Vaping decision closes loophole

The Therapeutic Goods Administration (TGA) has proposed amendments to clarify that nicotine products for e-cigarettes can only be imported for use when prescribed by a doctor.

“Nicotine is a poison, and the AMA opposes all use of nicotine-containing vaping products,” Dr Khorshid said.

“Exposure to nicotine can harm adolescent brain development, and nicotine vaping products contain carcinogens including formaldehyde and solvents.

“The evidence that vaping is effective as a quit smoking aid is inconclusive, but there is plenty of evidence that it causes harm. Multiple studies show that vaping can lead to previous non-smokers taking up tobacco smoking, and that people using vaping as a quit aid are significantly more likely to still be vaping after a year than people using nicotine patches or other therapies.

“The proposed change will stop people accessing nicotine for any use without a prescription, and will ensure that patients see their doctor for advice on the most reliable and safe smoking cessation methods.

“While doctors can already prescribe nicotine for vaping, it is very rare – the TGA estimates that only about 10 doctors in Australia currently do so.

“There is currently no TGA-approved nicotine vaping product, due to a lack of evidence of their efficacy or safety, and their use should be only as a method of last resort.

“While doctors are overwhelmingly reluctant to prescribe nicotine, the AMA anticipates an influx of patients asking their doctors for nicotine prescriptions for vaping when the changes come into effect, spurred on by a tiny but vocal minority of vaping advocates, backed by Big Tobacco.

“Doctors will need clear and well-communicated guidance on appropriate dosages and recommended timeframes for use. The AMA recommends including a time limit for prescribing these products to ensure that patients who do not intend quitting cannot have access to an ongoing supply.

“The prescribing criteria must also specify that nicotine-containing products may only be prescribed to current smokers, and we strongly recommend that the changes should be evaluated after 12 months to assess the impact on smoking rates.”

The AMA submission to the TGA is available here.

Dr Khorshid will give evidence today to the Senate Select Committee Inquiry into Tobacco Harm Reduction, which is examining the treatment of nicotine vaping products in developed countries similar to Australia, and any impacts on smoking rates.

The AMA submission to the Inquiry is available here.

Background

• Doctors can already prescribe nicotine for vaping products when used therapeutically, however, they must go through the TGA Access Pathways (Special Access Scheme, or Authorised Prescriber Pathway).
• Nicotine in vaping products for non-medical use is illegal to sell in all States and Territories, and illegal to possess in all States and Territories except South Australia.
• However, confusion exists around their importation from overseas because their illegal status is under State and Territory legislation.
• Changing the Schedule 4 entry for all human use would mean that nicotine for e-cigarettes would only be supplied in accordance with a doctor’s prescription.
• People with a prescription will be able to access the products under the TGA Personal Implementation Scheme, or through a pharmacy.
• There will be no difference to vaping shop sales, as selling nicotine for vaping products is already illegal in Australia.
• Sponsors/manufacturers cannot advertise unapproved products to the public or health professionals.
• If the interim decision is made official, the TGA has proposed an implementation date of 1 June 2021.