The federal government is cracking down on vaping, particularly the importing of nicotine vaping products (NVPs) and the rise in the illicit NVP market with its impact on children and adolescents.
Health and Aged Care Minister Mark Butler, speaking with journalist David Speers in an interview for the ABC’s 7.301 current affairs program in early May, described vaping as “a public health menace particularly impacting younger Australians”, referring to the strong action his government has taken to reduce smoking and stamp out vaping.
“Following public consultation led by the Therapeutic Goods Administration in December 2022, the government is proposing stronger regulation and enforcement of all e-cigarettes, including controls on their importation, contents and packaging,” Mr Butler said in a statement.2 “The government will work with states and territories to stamp out the growing black market in illegal vaping.”
He added that this would include:
- Stopping the import of non-prescription vapes.
- Increasing the minimum quality standards for vapes, including by restricting flavours, colours and other ingredients.
- Requiring pharmaceutical-like packaging.
- Reducing the allowed nicotine concentrations and volumes.
- Banning all single-use, disposable vapes.
With vaping issues the focus of increased media attention recently3 and with the government’s proposed legislation changes around smoking and vaping – part of the measures included in a $737 million fund allocation in the 2023-24 budget “to protect Australians against the harm caused by tobacco and vaping products”2 – it’s important for pharmacists to be abreast of the changes and how they affect pharmacies.
“Vaping was sold to governments and communities around the world as a therapeutic product to help long-term smokers quit,” Mr Butler said. “It was not sold as a recreational product – especially not one targeted to our kids, but that’s what it has become.
“Australia needs to reclaim its position as a world leader in tobacco control.
“These reform measures will help protect the health of Australians while reducing the pressure on our health system, and critically, they’ll help to achieve a reduction in smoking rates to five per cent or less by 2030.”
Nicotine vaping laws
Currently in Australia, NVPs can be lawfully obtained only through a pharmacy with a prescription from a medical professional. This law came into effect on 1 October 2021 when the nicotine vaping laws were changed in response to “a significant increase in the use of NVPs by young people in Australia and in many countries”.4
The TGA said in a 2021 statement:5 “There is evidence that [NVPs] act as a ‘gateway’ to smoking in youth, and exposure to nicotine in adolescents may have long-term consequences for brain development. The changes strike a balance between the need to prevent young people from taking up [NVPs], while allowing current smokers to access these products for smoking cessation on their doctor’s advice.”
Since 1 October 2021, all NVPs have been Schedule 4 (prescription only) medicines, meaning “consumers require a prescription for all purchases of NVPs”, including “purchases from pharmacies and overseas”.5
According to the TGA, no NVPs currently on the market are approved by the TGA or registered in the Australian Register of Therapeutic Goods (ARTG). This means NVPs are considered “unapproved medicines”.5 The only way to dispense NVPs is to follow the established pathways set out by the TGA.
“The main pathways for Australians to dispense unapproved NVPs are the Authorised Prescriber (AP) scheme and Special Access Scheme Category B (SAS B),” the TGA said in a 2022 statement.5
In 2021, the TGA also introduced a new standard specifically for unapproved and export-only NVPs. This is known as the ‘Therapeutic goods standard for nicotine vaping products order 2021’ (TGO 110) and came into effect on 1 October 2021. It includes “minimum safety and quality requirements for unapproved NVPs”.5
So, how does this relate to pharmacies?
The TGA says pharmacies may source unapproved NVPs from “Australian sponsors and/or wholesalers or directly from overseas” and can “hold the unapproved NVPs in your dispensary until you receive a prescription” from an AP or under an SAS.5 However, pharmacies are advised to check with the NVP sponsor or wholesaler “about conformance to TGO 110 prior to ordering the products”.5 The TGA warns pharmacists that only products that conform to TGO 110 requirements should be dispensed.5
According to the TGA, “pharmacists can dispense a prescription for NVPs with evidence of an AP or SAS B approval, subject to any applicable state or territory restrictions or requirements”.5
Only via pharmacies on prescription
Referring to this year’s vaping law changes, Minister Butler said on the 7.30 program: “The only way companies will be able to import vapes is to demonstrate that they’ll be for sale through a pharmacy on prescription by a health professional and that they comply with new standards.
“No more bubble gum flavours, no more pink unicorns on the wrappers – they’ve got to be pharmaceutical style with plain flavours, and not disposable.
“There’ll be products that are assessed against standards set in place by the TGA. At the end of the day, a sponsor needs to submit a product for approval … if there are products in the marketplace that comply with the standards, they need to be free of chemicals that the TGA lists as particularly dangerous [and] they need to be at particular nicotine levels – as well as all the other things I’ve set out around flavouring and presentation.
“If they’re compliant with those standards and can be prescribed by doctors as a smoking cessation device to help people with nicotine addiction, that’s something that will be able to be imported and sold through pharmacies only.
“Vaping is an emerging technology and we’ve got the chance to nip this in the bud. It’s going to be difficult because it really has flourished over the last two or three years.”
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This feature was originally published in the July issue of Retail Pharmacy magazine.