On October 1, liquid nicotine was rescheduled from a Schedule 7 poison to a Schedule 4 prescription-only medicine. This means that liquid nicotine, or a nicotine vaping product (NVP), can be prescribed by an Australian medical practitioner and dispensed by an Australian pharmacy for use in an e-cigarette device for smoking cessation.
The Therapeutic Goods Administration (TGA) has not assessed any e-cigarette as being safe, high quality and effective. This means medical practitioners must prescribe an ‘unapproved’ medicine if they choose to prescribe an NVP for smoking cessation.
How medical practitioners can prescribe an NVP
There are three ways medical practitioners can prescribe a nicotine vaping product:
- any registered medical practitioner can prescribe up to three months' supply for the person to purchase from an overseas website through the Personal Importation Scheme.
- any registered medical practitioner who has obtained TGA approval as an Authorised Prescriber (essentially completing an online form) can prescribe a product for dispensing by an Australian online or community pharmacy.
- any registered medical practitioner can prescribe a product for dispensing by an Australian online or community pharmacy through the Special Access Scheme.
Products dispensed by Australian pharmacies must adhere to a Therapeutic Goods Order (TGO 110) that ensures some level of quality and safety features, including child-resistant packaging. There are few such features for products imported through the Personal Importation Scheme.
The Royal Australian College of General Practitioners (RACGP) and Pharmaceutical Society of Australia (PSA) have developed smoking cessation guidelines that provide information on prescribing or dispensing, respectively.
The evidence for NVP effectiveness is limited. Two randomised clinical trials have shown NVPs to be slightly more effective than nicotine replacement therapy. However, this was in clinical trial conditions with participants receiving medical supervision and smoking cessation counselling.
A meta-analysis of studies tracking cigarette and e-cigarette use has shown that e-cigarettes, when used in real-world conditions, do not increase quitting, even among people who are motivated to quit.
NVPs should be considered a short-term approach for quit attempts. Repeated inhalation of a chemical cocktail is not risk-free, with cases of e-cigarette/vaping-associated lung injury (EVALI) reported in Australia.
Of concern is evidence suggesting that people who use NVPs to quit smoking might have difficulty in subsequently quitting vaping.
The Quitline is already receiving calls from people seeking help to quit vaping and, more worryingly, from people who are trying to support their children to quit vaping.
The rescheduling decision could increase quitting for reasons entirely unrelated to NVPs. The idea of a new 'thing' to try and/or the requirement for a prescription could see more people discussing smoking cessation with a medical practitioner. This creates an opportunity for people who smoke (or vape) to get best practice advice to become addiction-free.
Currently, only a small proportion of people trying to quit smoking use evidence-based tobacco dependence treatment. If medical practitioners were to adopt a policy of requiring patients to try Quitline plus TGA-approved pharmacotherapy before they can be considered for an NVP (plus Quitline), smoking cessation rates would increase.
However, it would be devastating if the rescheduling of liquid nicotine had the unintended consequence of channelling people away from safe and effective pharmacotherapies to an unproven product with limited effectiveness and high addiction potential.
This article was written by Dr Sarah White, Director of Quit Victoria at Cancer Council Victoria.
The Quit team is working with collaborators, including the Royal Australian College of General Practitioners, the Australian College of Rural and Remote Medicine, and the Pharmaceutical Society of Australia, to develop training on smoking cessation and nicotine vaping products for medical practitioners and pharmacists.
 Wang, Bhadriraju and Glantz. E-Cigarette Use and Adult Cigarette Smoking Cessation: A Meta-Analysis. American Journal of Public Health 2021; 111(2):230-246.
 Chan et al. E‐cigarette or vaping product use‐associated lung injury in an adolescent. Med J Aust 2021; 215 (7).
 Hajek et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. NEJM 2019; 380(7): 629-637.