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Prescriptions required for legal use of e-cigarettes

From 1 October 2021, Australians will require a prescription to legally access e-cigarettes containing nicotine (e-cigarettes), liquid nicotine,1,2 and other novel nicotine delivery products, such as heat-not-burn tobacco products.3

Read about the Therapeutic Goods Administration’s decision about e-cigarettes and what this means for prescribers.

Why is a prescription required for e-cigarettes?

In December 2020, the TGA made a final decision to amend the Poisons Standard for nicotine.1

The TGA recommended that from 1 October 2021:1

  • Schedule 7 (Dangerous Poisons) and Schedule 4 (Prescription Only Medicines) be amended to only allow nicotine in preparations for oromucosal or transdermal administration for human therapeutic use as an aid in withdrawal from tobacco smoking, or in tobacco prepared and packed for smoking
  • nicotine be added to Appendix D of the Poisons Standard, making possession without authority illegal (that is, other than in accordance with a legal prescription)
  • nicotine be removed from Schedule 6 (Poisons)
  • a new listing be added to Part 2 of the Poisons Standard (Containers), making it mandatory for child resistant closures to be fitted to liquid nicotine preparations when in Schedule 4.

Making e-cigarettes prescription only aims to reduce and prevent nicotine addiction among non-smokers, particularly adolescents. Allowing e-cigarettes to still be accessed via prescription considers the public’s demand for e-cigarettes to support their attempts to quit smoking.1

The TGA’s decision aligns with advice from medical experts in Australia, including the National Health and Medical Research Council and Australian Health Protection Principal Committee, who have warned about the harms of e-cigarettes.2

Further information about changes to nicotine scheduling can be found on the TGA’s website.

Why did the TGA make this decision?

The TGA’s decision considered the latest systematic reviews and reports published by the Irish Health Research Board, the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), and the Australian National University.1

The latest evidence shows direct health harms associated with e-cigarette use, concurrent use of e-cigarettes with tobacco products, and the potential for e-cigarette use to lead to nicotine addiction and tobacco use – particularly among adolescents.1

The TGA’s concern about nicotine addiction with e-cigarettes also extended to other electronic nicotine delivery systems, e-juice and heat-not-burn tobacco products.1

The TGA’s main reasons for making e-cigarettes prescription only were:1,2

  • e-cigarettes are no safer than other aids currently used to help people stop smoking
  • e-cigarettes don’t necessarily help people to stop smoking
  • risk of nicotine addiction for new or continuing e-cigarette users
  • novel nicotine delivery systems may encourage people to smoke
  • exposure to nicotine in adolescents may affect brain development, and potentially lead to learning and anxiety disorders
  • unknown toxicity of long-term exposure to heated and inhaled chemicals
  • risk of accidental exposure to children (particularly for liquid nicotine).

Time to develop prescribing guidelines and standards

A number of health peak bodies and professional organisations supported the TGA’s decision, including the Cancer Council, The Royal Australian College of General Practitioners (RACGP), the Public Health Association of Australia, The Pharmacy Guild of Australia and the Australian Medical Association.1

However, some supportive organisations also noted potential challenges for implementing the schedule changes in the absence of an approved product on the Australian Register of Therapeutic Goods.1

The organisations requested sufficient time to develop robust prescribing guidelines and quality and safety standards for unapproved products, to address excipients, labelling, limits on nicotine concentrations and volumes, and requirements for child resistant closures.1

Starting the changes from 1 October 2021 should allow time for businesses, health professionals and smokers to prepare for the changes.1

Further details on the TGA’s decision, including evidence supporting the changes, can be found in the TGA’s Notice of final decision to amend the current Poisons Standard – nicotine.

Australian Government response to the TGA’s decision

The Australian Government supports the TGA’s decision. The TGA’s decision follows extensive public consultation, is based on medical expert health advice, and is consistent with the existing ban on the sale of nicotine e-cigarettes without a doctor’s prescription in all Australian states and territories.2

The Government has responded with a range of measures to support the cessation of smoking and help prevent adolescents from starting smoking, including:2

  • development of a Telehealth Smoking Cessation item in consultation with RACGP, Australasian Medical Association and other medical experts (available by April)
  • provision of $1 million for an educational campaign.

Requirement for doctor–patient consultations

People who currently use e-cigarettes have raised concerns that making and attending medical appointments for an e-cigarette prescription will be inconvenient.1

In making their decision, the TGA considered the public’s concerns but felt that an appointment was required to safeguard the publics’ health against harms associated with nicotine addiction.1

Long-term health risks of e-cigarettes are still unclear. In addition, the TGA has not approved any e-cigarette product to help people quit smoking, despite having approved nicotine patches, gum, lozenges, mouth sprays and inhalators based on their proven efficacy and safety profiles.1

The TGA concluded that a doctor–patient consultation would ensure:1

  • other medications and nicotine replacement therapy (NRT) are discussed with patients before e-cigarettes are considered
  • patients can be advised on the appropriate use of higher quality e-cigarette products with reduced risks of injury
  • improved monitoring and management of long-term side effects from the use of nicotine e-cigarettes
  • increased likelihood that people will stop smoking and avoid relapse through behavioural and advice-based support.

What do Australian guidelines recommend?

When prescribing e-cigarettes, health professionals should consider the current body of evidence, and be guided by RACGP guidelines for supporting smoking cessation.1

The 2019 RACGP guidelines advise that health professionals from all disciplines can play an important role in supporting smoking cessation.4

All health professionals should systematically identify people who smoke and offer them advice and cessation treatment (or referral) at every opportunity.4

In the absence of contraindications, pharmacotherapy (NRT, varenicline or bupropion) is an effective aid when accompanied by behavioural support. Choice of pharmacotherapy is based on efficacy, clinical suitability and patient preference.4

Nicotine-containing e-cigarettes are not first-line treatments for smoking cessation.4

However, nicotine containing e-cigarettes may be recommended if a person: 4

  • has not been able to successfully stop smoking with approved medications, and
  • is still motivated to quit smoking, and
  • has brought up e-cigarette use with their health professional.

If an e-cigarette prescription is being considered, health professionals should educate patients on the following:4

  • No tested and approved e-cigarette products are available.
  • Long-term health effects of vaping are unknown.
  • Possession of nicotine-containing e-liquids without a prescription is illegal.
  • Only short-term use is recommended, to maximise possible benefits and minimise risk of harms.
  • Dual use with continued tobacco smoking should be avoided.

Further information about nicotine access can be found on the TGA’s website.

References

  1. Therapeutic Goods Administration. Notice of final decision to amend the current Poisons Standard – nicotine. Available at: https://www.tga.gov.au/scheduling-decision-final/notice-final-decision-amend-current-poisons-standard-nicotine (accessed 16 January 2021).
  2. Australian Government Department of Health. Media release: Preventing nicotine uptake by young Australians with prescription based vaping. 21 December 2020. Available at: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/preventing-nicotine-uptake-by-young-australians-with-prescription-based-vaping (accessed 16 January 2021).
  3. Therapeutic Goods Administration. Nicotine e-cigarettes: Information for medical practitioners, Available at: https://www.tga.gov.au/nicotine-e-cigarettes-information-medical-practitioners (accessed Feb 3, 2021)
  4. The Royal Australian College of General Practitioners. Supporting smoking cessation: A guide for health professionals. Available at: https://www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/supporting-smoking-cessation (accessed 16 January 2021).

 

This activity is sponsored by Frost & Sullivan.