine intake may result in anxiety, restlessness and insomnia, which may be mistaken for nicotine withdrawal.¹³
    • Nicotine (including in NRT or nicotine vapes) does not induce CYP450 enzymes and, therefore, does not cause these pharmacokinetic interactions.^12,15
• Nicotine
  • Nicotine interacts with some medicines (e.g. beta-blockers, benzodiazepines, insulin, methadone). Monitor for the need for a change in dose when a patient taking these medicines stops or reduces their smoking or vaping.¹⁵ See ‘Treatments’.
• Excipients in vapes
  • There is some evidence that aldehydes and carbonyls in some vapes can induce or inhibit CYP450 enzymes; however, the effects of this are unknown. Monitoring and dose adjustment of narrow therapeutic index medicines may be required.¹⁶

 

Age

The patient’s age will influence treatment choice. See ‘The need to refer’ and ‘Management in adolescents’.

 

Pregnant or breastfeeding

The patient’s pregnancy or breastfeeding status will influence treatment choice. See ‘The need to refer’ and ‘Management in pregnancy and breastfeeding’.

The need to refer

Refer the patient to a medical practitioner and smoking or vaping cessation support service (e.g. Quitline) in the following circumstances^9,16,17:

• age <12 years
• pregnancy (see ‘Management in pregnancy and breastfeeding’)
• pharmacotherapy is unsuitable (see ‘Treatments’ and ‘Formulation choice’)
• most suitable (including financially suitable) pharmacotherapy for the patient requires a prescription from a medical practitioner (see ‘Poisons Standard schedules’, ‘Management choice’ and ‘Using the treatments’)
• a medicine the patient uses may require review or a dose change when they stop smoking or vaping (see ‘Medical, medicines and lifestyle history’ and ‘Treatments’)
• patient continues to require vapes beyond 12 weeks (when initiated by a pharmacist)
• patient has not ceased or reduced smoking since initiating nicotine vapes
• patient requires more than 1 pod or cartridge (∼2 mL) of a vape per day.

 

Supply non-prescription pharmacotherapy, if appropriate, and refer the patient to a medical practitioner and smoking or vaping cessation support service (e.g. Quitline) in the following circumstances^9,17:

• cardiovascular disease
• diabetes
• mental illness
• substance use disorder
• multiple comorbidities
• breastfeeding (see ‘Management in pregnancy and breastfeeding’)
• age 12–17 years (vapes cannot be supplied as a Schedule 3 medicine to patients <18 years; see ‘Poisons Standard schedules’ and ‘Management in adolescents’).

 

In some jurisdictions, prescribing of bupropion and varenicline for smoking cessation may be within some pharmacist’s scope of practice. If prescribing of these is within scope, refer the patient to a medical practitioner without supply of bupropion or varenicline in the following situations. (Note: It may be appropriate to supply non-prescription pharmacotherapy in some of these situations.)

• age <18 years
• pregnancy
• mental health condition or history of a mental health condition where the use of pharmacotherapy for smoking cessation poses an unacceptable risk of mood disturbance (e.g. condition is not well controlled, severe)
• contraindication to varenicline or bupropion
• taking a medicine that interacts with bupropion
• taking a medicine that may require review or a dose change when the patient stops smoking
• intolerable adverse effects have previously been experienced with pharmacotherapy for smoking cessation (e.g. mood disturbance, cardiovascular adverse effects)
• patient has another chronic disease that is not well controlled or severe (e.g. asthma, COPD, diabetes, epilepsy, autoimmune or rheumatologic disease, severe hypertension)
• patient has had an acute cardiovascular or cerebrovascular event in the previous 12 months
• already taken 2 courses of varenicline (24 weeks) in the previous 12 months.

 

Make or understand diagnosis

Use the patient information gathered to understand the patient’s needs.

 

Treatments

Pharmacotherapy for nicotine cessation includes NRT, bupropion, varenicline and vapes.

Varenicline is a partial agonist at nicotinic acetylcholine receptors.^10,18,19 NRT, vapes and varenicline assist in smoking cessation by reducing the impact of withdrawal symptoms. Bupropion is thought to assist in smoking cessation by inhibiting neuronal re-uptake of dopamine and noradrenaline.¹⁰ NRT, varenicline and vapes may assist in vaping cessation by reducing the impact of withdrawal symptoms. See Table 3.

 

Table 3     Pharmacotherapy for smoking cessation

 

 

* This table does not list all possible drug interactions, contraindications or precautions. The listing of a class of interacting medicines does not imply that all medicines within the class will interact. Consult specialised references for further information.

^† The effects of other ingredients in nicotine vapes on other medicines are unknown.

^# A dose reduction of the interacting medicine may be needed when a patient taking these medicines stops using NRT or nicotine vapes (or reduces their dose).

 

Nortriptyline or clonidine are sometimes prescribed off-label as second-line pharmacotherapy to support smoking cessation.⁹

 

Cytisine is currently used overseas for smoking cessation. At the time of publication, cytisine is an unapproved product in Australia and is only available through the SAS or AP scheme. A 2023 Cochrane meta-analysis concluded that it increases smoking cessation rates compared to control, however, its place in smoking cessation therapy in Australia is unclear.²¹

 

There is no evidence to support the use of zero-nicotine vapes for smoking or vaping cessation.¹

 

Evidence suggests that complementary therapies, such as hypnotherapy and acupuncture, are not effective for smoking cessation.⁹ However, individual patients may report success with these methods.

Management goals

• Reduce cravings and symptoms of nicotine withdrawal.⁹
• Harm reduction.
• Aid long-term nicotine cessation.

 

Management choice

General notes

• Pharmacotherapy is indicated for smoking cessation when the patient is nicotine dependent.⁹ Smoking cessation pharmacotherapy can also be considered to manage nicotine dependence from vaping.¹ See ‘Clinical features’
• The greatest benefit for nicotine cessation is seen when pharmacotherapy is combined with behavioural support (e.g. Quitline) and follow-up.⁹ See ‘Non-pharmacological management’.
• Choice of treatment depends on the nicotine product the patient is dependent on (e.g. tobacco smoking, nicotine vapes), treatment effectiveness, level of dependence, patient preference, other medicines being used and co-existing conditions.²²
• Pharmacotherapy options reduce, but do not always completely alleviate, symptoms of nicotine withdrawal.
• Nicotine withdrawal symptoms are usually strongest in the first week after stopping smoking, decline steadily over time and rarely last more than 1 month.^9,10

 

Smoking cessation

• See Table 4.
• Pharmacists in some jurisdictions may be able to prescribe Schedule 4 (Prescription Only) bupropion or varenicline for smoking cessation depending on state or territory legislation.
• Varenicline, NRT and bupropion are first-line pharmacotherapies for smoking cessation.^9,22
• Nicotine vapes are not a first-line option for smoking cessation. They may be considered for patients who have failed to stop smoking with first-line pharmacotherapy combined with behavioural support.⁹
• All pharmacotherapy for smoking cessation should be used in combination with behavioural support.⁹
• NRT
  • Combination NRT (long-acting patch plus a faster-acting formulation) is equally as effective as varenicline and more effective than NRT monotherapy.^9,23 See ‘Using the treatments’.
  • NRT is safer than smoking, has low addictive potential and can be recommended to patients with nicotine dependence who are motivated to stop smoking.⁹ See ‘The need to refer’ and ‘Management in pregnancy and breastfeeding’.
  • All formulations of NRT (at equivalent doses) have similar effectiveness in achieving smoking cessation.^9,23
• Varenicline
  • Most effective monotherapy option available.^9,24
  • Equally as effective as combination NRT.²⁴
  • Can be used in combination with NRT. Combining with NRT may improve effectiveness.⁹
    • There is some evidence that varenicline combined with a NRT patch is more effective than varenicline alone.⁹
    • There is insufficient evidence that varenicline combined with oral NRT is more effective than varenicline alone; in practice they are sometimes used together.⁹
• Bupropion
  • Bupropion can be used first-line if varenicline and combination NRT are not suitable.^9,22
  • Less effective than varenicline or combination NRT.⁹
  • Equally as effective as NRT monotherapy.⁹
  • The use of bupropion in combination with NRT has not shown an additive benefit.⁹
• Nicotine vapes
  • The current evidence for the use of nicotine vapes for smoking cessation is uncertain.^1,25
    • There is some evidence of a benefit of nicotine vapes for smoking cessation in comparison to other pharmacotherapy, behavioural intervention or no treatment.²⁶
    • The evidence for serious harm from vapes is unknown as the longest follow-up after use is 2 years.²⁶
  • There are currently no TGA-approved vapes. Unapproved vapes have not been assessed for safety, quality or efficacy.
  • Nicotine vapes are an option, if the patient has failed to cease smoking after an appropriate trial of first-line therapy (e.g. 2 weeks of correct use of NRT at a dose appropriate to their level of nicotine dependence in combination with behavioural intervention).^9,22
  • If the patient has not had an appropriate trial of first-line therapy, recommended appropriate first-line therapy (e.g. correct use of NRT at a dose appropriate to their level of nicotine dependence in combination with behavioural intervention) prior to recommending vapes.
  • The decision to use vapes (an unapproved treatment) for smoking cessation must be made through an evidence-informed, shared decision-making process with the patient where the patient is made aware of the current evidence for their safety and efficacy.⁹
  • Closed system vapes (e.g. pre-filled cartridges or single-use pods) are recommended to reduce the risk of accidental poisoning and prevent the addition of other substances to the vaping substance.¹
  • If a prescription for an open system vape is received, contact the prescriber to discuss risk mitigation strategies (e.g. changing to a closed system device).
  • Vapes can only be supplied directly to the patient or their carer, regardless of whether they are supplied as a Schedule 3 or Schedule 4 medicine.⁵

 

Nicotine vaping cessation

• Evidence for the treatment of nicotine dependence is primarily based on studies of smoking cessation; there is limited evidence for nicotine vaping cessation.¹
  • ​Inform patients seeking treatment to aid nicotine vaping cessation that there is limited evidence to guide management and current recommendations are largely based on evidence for smoking cessation.
• There is currently no pharmacotherapy approved for vaping cessation. The use of smoking cessation pharmacotherapies for vaping cessation is off-label as they haven’t been trialled for this indication.​¹⁷
• NRT, varenicline or short-term use of vapes, combined with behavioural support (e.g. Quitline), are considered reasonable options for vaping cessation.¹
  • Always recommend first-line pharmacotherapies (NRT or varenicline) first.
• Combination NRT may be useful for patients with a high level of nicotine dependence, while NRT monotherapy may be sufficient for patients with a low level of nicotine dependence.¹
• If short-term use of vapes is trialled, balancing the aim of complete nicotine cessation with reducing the risk of the patient relapsing to or initiating tobacco smoking is required.¹
• All pharmacotherapy for vaping cessation should be used in combination with behavioural support.

 

Dual smoking and vaping cessation

• There is a lack of evidence to guide nicotine cessation in patients who are dual users of cigarettes and vapes.
• It may be reasonable to recommend smoking cessation pharmacotherapy; always recommend first-line pharmacotherapy first.
• If first-line pharmacotherapy is unsuitable, advise patients to initially switch completely to vaping and cease smoking, with the intention of ceasing vaping after an agreed treatment period.¹

 

Table 4     Some factors influencing choice of treatment for smoking cessation

 

 

* This table does not list all factors that influence the choice of treatment. Consult specialised references for further information.

^# Pharmacological therapy should be used in conjunction with behavioural support (e.g. Quitline).

 

NRT formulation choice

• The choice of NRT depends on the level of nicotine dependence, the patient’s preference and the suitability of individual formulations.⁹ See Table 5 and individual product information.
• If NRT is clinically appropriate, Quit Centre has an online tool to guide initial dosing. See quitcentre.org.au/nrt-tool

 

Table 5     Nicotine replacement therapy

References: RACGP⁹; AMH¹⁰; eMIMS¹⁷; Alfred Health²⁹

 

Management in adolescents

• There is insufficient evidence that smoking cessation programs and pharmacological interventions for adolescents who smoke are effective.⁹
• There is also insufficient evidence on how to support adolescents to cease vaping.¹
• Success rates of smoking cessation are lower in people who start smoking at a younger age.⁹
• Interventions generally focus on preventing adolescents from starting to smoke or vape.⁹
• Intensive, multi-session behavioural support is important in this age group.⁹
• NRT can be used by patients ≥12 years (for both tobacco smoking and vaping cessation), but adherence is likely to be an issue in adolescents.^9,17
  • Use of NRT for vaping cessation is off-label. Inform patients that the recommendation to use NRT for vaping cessation is primarily based on evidence from tobacco smoking cessation.⁹
• Bupropion and varenicline are not approved for use in patients <18 years.⁹
• Nicotine vapes are not recommended for use in patients <18 years; there have been no studies on their efficacy or safety in this population.⁹
• See ‘The need to refer’ and ‘Non-pharmacological management’.

 

Management in pregnancy and breastfeeding

See Table 6.

 

Pregnancy

• There is no safe level of smoking in pregnancy. Continued smoking during pregnancy leads to pregnancy complications and harmful effects for both the pregnant person and the fetus. Complete cessation of smoking (rather than simply cutting down) is recommended.⁹
• Non-pharmacological smoking cessation strategies should be tried first (see ‘Non-pharmacological management’).^9,27
• If non-pharmacological strategies are unsuccessful, NRT may be recommended by a medical practitioner.⁹ See ‘The need to refer’.
  • Evidence for the safety of NRT in pregnancy is limited; it may be a safer alternative to cigarette smoking as it provides a clean source of nicotine (without the other chemicals) and generally delivers a lower level of nicotine.²⁷
• If NRT is recommended by a medical practitioner, faster-acting formulations are preferred.^9,27
• Bupropion, varenicline and vapes are not recommended for nicotine dependence in pregnancy; there is currently insufficient evidence for their safety and efficacy in this population.^1,9,27
• Advise people living with a pregnant person to avoid smoking around them. Encourage them to also cease smoking as this can help the pregnant person to stop smoking.⁹

 

Breastfeeding

• Non-pharmacological strategies are preferred. NRT is considered safer than continuing to smoke.^9,27
• Minimise nicotine in breast milk by using a faster-acting formulation and breastfeeding just before using NRT.^9,27
• If unable to stop smoking completely, encourage continued breastfeeding and minimisation of the infant’s exposure to second-hand smoke.⁹
• Bupropion, varenicline and vapes are not recommended for nicotine dependence in breastfeeding; there is currently insufficient evidence for their safety and efficacy in this population.^1,9,27

 

Table 6     Management in pregnancy and breastfeeding

 

 

* Consult specialised references for further information about safety in pregnancy and breastfeeding.

 

Management in patients with co-existing medical conditions

Smoking cessation pharmacotherapy options are available for patients with cardiovascular disease, diabetes, mental illness and substance use disorder (see ‘Treatments’).⁹ However, patients may need additional support (see ‘The need to refer’ and ‘Non-pharmacological management’). Smoking and vaping cessation should be integrated into the patient’s chronic disease management program.​⁹

Using the treatments

See individual product information and specialised references.

 

Advise patients to reduce their caffeine intake by half when stopping tobacco smoking.

 

NRT

Australian guidelines recommend the following initial NRT doses for smoking cessation⁹:

• Smokes within 30 minutes of waking and smokes >10 cigarettes a day
  • highest-strength patch + highest-strength gum OR highest-strength lozenge OR 1 mg oral spray
• Smokes within 30 minutes of waking and smokes ≤10 cigarettes a day OR smokes more than 30 minutes after waking and smokes >10 cigarettes a day
  • highest-strength patch + lowest-strength gum OR lowest-strength lozenge OR 1 mg oral spray
• Smokes more than 30 minutes after waking and smokes ≤10 cigarettes a day
  • lowest-strength gum OR lowest-strength lozenge OR 1 mg oral spray.

 

Titrate the dose according to the patient’s withdrawal symptoms. Underdosing can undermine a patient’s confidence in treatment. Patients with high nicotine dependence may benefit from the use of two patches at the same time (see ‘Clinical features’). However, the evidence supporting the use of two patches is inconclusive.^9,23

 

Premature discontinuation of NRT can lead to relapse. Tapering the dose of NRT at the completion of a course of treatment does not influence successful long-term smoking cessation. Patients who have successfully stopped smoking after an initial 8-week course of NRT may consider a follow-up course. The optimal duration of NRT has not been established.^9,23

 

Food and drink can reduce buccal absorption of nicotine. Avoid acidic beverages (e.g. coffee, soft drinks) for 15 minutes before use of sublingual/buccal NRT formulations, and avoid eating or drinking while using sublingual/buccal NRT formulations.¹⁷

 

Using the highest-strength patch for 2 weeks before stopping smoking completely can increase the likelihood of success. However, further research is needed.^9,23

 

Faster-acting NRT can be used to reduce the number of cigarettes smoked each day. However, the evidence of the effectiveness of this approach is uncertain.^9,17

 

Vapes

Advise the patient of the evidence for vapes and how to use them. This may include^1,12:

• evidence
  • vapes are unapproved products that have not been assessed by the TGA for their quality, safety and efficacy or performance
  • nicotine vapes are not first-line pharmacotherapy for smoking or vaping cessation; there are other smoking cessation medicines that have been approved by the TGA for quality, safety and efficacy
• how to use the vaping device
  • some suppliers of vaping devices have instructions about how to use the device
• avoiding smoking in combination with vaping
  • continued tobacco smoking while trying to stop smoking using vapes may lead to increased nicotine consumption and/or cumulative cardiovascular adverse effects^1,30,31
• how much and how often to use vapes
  • the ‘dose’ of nicotine delivered from a vape depends on a number of factors including the nicotine concentration, the device used, and the inhalation technique
  • there is no distinct end-point as there is with smoking (i.e. finishing and stubbing out a cigarette); the volume of vaping substance in a single pod or cartridge is far more than would typically be used in a single vape session
• duration of treatment
  • the long-term effects of vaping are unknown
  • vaping should only be used short-term for smoking cessation – the optimal duration of nicotine vapes has not been established
  • do not continue supplying vapes without a prescription for longer than 12 weeks
  • current Australian guidelines recommend a maximum treatment duration of 12 months, however, there may be instances where the prescriber and patient agree that longer-term use of a nicotine vape is needed to avoid relapse to tobacco use
• weaning strategies
  • the optimal strategy to titrate down nicotine vaping use to achieve cessation has not been established. Suggestions include:
    • attempting weaning or cessation after 12 weeks
    • transitioning from nicotine vapes to NRT
    • ​limiting vaping to particular times or places
    • increasing the time between vapes
    • tapering the dose (e.g. reducing the nicotine concentration every 2–4 weeks as well as the number of vape session per day)
• how to store and dispose of the medicine and device
  • return any containers with vaping liquid (e.g. cartridges, pods) or empty containers that may contain residual nicotine to the pharmacy for disposal through the return of unwanted medicines (RUM) program
  • the device should be switched off and batteries removed prior to disposal in household waste; contact local council for advice on disposal of vaping device batteries
• how to reduce the risk or impact of accidental nicotine poisoning
  • ​using nicotine vapes with a nicotine concentration of ≤20 mg/mL
  • using a closed system device
  • keeping vapes out of reach of children and avoiding use of vapes in front of children
  • call 000 if inadvertent exposure or ingestion of a nicotine vaping substance has occurred in a child (or adult who is experiencing signs and symptoms suggestive of nicotine overdose)³²
  • contact the Poisons Information Centre (13 11 26) and seek urgent medical assistance if inadvertent exposure or ingestion of a nicotine vaping substance has occurred in an adult.

 

Nicotine vape doses

There is limited evidence for starting nicotine concentrations for the treatment of nicotine dependence. Nicotine vapes contain nicotine in either free-base (bioactive form) or salt form. Free-base and salt products with the same nicotine concentration are not directly interchangable.¹ See Table 7 for suggested reasonable starting concentrations for new and current users of nicotine vapes. Review the appropriateness of the nicotine vape concentration at all follow-ups and adjust according to the patient’s needs.

 

Table 7     Nicotine vape suggested starting concentration

 

Reference: RACGP ¹

 

* Only vapes with a nicotine concentration ≤20 mg/ml can be supplied as a Schedule 3 (Pharmacist Only) medicine. See ‘Poisons Standard schedules’ and ‘Therapeutic vaping goods’ for full list of requirements for supply of therapeutic vaping goods without a prescription.

 

There is limited evidence for the volume of nicotine vape liquid that should be used for the treatment of nicotine dependence. The following factors should be considered when determining an appropriate quantity for the patient:

• The dose of nicotine received by a patient using a nicotine vape varies depending on the device, type of nicotine (free-base or salt), concentration and the length and intensity of inhalation.^1,33
• Patients will self-titrate to achieve the nicotine level required to satisfy their craving.¹
• The safety of vapourised chemicals (including excipients, chemicals originating from devices and chemicals formed by chemical reactions with the heating element) in vapes is currently unknown.³³ There are concerns that inhaling high volumes of vape liquid in low concentration products could increase risk of adverse effects due to an increased quantity of inhaled chemicals.^1,26
• If the concentration of nicotine vape is too low for the patient, they may use a higher volume of vaping substance, which will increase the cost to the patient.
• A suggested reasonable quantity of nicotine vape liquid to use is 1 pod or cartridge (∼2 mL) per day. If a patients usage exceeds this, they should be referred to a medical or nurse practitioner for a higher concentration product.³⁴

 

Varenicline

• Start at least 1 week before planned smoking cessation. Alternatively, the patient can start using varenicline and then stop smoking anytime between day 8 and day 35 of treatment.¹⁷
• Continue treatment for 11–23 weeks.^10,17
• Swallow tablets whole.¹⁷
• There is a risk of nicotine withdrawal symptoms and an urge to smoke after varenicline is ceased; reducing the dose gradually or using a faster-acting NRT product may minimise this.¹⁰

 

Bupropion

• Start at least 1 week before planned smoking cessation.^10,17
• Continue treatment for 7–9 weeks.^10,17
• Can be used in combination with NRT (e.g. a faster-acting product to manage nicotine cravings – blood pressure should be monitored if this combination is used).^10,17
• Swallow tablets whole.¹⁰
• Alcohol consumption should be minimised (or avoided) as it alters the seizure threshold and increases the risk of other adverse effects.^10,17

Adverse effects

Advise the patient of the following potential adverse effects of treatment.

NRT

• Adverse effects of NRT are usually minor and transient, and some may be related to smoking cessation (e.g. sleep disturbance, dizziness, weight gain, headache).¹⁷ See Table 8 and ‘Non-pharmacological management’.
• Signs of nicotine overdose include nausea, vomiting, bradycardia and convulsions.^17,35
• NRT is intended for transdermal or sublingual/buccal absorption. Swallowed nicotine may exacerbate symptoms of oesophagitis, gastritis and gastric ulcers.¹⁷

 

Table 8     Adverse effects of NRT

 

References: RACGP⁹; eMIMS¹⁷

 

Nicotine vapes

• cough, dry or irritated mouth and throat (throat irritation particularly with free-base form at concentrations >20 mg/mL)¹
• headache^1,12
• nausea¹
• lung injury¹
• burns¹
• intentional or accidental poisoning¹
  • nicotine overdose – signs and symptoms include nausea, vomiting, bradycardia, convulsions
  • see ‘Using the treatment’ for guidance on actions to take if intentional or accidental poisoning is suspected
• long-term adverse effects are unknown⁹
• adverse effects from carrier fluids (propylene glycol and glycerol), flavourings and contaminants
  • flavourings have not been assessed as being safe when inhaled. Different flavourings may have different safety profiles and ingredients (e.g. the ‘mint’ flavour in two different products may be made of different ingredients)³⁶
  • known carcinogens have been found in vape aerosols.³⁶ The extent to which vape use increases the risk of cancer is currently unknown.¹² The TGO 110 recommends a maximum of 10 ppm for specified contaminants.³⁶

 

Varenicline¹⁰

• gastrointestinal effects – severe nausea may be relieved by taking with food or with a reduction in dose
• increased appetite/weight
• headache
• insomnia
• abnormal dreams
• taste disturbance

 

Bupropion¹⁰

• gastrointestinal effects
• insomnia – taking once daily doses in the morning may reduce the chance of insomnia – when dosing increases to twice daily, separate doses by 8 hours and avoid bedtime doses
• dry mouth
• dizziness, concentration difficulties – be careful driving or operating machinery if affected
• agitation

 

This guideline does not list all possible adverse effects. Consult specialised references for further information.

 

Non-pharmacological management

Advise patients about behavioural strategies to assist them to stop smoking or vaping. Successful long-term smoking cessation is more likely if pharmacotherapy is combined with evidence-based, multi-session behavioural intervention (e.g. Quitline).⁹ Behavioural intervention (e.g. Quitline) is also recommended for vaping cessation.¹ Patients can also use apps, such as My QuitBuddy, for ongoing support. Best practice smoking cessation support (including both pharmacotherapy and multi-session behavioural intervention) is especially important for achieving long-term smoking cessation in patients with a mental illness.^9,37

 

Addressing barriers to smoking and vaping cessation

Discuss the patient’s individual barriers and previous attempts to stop smoking or vaping. Discuss what strategies have been helpful in past attempts.

• Explain the benefits, costs, options and accessibility of assistance that is available (e.g. pharmacotherapy, counselling services).^9,38
• Discuss the health and financial benefits of smoking and vaping cessation specifically for the patient. The National Cessation Platform (quit.org.au) has useful information about the benefits that can be tailored for the patient.⁹
• Discuss the health implications of continuing to smoke or vape (e.g. possible lung damage).^9,37
• Provide information about relaxation techniques (e.g. mindfulness, meditation, breathing exercises).^9,37
• Discuss strategies to minimise weight gain (e.g. healthy eating, exercise) and advise that the health benefits of stopping smoking outweigh the risks of weight gain.⁹
• Suggest ways to manage high-risk social situations when first stopping smoking or vaping and practising ways of saying no when a cigarette or vape is offered.^9,37

 

Behavioural strategies

Discuss some practical tips for stopping smoking or vaping:

• Write a list of reasons that you want to stop smoking or vaping and things you will look forward to when you stop.³⁷
• Make a plan and set a date to stop smoking or vaping. Decide what support options will work best for you.³⁷
• Tell family and friends of the plan to stop smoking or vaping, and explain how they can help (e.g. stopping together, not offering a cigarette or vape).³⁷
• ​Practise stopping (e.g. experiment with not smoking or vaping in situations you normally would, make home and car smoke and vape-free, stop carrying a lighter).³⁷
• Identify situations and triggers that make you want to smoke or vape (e.g. coffee, alcohol, friends who smoke or vape), and plan for these.^9,37
• Prepare for healthy eating (e.g. buy healthy snacks before stop day).³⁷
• Reduce coffee and tea intake when you first stop smoking, to prevent caffeine-induced anxiety and restlessness.¹⁵ See ‘Medical, medicines and lifestyle history’. (This only applies to smoking cessation)
• The ‘4Ds’ can help to deal with cravings³⁷
  • Delay for at least 5 minutes, the urge will pass.
  • Deep breathe, slowly.
  • Drink water, to take time out; sip slowly.
  • Do something else, to keep your hands busy.
• Exercise every day. This will help to reduce stress and weight gain.³⁷
• Reward yourself with the money that has been saved.^9,37
• If you have a cigarette or vape, it does not mean the attempt has failed. Keep trying to stop. Remind yourself of all the times you have resisted the urge to smoke or vape, follow the ‘4Ds’ and adjust your stop smoking or vaping plan.³⁷

 

Support services

Refer patients to smoking and vaping cessation support services for additional support.

 

Quitline provide free, multi-session behavioural intervention. Quitline counsellors assess the patient’s smoking or vaping history and use motivational interviewing to help them develop a plan to stop smoking or vaping. Quitline is tailored to meet the needs of priority populations including patients living with mental illness, pregnant patients and young people. Quitline also provides Aboriginal and Torres Strait Islander counsellors, and is able to assist people with hearing or speech impairment, or people needing an interpreter.³⁷

 

Pharmacists can refer patients to Quitline at www.quitcentre.org.au/referral-form. Alternatively, patients can contact Quitline by phone on 13 78 48.³⁷

 

Written information

• Provide the patient with Smoking, Vaping, Nicotine Replacement Therapy and Staying a Non-smoker Self Care Fact Cards or other consumer information.
• Resources can be ordered from org.au/resource-order-form

 

Labelling of nicotine vaping products

• ​It is recommended that pharmacists dispense supplies of therapeutic vaping substances prescribed by a pharmacist under Schedule 3 supply using the same processes as dispensing Schedule 4 medicines. See ‘Professional practice guidelines for pharmacists: Nicotine dependence support; Dispensing‘.
• Attach cautionary advisory label 21 to therapeutic vaping goods that contain nicotine. See ‘Cautionary advisory labels‘.
  • Inadvertent exposure to nicotine vape liquid (ingestion or absorption through skin or mucus membranes) by a person other than the patient is a cause of poisoning. See ‘Using the treatments’.
• Include the words ‘do not swallow’ and dosing information on the dispensing label.

 

Review

Invite the patient to contact the pharmacy if they have any questions or concerns about the medicine or advice provided.

 

Advise the patient to return to the pharmacy or consult a medical practitioner if they experience:

• concerning or unexpected adverse effects from treatment
• inadequate response to treatment
• difficulty using the treatment.

 

Suggest that patients return for follow-up within 1 week of the stop use date and for additional planned follow-up visits to review progress.⁹ Review can include:

• enquiring about the patient’s perspective on their progress
• identifying and addressing any concerns the patient has regarding the management plan
• working with the patient to determine whether pharmacotherapy should be continued, ceased or modified (e.g. dose titration of nicotine vapes)
• ​discussing behavioural strategies to help with smoking or vaping cessation and encouraging patients to use support services such as Quitline
• encouraging patients to avoid dual smoking and nicotine vaping
• reaffirming that the long-term risks of nicotine vapes are unknown (if patient is using nicotine vapes)
  • discuss switching to approved smoking cessation pharmacotherapy to maintain their nicotine cessation progress and prevent relapse.

 

For varenicline or bupropion supplied via pharmacist prescribing:

• advise patient to return for review 2–3 weeks after commencing the pharmacotherapy (or shortly after quit date if more than 3 weeks after starting the pharmacotherapy) and at the end of the treatment course
• encourage ongoing support (e.g. from Quitline)
• measure the patient’s blood pressure at each review.

 

If relapse occurs, offer support and encourage further attempts. Acknowledge that it may take numerous attempts to stop smoking or vaping.

Document the interaction with the patient, including patient details, assessment, the agreed management plan (e.g. medicines, recommendations, education, advice), adverse events and any communication with other healthcare professionals (e.g. referral), according to relevant legislative, organisational and other professional requirements.²

 

To facilitate multi-session behavioural support, it is recommended that:

• all patient interactions regarding smoking or vaping cessation are documented in the patient’s clinical record and,
• relevant information about the smoking or vaping cessation support being provided to the patient is communicated to the patient’s regular general practitioner or practice (if they have one), with the patient’s consent.

 

Documentation also supports ongoing patient relationships, quality use of medicines and collaboration between healthcare providers. Documentation is especially important for:

• patients with an established relationship with the pharmacy
• patients who make repeated requests involving the same condition
• patients who are at high risk of adverse events
• supply and referral situations
• decline to supply situations
• supply of Schedule 4 (Prescription Only) medicines
• supply of unapproved medicines or medicine for off-label use.

 

When nicotine vapes are supplied as a Schedule 3 (Pharmacist Only) medicine or zero-nicotine vapes are supplied without a prescription:

• complete a SAS-C notification according to legislative requirements
• obtain and document informed consent from the patient (as vapes are an unapproved product) – See ‘Professional practice guidelines for pharmacists: Nicotine dependence support; Appendix 4 Template written consent form for unapproved therapeutic vaping goods‘.

 

Report adverse effects to the Therapeutic Goods Administration (TGA) as appropriate.² Report deficiencies or defects of therapeutic vaping goods that are believed to have occurred during the manufacture, storage or handling of these products to the TGA.³⁶

 

Additional documentation requirements for pharmacist prescribing of Schedule 4 (Prescription Only) medicines

 

Documentation requirements for pharmacist prescribing of Schedule 4 (Prescription Only) medicines include:

• date of consultation
• pharmacist who provided the consultation
• any relevant patient consent obtained (e.g. to communicate with patient’s medical practitioner)
• relevant medical, medicines and lifestyle history
• information relevant to diagnosis or treatment (e.g. symptoms, assessment results)
• clinical opinion reached by the pharmacist
• agreed management plan
• details of any medicines supplied (name, strength, formulation, instructions, quantity)
• treatment information offered to the patient.

 

When prescription medicines are supplied via pharmacist prescribing, provide a copy of the clinical record to the patient and, with the patient’s consent, to their usual medical practitioner or medical practice.

1. Royal Australian College of General Practitioners. Supporting smoking and vaping cessation: A guide for health professionals. Guidance updates on smoking and vaping cessation support related to changes to Australia’s vaping regulation. 2024. At: www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/supporting-smoking-cessation
2. Pharmaceutical Society of Australia. Professional practice standards. Version 6. Canberra: PSA; 2023. At: www.psa.org.au/practice-support-industry/pps
3. Pharmaceutical Society of Australia. Code of ethics for pharmacists. Canberra: PSA; 2017.
4. Therapeutic Goods Administration. Poisons standard. 2024. At: www.tga.gov.au/how-we-regulate/ingredients-and-scheduling-medicines-and-chemicals/poisons-standard-and-scheduling-medicines-and-chemicals/poisons-standard-susmp
5. Therapeutic Goods Administration. Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. 2024. At: www.legislation.gov.au/C2024A00050/asmade/text
6. Therapeutic Goods Administration. Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022. 2024. At: www.legislation.gov.au/F2022L01766/latest/text
7. Therapeutic Goods Administration. Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021. 2024. At: www.legislation.gov.au/F2021L00595/latest/versions
8. Therapeutic Goods Administration. Vapes: information for pharmacists. July 2024. At: www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-pharmacists
9. Royal Australian College of General Practitioners. Supporting smoking cessation a guide for health professionals. 2024. At: www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/supporting-smoking-cessation
10. Rossi S, ed. Psychotropic drugs. Australian medicines handbook; . At: https://amhonline.amh.net.au/chapters/psychotropic-drugs
11. NSW Health. Guide to support young people to quit e-cigarettes. 2024. At: www.health.nsw.gov.au/tobacco/Pages/vaping-resources.aspx#professionals
12. Greenhalgh EM, Scollo MM, Winstanley MH. Tobacco in Australia: facts and issues. Melbourne: Cancer Council Victoria; 2024. At: www.TobaccoInAustralia.org.au
13. Preston CL, ed. Stockley’s drug interactions. 2024. At: www.medicinescomplete.com
14. Indiana University. Drug interactions Flockhart table. 2024. At: https://drug-interactions.medicine.iu.edu/MainTable.aspx
15. Quit. Drug interactions with smoking. 2020. At: www.quit.org.au/health-professional-resources
16. Harry NM, Folorunsho IL, Anona K, et al. A review of the effect of vaping on the plasma levels of clozapine and its clinical implications. JAMMR 2024;36(7):48–56.
17. Medicines information. eMIMs cloud; 2024. At: www.emims.com.au/Australia/drug/search.
18. Karnieg T, Wang X. Cytisine for smoking cessation. CMAJ 2018;190(19):E596.
19. National Centre for Smoking Cessation and Training. Cytisine. 2024. At: www.ncsct.co.uk/publications/Cytisine-SPC
20. NSW Health. Quick guide to drug interactions with smoking cessation. 2019. At: www.health.nsw.gov.au/tobacco/Pages/tools-for-health-professionals.aspx
21. Lindson N, Theodoulou A, Ordóñez-Mena JM, et al. Pharmacological and electronic cigarette interventions for smoking cessation in adults: component network meta‐analyses. Cochrane Database of Systematic Reviews 2023, Issue 9.
22. Overview of tobacco smoking and nicotine dependence. Therapeutic Guidelines; . At: https://tgldcdp.tg.org.au/viewTopic?etgAccess=true&guidelinePage=Addiction%20Medicine&topicfile=alcohol-drug-problems&guidelinename=auto&sectionId=c_AMG_Overview-of-tobacco-smoking-and-nicotine-dependence_topic_2#c_AMG_Overview-of-tobacco-smoking-and-nicotine-dependence_topic_2
23. Theodoulou A, Chepkin SC, Ye W, et al. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews 2023;(6).
24. Varenicline for tobacco smoking and nicotine dependence. Therapeutic Guidelines; . At: https://tgldcdp.tg.org.au/viewTopic?etgAccess=true&guidelinePage=Addiction%20Medicine&topicfile=alcohol-drug-problems&guidelinename=auto&sectionId=c_AMG_Varenicline-for-tobacco-smoking-and-nicotine-dependence_topic_2#c_AMG_Varenicline-for-tobacco-smoking-and-nicotine-dependence_topic_2
25. Therapeutic Goods Administration. Guidance on the use of vapes for smoking cessation or the management of nicotine dependence. 2024. At: www.tga.gov.au/resources/resource/guidance/guidance-use-vapes-smoking-cessation-or-management-nicotine-dependence
26. Lindson N, Butler AR, McRobbie H. Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews 2024;(1).
27. Royal Women’s Hospital. Pregnancy and breastfeeding medicines guide. 2024. At: https://thewomenspbmg.org.au/
28. Overview of substance use and addictive behaviours. Therapeutic Guidelines; . At: https://tgldcdp.tg.org.au/viewTopic?etgAccess=true&guidelinePage=Addiction%20Medicine&topicfile=alcohol-drug-problems&guidelinename=auto&sectionId=c_AMG_Overview-of-substance-use-and-addictive-behaviours_topic_30#c_AMG_Overview-of-substance-use-and-addictive-behaviours_topic_30
29. Alfred Health. Patient resources:nicotine. 2023. At: www.alfredhealth.org.au/patients-families-friends/patient-resources?category=5&keywords=nicotine
30. Mohammadi L, Han DD, Xu F, et al. Chronic e-cigarette use impairs endothelial function on the physiological and cellular levels. Arterioscler Thromb Vasc Biol 2022;42(11):1333–50.
31. Nabavizadeh P, Liu J, Rao P, et al. Impairment of endothelial function by cigarette smoke is not caused by a specific smoke constituent, but by vagal input from the airway. Arterioscler Thromb Vasc Biol 2022;42(11):1324–32.
32. Royal Children’s Hospital Melbourne. Nicotine poisoning. 2019. At: www.rch.org.au/clinicalguide/guideline_index/Nicotine_Poisoning/
33. Banks E, Yazidjoglou A, Brown S, et al. Electronic cigarettes and health outcomes: systematic review of global evidence. Report for the Australian Department of Health. National Centre for Epidemiology and Population Health, Canberra; 2022.
34. Morgan J, Kelso C. Nicotine vaping product analysis: Evidence from the University of Wollongong. 2021. At: www.tga.gov.au/resources/publication/publications/nicotine-vaping-product-analysis-evidence-university-wollongong
35. Tonstad S, Gustavsson G, Kruse E, et al. Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. Nicotine Tob Res 2014;16(9):1266–71.
36. Therapeutic Goods Administration. Requirements for unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence: Guidance on the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and related matters. 2024. At: www.tga.gov.au/resources/resource/guidance/therapeutic-vapes
37. Quit. 2024. At: www.quit.org.au
38. Smith AL, Carter SM, Chapman S, et al. Why do smokers try to quit without medication or counselling? A qualitative study with ex-smokers. BMJ Open 2015;5.

There are major health benefits for everyone who stops smoking, with benefits beginning soon after ceasing.⁷

 

References: Greenhalgh⁷; eTG²⁴; Rigotti²⁵; Roelsgaard²⁶; CDC²⁷; Collins²⁸; RACGP²⁹

Health professionals report that lack of time can be a barrier to providing nicotine dependence support. However, brief advice using the 3-step model Ask, Advise, Help can be used to initiate discussions about smoking cessation and link patients to more comprehensive support.³

 

The Ask, Advise, Help model outlined below is focused on smoking cessation. This model can be adapted for use in conversations about vaping cessation. When asking patients about vaping, follow-up questions are needed to find out if the patient is using vaping as a smoking cessation strategy so advice and help can be tailored accordingly.

 

Ask

Ask all patients if they smoke when routinely gathering patient information. Pharmacists gather patient information when:

• prescribing medicines (including Schedule 2 and Schedule 3 medicines)
• dispensing medicines
• providing professional services (e.g. screening, case finding and risk assessment, medicine review, wound management)
• administering medicines (e.g. vaccines, injectable medicines).

 

Gathering patient information about the patient’s medicines and medical conditions provides an opportunity to ask if the patient smokes.

 

Ask the person if they smoke, then:

• if they say yes, progress to ‘Advise’
• if they say no, congratulate them (e.g. ‘That’s great!’) and consider asking follow-up questions about prior smoking history, if applicable.

 

Advise

Advise all patients who smoke to stop using a personalised, non-confrontational approach. Tailor the advice to the patient’s reason for presentation. For example:

• If the patient is requesting a medicine for a cough, discuss the respiratory effects of smoking.
• If the patient is getting their blood pressure checked, discuss the cardiovascular risks of smoking.
• If the patient is having a wound dressing changed, discuss how smoking can delay wound healing.
• If the patient is getting a flu vaccination, discuss how smoking increases susceptibility to acute respiratory infections.

 

Provide advice about ways to stop smoking (e.g. behavioural interventions, pharmacotherapy).

 

Help

Determine the best way for you to provide help to the patient to stop smoking, considering your scope of practice and availability, individual patient factors (e.g. medicine interactions, co-existing medical conditions) and the patient’s availability. Help may include:

• arranging referral to a behavioural intervention program (e.g. Quitline) on behalf of the patient
• providing a nicotine dependence support consultation to encourage the use of first-line pharmacotherapy options for smoking cessation (e.g. NRT)
• arranging referral to the patient’s regular medical practitioner to discuss smoking cessation strategies.

 

Arrange follow-up with the patient to discuss progress or next steps.

 

Record the patient’s smoking status in their clinical record (if they have one), along with any notes about the advice or help provided.

Individuals under the age of 18 require a prescription written by a medical or nurse practitioner to access unapproved therapeutic vaping goods for the treatment of nicotine dependence (subject to state or territory legislation).

 

A prescription is also required if a patient requires a therapeutic vaping good with a concentration >20 mg/mL.

 

See the TGA website, Vapes: information for prescribers and Vapes: information for pharmacists for further information.

 

Authorised Prescriber (AP) scheme

Medical practitioners can apply to the TGA for approval to become an ‘authorised prescriber’ of an unapproved product.¹⁹

 

Pharmacists who dispense prescriptions for therapeutic vaping goods written by an authorised prescriber can confirm the validity of the prescription using the TGA online validation tool or by contacting the prescriber.

 

Special Access Scheme

The Special Access Scheme (SAS) allows an individual patient to access an unapproved product.³⁰

 

The SAS-C pathway facilitates patient access to therapeutic vaping substances for patients 16 years or over. SAS-C is a notification system only, and no TGA pre-approval is needed. The SAS-C notification can be submitted online.

 

The SAS-B pathway can be used if an unapproved product cannot be accessed through SAS-A or SAS-C pathways (e.g. therapeutic vaping goods for patients <16 years). Medical and nurse practitioners must submit a new application for each patient for whom they prescribe therapeutic vapes. Under SAS-B, an approval letter from the TGA must be obtained prior to prescribing.

 

Pharmacists who dispense prescriptions for nicotine vaping products written under SAS-B and SAS-C can confirm the validity of the prescription using the TGA online validation tool or by contacting the prescriber.

 

State or territory regulations for therapeutic vaping goods

Legislation covering control of therapeutic vaping goods differs in each state and territory. Information about state or territory legislation relating to therapeutic vaping goods is available here.

Vaping devices are battery-operated devices that heat vaping substances to form a vapour that is inhaled.¹⁵

 

Vaping devices can be¹⁵:

• open systems that have a refillable reservoir for the vaping substances (could be a refillable cartridge or pod)
• closed systems that have non-refillable pods or cartridges.

 

Access to vaping devices

Therapeutic vaping devices that do not contain, and are not packaged with, a therapeutic vaping substance do not require a prescription and do not need authorisation for supply under Authorised Prescriber or Special Access Scheme. However, a pharmacist must be satisfied the device will only be used for smoking cessation or the management of nicotine dependence prior to supply (i.e. if the therapeutic vaping device is being sold without a therapeutic vaping substance, the pharmacist needs to discuss the intended use with the patient).¹²

 

Only therapeutic vaping devices that are included in the TGA list of notified vapes can be supplied.¹²

 

Standards for vaping devices

Therapeutic vaping devices must comply with either the Essential Principles or the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023 (MDSO).¹² See Vapes: information for pharmacists.

 

Sponsors of therapeutic vaping devices that are included in the TGA list of notified vapes have stated that their devices comply with the applicable standards. However, the devices on the list have not been assessed by the TGA for quality, safety, efficacy or performance.²⁰

 

Storage of vaping devices

As with other therapeutic vaping goods, therapeutic vaping devices that do not contain therapeutic vaping substances should be stored in the dispensary out of the line of sight of the public.¹²

Health professional resources

• Vaping hub – provides information from the TGA on the regulations for accessing therapeutic vaping goods and links to information for patients, prescribers and pharmacists. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub
• Navigating vaping reforms – provides information from PSA about the support available for pharmacists about the changes to vaping regulations. At: psa.org.au/career-and-support/navigating-vaping-reforms
• Vapes: information for pharmacists – provides information from the TGA about therapeutic vaping goods relevant to pharmacists. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-pharmacists
• Vapes: information for prescribers – provides information from the TGA about prescribing therapeutic vaping goods. At: www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-prescribers
• About vaping and e-cigarettes – provides answers to common questions about therapeutic vaping goods and how to access them in Australia. At: www.health.gov.au/topics/smoking-vaping-and-tobacco/about-vaping
• Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 – outlines the minimum safety and quality standards for unregistered nicotine vaping products, particularly in relation to ingredients, nicotine concentration, labelling requirements and record keeping. At: legislation.gov.au/Details/F2021L00595
• List of notified vapes – a list of therapeutic vaping goods that can be prescribed and dispensed in Australia. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/table/list-notified-vapes
• Prescribing and dispensing therapeutic vapes to patients under 18 years – a brief fact sheet that summarises the regulations that apply to supply of vapes to patients under 18 years. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-prescribers/prescribing-and-dispensing-therapeutic-vapes-patients-under-18-years
• Royal Australian College of General Practitioners. Supporting smoking cessation: a guide for health professionals – provides guidance for primary care health professionals on smoking cessation, including support strategies, treatments and their place in therapy. At: racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/supporting-smoking-cessation
• Quit Centre – has resources for health professionals, including clinical tools, online training, links for referring patients to Quitline. At: quitcentre.org.au
• Tobacco in Australia: facts and issues – a comprehensive review of major issues in smoking and health in Australia compiled by the Cancer Council Victoria. At: tobaccoinaustralia.org.au
• World Health Organization. Clinical treatment guideline for tobacco cessation in adults – international guidance for health care providers, policy makers and health service managers. At: who.int/publications/i/item/9789240096431
• World Health Organization. Framework convention on tobacco control, guidelines for the implementation of article 14 – guidance relating to tobacco cessation support. At: https://fctc.who.int/publications/m/item/guidelines-for-implementation-of-article-14
• Using a carbon monoxide monitor – provides information about using carbon monoxide monitoring as a motivational tool in smoking cessation. At: cancer.nsw.gov.au/getmedia/2bfdf618-34c9-4b01-b705-7ab3dd1337d9/Using-a-Carbon-Monoxide-Monitor-Factsheet.PDF
• Pathology tests explained: nicotine/cotinine – provides information about cotinine testing, which is sometimes used to determine compliance with smoking cessation. At: https://pathologytestsexplained.org.au/ptests-pro.php?q=Nicotine

 

Patient resources

• Vapes: information for individuals and patients – provides information for patients about therapeutic vaping goods and how to access them. At: www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-individuals-and-patients
• National Cessation Platform Quit – has various resources for people who smoke or vape. At: quit.org.au
• Quitline: Phone 13 78 48 – provides free, multi-session behavioural interventions with personalised and culturally appropriate support tailored to individual needs. Quitline also provides counsellors who are Aboriginal or Torres Strait Islanders.
• My QuitBuddy app – provides quit plans, tips for overcoming cravings and tracking systems to chart progress. At: health.gov.au/resources/apps-and-tools/my-quitbuddy-app
• Disposal of vapes – provides information about how to dispose of vapes. At: https://recyclingnearyou.com.au/vapes
• Local stop smoking programs may be provided in some areas by hospitals, Aboriginal and Torres Strait Islander Health Services and community health facilities.

1. Department of Health and Aged Care. National Tobacco Strategy 2023–2030. At: www.health.gov.au/sites/default/files/2023-05/national-tobacco-strategy-2023-2030.pdf
2. Australian Institute of Health and Welfare. Tobacco and e-cigarettes. 2024. At: https://www.aihw.gov.au/reports-data/behaviours-risk-factors/smoking/overview
3. Royal Australian College of General Practitioners. Supporting smoking cessation: a guide for health professionals. 2nd edn. Melbourne: RACGP. At: racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/supporting-smoking-cessation
4. Carson-Chahhoud KV, Livingstone-Banks J, Sharrad KJ, et al. Community pharmacy personnel interventions for smoking cessation. Cochrane Database Syst Rev 2019;10(2019):CD003698.
5. Royal Australian College of General Practitioners. Supporting smoking and vaping cessation: a guide for health professionals. Guidance on smoking and vaping cessation support related to changes to Australia’s vaping regulation.. Melbourne: RACGP; 2024.
6. Pharmaceutical Society of Australia. Professional practice standards. Version 6. Canberra: PSA; 2023.
7. Campbell MA, Ford C, Winstanley MH. The health effects of secondhand smoke. In: Scollo MM, Winstanley MH (eds). Tobacco in Australia: facts and issues. Melbourne: Cancer Council Victoria; 2017. At: tobaccoinaustralia.org.au/chapter-4-secondhand
8. Winnall W, Greenhalgh EM, Scollo MM. E-cigarettes. In: Greenhalgh EM, Scollo MM, Winstanley MH (eds). Tobacco in Australia: facts and issues. Melbourne: Cancer Council Victoria; 2023. At: tobaccoinaustralia.org.au/chapter-18-e-cigarettes/18-6-the-health-effects-of-e-cigarette-use
9. National Health and Medical Research Council. 2022 CEO statement on electronic cigarettes. 2022. At: nhmrc.gov.au/health-advice/all-topics/electronic-cigarettes/ceo-statement
10. Baenziger ON, Ford L, Yazidjoglou A, et al. E-cigarette use and combustible tobacco cigarette smoking uptake among non-smokers, including relapse in former smokers: umbrella review, systematic review and meta-analysis. BMJ Open 2021;11(3):e045603.
11. Pharmaceutical Society of Australia. Code of ethics for pharmacists. Canberra: PSA; 2017.
12. Therapeutic Goods Administration. Vapes: information for pharmacists. 2024. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-pharmacists
13. Therapeutic Goods Administration. Advertising: getting started. 2022. At: tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-getting-started
14. Therapeutic Goods Administration. Vapes: information for sponsors, importers and manufacturers. 2024. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-sponsors-importers-and-manufacturers
15. Therapeutic Goods Administration. Requirements for unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence. Guidance on the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO110) Order 2021 and related matters. 2024. At: www.tga.gov.au/sites/default/files/2022-09/nicotine-vaping-products-and-vaping-devices-september-2021_0_0.pdf
16. Sansom L, ed. Australian pharmaceutical formulary and handbook. 26th edn. Canberra: Pharmaceutical Society of Australia; 2024.
17. Return Unwanted Medicines. FAQs. 2024. At: https://returnmed.com.au/faqs
18. Pharmacy Board of Australia. Guidelines on compounding of medicines. 2024. At: www.pharmacyboard.gov.au/Codes-Guidelines.aspx
19. Therapeutic Goods Administration. Vapes: information for prescribers. 2024. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-prescribers
20. Therapeutic Goods Administration. List of notified vapes. 2024. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/table/list-notified-vapes
21. Australian Government Department of Health. The pharmaceutical benefits scheme. 2024. At: www.pbs.gov.au
22. Pharmaceutical Society of Australia. Dispensing practice guidelines. Canberra: PSA; 2019.
23. Royal Australian College of General Practitioners. Guidelines for preventive activities in general practice. 10th edn. East Melbourne: RACGP; 2024.
24. eTG complete. Melbourne: Therapeutic Guidelines; 2024.
25. Rigotti NA. Patient education: Quitting smoking (beyond the basics). 2021. At: www.uptodate.com/contents/quitting-smoking-beyond-the-basics
26. Roelsgaard IK, Ikdahl E, Rollefstad S, et al. Smoking cessation is associated with lower disease activity and predicts cardiovascular risk reduction in rheumatoid arthritis patients. Rheumatology (Oxford) 2020;59(8):1997–2004.
27. Centers for Disease Control and Prevention. Health effects of cigarette smoking. 2020. At: www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/index.htm
28. Collins GG, Rossi BV. The impact of lifestyle modifications, diet, and vitamin supplementation on natural fertility. Fertil Res Pract 2015;1:11.
29. Royal Australian College of General Practitioners. Management of type 2 diabetes: a handbook for general practice. East Melbourne: RACGP; 2020.
30. Therapeutic Goods Administration. Special access scheme (SAS): guidance for health practitioners accessing unapproved therapeutic goods. 2024. At: tga.gov.au/resources/resource/guidance/special-access-scheme-sas-guidance-health-practitioners-accessing-unapproved-therapeutic-goods
31. van der Sterren A, Greenhalgh EM, Knoche D, et al. 8.1 Aboriginal and Torres Strait Islander peoples: health and smoking – an overview. In: Greenhalgh EM, Scollo MM, Winstanley MH (eds). Tobacco in Australia: facts and issues. Melbourne: Cancer Council Victoria; 2021. At: tobaccoinaustralia.org.au/chapter-8-aptsi/8-1-overview
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33. Therapeutic Goods Administration. Authorised prescriber scheme: guidance for medical practitioners, human research ethics committees, specialist colleges and sponsors. 2024. At: tga.gov.au/sites/default/files/2024-03/authorised-prescriber-scheme-guidance.pdf
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35. Therapeutic Goods Administration. Therapeutic goods (medical devices) regulations 2022. At: legislation.gov.au/F2002B00237/latest/versions
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37. Therapeutic Goods Administration. Vapes: information for individuals and patients. 2024. At: tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/vapes-information-individuals-and-patients

The development of the Professional practice guidelines for pharmacists: nicotine dependence support has been funded by the Australian Government Department of Health and Aged Care. The information and views in this document do not necessarily represent or reflect the views of the Australian Government Department of Health and Aged Care.

 

The work to develop the guidelines included review by experts, stakeholder feedback, and the consensus of organisations and individuals involved.

 

The Pharmaceutical Society of Australia thanks all those involved in the review process and gratefully acknowledges the contribution of the following individuals and organisations.

 

Project Advisory Group

• Emma Dean, Quit Centre
• Nicholas Elmitt, Australian Medical Association
• Serena Hossain, Royal Australian and New Zealand College of Psychiatrists
• Jennifer Kyi, Quit Centre
• Alice Nugent, National Aboriginal Community Controlled Health Organisation
• Hester Wilson, Royal Australian College of General Practitioners
• Nick Yim, Australian Medical Association
• Representatives for the Australian Government Department of Health and Aged Care

 

PSA Project Team

• Claire Antrobus
• Chris Campbell
• Ness Clancy
• Tara Edmonds
• Nikita Grant
• Jarrod McMaugh
• Nena Nikolic
• Jacob Warner

 

This publication contains material that has been provided by the Pharmaceutical Society of Australia (PSA), and may contain material provided by the Commonwealth and third parties. Copyright in material provided by the Commonwealth or third parties belong to them. PSA owns the copyright in the publication as a whole and all material in the publication that has been developed by PSA. In relation to PSA owned material, no part may be reproduced by any process except in accordance with the provisions of the Copyright Act 1968 (Cth), or the written permission of PSA. Requests and inquiries regarding permission to use PSA material should be addressed to: Pharmaceutical Society of Australia, PO Box 9464, Deakin ACT 2600. Where you would like to use material that has been provided by the Commonwealth or third parties, contact them directly.

 

Disclaimer

Neither the PSA, nor any person associated with the preparation of this document, accepts liability for any loss which a user of this document may suffer as a result of reliance on the document and, in particular, for:

• use of the Guidelines for a purpose for which they were not intended
• any errors or omissions in the Guidelines
• any inaccuracy in the information or data on which the Guidelines are based or which is contained in them
• any interpretations or opinions stated in, or which may be inferred from, the Guidelines.

 

Notification of any inaccuracy or ambiguity found in this document should be made without delay in order that the issue may be investigated and appropriate action taken. Please forward your notification to:

Pharmaceutical Society of Australia,

PO Box 9464, Deakin, ACT 2600.

ISBN: 978-0-6486003-5-0

Date of Publication: September 2024

© Pharmaceutical Society of Australia Ltd, 2024