From 1 October 2024, therapeutic vapes with a nicotine concentration of 20mg/mL or less will be available in pharmacies to patients 18 years or over without a prescription.
PDL thanks members for their patience as Guild Insurance, the underwriter of the PDL Master Policy, has reviewed and assessed policy holder risks and responsibilities for the Schedule 3 (S3) supply of therapeutic vaping products.
PDL is pleased to confirm the PDL Master Policy will provide automatic cover for members who supply S3 vaping products in line with legislative requirements, their individual scope of practice and the terms and conditions of the PDL Master Policy. Members do not need to inform PDL if they supply S3 vaping products from 1 October 2024. PDL encourages members to confirm that their business insurance cover includes this service before commencing supply.
There will be no changes in the PDL Master Policy cover or premiums on 1 October 2024. Guild Insurance have advised PDL there will be changes to the PDL Master Policy at policy renewal on 30 April 2025.
Please read the Guild Insurance Pharmacy Business Insurance and PDL Master Policy Therapeutic Vape FAQs (25 September 2024) document for more details regarding these changes in policy cover. It also identifies how these changes to the policy cover will apply to Guild Insurance Pharmacy Business Policy cover, when implemented at renewal.
PDL Professional Officers suggest pharmacists consider the following if choosing to supply S3 vaping products
- As with all areas of practice, pharmacists involved in supply of nicotine vaping products are expected to work within their scope of practice as determined by the legislative authorities in place, their training and education, accountability through policies and documentation and in line with professional practice standards and guidelines.
- The PSA Professional Practice Guidelines for Pharmacists: nicotine dependence support (Sept 2024) is the guideline for the profession regarding smoking cessation, nicotine dependence and supply of vaping products. These guidelines are available to all pharmacists.
- PDL encourages pharmacists to offer a professional consultation in a suitable setting, ensuring privacy and confidentiality in line with clinical and professional expectations.
- PDL appreciates that pharmacists will make a personal decision regarding their willingness to supply a vaping product. PDL supports pharmacists’ autonomy when balanced with regard for patients’ health and wellbeing. All conversations with patients, colleagues and employers should be respectful and professional and decisions made on a case-by-case basis.
- PDL is aware the Pharmacy Board directs pharmacists to follow the Ahpra Shared Code of Conduct when dealing with patients. The Code includes reference to a practitioner choosing to decline supply of a medicine or product. A professional and empathetic approach would be expected when nicotine vaping products are not offered by a pharmacist or pharmacy.
- Pharmacists and pharmacy owners must comply with TGA requirements. The TGA Vaping hub is the primary reference for information. State or Territory legislation must also be followed and should be confirmed prior to supply of any vaping product.
- Pharmacists may only supply a therapeutic vaping product that is on the TGA’s list of notified vapes. Schedule 3 supply rules do not include any vaping product that can be diluted by a patient.
- It is vital that pharmacists ensure patients are fully informed of the known risks and benefits of supply, and patients understand these are unapproved products with limited safety data. Pharmacists should seek informed consent from a patient. PDL strongly recommends this consent is documented in a manner that is formal and retrievable. The Australian Commission on Safety and Quality in Health Care has defined informed consent as a person’s decision, given voluntarily, to agree to a healthcare treatment, procedure or other intervention that is made:
- Following the provision of accurate and relevant information about the healthcare intervention and alternative options available; and
- With adequate knowledge and understanding of the benefits and material risks of the proposed intervention relevant to the person who would be having the treatment, procedure or other intervention.
- PDL recommends that professional clinical records are made and retained when a vaping product is supplied. There may be several options to record information gathered from a patient during the assessment and counselling process, this may also include a record through the dispensing software. It is important that any records are accessible to other pharmacists for future consults with the patient.
- PDL reminds members of their insurance policy obligation to report any incidents or errors to PDL. Furthermore, any adverse events involving vaping products should be reported to the TGA and the product sponsor.
PDL recognises the challenges and opportunities for pharmacists with the availability of S3 supply of vaping products. PDL encourages pharmacists to educate themselves on this area of practice before commencing any service and consider the risks and benefits for themselves and patients.
For immediate advice and incident support, call PDL on 1300 854 838 to speak with one of our Professional Officers. We are here to support our pharmacist members 24/7, Australia-wide.
Insurance issued by Guild Insurance Limited ABN 55 004 538 863, AFS Licence No. 233791 and subject to terms, conditions and exclusions. Guild Insurance supports PDL through the payment of referral fees. This information is of a general nature only. Please refer to the policy wording and policy schedule for details. For more information, call PDL on 1300 854 838.
