Nicotine vaping products: practice implications of scheduling changes

• From 1 October 2021 a change to the Poisons Standard clarifies the regulation of nicotine for use in e-cigarettes as a Schedule 4 medicine.
• A prescription will be required for Australians to legally access nicotine e-cigarettes and nicotine vaping products for any purpose, including importing from overseas online retailers.
• This regulatory change provides an opportunity for GPs to have conversations with patients about smoking cessation.
• By filling in a short online form, prescribers can seek authorisation from the Therapeutic Goods Administration (TGA) to be Authorised Prescribers for any number of patients, or apply to the Special Access Scheme for individual patients. Both routes provide domestic access to nicotine vaping products. Applications can be made online and are very fast and simple to complete.
• Any prescriber can write a prescription for nicotine vaping products without requiring TGA approval if accessed from overseas through the Personal Importation Scheme.

From 1 October 2021, the Poisons Standard clarifies the regulation of nicotine as a Schedule 4 medicine. This includes nicotine for use in e-cigarettes, e-juice, heat-not-burn tobacco products and other novel nicotine products, even if no therapeutic claim is made.¹ This scheduling change aligns with state and territory laws, which prohibit the sale or possession (other than in South Australia) of nicotine vaping products.

Consumers will require a prescription from an Australian-registered medical practitioner to access nicotine vaping products for e-cigarettes including access from overseas.² This has implications for practice, and represents an opportunity for GPs to discuss smoking cessation strategies with current smokers and nicotine vape users.

To enhance safety, child-resistant closures for nicotine vaping products will also be mandatory.

Products not affected by the change

Nicotine replacement therapies currently available without prescription (from pharmacies and some retail outlets including sprays, patches, lozenges and gums) are not affected. These products have been assessed by the TGA as safe and effective for retail sale.²

There are no changes to the availability of e-cigarettes that do not contain nicotine, or tobacco prepared and packed for smoking.²

The TGA Delegate who handed down the decision considered both consumer demand for nicotine vaping products to help people stop smoking, and the public health need to reduce and prevent initiation of nicotine addiction among non-smokers, particularly adolescents.¹ The TGA Delegate considered an extensive body of local and international data (summarised in Box 1) and public submissions received from individuals, health care professionals, public health academics and government and peak health bodies to determine the status of nicotine as an unapproved therapeutic good.

Areas of concern that were reviewed comprehensively and informed the final decision were:¹

• evidence of the direct health harms associated with nicotine vaping products use
• the potential for nicotine vaping products use to lead to nicotine addiction particularly among adolescents
• the potential for nicotine vaping products use to lead to tobacco use particularly among adolescents
• concurrent use of nicotine vaping products and tobacco products.

Box 1. Key materials considered in making the final decision

Nicotine vaping products are an ‘unapproved’ therapeutic good

There are currently no nicotine vaping products entered on the Australian Register of Therapeutic Goods, so these products are only available as ‘unapproved’ goods.³ 'Unapproved' therapeutic goods have not been evaluated by the TGA for quality, safety, efficacy or performance.³

If a patient and their prescriber agree that an ‘unapproved’ nicotine vaping product is the most clinically appropriate approach for smoking cessation, then it can be legally accessed with a valid prescription in three ways. 

An infographic illustrating these three pathways is available for download or print.

If it is decided that nicotine will be accessed through an Australian supplier (eg, local pharmacy) then prescribers must be TGA authorised under the Authorised Prescriber Scheme or TGA approved under the Special Access Scheme before writing the prescription.⁴

1. Authorised Prescriber Scheme

• Medical practitioners may seek authorisation from the TGA to prescribe nicotine vaping products directly to any number of patients under their immediate care without requiring separate approval for individual patients.
• Human Research Ethics Committee (HREC) approval or specialist college endorsement is not required for nicotine in solution, salt or base form that is to be used for smoking cessation purposes.
• The TGA does not need to be notified each time nicotine vaping products are prescribed during the period of approval (5 years). However, prescribers must report to the TGA every 6 months on the number of patients treated.
• There is no charge for applying, and prescribers will need to submit their name, address and AHPRA number.
• Apply to become an Authorised Prescriber of nicotine using the SAS & Authorised Prescriber Online System, or downloadable form.
• Allow sufficient time for the application to be approved, as the anticipated timeframe for review and approval is 48 hours.

2. Special Access Scheme

• The SAS allows practitioners to access nicotine vaping products for a single patient on a case-by-case basis.
• The SAS Category B application must be completed in full and include three patient identifiers, the patient diagnosis and indication, product details and prescriber details. The application requires clinical justification for the use of the product.
• Lodge SAS applications using the SAS & Authorised Prescriber Online System, or downloadable form.
• Allow sufficient time for the application to be approved, as the anticipated timeframe for review and approval is 48 hours.

3. Personal Importation Scheme

If nicotine is being accessed from an overseas supplier, a prescription can be written under the Personal Importation Scheme, with the following conditions:⁴

• Any prescriber can write a script for a single patient to access nicotine vaping products for personal importation. TGA approval for the prescriber is not required.
• The order should be accompanied by the prescription.
• Patients are not permitted to import more than 3 months' supply via the personal importation scheme in any one importation. If a patient wants to access more than a 3-month supply in a single importation, prescribers will need to apply for approval through the Authorised Prescriber Scheme or Special Access Scheme before providing the prescription.

As there are currently no TGA-approved nicotine vaping products, regulatory changes may create the perception of an uncertain clinical practice environment. However, this change provides an opportunity for GPs to have new conversations with patients about potential risks and benefits of nicotine vaping products, and how to reduce the risks associated with nicotine use.⁵ GPs can fully assess a patient’s need for nicotine vaping products and determine their willingness to try alternative approaches to smoking cessation.

The scheduling decision is in keeping with the RACGP’s current guidelines on smoking cessation.⁶ The guidelines state that nicotine vaping products are not recommended as first-line treatments for smoking cessation but are a reasonable intervention for those who have unsuccessfully attempted to stop smoking with approved pharmacotherapies and are still motivated to quit. The guidelines note the potential benefits of nicotine vaping products to assist in smoking cessation, which is consistent with recent evidence. ^7,8

Before prescribing nicotine vaping products, prescribers should ensure the patient is aware that:⁶

• there are no approved vaping products available
• the long-term health effects of vaping are unknown
• access to nicotine vaping products without a prescription is illegal
• in order to maximise possible benefit and minimise risk of harms, only short-term use to support smoking cessation is recommended
• dual (concurrent) use with tobacco smoking must be avoided.

Prescriptions are non-PBS and can be handwritten or added into medical software (eg, Best Practice: setup – customer preparations – add; Medical Director: Clinical – Recipes – add) in accordance with state and territory legislation.

• RACGP Guidelines: Supporting smoking cessation
• TGA: Nicotine e-cigarettes hub
• TGA: Information for Authorised Prescribers
• TGA: Special Access Scheme
• Policy and regulatory approach to electronic cigarettes (e-cigarettes) in Australia
• TGA: Standard for unregistered nicotine vaping products

• Telehealth smoking cessation MBS item

Recent studies with emerging evidence for nicotine vaping products to assist in smoking cessation:

• Chan GCK et al, 2021, A systematic review of randomised controlled trials and network meta-analysis of e-cigarettes for smoking cessation (Addiction Behaviour)
• Patnode CD et al, 2021, Interventions for tobacco cessation in adults, including pregnant persons (JAMA)
• Wang RJ et al, 2021, E-cigarette use and adult cigarette smoking cessation: A meta-analysis (AJPH)