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Nicotine e-cigarettes: Information for pharmacists
This page provides an overview of what pharmacists need to know in relation to dispensing nicotine-containing e-cigarettes or e-liquids in Australia.
Nicotine e-cigarettes require a prescription
Electronic cigarettes, also known as e-cigarettes, electronic nicotine delivery systems (ENDS) or e-cigs, are devices 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 access nicotine e-cigarettes and nicotine liquids in Australia. This will provide an opportunity for consumers to receive appropriate advice from a doctor and their pharmacist 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 on the Australian Register of Therapeutic Goods (ARTG). Medicines not included on the ARTG are known as ‘unapproved’ medicines. There are established pathways for legal access to unapproved nicotine e-cigarettes, with a doctor’s prescription.
If a medical practitioner determines that nicotine e-cigarettes are a suitable smoking cessation option for their patient, the medical practitioner can apply to the TGA for authority to prescribe the unapproved product through the Authorised Prescriber Scheme or the Special Access Scheme (SAS).
Recent changes to the Authorised Prescriber scheme mean that medical practitioners may apply for Authorised Prescriber approval to prescribe nicotine as an aid to stop smoking by submitting their name, AHPRA number and address on an online form. For the five year duration of the approval no further applications or permissions are required.
Dispensing nicotine e-cigarettes
Pharmacists can dispense a prescription for nicotine e-cigarettes with evidence of a SAS or Authorised Prescriber approval.
Pharmacists can also extemporaneously compound as long as they meet Pharamcy Board of Australia requirements.
Pharmacy wholesalers can apply for an import permit under the following pathways:
- Import Declaration (N10)
- Self-Assessed Clearance (SAC) declaration.
The flow chart below illustrates the steps leading up dispensing a prescription for nicotine-cigarettes.
Report side effects and problems
We strongly encourage consumers and health professionals to report any suspected side effects related to e-cigarettes.
The TGA has an important role in monitoring the safety of ‘unapproved’ products. Reporting side effects and problems helps us to understand the safety of a product. We investigate significant safety concerns as part of ensuring product safety in the Australian community.