Script needed

woman vaping in a restaurant

Nicotine e-cigarettes laws are changing from 1 October, reminds the TGA, with pharmacists to play ‘an important role’

The TGA has published a reminder that Australians who use nicotine e-cigarettes or nicotine liquids will need a valid Australian medical prescription to access these products from 1 October 2021.

From that time, a script will be required to legally access nicotine e-cigarettes and nicotine vaping products for any purpose, including importing from overseas online retailers.

“This will provide an opportunity for consumers to receive appropriate medical advice on the use of, and risks associated with, these products,” said the TGA.

“Certain other novel nicotine delivery products will also require a prescription, including heat-not burn tobacco.”

Nicotine replacement therapies such as sprays, patches, lozenges and chews that do not require a prescription will continue to be available from pharmacies and some retail outlets.

The changes do not apply to e-cigarette products that do not contain vaporiser nicotine.

There are currently no TGA-approved nicotine e-cigarettes on the ARTG. However recent changes mean that medical practitioners may apply for Authorised Prescriber approval to prescribe nicotine as an aid to quit smoking.

A medical practitioner can also apply to the TGA for authority to prescribe the unapproved product through the Special Access Scheme.

Pharmacists can therefore dispense a prescription for nicotine e-cigarettes with evidence of a Special Access Scheme or Authorised Prescriber approval.

The TGA added that pharmacists can extemporaneously compound as long as they meet Pharmacy Board of Australia requirements.

Meanwhile pharmacy wholesalers can apply for an import declaration from the Australian Border Force under an Import Declaration (N10) or Self-Assessed Clearance (SAC) declaration.

The Pharmacy Guild said the changes are necessary to protect public health, and community pharmacists will play a big role on the frontline.

“The decision to require a prescription to access nicotine e-cigarettes and nicotine liquids is an important measure to protect consumers, and to assure pharmacists that products being supplied have been assessed for safety and quality,” Anthony Tassone, Victorian branch president of the Pharmacy Guild, told AJP.

“The Guild acknowledges there are benefits as well as risks associated with the use of nicotine. It should only be used for smoking cessation purposes.

“It also recognises there are some public health concerns associated with the use of nicotine in e-cigarettes,” said Mr Tassone.

“The Guild believes the availability of nicotine containing e-cigarettes on prescription should be to facilitate access for smoking cessation purposes only.

“As the most frequently visited and accessible primary healthcare destination in Australia – community pharmacies will play an important role in patients accessing these products when they become available.”

The scheduling decision is in keeping with the RACGP’s current guidelines on smoking cessation, said NPS MedicineWise in a recent article.

“The guidelines state that nicotine vaping products are not recommended as first-line treatments for smoking cessation, but are a reasonable intervention for those who have unsuccessfully attempted to stop smoking with approved pharmacotherapies and are still motivated to quit,” it said.

“The guidelines note the potential benefits of nicotine vaping products to assist in smoking cessation, which is consistent with recent evidence.”

Prescriptions are non-PBS and can be handwritten or added into medical software, said NPS MedicineWise.

All should include nicotine concentration (in mg/mL), volume of liquid (or number of pods) for 3 months’ (90 days) supply, and number of repeats if clinically appropriate, it added.

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