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Have GPs been supported for vaping to go prescription-only from October?


Anastasia Tsirtsakis


26/08/2021 4:28:18 PM

Patients are already being urged to see their GP ahead of the change to discuss their smoking cessation options, even though the TGA is yet to register any nicotine vaping products.

A man vaping.
By going the prescription only route, current smokers will be able to access nicotine vaping products for smoking cessation, while preventing uptake from adolescents and young adults, according to the

The use of nicotine vaping in Australia is on the rise, up from 9% in 2016 to 11% in 2019.
 
However, from 1 October, legislative changes will mean people have to obtain a valid prescription from their GP to legally obtain nicotine vaping products from overseas, including e-cigarettes, pods and liquid nicotine.
 
The Therapeutic Goods Administration (TGA) has urged people to consult with their GP to discuss their smoking cessation options to help prepare for the impending change.
 
But as the deadline draws near, there are concerns GPs will be left exposed – particularly as the regulator is yet to register any nicotine vaping products, despite reportedly working closely with several potential applicant companies.
 
Professor Nick Zwar, Chair of the Expert Advisory Group for the RACGP’s Supporting smoking cessation: A guide or health professionals, says this complicates matters for the prescribing doctor.
 
‘Nowhere in the world has a manufacturer of nicotine vaping products yet applied for and been recognised as a therapeutic good,’ he told newsGP.
 
‘So no nicotine vaping product has had the full assessment – effectiveness, safety – all of that sort of stuff that a medicine gets when it’s going to go on the register of medicines.’
 
Vaping products stocked and dispensed by an Australian pharmacy meet the Therapeutic Goods Order (TGO) 110 standard, which ensures the product includes an ingredient list, nicotine concentration, has childproof packaging, and excludes any prohibited ingredients.
 
However, Professor Zwar says those assurances do not change the fact that GPs would still be prescribing an unregistered product with uncertainties about long-term safety.
 
‘We just don’t know the long-term safety of nicotine vaping products,’ he said. ‘TGO helps a bit on that, but it’s not like a medicine where you produce a generic blood pressure tablet, for example, and it’s going to be tested and proven to be basically the same ingredients.
 
‘There are many, many manufacturers of nicotine vaping products from around the world, so it’s a much broader range than you would get if it was a medicine being produced by the pharmaceutical industry.’
 
He is also concerned that GPs, at this stage, have not been adequately prepared to prescribe nicotine vaping products.
 
‘Realistically, I think if patients go into their GP at the moment and ask about it, very few will be ready because there has been no widespread education program rolled out for GPs,’ Professor Zwar said.
 
‘There’s quite a lot of issues that need to be covered to help GPs to make an informed choice about whether they’re going to prescribe at all, and if so, to whom and with what and for how long, and when should they see the patient again.’

To help bridge the gap and support practitioners, the RACGP is preparing a revised guideline for the use of vaping products and has also been funded to create an education module for its smoking cessation guidelines.
 
But due to limited evidence, the college’s current guidelines still only recommend nicotine containing vaping products as a second-line treatment.
 
And while GPs wait for more clarity, Professor Zwar fears they may find themselves in the firing line of some patients, particularly those who have been importing and consuming vaping products for years.
 
‘If it’s not happening already, it’ll be happening soon as people realise … that they need a prescription,’ he said.
 
‘GPs will be in a difficult situation of not being familiar with the pathways and whether they want to be involved or not. Unfortunately, it’s likely there’s going to be some pretty uncomfortable interactions between GPs and people.
 
‘But ultimately, it’s not the GPs’ fault – we didn’t make this decision; the decision was made by Government and then enacted by the TGA. So if people are unhappy, then it’s not reasonable for them to take it out on their doctor.’

Vaping-Article-1.jpg
The RACGP’s current smoking cessation guidelines only recommend nicotine containing vaping products as a second-line treatment.

Other countries including the US, Canada and UK also have prescription systems in place, but Australia is the only country in the world to restrict access to prescription-only.
 
To facilitate nicotine and smoking cessation counselling services, the Federal Government has introduced new temporary Medicare Benefits Schedule (MBS) items for face-to-face and telehealth consultations.
 
The TGA has also provided GPs with three pathways to prescribe nicotine-containing products:

  • Becoming an Authorised Prescriber – this is free and takes a few minutes
  • Through the Special Access Scheme
  • Providing a prescription for three months’ supply via the Personal Importation Scheme
If a GP and patient opt for the personal importation scheme, the patient will need to arrange for a copy of their prescription to be enclosed in the package being shipped to them, otherwise Australian Border Force officials will have the right to stop the import and destroy the product.
 
Currently, there is no requirement for the patient to have an established clinical relationship with the GP in order to claim the telehealth MBS rebate, which Professor Zwar says may make access easier in instances where the person’s own GP is not a prescriber, and where they struggle to find an alternative locally.
 
The move to make nicotine vaping prescription-only was flagged in September last year, when the TGA passed down an interim decision aimed at streamlining the process around access to bring it in line with local requirements for nicotine-containing products dispensed from Australian pharmacies.
 
‘These changes balance the need to prevent adolescents and young adults from taking-up nicotine vaping [and potentially smoking], while enabling current smokers to readily access these products for smoking cessation with appropriate medical advice,’ the TGA stated at the time.
 
While the changes were announced nearly a year ago, the legislation is still proving to be a divisive issue.
 
Vaping advocates argue the move will lead to former smokers relapsing, but Professor Zwar says this assertion has no evidence to back it up.
 
‘Smoking is still one of the most – if not the most – major preventable causes of disease and death in the country. So, clearly, we want to help people stop smoking and stay a non-smoker,’ he said.
 
‘Having said that, that doesn’t mean they should have access to products that could potentially be dangerous, [and] their efficacy for smoking cessation is still very much under investigation.
 
‘If you look at the best quality trials, there are only three and only one of them had substantial numbers of people involved. But that’s glossed over or not talked about by [vaping] advocates.
 
‘To say that caution and careful consideration of where nicotine vaping fits in and could be of assistance to reducing tobacco use … is “the wrong thing to do” and somehow would cause people to return to smoking and, ultimately, perhaps die of it – I just find that’s extraordinary as an assertion – and yet it is made as if it’s beyond dispute.’
 
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Dr Duncan MacWalter   27/08/2021 6:46:44 AM

The AZ covid vaccine seems to have shifted the boundary on risks, informed consent and patient autonomy.
I think it's awful that the Fed Govt are to weak to regulate nicotine vaping independently, and hide behind General Practice to take the risks for them.

But risk of death is about 1 per million (and that's mainly linked with cutting the vape with vitamin E and cannabis). Sound a familiar risk bracket?
We're 'happy' with opioid substitution programs the maintain stability.
We prescribe other drugs 'off-label' eg ozempic for weight loss.

I'm not a smoker, and this isn't an area I've a particular desire to get involved in, but I have friends who smoke of their out of vape liquid. And I've many patients that have moved from cigarettes to vapes knowing that although it might not be no-risk it's less-risk.


A.Prof George Theodore Somers   27/08/2021 9:44:00 AM

Non nocere. Prescribing likely harmful products with only potential benefit rails against this ethical oath. Prescribing dangerous goods to adults for the benefit of a completely different population - youths - is also not ethical. That is going on here for the medical profession to even countenance this imposition?


Dr Peter James Strickland   27/08/2021 10:42:12 AM

From the 1980s and 1990s era many heroin addicts found it easier to give up heroin than nicotine. Nicotine is very addictive, and on lighting up a cigarette has an effect of vasospasm within about 30 secs, and especially into the "family duals" in males, and thus affecting potency. By prescribing nicotine one is actually prescribing to a drug addict here, and it appears there is going to have to be a lot of Addict Clinics established to treat this problem in the community. It is NOT the responsibility of GPs to treat drug addicts unless they choose to do so ---if not, simply send the patients to the local Medicare/Centrelink office to seek advice on these Addict Clinics, and there will need to be a lot of them if smoking became illegal!