In the wake of the Therapeutic Goods Administration’s (TGA) move to make all nicotine vaping products prescription-only from 1 October 2021, we provide GPs with practical information on your prescribing responsibilities.
The reclassification of all nicotine vaping products to Schedule 4 medicines includes nicotine e-cigarettes, nicotine pods and liquid nicotine, and products purchased in Australia and from online overseas suppliers. Nicotine replacement therapies such as sprays, patches, lozenges, chews and gums will continue to be available without a prescription.
To coincide with this change, 18 temporary MBS item numbers for nicotine and smoking cessation counselling provided by GPs were introduced. These include face-to-face and telehealth items (video and phone) and are in effect until 30 June 2022.
Prescribing unapproved nicotine vaping products
There are currently no nicotine vaping products approved by the TGA and registered on the Australian Register of Therapeutic Goods, so any prescriptions provided would be of an ‘unapproved product’.
The TGA has developed a standard for unapproved nicotine vaping products, which also comes into effect on 1 October 2021. If you believe a nicotine vaping product is clinically appropriate for a patient, these products can be prescribed through the established pathways below.
Authorised Prescriber Scheme (APS)
For patients filling their script at an Australian (physical or online) pharmacy, a medical practitioner can fill in a downloadable or online form to apply to the TGA to be an Authorised Prescriber to supply nicotine vaping products.
Under the APS, doctors can prescribe a nicotine vaping product directly to a patient under their immediate care without requiring separate approval for individual patients. Doctors are required to provide reports of the patients treated to the TGA every six months.
Special Access Scheme (SAS)
This scheme allows medical practitioners to apply to the TGA for approval to prescribe nicotine vaping products for an individual patient on a case-by-case basis. Doctors can apply through the SAS Category B pathway for approval from the TGA before a prescription for a nicotine vaping product can be provided.
Personal Importation Scheme (PIS)
While the APS and SAS are the preferred prescribing pathways, under the PIS doctors can prescribe a three-month supply of a nicotine vaping product without the need for TGA approval. This allows the patient to import the product from overseas, providing certain conditions are met. There is less opportunity to be aware of what nicotine vaping products are being imported, thereby increasing the medico-legal risk for the prescribing doctor.
The RACGP’s smoking cessation guidelines state nicotine vaping products are not a first-line treatment for smoking cessation. However, they may be a reasonable intervention to recommend for patients who have unsuccessfully attempted to stop smoking with approved pharmacotherapies and are still motivated to quit.
The RACGP and NPS MedicineWise resources recommend that before prescribing nicotine vaping products, doctors should ensure the patient is aware:
- 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
- that to maximise possible benefit and minimise the risk of harm, only short-term use to support smoking cessation is recommended
- dual use with tobacco smoking should be avoided.
Doctors prescribing nicotine vaping products are responsible for adhering to the standards of good medical practice and obtaining informed consent. As with any ‘unapproved’ therapeutic product, a doctor’s responsibility also extends to the patient’s use of the product and any associated adverse reactions.
Doctors should make the patient aware of the need to return for regular monitoring and review to ensure the treatment’s ongoing efficacy and to manage any adverse events. The TGA strongly encourages health professionals and consumers to report any suspected adverse effects to help build a safety profile.
GPs who comply with the regulations, and who appropriately follow professional guidelines have cover under their Avant Practitioner Indemnity Policy* for claims and requests for indemnity in relation to prescribing nicotine vaping products, subject to the full terms and conditions of their policy.
*IMPORTANT: Professional indemnity insurance products are issued by Avant Insurance Limited, ABN 82 003 707 471, AFSL 238 765. The information provided here is general advice only. You should consider the appropriateness of the advice having regard to your own objectives, financial situation and needs before deciding to purchase or continuing to hold a policy with us. For full details including the terms, conditions, and exclusions that apply, please read and consider the policy wording and Product Disclosure Statement, which is available at www.avant.org.au or by contacting us on 1800 128 268.
TGA’s Nicotine Vaping products: Frequently Asked Questions
NPS MedicineWise: scheduling changes to nicotine
NPS MedicineWise and Department of Health’s flowchart: Accessing nicotine e-cigarettes and nicotine vaping products