Key takeaways
- From 1 October 2024, patients over the age of 18 will be able to access therapeutic vapes with a nicotine concentration of 20mg/mL or less (‘vapes’) from pharmacies without a prescription.
- The legislative changes relevant to the dispensing of vapes have identified a number of challenges for pharmacists.
- Pharmacists who opt to dispense vapes are encouraged to review the advice and recommendations set out in the PSA Professional Practice Guidelines for Pharmacists: nicotine dependence support (Sept 2024).
Background
Historically, vapes have been prescribed by medical and/or nurse practitioners under the proviso that the vapes were clinically required for the purpose of ceasing smoking/managing nicotine dependence. Pharmacists who dispensed the vapes could do so with an understanding that the patient had received relevant medical advice as part of a considered treatment plan.
From 1 October 2024, pharmacists who opt to dispense vapes will find themselves navigating the new legislative framework implemented by the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (the Act) and other reforms.[i] The Pharmaceutical Society of Australia (PSA) has recently published guidelines relevant to pharmacists who opt to provide nicotine dependence support (the PSA Guidelines)[ii].
1. Accessing Vapes: The New Legislative Regime
1.1 From 1 October 2024:
(a) vapes will move to the Schedule 3 – Pharmacist Only medication class
(b) pharmacists will be permitted to dispense vapes to the community without a prescription, and
(c) patients over 18 years of age will be able to ‘by-pass’ a consultation with their medical/nurse practitioners and simply present to their local pharmacist requesting a vape.
1.2 Pharmacists will now be responsible for the:
(a) consultation of patients, with a view to determining whether a vape is clinically appropriate for their condition and is for the purpose of smoking cessation or the management of nicotine dependence
(b) dosing of patients in proportion to their condition, and
(c) dispensing vapes in accordance with best practice.
1.3 These legislative changes create a number of potential challenges for pharmacists, particularly because:
(a) the cohort of vapes available for dispensing is broad and simply requires a vape to be of a nicotine concentration of 20mg/mL or less, and be on the Therapeutic Goods Administration’s (TGA) approved list of “notified” vapes
(b) until the recent publication of the PSA guidelines, little by way of guidance has been provided to pharmacists as to what is expected of them, with only a fairly loose framework being put forward by the TGA.[iii]
1.4 The TGA has provided a list of therapeutic vaping goods for the use in smoking cessation or management of nicotine dependence which can legally be supplied in Australia[iv]. This list is separate to the Australian Register of Therapeutic Goods and is comprised of products that have not been tested and approved by the TGA. The vapes are therefore described as “unapproved therapeutic vaping goods” and have only been “notified as complying with applicable standards”[v].
1.5 The fact that there is little known evidence about the long-term effects of vape use, raises concerns as to the nature and extent of informed consent obtained, as well as the exposure of pharmacists to future complaints and litigation.
1.6 Pharmacists who often find themselves working in a busy and time poor environment will now have to take additional steps to ensure that, when dispensing vapes, they comply with their new professional obligations and that such compliance is clearly documented.
2 Resources to Navigate the New Regime: The PSA Guidelines
2.1 The recently published PSA Guidelines:
(a) set out the requirements for the supply of vapes without a prescription
(b) provide detailed advice for practitioners relevant to gathering patient information; assessing patient needs; agreeing on and discussing the agreed management plan, and documenting the interaction with the patient.
2.2 The PSA Guidelines provide that vapes can only be supplied by pharmacists without a prescription when:
(a) supplied to patients ≥18 years
(b) the product is in the final dosage form
(c) it is being used for smoking cessation or management of nicotine dependence
(d) evidence of the patient’s identity and age are sighted (cannot be supplied to a third party unless they are the patient’s carer)
(e) advice is provided to the patient on alternative management options and appropriate use of the product
(f) contact details for smoking cessation support services are provided
(g) the quantity supplied does not exceed the quantity that is reasonably required for a patient’s therapeutic use for one month and products are only supplied once a month (a smaller quantity can be supplied more frequently)
(h) the concentration of nicotine in the product is ≤20 mg/mL
(i) the patient is informed that vaping products are unapproved products
(j) informed consent is obtained from the patient for the use of an unapproved product (this can be written or verbal)
(k) supply is in accordance with good pharmacy practice (i.e. reputable and relevant guidelines are followed).
2.3 Additional requirements for the sourcing and supply of vapes include the following:
(a) vapes are only available in pharmacies or pharmacy settings
(b) the dispensing of vapes to patients <18 years is restricted in some jurisdictions even with a valid prescription
(c) some of the patient’s personal details will need to be obtained and recorded to satisfy legislative, organisational and professional requirements
(d) a SAS-C notification must be submitted for each supply of a therapeutic vaping good without a prescription. It must be submitted within 28 days of supplying the vape with best practice to submit it on the day of supply
(e) all vapes must be supplied directly to the patient or their carer, regardless of whether they are supplied with or without a prescription.
2.4 The PSA Guidelines recognise that in view of the new legislative regime (and in addition to the general requirements for the supply of scheduled medicines):
(a) quality systems will be needed to deliver nicotine dependence support
(b) the service delivery should be:
(i) safe and therapeutically appropriate for a patient
(ii) applied consistently, and
(ii) aligned with evidence and scope of practice.
(c) the actions required for this service delivery should be:
(i) applicable to all pharmacists in an oversight role where support is provided e. pharmacists in a senior clinical, managerial or organisational oversight role in the pharmacy or health service, and
(ii) applicable to all pharmacists who actually provide the support.
(d) increased responsibility and obligations to plan, resource, monitor and review the service and support provided will attach to community pharmacy owners, pharmacist managers, sole operators and directors of a pharmacy.
2.5 The PSA Guidelines make plain that:
(a) they do not address legislative guidelines in detail due to the evolving nature of the legislative regime relating to the management of nicotine dependence
(b) at all times pharmacists must comply with relevant Commonwealth, State or Territory legislation
(c) pharmacists are expected to apply professional judgment when applying the guidelines in practice and “make risk-benefit assessments from time-to-time based on the best available information and current evidence”, and
(d) records of assessments should be kept and all significant decisions should be documented.
3. Comments
3.1 The robust framework previously imposed on general practitioners and/or nurse practitioners in relation to consulting patients for vapes will now fall to pharmacists. It is difficult to conceptualise how this level of care could be facilitated during busy periods in a pharmacy, especially if patients are merely walking up to the ‘scripts in’ counter and demanding a vape.
3.2 Pharmacists are encouraged to give due consideration to the recommendations and suggestions as set out in the PSA Guidelines. This includes:
(a) exploring how to best manage the consultation and dispensing of vapes, which may be best supported by a booking system (similar to that of a vaccination service), allowing suitably trained pharmacists sufficient time to perform an appropriate consultation with the patient prior to making the decision as to whether it is appropriate to dispense
(b) proprietor pharmacists considering whether to offering vaping products as part of their services as a viable option to them
(c) ensuring that appropriate training is provided to all pharmacists and dispensary staff and professional advice is sought on the issues of informed consent, record-keeping and follow-up
(d) ensuring proper and adequate documentation is retained of all of the steps taken and advice given when supplying a vape to a patient. While the PSA Guidelines suggest that informed consent should be obtained in writing and verbally, it is recommended from a medico-legal and risk management perspective that discussions with, and advice given to, patients be thoroughly documented. Practitioners should be encouraged to seek out record-keeping courses to assist them in this regard, and
(e) referring to the Health Professional Resources at page 40 of the PSA Guidelines.
3.3 Pharmacists and, in particular those in an oversight role, should contact their professional associations, as well as their professional indemnity insurers for assistance in the implementation of quality systems and training relevant to the delivery of nicotine dependency support.
This Insight was written by Principal Joanne Hayes and Solicitor Jessica Galea. Please contact Joanne or Jessica if you have any questions or would like more information.
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Disclaimer: This information is current as of October 2024. This article does not constitute legal advice and does not give rise to any solicitor/client relationship between Meridian Lawyers and the reader. Professional legal advice should be sought before acting or relying upon the content of this article.
[i] The Act commenced on 1 July 2024.
[ii] The PSA Professional Practice Guidelines for Pharmacists: nicotine dependence support (Sept 2024).
[iii] In July 2024, the TGA updated published information an article Vapes: Information for Pharmacists regarding the “changes to the regulation of vapes, and what the changes mean for sourcing these products and the requirements for dispensing”.
[iv] TGA publication: Notified vaping goods for smoking cessation or nicotine dependence.
[v] The following can be noted:
“These lists contain vaping substances, vaping devices, vaping kits and vaping accessories that have been notified by a product sponsor to comply with quality standards, including the Therapeutic Goods (Standard for Therapeutic Vaping Goods) Order 2021 (TGO110), and Therapeutic Goods (Medical Device Standard – Therapeutic Vaping Devices) Order 2023 (MDSO).
The goods included in this list have not been assessed by the TGA for quality, safety and efficacy or performance.
Product information has been self-declared by sponsors and the TGA cannot guarantee and assumes no legal liability or responsibility for the accuracy, currency, completeness or interpretation of the information. It is an offence to provide false or misleading information to a government agency.
The TGA will be conducting routine compliance assessments as part of ongoing compliance monitoring”. (emphasis added)
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