Published by InSight+ on 8 July 2024: https://insightplus.mja.com.au/2024/26/pharmacies-will-soon-be-able-to-supply-vapes-without-prescription-how-might-it-work-in-practice/
Pharmacists will be able to supply therapeutic vaping products without a prescription from October 2024. This policy represents a substantial change in practice and is being implemented in a short timeframe. What will this mean for current prescribers, pharmacists and patients?
To secure support from the Greens for the next stage of vaping regulation reforms, the Health Minister, the Hon Mark Butler, agreed to amend the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 to remove the prescription requirement for supply of therapeutic vaping products. Sale of all vaping products (regardless of nicotine content) outside of pharmacies will be illegal after 1 July 2024. A prescription from a medical or nurse practitioner will be required until 1 October, thereafter therapeutic vaping products will be moved to Schedule 3 of the Poisons Standard, allowing them to be supplied by pharmacists to adults without a prescription.
In April this year, we published a proposal for pharmacist-only supply of vaping products. Although the amended bill adopts some of our proposal, there are several key differences. In the plan we laid out, the down-scheduling of nicotine vaping products to pharmacist-only supply (Schedule 3) would be supported by a period of consultation with the pharmacy profession, and time for a clinical advisory group to develop guidelines for training, accreditation and dispensing. Based on timelines of other pharmacy practice changes, we estimated 18–24 months for this process, assuming support from pharmacists. Instead, the amended bill has passed without a consultation process and the new classification will commence in three months.
We also recommended pairing the Schedule 3 classification with extra requirements that could be specified in Appendix M of the Poisons Standard, including specific training for pharmacists on vaping products, and possibly real-time monitoring of sales. The announced policy omits these additional requirements.
Furthermore, our proposal did not address supply of vaping products that have not been through the standard Therapeutic Goods Administration (TGA) approval process. In general, therapeutic goods must be approved by the TGA before being supplied in Australia. To be approved, sponsors must supply evidence of quality, safety and efficacy of the product, which is assessed by the TGA. There are currently no TGA-approved vaping products, however, the TGA have encouraged vaping product manufacturers to seek such approval.
What are the current requirements for supply of vaping products?
There are some restricted pathways for supply of unapproved therapeutic goods. Because there are no TGA-approved vaping products, it is via these pathways that nicotine-containing vaping products that meet a quality standard developed by the TGA (TGO110) have been supplied.
Like any other manufactured unapproved therapeutic good, supply of nicotine-containing vaping products by pharmacists currently requires a prescription from a medical or nurse practitioner, who then report some details of these prescriptions to the TGA.
General retailers, such as tobacconists, were permitted to sell nicotine-free vaping products under tobacco control laws until 1 July 2024 in most states and territories. Vaping product sales have been banned in Western Australia since 2014.
What happens now?
The amended bill that has been passed by Parliament will allow all vaping products to be Schedule 3 after 1 October, irrespective of whether they have been through the usual TGA approval process. Therefore, the supply of both approved and unapproved vaping products by pharmacists without a prescription will be permitted.
This does not mean pharmacies will start selling strawberry cheesecake flavoured vapes to anyone who requests one, or to children. Pharmacists are health care professionals who operate under professional codes of practice and within legislative requirements. They will need to assess the patient’s therapeutic need and provide counselling before supply occurs. Additionally, the TGA are tightening the product standards and quality control requirements for all therapeutic vaping products, such as restriction on allowable flavours (only mint/menthol and tobacco flavour permitted), packaging and labelling requirements (pharmaceutical style plain packaging), and the maximum nicotine content allowed (no more than 20 mg/mL base nicotine equivalent).
Furthermore, it will be for individual pharmacies to decide whether to supply vaping products without a prescription. Although pharmacists have a proven track record of delivering similar interventions, not all pharmacies currently have the necessary time, space and resources to deliver this new service. Planning for this additional service provision would ideally have been addressed via in-depth consultation with the profession prior to the passing of this legislation. Because pharmacist supply of unapproved therapeutic goods without a prescription represents a major practice change, the pharmacy profession should have been more involved in the rescheduling decision and given time to consider and address important concerns such as professional indemnity.
Pharmacies may therefore choose to continue to supply unapproved vaping products only on prescription.
What are the benefits of this policy change?
Firstly, the new law ends the legal supply of vaping products outside a health care context from 1 July and should make enforcement efforts related to illegal vaping product supply easier.
The greater patient access that pharmacist-only supply provides, and the likely preference of pharmacists to only dispense TGA-approved vaping products, may encourage vaping product manufacturers to invest in obtaining TGA approval. This regulatory change may thereby contribute to improving the quality of vaping products available in Australia.
One of the concerns of the prescription-only (Schedule 4) classification for vaping products was that possession of a Schedule 4 medicine without a prescription is an offence in every Australian state and territory that can incur serious penalties. Removing the mandatory prescription requirement aligns with the government’s intention to avoid criminalising individuals in possession of vaping products for personal use only.
Where to from here?
Medical and nurse practitioners will continue to have a critical role in prescribing vaping products for treatment of nicotine dependence both before and after 1 October. Medical and nurse practitioners and pharmacists will also require guidance on how to assist people who want to stop vaping.
Given the change in regulations, the pharmacy profession will need to shape how a pharmacist-only model for therapeutic vaping product supply operates in practice by developing professional standards, codes of practice, and training programs for pharmacists who wish to participate.
Currently, advertising restrictions apply to Schedule 3 products. Although the restrictions on advertising and signage related to vaping products should continue, some controls may be needed on product storage within the pharmacy (eg, out of sight). Pharmacies that elect to supply unapproved vaping products only on prescription after 1 October should be permitted to communicate this policy via in-pharmacy signage.
Further consideration should be given to recording and monitoring vaping product supply, with or without prescription. Centralised recording of patient details and the products supplied can help to ensure supply remains within therapeutic limits, assist with adverse event monitoring, and reduce the risk of diversion to non-therapeutic use.
Public education is urgently needed. The public may get the impression from some media reporting that all pharmacies will have vaping products in stock (and will supply these without a prescription, and without any questions) from 1 October. We think this is unlikely.
In conclusion, there is significant detail to be worked out for how a pharmacist-only model for vaping products will operate. The late-stage amendments to the bill will have implications for prescribers, pharmacists and patients. The model itself, however, can be effective if properly supported and if concerns such as professional indemnity are addressed.
Pharmacists are trusted health care professionals who are experienced in the supply of a wide range of therapeutic goods, including those for the treatment of nicotine and other drug dependence. However, ensuring pharmacists are supported and adequately resourced to implement this policy change will be critical to its success.
Professor Coral Gartner is an ARC Future Fellow, and the Director of the NHMRC Centre of Research Excellence on Achieving the Tobacco Endgame in the School of Public Health at the University of Queensland.
Dr Samuel Brookfield is a Senior Principal Social Scientist with the NHMRC Centre of Research Excellence on Achieving the Tobacco Endgame in the School of Public Health at the University of Queensland, and a clinical nurse at the RBWH Emergency & Trauma Centre.
Associate Professor Kathryn Steadman is an academic in the School of Pharmacy at the University of Queensland with a multi-disciplinary research program focusing on answering clinical questions using pharmaceutical science methods.
Professor Lisa Nissen is currently the Program Director of Health Workforce Optimisation at the Centre for the Business & Economics of Health, The University of Queensland. Lisa represents the pharmacy profession and provides advice on the role of pharmacists in health care and the quality use of medicines to local, national and international groups; this has included organisations such as the Commonwealth Department of Health and Aging, the International Pharmacy Federation, and the World Health Organisation.
