The TGA has made an interim decision to allow nicotine-containing solutions for vaping to be sold only through pharmacies
This week the TGA announced an interim decision that, if made final, would mean that certain nicotine-containing products could only be supplied with a doctor’s prescription.
“This is consistent with existing state and territory laws which make the sale of nicotine e-cigarettes/fluids (except for prescription medical use) illegal throughout Australia and its possession or use illegal everywhere but in South Australia,” the TGA says.
“The main impact of the decision, if confirmed through a final decision, is that importing these products purchased from overseas internet sites without a valid prescription would be illegal, and subject to impounding by the Australian Border Force.
“Personal imports under the TGA Personal Importation Scheme, with a valid prescription, are permitted.
“To support smoking cessation, the requirement for a prescription would provide an opportunity for patients to consult with their medical practitioner as to whether e-cigarettes or other products containing nicotine are right for you as an aid to stop smoking.
“Medical practitioners are well placed to support smoking cessation and advise on how to reduce the risks associated with nicotine use.
“It is anticipated that nicotine e-cigarette products for smoking cessation will be available from both community pharmacies and appropriate Australian online pharmacies.”
The TGA says that the requirement for a prescription will also prevent the rapid growth of youth uptake in vaping seen in Australia and overseas, and a potential pathway to cigarette smoking by young people.
“Between 2015 and 2019, e-cigarette use by young people increased by 72% in the US, 150% in Canada and 96% in Australia,” it warns.
It notes that the proposed changes would also not affect access to registered products to help smokers quit such as gums, sprays and patches.
A PSA spokesperson said that the organisation is currently consulting its members to formulate a response and will make a submission to the public consultation on the interim decision on the proposed changes to nicotine.
“PSA supports smoking cessation therapies but we are cautious about promoting nicotine products to Australians and echo the federal government’s concerns around protecting the health of children and young people,” they said.
“Pharmacists have a vital role in supporting people who wish to quit smoking. There are a range of approved smoking cessation products available and pharmacists can also support smoking cessation through evidence-based public health and harm minimisation activities.
“PSA is also considering the implications of the interim decision on pharmacists’ practice.
“For example, the requirement for a doctor’s prescription for e-cigarettes and other nicotine-containing products provides clarity on the mechanism for legal access for consumers, however, PSA notes there is currently no e-cigarette product registered in Australia.
“This would mean the wholesaler or pharmacist would be required to apply for a permit and arrange to import the product.”
When the issue was flagged earlier this week Anthony Tassone, Victorian branch president of the Pharmacy Guild, told the AJP that “a clear understanding of the evidence base will be crucial to do what’s best for patients”.
“The Guild’s current position, pending any announcement by the TGA in relation to scheduling, is that we currently don’t support e-cigarettes given the potential harm, as the risk profile for these products has not been well established previously against any therapeutic benefit,” he told the AJP.
“The TGA has previously not approved the use of e-cigarettes as a smoking cessation tool.
“If the TGA as a regulator now approves the nicotine containing e-cigarettes as a tool to help smokers quit, on a prescription-only basis, we will review our policy accordingly and the potential benefit for patients.”
Meanwhile the National Retail Association has issued a statement claiming that the “proposed monopoly for chemists” is “already unravelling” as pharmacist and doctor groups have raised such concerns.
Dr Stephen Bright, Senior Lecturer Addiction, School of Medical and Health Sciences, Edith Cowan University, said that “Anything we can do to reduce tobacco smoking in society is a good thing”.
“According to the British Medical Association, e-cigarettes are 95% less harmful than smoking.
“Vaping is a harm reduction strategy that is consistent with Australia’s national drug strategy.
“For vaping to be an effective harm reduction tool, it would be best for the product to be available over the counter in pharmacies, where health advice can be administered, without too much regulation.
“Pharmacies already stock nicotine products and are well placed to make sure nicotine for vaping is well regulated, though still easily available.
“There are concerns that if it is too hard to access vaping, then people may revert to smoking.”
Simon Chapman, Emeritus Professor in the Sydney School of Public Health at the University of Sydney, said that, “We made every conceivable regulatory error allowing tobacco to be sold anywhere, unregulated”.
“E-cigarettes have unknown long-term health consequences and are powerfully addictive. If they are to be made available, prescription access makes perfect sense.”
The interim decision will be open for public consultation until 6 November 2020, with a final decision expected in mid-December, with an implementation date of either 1 April or 1 June 2021. The public can sign up to webinars explaining the interim decision on 8 and 9 October 2020.