This article applies to organisations that employ health practitioners
Therapeutic Goods (Medicines – Authorised Supply) Amendment (Vaping) Rules 2023 (Cth)
On 1 January 2024, the Therapeutic Goods (Medicines – Authorised Supply) Amendment (Vaping) Rules 2023 (Cth) (the Amending Rules) amended the Therapeutic Goods (Medicines – Authorised Supply) Rules 2022 (Cth) (the Rules) to introduce a new Special Access Scheme pathway to enable both medical and nurse practitioners to supply certain therapeutic vaping goods for smoking cessation or the management of nicotine dependence, where clinically appropriate.
Background
Organisations will already be aware that there are currently no therapeutic vaping substances or devices that have been evaluated by the Therapeutic Goods Administration (the TGA) and included in the Australian Register of Therapeutic Goods (ARTG) for smoking cessation or the management of nicotine dependence. Therapeutic goods that are not included in the ARTG are known as unregistered or “unapproved” goods. There are established pathways for patients to lawfully access unapproved goods, but such goods are not assessed by the TGA for quality, safety and efficacy or performance.
Established access pathways – the new “Special Access Scheme C”
The “Special Access Scheme C” pathway has been established by the introduction of the new rule 5A of the Rules. The pathway is designed to facilitate legitimate patient access to therapeutic vaping goods, irrespective of nicotine content, for smoking cessation or the management of nicotine dependence where clinically appropriate. The pathway applies to both medical and nurse practitioners (and health practitioners where the supply is requested by a medical or nurse practitioner). The list of therapeutic vaping goods is set out in the new Schedule 1A of the Rules.
When using this pathway to supply a therapeutic vaping good to a patient who is 16 years of age or over, medical and nurse practitioners are responsible for:
- meeting the conditions set out in rule 5A and Schedule 1A of the Rules;
- ensuring that the patient has given informed consent prior to treatment;
- adhering to relevant standards of good medical practice; and
- reporting any adverse events suffered by a patient in relation to the therapeutic vaping good or any defects in the therapeutic vaping good to the TGA and to the sponsor of the good in accordance with the reporting guidelines set out in the SAS Guidance.
The definition of SAS Guidance, which refers to a document published by the TGA, has been amended by the Amending Rules to reflect the updated version of the document following its review since its initial publication in September 2017. The document is now titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 1.0, January 2023).
Medical and nurse practitioners must also submit a notification form to the TGA within 28 days of supplying a therapeutic vaping good (the supply of therapeutic vaping goods through the new pathway is captured by the existing notification requirement set out in section 19 of the Therapeutic Goods Act 1989 (Cth)).
Conclusion
Organisations that employ medical and nurse practitioners should ensure that their systems and processes are appropriately updated to reflect the introduction of the new pathway for supplying therapeutic vaping goods to patients for smoking cessation or the management of nicotine dependence, where clinically appropriate and the obligations on practitioners when doing so, as outlined above.
