TGA pokes its nose into nicotine-script mills

4 minute read

General Practice Smoking

By

Laura Woodrow

Joining the single-product-clinic gang alongside cannabis and Ozempic are vape-only prescribers.

The TGA is investigating telehealth companies offering only nicotine vape prescriptions for illegal advertising, as the sector raises concerns over vertical integration and unsafe models of care.

“Although [vape-only prescription] services are not illegal, advertising them could, depending on the context, amount to encouraging patients to request a particular prescription medicine and may therefore amount to unlawful advertising of that prescription medicine,” a TGA spokesperson said.

The platforms under investigation include medicalnicotine.com.au, myduke.com.au, quitmate.com.au and medmate.com.au.

The TGA did not provide any further information as the investigations are ongoing.

At the beginning of this month, the federal government introduced new laws that limit access to nicotine vapes to prescription-only.

In the wake of this change, it seems vape-only prescription platforms may join those dedicated to cannabis and weight-loss-drug telehealth prescribers.

Such providers have proved a divisive topic among GPs, with some criticising the confusing business model while others praise the accessibility.

Some of the companies under investigation have adopted vertically integrated business models, mirroring those adopted by some cannabis-only prescription platforms.

While these models are legal, they, unsurprisingly, put regulators on edge.

One such culprit, MEPH Pharmacy Ltd’s MyDuke, under investigation by the TGA, requires that patients redeem prescriptions issued through their service at MyDuke’s online pharmacy.

A spokesperson for MyDuke said that they were “unaware of any assessment by the regulator” and that smoking cessation was “no different” to the other tens of thousands of telehealth consultations untaken in Australia daily.

MEPH Pharmacy Ltd has previously been fined almost $40,000 for unlawful advertising of nicotine vapes.

Similarly to MyDuke, SmokerHealth, previously MedicalNictoine, provides online scripts that must be used at Quitmed.

In an email to customers in February, the company said that as “1 March looms ever close”, “there are already some excellent online pharmacy options for ordering products, with delivery anywhere in Australia within days”.

Speaking to The Guardian, RACGP president Dr Nicole Higgins said that patients should be allowed to choose where to use their prescription.

“To all people using nicotine products, I encourage you to have a chat to your GP about quitting,” she said.

“We can talk through a full range of options, rather than just pushing you towards one particular product or service. 

“Remember too, GPs provide holistic care and will take full account of your circumstances and medical history.”

Chief executive of the Consumers Health Forum, Dr Elizabeth Deveny, urged patients to remember that there may be “good clinical reason” for doctors to not prescribe nicotine vapes for smoking cessation.

“We are concerned this model, ‘quickly go over here and get a service’ where you might pay upfront, means you get it quickly but without the same questions asked [as your own GP would ask],” she said.

“We’re not sure that model necessarily ticks all the boxes that we want to see in a safe, person-centred, high-quality model of care.”

The Medical Board of Australia raised concerns over prescriptions which may be issued without a consultation by some of these online services.

“Prescribing or providing healthcare for a patient without a real-time direct consultation, whether in-person, via video or telephone, is not good practice and is not supported by the Board,” said the board.

According to Guardian Australia, who used the SmokerHealth platform in February, a six-month script for nicotine vapes was issued within minutes, following a $40 payment and a short questionnaire.

A Pharmaceutical Society of Australia spokesperson said that vaping is not a first-line treatment for smoking cessation.

“The body of scientific evidence points to registered Nicotine Replacement Therapy, and other prescription-only medicines as being the most effective way to quit, in combination with supports such as Quitline or health professional consultations.

“The PSA’s view remains firm in that it is not the role of health professionals, including pharmacists, to recommend unregulated products purporting to be therapeutic goods to patient.”

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Amid the growing demand for smoking cessation support, Sydney’s Ramsay Mental Health has opened a “first of its kind” clinic in St Leonards.

The clinic will be run by Professor Renee Bittoun, an expert in smoking cessation who opened Australia’s first smokers’ clinic in the 80s.

The clinic offers a “comprehensive vaping cessation program” for people of all ages.

According to Professor Bittoun, children as young as 12 are seeking vaping cessation help.

“The use of vapes has increased dramatically in recent years, particularly among young people,” Professor Bittoun said.

“Marketing campaigns often target teenagers and young people, hoping to get them addicted for life.

“The younger you are when you start your exposure to nicotine, the harder it is to quit.”

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Ken Lambert
Ken Lambert
8 months ago

I’m angry at the stupid policy around vapes that is driving up illegal potentially dangerous imports and now these clinics. I get that vapes are a huge emerging problem for adolescent and young adult users. We have an insane situation where plus 18s can get cigarettes from the local servo but getting a life long rusted on smoker who has already failed multiple smoking ceasation attempts, done significant damage to their lungs and heart, cannot get access to much more safe nicotine vapes except for the idiotic special prescription scheme. The safety of this is well established in the literature. Just make it easy for us to prescribe rather than near impossible for those above 40 who have had at least 20 pack years up their sleeve.

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Colin Mendelsohn
Colin Mendelsohn
8 months ago

If these telehealth clinics are a problem, the RACGP needs to take responsibility for them. The RACGP supports the prescription model, but very few GPs are willing to prescribe. Dr Higgins’ advice to “chat to your GP” is a waste of time in most cases.

Telehealth services have arisen to meet the need and are the only way to legally access regulated vapes for many. Dr Higgins can’t have it both ways.
 
The PSA spokesperson is quite wrong in claiming that NRT and other prescription medicines are the most effective way to quit. The latest Cochrane review found high-quality evidence that vaping was more effective than NRT (RR 1.59) (Lindson 2024). A Cochrane network meta-analysis also found that vaping and varenicline are the two most effective monotherapies. (Lindson 2023)

4
Joe Kosterich
Joe Kosterich
8 months ago

As usual, government agencies wring their hands over problems that they have created through their misguided policies.
They refuse to learn that banning something which people want and that does no harm to anyone else does not and will never stop demand.
In turn there will be money to be made in catering to the demand.
The solution remains simple- adopt theNZ model.

3
Carolyn Beaumont
Carolyn Beaumont
8 months ago

20,000 annual Australian smoking-related deaths. That is approximately 2.5 times the Covid death rate in Australia. Let’s keep that figure at the forefront of every health policy. It is tragic, it is happening every day, and it is not slowing. Lung cancer – approximately 90% are smokers. Life expectancy from diagnosis averages less than 5 years. Stroke, heart attacks, vascular disease, respiratory disease, other cancers, fertility and neonatal issues. Financial consequences, money spent on cigarettes instead of food, education, electricity. In so many ways, cigarettes contribute to the cycle of poverty and socio-economic inequality.

Vaping is contentious, but can be a lifesaver for thousands of adult smokers. It IS effective, much evidence supports this. And of course we also need to reduce youth uptake and the blackmarket, which go hand in hand. Providing relatively easy access for adults to pharmacy-only vapes is sensible. If they can buy cigarettes practically anywhere, then we need to replace that with an equally accessible and safer alternative. 20,000 smoking-related deaths deserve no less.

As the founder and GP for SmokerHealth (formerly MedicalNicotine), I need to dispute some allegations made against me. It is said that I ‘provide online scripts that must be used at Quitmed’. This is not wholly correct. Let me provide some context: In the evolving landscape of e-medicine, when e-scripts aren’t always available (as is the case with unregulated but legal vaping products), there is a need to think laterally and provide a legitimate script to pharmacists without the risk of script fraud and re-use.

I have spent months leading up to the March 1 personal importation bans, engaging with pharmacists nationally about the prescription vape model. There is much education to be done, and of the handful of Australian pharmacists who are prepared to stock vapes, they tend to have only 2-3 brands. One of which is owned by Big Tobacco. It is also very rare for a pharmacist to have liquids for open systems (which is what many adult vapers prefer). So although the ideal is for an adult ex-smoker to go to their local pharmacist for their preferred therapeutic vape, in reality this is simply not happening and likely won’t for sometime. I welcome the opportunity to discuss the many reasons why this is the case.

So I provide 2 script options – 1 is for physical pharmacies nationwide, and has at least 150 pharmacies who are happy with my process of providing a script in a safe and secure manner direct to that pharmacist. In my questionnaire, the patient selects from a dropdown list of participating pharmacies, and the script is valid for that pharmacy only. The second option is for the online pharmacy mentioned, Quitmed. It is true that for ONLINE pharmacies, I only work with one. That is for 2 reasons: firstly, they have, in my opinion, the largest range of pharmacy-grade therapeutic vapes in Australia, and are committed to expanding this range. This is a good thing for established adult vapers. They frequently tell me that without access to preferred products, they’ll simply buy a blackmarket vape or return smoking. It’s a sad reality, but we must face it. Secondly, due to the security and re-use reasons mentioned, the safest course of action is to send the script directy to the pharmacist rather than the patient. But I am always open to dialogue, and if the patient has a particular pharmacy (online or physical) not listed with me, then of course I’ll accomodate that.

Dr Elizabeth Deveny asserts that my model means ‘you get it quickly but without the same questions asked as your own GP would ask’. Anyone who knows me and my commitment to tobacco harm reduction, reducing youth uptake and reducing 20,000 Australian smoking-related deaths every year, would know that I am one of Australia’s most seasoned clinicians in the field. This is borne through 4 years of conversations with smokers, through engaging in global research, with scientists, health practitioners, and consumer groups. I know the questions to ask, and I know how much information I can honestly expect a smoker to volunteer at a first consult. I know how complicated their lives can be, that there are often co-existing mental health difficulties such as anxiety, ADHD, drug use. They can be edgey and suspicious of doctors in general. I focus on making the process easy, and gradually building the clinical relationship through repeat visits, email followup, phone calls (when timezones, jobs etc allow) and occasional newsletters.

It is worth addressing why I choose mostly written communication with my patients, rather than conventional phone or video consults. Firstly, timezones. I’m in Victoria, and many patients are from WA. There’s a 3 hour gap, so realistically I can’t make calls until midday. Consider also that as a whole, heavy smokers are more likely to work jobs such as construction, mining or hospitality. These jobs don’t lend themselves to taking time out for a phone consult. In the early stages of my business I did talk to every patient, and from that I gained much knowledge about their needs and the general nature of the adult heavy smoker cohort. It also involved many missed calls and time spent trying to follow them up. I have found my current model simply works much more effectively, and I have much positive patient feedback.

I am committed to making the pharmacy vape model work, and I continue to educate pharmacies where I can. However, we have a long way to go. There is much media misinformation about the effectiveness of vaping for smoking cessation, and unfortunately the constant barrage of negative coverage flows through to the opinions of health professionals.

With the greatest respect for the Medical Board of Australia, I do disagree with their comment that my method of e-medicine is not ‘good medical practice’. I am a GP, and for 4 years now I have worked solely in this field. I have many many loyal patients, and there is certainly continuity of care albeit in a less conventional manner. I have pages of anecdotes about their difficulties with the firstline NRTs, and why vaping has been successful for them. Until I started working in this field, I had no appreciation of the difficulties adult smokers face if NRT fails. I am also aware that adults vape for a variety of reasons – the social and behavioural ritual, the calming/relaxing aspect, the way that vapes can mimic the nicotine delivery of cigarettes in a way that other NRT can’t. The health benefits they report since stopping smoking are phenomenal, and they frequently acknowledge quite openly that if it weren’t for vapes, that they would simply resume smoking even though they hate that. Many adult smokers have had negative experiences with doctors in the past, feeling judged and not heard. Their ideas, concerns and expectations are not always met, and so they are often somewhat wary with me initially. What I have found to be very effective, is the written questionnaire style. It is NOT brief, but rather is a highly revised questionnaire over 4 years that captures relevant information about their smoking and vaping needs, and medical history. I would also suggest that the relative ease of writing, rather than having to speak to a doctor and risk further judgement, encourages my patients to really open up. And indeed they do. I have 4 years evidence of this, and their lived experiences make for compelling reading. I have presented to international conferences about this.

The Guardian Australia state that I provided a script ‘within minutes’ after a ‘short questionnaire’. As mentioned, my questionnaire is relevant and based on experience. It may appear short (I disagree), but it provides adequate scope. The script can often be issued very quickly, as I am generally at the computer when questionnaires come in, and the review does not take long in simple cases. Obviously sometimes their answers require contact to clarify things before approving a script. In the case of The Guardian posing as a legitimate patient, I have it on authority that they selected a reason for vaping as ‘relaxing’. This is actually one of the most common reasons adults choose to vape (and smoke), so it did not create any red flags for me. My rationale is that it is better to provide a script for a pharmacy vape, otherwise the person will likely buy a blackmarket vape or smoke.

In my view, having continuity of care is the ideal. But it starts with the patient-doctor relationship, with them not being judged, and with being able to easily access a script for a legal pharmacy therapeutic vape. They can then continue their smoke-free journey on their terms, and then the real opportunity for preventive care occurs. That is why I recently established ‘SmokerHealth’, which is the more comprehensive telehealth service that follows on from the initial vaping script. It is a bulkbilled service, that every patient is invited to sign up to. It provides lung cancer screening, and cardiovascular and respiratory disease management. It aims to prevent the 20,000 Australian annual smoking-related deaths, and starts with the small step of gaining their trust.

I am always open to discussion, and being as human as the rest of us I acknowledge there may be aspects of my business model that need adjusting. I welcome the opportunity for the pharmacy vape industry to be accessible to all adult smokers and vapers, as it will play a crucial role in stopping the blackmarket and reducing youth uptake and will, quite simply, save lives.

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