What are we, smoking? Implications for Pharmacists resulting from new Vaping Reforms

By Amy Rumble Thomas Coltrona Asra Khan

7 April 2025

Electronic cigarettes, known as ‘vapes’, have recently challenged paper cigarettes as the go-to nicotine delivery system in popular culture. This is largely because vapes are promoted as exposing users to fewer toxins than paper cigarettes and have a larger variety of flavours (and colours).

Historically, vapes were readily available at smoke shops, petrol stations and convenience stores, but advocacy groups raised concerns about children and adolescents being exposed to vaping from a young age.

1 July 2024 saw the national introduction of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. This legislation restricted the sale of vapes to consumers holding a prescription.¹ Consequently, vapes containing nicotine can now only legally be sold by pharmacists, and the flavours are currently limited to mint, menthol and tobacco.²

On 1 October 2024, further reforms were introduced around the country, allowing those over the age of 18 to buy vapes, which contain a nicotine concentration below 20mg/ml, from their local pharmacy without a prescription.³ The classification of nicotine has also changed from a Schedule 4 poison under the Therapeutic Goods (Poisons Standard – June 2024) Instrument 2024 to a Schedule 3 poison.⁴

Although these further reforms seem relatively minor, they raise concerning implications for pharmacists, particularly potential impacts on their duty of care towards customers, and consequential impacts on their indemnity insurance. These concerns likely form part of the reasons why Western Australia has recently announced that it intends to introduce legislation to override the new federal laws and continue limiting the availability of nicotine vapes to prescription only sales.⁵

 

The purpose behind the new vape reforms

The aim of the vape reforms is to reduce the prevalence of vaping in Australia, particularly among young people.⁶ Limiting the permitted sale and supply of vaping goods to health professionals is intended to ensure that health practitioners can supervise vape users and encourage them to quit smoking altogether.⁷

As health care professionals – and now one of the sole legal distributors of nicotine vapes – pharmacists are among the key players in the enforcement of/compliance with the law.

 

What changes do the new vape laws bring for pharmacists?

From 1 October 2024, pharmacists have been required to do the following:

1. Ensure that the people to whom they are supplying nicotine vapes are over the age of 18 years. This includes checking customer’s identification.

2. Provide advice to customers about:

2.1. alternative methods to quit smoking and/or vaping;
2.2. appropriate doses of nicotine and the frequency of vape usage;
2.3. the length of any treatment; and
2.4. how nicotine consumption may interact with customers’ other medications.⁸

 

Civil Liability Issues

Pharmacists registered under the Health Practitioner Regulation National Law (WA) are deemed to be health professionals for the purposes of the Civil Liability Act 2002 (WA).⁹ Accordingly, pharmacists have a duty of care towards customers who seek their advice or purchase medication from them, as the customers rely on the advice they provide.¹⁰Pharmacists have a duty to prevent or minimise the opportunities for customers to suffer harm, and to refuse to dispense medication or goods that they may misuse.¹¹

Compliance with this duty is assessed against what a reasonable pharmacist would do in the same situation, which is informed by guidelines published by professional bodies such as the Pharmaceutical Society of Australia.¹² Accordingly, any harm that a customer may suffer, as a result of a pharmacist’s failure to properly advise them or failure to refuse to dispense nicotine vapes, in certain circumstances, may expose them to a risk of civil liability for negligence.

As part of their duty of care, a pharmacist must exercise appropriate skill and judgement when providing advice or dispensing medication to a customer, to prevent the risk of harm.¹³ However, for a pharmacist to be found liable for any harm suffered by a customer as a result of the pharmacist’s conduct, the harm suffered must have been reasonably foreseeable.¹⁴

As vapes are still relatively new, and have not been the subject of long term academic research quite like cigarettes, they bring uncertainty for pharmacists, both in terms of advising customers with appropriate skill and judgement, and in reasonably foreseeing any harm customers may suffer from their use of vapes.

Pharmacists may lack adequate training, resources and regulations to provide advice and counselling

Because of the recency of the new vape laws, pharmacists may not yet have received sufficient education or training on how to provide the correct advice to customers or on how to appropriately supervise the sale, distribution and usage of vapes.

While there are now training processes that are slowly being developed and delivered to pharmacists, it may take time before a majority of pharmacists receive and implement this training. Until this has occurred, it may even be difficult to say who is appropriately qualified to provide advice on vaping goods.

Vaping Goods are not currently approved by the Therapeutic Goods Administration

An important aspect in the regulation and sale of vaping goods is for pharmacists to inform their customers if the vaping good is an unapproved therapeutic good.¹⁵ Currently, almost no vaping goods have been approved by the Therapeutic Goods Administration (TGA) for consumption and/or use by the public. To accommodate this, some restrictive pathways have been developed for the supply of unapproved vaping goods until an approval process has been undertaken.¹⁶ However, this creates uncertainty as to how any adverse effects from vaping will be handled by the TGA, and who will be held liable.

This is not just a short-term issue. Until the TGA finalises the approval process, pharmacists will be providing vaping goods for therapeutic use despite currently limited information available regarding both the dangers and therapeutic benefits of vaping.¹⁷ Accordingly, they risk long-term liability implications for current sales.

Burden on pharmacists to report issues and adverse consequences

The new vaping laws bring with them new obligations for pharmacists, as they must now monitor vape products and their use and report to the TGA any ‘adverse effects’ suffered by their customers, or any defects in the vaping products themselves.¹⁸

For health professionals, an ‘adverse event’ is ‘an incident in which a person receiving healthcare was harmed’.¹⁹ Should an adverse event arise, and a pharmacist is unable to produce records on the advice they provided to the customer (such as the exact dose of nicotine they prescribed and any advice they have given as to the risks of use), they may face action from medical regulators as well as medical negligence claims from their customers. However, as there are not yet any specific regulatory measures in place for pharmacists to follow regarding the dispensing of vape products, it seems inevitable that such procedures would need to be implemented in order to facilitate oversight and implementation of the new legislation.

 

Insurance Implications

As a result of the heightened legal risks for pharmacists caused by the new legislation, there are concerns that this may lead to increased insurance premiums. Mr Paul Cassidy, Chief Executive Officer of Guild Group and Guild Insurance, stated that “understanding the potential premium increases and ensuring compliance with all relevant regulations are critical steps in mitigating risk”.²⁰ As Guild Insurance is one of the primary insurance providers for allied healthcare professionals, including pharmacists, this indicates that in the near future, pharmacists may have to pay increased insurance premiums due to the increased risk that the vape reforms brings them.

It should also be noted that the vaping reforms do not include any specific limitations of liability for pharmacists who intend to sell and provide advice on vaping goods.²¹ However, it is possible that pharmacists’ current liability insurance may cover any advice given under the new laws. Each individual pharmacist will need to review their policy and consult with their provider in order to be sure.

 

Potential Solutions

With lingering uncertainty as to what the vaping reforms may bring, the most obvious short-term solution is for pharmacists to choose not to stock or provide vaping products for sale. Inferentially, this seems to be exactly what a lot of pharmacists are doing, as nationally only 3,500 vapes were sold without a prescription within the first month of the reforms.²²

However, whilst it is not mandatory for a pharmacy to sell vaping goods, some pharmacies may not have the luxury of choosing not to sell vaping goods for commercial reasons. Pharmacies attached to a medical centre may also not wish to affect longstanding relationships with doctors who refer them a regular stream of customers.

A more practical solution may be for pharmacists to establish internal systems to help manage the sale and distribution of vaping goods to customers and to record any advice given to customers. These could be drawn from current systems in place for Schedule 8 therapeutic goods, such as storage and record keeping requirements, and mandatory reporting to the Department of Health under the Medicines and Poisons Regulations.²³ Developing an internal system for vapes may involve recording and documenting suppliers, products and quantities received, customer details (including scans of IDs), advice given, and products sold. Pharmacists could also document dosages of nicotine they provided and reasons why.

 

The Reforms Moving Forward

While there are currently many uncertainties, it is likely going forwards that we may see an increase in training, procedures and regulations available to pharmacists to appropriately monitor and control the sale and distribution of vaping goods. However, it would also be useful if government, or any pharmaceutical boards released some best practice guidelines for pharmacists to follow or regulatory processes for them to implement. In any event, it is likely that as time passes, more flaws in the system will become visible and the required solutions more apparent. In the meantime, the risk of greater legal liability may just be the cost pharmacists have to bear if they wish to remain in the vaping market.

 

1. Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024.
2. Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 s 41QB.
3. Department of Health and Aged Care: Therapeutic Goods Administration, ‘Vapes: information for pharmacists’, Vaping hub (Web Page, 1 October 2024) <Vapes: information for pharmacists | Therapeutic Goods Administration (TGA)>; Supplementary Explanatory Memorandum, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (Cth) 2, 11; Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 sch 4 pt 1 s 13; Therapeutic Goods (Poisons Standard—February 2025) Instrument 2025 pt 2 sch 3.
4. Supplementary Explanatory Memorandum, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (Cth) 2, 11; Therapeutic Goods (Poisons Standard – June 2024) Instrument 2024.
5. Hamish Hastie, ‘WA moves to circumvent national ‘watered-down’ vaping ban’, WAToday (online, 25 September 2024). https://www.watoday.com.au/national/western-australia/wa-moves-to-circumvent-national-watered-down-vaping-ban-20240925-p5kdgr.html.
6. Replacement Explanatory Memorandum, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (Cth) 3-5.
7. Department of Parliamentary Services (Cth), Bills Digest (Digest No 61of 2023-24, 13 May 2024).
8. Therapeutic Goods Administration, Department of Health and Aged Care, ‘Vapes: information for pharmacists’, Therapeutic Goods Administration (Web Page, 19 July 2024) <Vapes: information for pharmacists | Therapeutic Goods Administration (TGA)>.
9. Civil Liability Act 2002 (WA) s 5PA(a)(xi).
10. Kelvin Yung Ming Lau, ‘A duty to care – pharmacists’ negligence: implications for pharmacists and lessons arising’ (2003) 5 Legal issue in Business 9; Rogers v Whitaker (1992) 175 CLR 479; Bronger v Greenway Health Centre Pty Ltd (t/as Greenway Plaza Pharmacy) [2022] NSWLEC 91 [115]; Donoghue v Stevenson [1932] AC 562.
11. Kelvin Yung Ming Lau, ‘A duty to care – pharmacists’ negligence: implications for pharmacists and lessons arising’ (2003) 5 Legal Issue in Business 9, 10 referencing J. Healy, Medical negligence: Common law perspectives (1999) 245.
12. Pharmaceutical Society of Australia, ‘Guidelines’, Pharmaceutical Society of Australia (Web Pages, 2025) <https://www.psa.org.au/resource/guidelines/>.
13. Rogers v Whitaker (1992) 175 CLR 479.
14. Wyong Shire Council v Shirt (1980) 146 CLR 40.
15. Therapeutic Goods Administration, Department of Health and Aged Care, ‘Vapes: information for pharmacists’, Therapeutic Goods Administration (Web Page, 19 July 2024) <Vapes: information for pharmacists | Therapeutic Goods Administration (TGA)>.
16. Coral Gartner et al, ‘Pharmacies will soon be able to supply vapes without prescription: how might it work in practice?’ (2024) (26) InSight <Pharmacies will soon be able to supply vapes without prescription: how might it work in practice? | InSight+ (mja.com.au)>.
17. The Pharmacy Guild of Australia, ‘Weighing up the insurance risks’, The Pharmacy Guild of Australia (Web Page, 2 July 2024) <Weighing up the insurance risks – The Pharmacy Guild of Australia>.
18. Therapeutic Goods Administration, Department of Health and Aged Care, ‘Vapes: information for pharmacists’, Therapeutic Goods Administration (Web Page, 19 July 2024) <Vapes: information for pharmacists | Therapeutic Goods Administration (TGA)>.
19. Ahpra & National Boards, ‘Code of Conduct’ (June 2022) at page 13.
20. The Pharmacy Guild of Australia, ‘Weighing up the insurance risks’, The Pharmacy Guild of Australia (Web Page, 2 July 2024) <Weighing up the insurance risks – The Pharmacy Guild of Australia>.
21. Jake Evans, ‘Major pharmacy chains reject vape laws, signalling franchises shouldn’t sell vaping products’, Australian Broadcasting Corporation (online, 28 June 2024) <https://www.abc.net.au/news/2024-06-28/big-pharmacy-brands-reject-vape-sales-ban/104031894>. 
22. Rhiana Whitson, ‘Big tobacco and Chemist Warehouse battling to gain market share in Australia’s pharmacy vape market’, ABC (online), (online at 11 December 2024) <https://www.abc.net.au/news/2024-12-11/vaping-chemist-warehouse-liber-pharmaceuticals/104700836>.
23. Medicines and Poisons Regulations 2016 (WA) see pt 5, pt 11, pt 12.

Disclaimer: The information published in this article is of a general nature and should not be construed as legal advice. Whilst we aim to provide timely, relevant and accurate information, the law may change and circumstances may differ. You should not therefore act in reliance on it without first obtaining specific legal advice.