On 1 July 2024, the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (the ‘Act’) came into effect nationwide, introducing new restrictions on vape sales. Under this legislation, nicotine-containing vapes could only be legally sold by pharmacists to individuals with a valid prescription.
Soon after, further reforms were introduced enabling nicotine vapes to be purchased at pharmacies without a prescription. These reforms, by way of the Therapeutic Goods (Vaping Goods – Possession and Supply) Amendment were introduced around the country on 1 October 2024, allowing those over the age of 18 to buy vapes, which contain a nicotine concentration below 20mg/ml, from their local pharmacy with no prescription.
A pharmacist’s duty of care
The changing regulatory environment and new health evidence brings the potential legal risks involved in selling vapes into sharp focus. A key issue is that no vaping product has received approval from the Therapeutic Goods Administration (TGA) for safety, efficacy, or performance. The provision and supply of vape products without solid clinical evidence supporting their use for those seeking to give up or reduce their nicotine dependence may expose pharmacists to claims of negligence in fulfilling their duty of care.
Pharmacists owe a duty of care to customers who seek their guidance when purchasing medications, as these individuals rely on the professional advice provided. This duty includes taking reasonable steps to prevent or reduce the risk of harm, including the responsibility to withhold medications or products that may be misused. Therefore, if a customer suffers harm due to a pharmacist’s failure to provide appropriate advice or to refuse the supply of nicotine vapes when necessary, the pharmacist may be exposed to potential civil liability for negligence.
The new vaping legislation imposes additional responsibilities on pharmacists, requiring them to monitor the use of vape products and report any adverse effects experienced by customers, as well as any product defects, to the TGA.
Pharmacists have been required to do the following:
- Ensure that the people to whom they are supplying nicotine vapes are over the age of 18 years. This includes checking customer’s identification.
- Provide advice to customers about:
- alternative methods to quit smoking and/or vaping;
- appropriate doses of nicotine and the frequency of vape usage;
- the length of any treatment; and
- how nicotine consumption may interact with customers’ other medications.
Risk management
Given the ongoing uncertainty surrounding the impact of the vaping reforms, the most straightforward short-term response for pharmacists may be to opt out of stocking or supplying vaping products. For commercial reasons, some pharmacies may not have the option to stop selling vaping products, for example, pharmacies located within medical centres might be reluctant to jeopardize established relationships with their customers or suppliers.
For those opting to proceed with sales, pharmacists should have regard to insurance implications, and their stores will need to show robust processes or procedures to satisfy their regulatory obligations under the Act. Creating an internal system for managing vapes could include tracking and documenting suppliers, product types and quantities received, customer information, advice provided, and products sold.
Product liability presents another significant risk. Consumers might report harm from using vape products, such as allergic reactions or injuries caused by lithium battery failures. These claims could result in substantial financial losses and damage to the pharmacy’s reputation.
Consequently, it is highly recommended that pharmacies carefully assess the decision to stock and sell vape products with increased threats of damage to their premises. Insurers have already indicated that these risks are likely to lead to increased premiums for pharmacies.
Contact a Bellrock Advisor to understand more about this risk in the context of your own business operations.
