E-cigarettes (vapes) – information for pharmacists

Vaping reforms

From 1 October 2024, therapeutic vapes with a nicotine concentration of 20mg/mL or less can be sold in Victorian pharmacies to patients 18 years or over* without a prescription as a Schedule 3 poison.

A pharmacist will need to be satisfied it is clinically appropriate for the purposes of smoking cessation or the management of nicotine dependence and fulfill the following steps:

• request and sight evidence of the patient's identity and age
• provide professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines
• provide contact details about smoking cessation support services to the patient
• ensure the quantity of the goods does not exceed the quantity that is reasonably required for a patient's therapeutic use for 1 month and that quantity is supplied to the patient only once in a month.

Pharmacists in Victoria must not supply e-cigarette (vaping) products to persons under 18 years of age. This includes a registered pharmacist supplying (dispensing) a vaping product on a prescription issued by a register medical practitioner or registered nurse practitioner.

Before supplying a vaping product pharmacists should familiarise themselves with Commonwealth requirements available at the Therapeutic Goods Administration.

These changes will help facilitate patient access while maintaining appropriate controls and protections.

Note, pharmacies are not required to obtain a licence to sell e-cigarette products in Victoria.

The Tobacco Act 1987

In Victoria, the Tobacco Act 1987 (Tobacco Act) prohibits the supply of vaping products to persons under 18 years of age. This includes a registered pharmacist supplying (dispensing) a vaping product on a prescription issued by a register medical practitioner or registered nurse practitioner.

It should be noted that whilst the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 2017 authorises a registered pharmacist to supply a vaping product on a prescription issued by a register medical practitioner or registered nurse practitioner, this authorisation does not override the prohibition of supply of vaping products to persons under 18 years of age under the Tobacco Act 1987 in Victoria.

The Tobacco Act 1987 prohibits the sale of vaping products to a person under 18 years. This includes online sales and deliveries via post or couriers. Pharmacies selling vaping products online need to ensure that there is a procedure in place to check ID at the time of sale and at the point of delivery.

Under the Tobacco Act, vaping products and the packaging containing these products must not be visible to the public. Pharmacies can choose how these products are stored but they should be stored in a way that are not visible to customers until a customer asks to buy a specified product. You can open a drawer, room or storage unit to get the requested product for the customer, but you must close or cover it again as soon as you have retrieved the requested product.

Prescribing and supplying Schedule 3 poisons

From 1 October 2024, therapeutic vapes with a nicotine concentration of 20mg/mL or less can be sold in Victorian pharmacies to patients 18 years or over* without a prescription as a Schedule 3 poison. Schedule 3 poisons have a greater potential for misuse or abuse than Schedule 2 poisons. Accordingly, the supply of Schedule 3 poisons is subject to regulations that require the personal involvement of a registered health practitioner (usually a pharmacist) to exercise competent professional judgement in assessing both the appropriateness of the medicine and the quantity that is to be supplied, in addition to providing professional advice about the safe and effective use of the medicine (regulations 134 to 141).

Under the pharmacist's care and all reasonable steps

Before supplying a Schedule 3 vape, a pharmacist must have the patient under their care and take all reasonable steps to ensure a therapeutic need exists for that vape. Where the regulations require health practitioners to take 'all reasonable steps' (e.g. to ensure there is a therapeutic need), an objective test must be applied to the particular circumstances as to whether or not the steps taken were sufficient. Such a test would involve considering if the steps taken would be in accordance with those that another member of the corresponding profession would take in that situation.

Complying with this requirement would not be achieved if a pharmacist supplies a scheduled medicine merely because a patient requests that they do so.

Pharmacists are strongly advised to read All reasonable steps and other key terms – requirements for health practitioners to gain a greater understanding of how compliance might be achieved.

Recording supplies of Schedule 3 poisons

There is no mandatory recording requirement for the supply of a Schedule 3 poison. However, in order to take 'all reasonable steps' to ensure a therapeutic need exists (where there is reason to believe a Schedule 3 poison might be misused, abused or used excessively), a supplier should make a record, similar to the record required for Schedule 4 poisons, so that frequency of use may be reviewed if further supplies are sought.

Directions and labelling

A pharmacist who supplies a Schedule 3 vape must:

• personally deliver or personally supervise its delivery when a person attends a pharmacy (note, this requirement does not preclude the use of a courier where a pharmacist has consigned a product for delivery); and
• provide directions for the use of the vape; and
• place a label on the container which uniquely identifies the supplier.

Victoria recognises the Therapeutic Goods (Poisons Standard) (Therapeutic Vaping Goods) Labelling Exemption 2024 issued on 27 September 2024. The labelling exemption is an administrative instrument made under the current Poisons Standard and has the effect of exempting certain vaping goods from the requirement to be labelled with the signal words for Schedule 3 medicines ('Pharmacist Only Medicine').

The labelling exemption is designed to ensure that certain vaping goods labelled by the sponsor in accordance with the labelling requirements for Schedule 4 poisons may be supplied by pharmacists under the new Schedule 3 entry for nicotine introduced by the recent Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, from 1 October 2024.

The exemption applies until 30 September 2025 unless revoked earlier.

Internet and indirect supply of medicines

The Drugs, Poisons and Controlled Substances Regulations 2017 do not preclude the use of internet and indirect supply models for Schedule 3 or Schedule 4 vapes.

Section 5 of the Guidelines for Dispensing of Medicines published by the Pharmacy Board of Australia provides further guidance for pharmacists on mail-order dispensing and other indirect supply of medicines.

Restrictions on storage and display

Regulation 143 of the Drugs, Poisons and Controlled Substances Regulations 2017 outlines restrictions on storage and display of Schedule 3 poisons.

A pharmacist must not keep, store or display a Schedule 3 vape:

1. in a manner which readily allows self-selection by the public; or
2. in a manner which promotes the sale of that Schedule 3 poison or draws undue attention to it.

Schedule 3 vapes should be kept behind the counter, away from public access and view.

Prohibition on supply to support drug dependency

Regulation 146 of the Drugs, Poisons and Controlled Substances Regulations 2017 prohibits a pharmacist from supplying a Schedule 3 vape merely for the purpose of supporting drug dependence of a person.

Under the changes made by the Commonwealth Vaping Reforms Act, nicotine is only a Schedule 3 poison when it is included in therapeutic vaping goods (within the meaning of the Therapeutic Goods Regulations 1990) in final dosage form for smoking cessation or the management of nicotine dependence and:

• it is supplied to a person aged 18 years and over; and
• the pharmacist requests and sights evidence of the patient's identity and age; and
• the pharmacist provides professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and
• the pharmacist provides contact details about smoking cessation support services to the patient; and
• the quantity of the goods supplied does not exceed the quantity that is reasonably required for a patient's therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and
• the concentration of nicotine in the goods does not exceed 20 mg/mL.

Where a pharmacist complies with all the above requirements before supplying a vape as a Schedule 3 poison, it is the department's view that the pharmacist will not be supplying the nicotine merely for the purposes of supporting the drug dependence of a person, and accordingly will not be in breach of regulation 146.

Notes

* Legislation regulating the age of purchase of vaping products may vary in other states and territories.