Strict legal requirements to dispense nicotine vaping products for smoking cessation are now in use. What do pharmacists need to know?

For the past month, Australians who want to buy nicotine vaping products or electronic cigarettes (e-cigarettes) to quit smoking have had a new point of purchase: pharmacies.

Pharmacists will need to source and supply these nicotine products and may need to consult guidelines to navigate situations that are bound to crop up.

Nicotine vaping products have become increasingly popular both in Australia and overseas.¹ Between 2016–2019 there was an increase in Australians who had ever used an e-cigarette (from 9% to 11%).² And among younger Australians (18–24 years), 64% of those who currently smoke and 20% of those who do not smoke report having tried e-cigarettes.²

While these vaping products may be used to help quit smoking,³ there is limited evidence on their benefits as a quit smoking tool.³ While not currently first-line treatment for patients wanting to quit, they may be appropriate in certain situations. This includes people who have unsuccessfully tried approved treatments but still wish to quit smoking and have discussed e-cigarette use with their healthcare professional.⁴

 So what are the regulations, and what do pharmacists need to know? 

Since 1 October 2021 Australians have required a valid prescription to access nicotine vaping products.⁵ This includes nicotine e-cigarettes, nicotine pods and liquid nicotine.⁵ 

This change aims to⁵:

• prevent those who do not smoke (particularly adolescents and young adults) from taking up e-cigarette use
• allow people who currently smoke to access these products as a quit smoking aid with appropriate medical advice. 

Patients with a valid prescription may access these products either by importing from overseas or having their prescription dispensed at a pharmacy.⁶

Currently, there are no nicotine vaping products approved by the Therapeutic Goods Administration (TGA) and registered in the Australian Register of Therapeutic Goods (ARTG).⁷ They are therefore ‘unapproved’ medicines.⁷ 

The PSA, with support from the Commonwealth Department of Health, has developed Guidelines for pharmacists providing smoking cessation support.⁸ They cover information relevant to pharmacists to assist in the safe and appropriate use of these products, which includes:

• prescribing pathways
• accessing nicotine vaping products
• key counselling considerations
• compounding considerations.

AP has also compiled a series of questions to help. 

Question 1: A patient comes into the pharmacy and presents a prescription for a nicotine vaping product. Where do I start? 

Start with the basics. Pharmacists must adhere to all relevant standards and guidelines (e.g. Professional Practice Standards, version 5⁹ and the Pharmacy Board of Australia’s Guidelines for dispensing of medicines¹⁰) when dispensing nicotine vaping products.

Patients with a valid prescription for a nicotine vaping product may access the product through a pharmacy via the Authorised Prescriber Scheme (AP) or Special Access Scheme (SAS) Category B.⁷ When presented with a valid prescription pharmacists can dispense the product once they have confirmed approval through the AP or SAS pathways.⁷ There may also be certain state or territory requirements, and pharmacists must be aware of and adhere to these.⁷

Pharmacists must understand and identify safety considerations when dispensing nicotine vaping products that are relevant to an individual. This could include potential drug interactions between nicotine and other medicines and how to manage them, as well as storage considerations to avoid adverse consequences from occurring (e.g. accidental poisoning in children).⁸

Adequate counselling must accompany the dispensing of any nicotine vaping product for a patient to ensure appropriate use. Key counselling points may include⁸:

• how much and how often to use the product
• common adverse effects and how to manage them
• support available to help quit smoking (e.g. Quitline).

Patients should also be advised that nicotine vaping products are ‘unapproved’ products, and therefore have not been assessed for their safety, quality and efficacy.⁷ Further information about safety considerations and counselling points are covered in the PSA guidelines.

Pharmacists also have an obligation to monitor patients who are continuing treatment to ensure the product continues to be safe and effective for an individual.⁹ Pharmacists should report any adverse effects suspected to be related to nicotine vaping products to the TGA (www.tga.gov.au/reporting-problems).⁷

Question 2: How do I ensure that I am ready to supply nicotine vaping products to patients with a valid prescription?

Pharmacists should become familiar with the PSA Guidelines for pharmacists providing smoking cessation support.⁸

 This will provide pharmacists with information needed to ensure they are supporting patients consistent with the rules and regulations. The TGA Nicotine vaping products website (www.tga.gov.au/nicotine-vaping-products) has useful information relevant to pharmacists, prescribers and patients. The PSA Pharmacist to Pharmacist Advice Line is also available to PSA members.

Pharmacies may source unapproved nicotine vaping products to dispense to patients through either an Australian sponsor/wholesaler or directly from an overseas supplier.⁷ Pharmacists must only dispense products that meet the requirements of the TGA’s Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021¹¹ (TGO 110). The TGO 110 outlines the minimum safety and quality requirements of unapproved nicotine vaping products.⁷

If pharmacists choose to source products directly from an overseas supplier, they must ensure that these products meet the requirements of the TGO 110. In these situations, the pharmacy will be considered the sponsor of these products and will be required to meet the obligations set out in the TGO 110 for Australian sponsors. This includes appropriate record-keeping.⁷ Pharmacists should become familiar with these requirements.

They should also ensure that all relevant pharmacy staff have adequate knowledge about the change in requirements to access nicotine vaping products so that patients are supported and queries are answered accurately. There may be an increase in patient queries about how to access these products. 

Question 3: Can I extemporaneously compound nicotine vaping products?

Compounding is discouraged in most pharmacy environments given the hazards of handling liquid nicotine and regulatory challenges of complying with TGO 110. 

However, if pharmacists extemporaneously compound nicotine vaping products they must ensure adherence to requirements outlined in relevant standards and guidelines (e.g. Professional Practice Standards, version 5⁹ and the Pharmacy Board of Australia’s Guidelines on compounding of medicines).¹²

If pharmacists extemporaneously compound any nicotine vaping product they will be considered the Australian sponsor of the product. They therefore need to ensure the product meets all the requirements outlined in the TGO 110 for nicotine vaping products (including those related to labelling, packaging and ingredients) as well as maintain adequate records that adhere to these requirements.⁷

Question 4: Is there anywhere else Australians can obtain nicotine vaping products?

All patients in Australia require a valid prescription for nicotine vaping products from 1 October 2021.⁶ Patients may choose to have their prescription dispensed at a pharmacy or they may use the Personal Importation Scheme to import products from overseas.⁶ If patients choose to obtain nicotine vaping products through the Personal Importation Scheme they can only order a maximum of 3 months’ supply at once and a maximum of 15 months’ supply in a 12-month period.⁶ Patients should arrange for a copy of their prescription to be included in the packaging with the product to prevent it being held at the border by the Australian Border Force.⁶ If patients choose to import their own nicotine vaping products, they are encouraged to confirm with the overseas supplier that the product meets TGO 110 requirements, is appropriately labelled, has child-resistant packaging and has manufacturing controls.⁶ Further information for patients about accessing nicotine vaping products is available on the TGA website: www.tga.gov.au/nicotine-vaping-products-information-consumers

Question 5: Can I refuse to dispense a prescription?

If pharmacists choose not to dispense a prescription for a nicotine vaping product they must consider their obligations to the patient and their health and wellbeing. Document the refusal and any advice and information provided to the patient.⁹ Pharmacists must also consider any action they should take to fulfil their obligation to make the health and wellbeing of the patient their first priority.¹² This may include actions such as contacting the prescriber, or referring the patient back to their prescriber or another healthcare professional. 

Question 6: How should pharmacists respond to patients concerned about the new way to access nicotine vaping products?

Patients may be confused and concerned about the regulatory changes that have come into effect for nicotine vaping products. Pharmacists should reassure patients that these changes have been implemented to support safe and appropriate use of nicotine vaping products. These changes ensure patients who are using these products to help with quitting smoking can access these while also receiving appropriate medical advice and monitoring.⁶

Patients should also be advised that nicotine vaping products are ‘unapproved’ products and have not been assessed in Australia for their safety, quality and efficacy.⁵ If products are dispensed through a pharmacy, these changes support patients to obtain products that meet specified minimum safety and quality requirements.⁷ 

References

1. Douglas H, Hall W, Gartner C. E-cigarettes and the law in Australia. Aust Fam Physician 2015 Jun;44(6):415–8.
2. Alcohol and Drug Foundation. Vaping in Australia. 2021. At: https://adf.org.au/talking-about-drugs/parenting/vaping-youth/vaping-australia/
3. Australian Government Department of Health. About e-cigarettes. 2021. At: www.health.gov.au/health-topics/smoking-and-tobacco/about-smoking-and-tobacco/about-e-cigarettes
4. The Royal Australian College of General Practitioners. Supporting smoking cessation: a guide for health professionals. 2nd edn. East Melbourne: RACGP; 2019.
5. Therapeutic Goods Administration. Nicotine vaping product access. 2021. At: www.tga.gov.au/nicotine-vaping-product-access
6. Therapeutic Goods Administration. Nicotine vaping products: information for consumers. 2021. At: www.tga.gov.au/nicotine-vaping-products-information-consumers
7. Therapeutic Goods Administration. Nicotine vaping products: information for pharmacists. 2021. At: www.tga.gov.au/nicotine-vaping-products-information-pharmacists
8. Pharmaceutical Society of Australia. Guidelines for pharmacists providing smoking cessation support. Canberra: PSA; 2021. 
9. Pharmaceutical Society of Australia. Professional Practice Standards, version 5. Canberra: PSA; 2017.
10. Pharmacy Board of Australia. Guidelines for dispensing of medicines. 2015. At: www.pharmacyboard.gov.au/codes-guidelines.aspx
11. Australian Government. Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021. 2021. At: www.legislation.gov.au/Details/F2021L00595
12.  Pharmaceutical Society of Australia. Code of Ethics for Pharmacists. Canberra: PSA; 2017.

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