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Nicotine e-cigarettes: Information for medical practitioners
This page provides an overview of how medical practitioners can prescribe nicotine e-cigarettes and e-cigarette fluids for their patients where appropriate.
Nicotine e-cigarettes require a prescription
Electronic cigarettes, also referred to as e-cigarettes, electronic nicotine delivery systems (ENDS) or e-cigs, are products that heat a liquid ('juice') to make vapour for inhalation ('vaping').
From 1 October 2021, consumers will need a prescription from an Australian-registered medical practitioner to legally import nicotine e-cigarettes and liquid nicotine in Australia. This aligns with current domestic restrictions under State and Territory law that prohibit the supply of nicotine containing e-cigarettes in Australia without a valid medical prescription.
This measure is designed to prevent the use of such products by non-smokers, particularly youth and young adults. It will provide an opportunity for current smokers to receive appropriate advice from a medical practitioner on the use of, and risks associated with, these products.
Certain other novel nicotine delivery products will also require a prescription, including heat-not burn tobacco.
Nicotine replacement therapies (including sprays, patches, lozenges and chews) that do not require a prescription will continue to be available from pharmacies and some retail outlets.
Nicotine e-cigarettes are ‘unapproved’ products
Generally, therapeutic goods (such as medicines, medical devices and biologicals) must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported into, supplied in, or exported from Australia.
There are currently no TGA approved nicotine e-cigarettes in the Australian Register of Therapeutic Goods (ARTG). Medicines not included in the ARTG are known as ‘unapproved’ medicines. There are established pathways for legal access to unapproved nicotine e-cigarettes, with a doctor’s prescription.
Determine if nicotine e-cigarettes are suitable
You may determine that it is appropriate to trial nicotine e-cigarettes to assist with smoking cessation in your patient. To assist, in the coming months, TGA will publish further information resources on the use of e-cigarettes in smoking cessation e.g. from the NZ Ministry of Health.
The Royal Australian College of General Practitioners (RACGP) has published the second edition of Supporting smoking cessation: A guide for health professionals.
These guidelines stipulate that nicotine containing e-cigarettes are not first line treatment for smoking cessation. However for people who have tried to achieve smoking cessation with approved pharmacotherapies but failed, and who are still motivated to quit smoking and have brought up e-cigarette usage with their healthcare practitioner, nicotine containing e-cigarettes may be a reasonable intervention to recommend.
There are various smoking cessation aids included in the ARTG, including over-the-counter nicotine replacement therapies (including sprays, patches, lozenges and chews) and prescription medicines. There are also non-pharmaceutical approaches to smoking cessation.
Use an established access pathway
If you determine that an unapproved nicotine e-cigarette product is clinically suitable for a patient, there are three pathways to access the product:
- Authorised Prescriber scheme
- Special Access Scheme
- Personal Importation Scheme
If a patient intends to fill their prescription at an Australian (physical or on-line) pharmacy, you will need to apply to the TGA for access to the product through the Authorised Prescriber Scheme or the Special Access Scheme B before you provide a prescription.
A flow chart outlining the steps leading to dispensing the prescription is set out below.
Personal Importation Scheme
The Personal Importation Scheme allows Australian residents or visitors to import certain medicines from overseas for their own personal use or the use of an immediate family member, subject to conditions.
A valid prescription from an Australian-registered medical practitioner is required to import prescription only medications. Any medical practitioner who considers it is appropriate for their patient to use nicotine e-cigarettes for smoking cessation can prescribe nicotine e-cigarettes for personal importation. Medical practitioners do not need TGA approval to prescribe nicotine e-cigarettes for their patient when they access them through the personal importation scheme.
Individuals may import up to a three month supply of medicines per import (based on the maximum daily dose recommended by the manufacturer), but not exceed 15 months’ supply in a 12-month period. They should include a copy (scan or photocopy) of their prescription with the order.
If a patient needs to import more than a 3 month supply in a single import, you will need to apply for access to the product through the Authorised Prescriber Scheme or Special Access Scheme before providing the prescription.
Authorised Prescriber scheme
A medical practitioner may be granted authority to become an 'Authorised Prescriber' of a specified ‘unapproved’ therapeutic good (or class of unapproved therapeutic goods) to a class of patients with a particular medical condition. Recent changes to the Authorised Prescriber Scheme mean that medical practitioners may apply for Authorised Prescriber approval to prescribe nicotine e-cigarettes as an aid to stop smoking without the need for ethics committee approval.
Once a doctor becomes an Authorised Prescriber, they do not need to notify the TGA each time they prescribe the unapproved product during the period of approval. However, they must report to the TGA the number of patients treated every six months. For the five year duration of the approval, no further applications or permissions are required.
You can apply to become an Authorised Prescriber of nicotine, using the SAS & Authorised Prescriber Online System or downloadable forms. A simplified online form will be coming soon.
The AP nicotine application form will be published well ahead of 1 October 2021
For more information, refer to the Authorised Prescriber webpage.
Special Access Scheme (SAS)
The SAS provides for the import and supply of an unapproved therapeutic good to a single patient on a case-by-case basis.
For more information about SAS and how to submit an application, refer to the Special Access Scheme webpage. The SAS Online System is the preferred method of submission to reduce processing times for applicants.
We strongly encourage consumers and health professionals to report any suspected adverse events involving e-cigarettes.
The TGA has an important role in monitoring the safety of ‘unapproved’ medicines. Reporting adverse events helps us to build a profile of the safety of a medicine. Significant safety concerns are investigated as part of ensuring product safety in the Australian community.