Australia TGA Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products | Cannabis Law Report | Where to buy Skittles Moonrock online

We asked for information on stakeholders’ experiences, observations and knowledge of the use of unapproved medicinal cannabis products, including medicinal cannabis medicines and medicinal cannabis devices.

Specifically, we sought feedback on:

• Whether there is appropriate regulatory oversight of unapproved medicinal cannabis products being accessed via the unapproved pathways, the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme and
• If there are safety risks associated with unapproved medicinal cannabis products, particularly those products containing delta-9-tetrahydrocannabinol (THC), noting the rapid growth in the number of Australian patients that have been prescribed these products since 2017.

Participation

We received 790 submissions from the following stakeholder groups:

• Academics
• Advocacy/special interest groups
• Consumers and patients
• Carers and people with a special interest
• Industry/sponsors
• Peak body organisations
• State and territory, and other Commonwealth Departments
• Healthcare professionals (e.g. medical practitioners, pharmacists, nurse practitioners etc)
• Medical colleges

Overall stakeholder support

There was agreement across stakeholder groups that the current access framework, used for exceptional clinical circumstances, is not fit-for-purpose and not proportionate to the potential safety and quality risks associated with unapproved medicinal cannabis products. While reform was generally supported, there was a strong desire to carefully consider any impact to patient access.

Key considerations

• There is limited consumer/patient knowledge of the unapproved status of medicinal cannabis, and that these products have not been evaluated by the TGA for safety, quality, efficacy or performance.
• Safety concerns were raised around products with high amounts of THC being accessed under the unapproved pathways. While it was not possible to determine a ‘safe’ upper limit for THC from the consultation, submissions did note that high potency THC products can increase risks of harm, such as acute psychosis and cannabis use disorder.
• Safety risks across all dosage forms were identified, with the most prominent concern relating to dried herb (smoking/vaping) and concentrated extracts (vaping). The availability of confectionary-like formulations, such as pastilles and gummies, was also raised as a concern in many submissions, noting the potential risks of accidental ingestion, particularly by children.
• Many submissions support greater enforcement of product quality standards, with consistent application and enforcement measures in place for both domestic and imported medicinal cannabis products. There were also strong calls for the establishment of device quality standards for medicinal cannabis.
• All stakeholder groups would like strengthened packaging and labelling requirements, with calls for restrictions to inappropriate product trade names, the introduction of plain packaging, standardisation of THC/CBD expression, mandatory warning statements, transparency of registration status, Product Information documents and child-resistant closures.
• Most stakeholders consider cannabidiol (CBD), a prescription medicine in Australia, to be well tolerated by patients. Some submissions highlighted the potential for contraindications and interactions. While CBD was viewed as having a more favourable safety profile compared to THC, stakeholders also emphasised the limited availability of high-quality safety and efficacy data.
• There is strong support for restricting access to THC-containing products in certain high-risk populations, to minimise the potential for adverse clinical outcomes.

It was evident from submissions that many consumers/patients are not aware of the nature and implications of the unapproved status of the majority of medicinal cannabis products prescribed. As such, the TGA is undertaking actions to support health care practitioners and consumers to better understand the risks associated with unapproved medicinal cannabis products. In doing this, we will also aim to explore collaborative clinical education opportunities with other health regulators, reminding prescribers of their responsibilities and conditions of their approvals when prescribing unapproved medicinal cannabis products.

The TGA will continue to engage with stakeholders as part of a broad collaborative approach to strengthen the medicinal cannabis framework in order to better safeguard the Australian community.

For further questions, contact medicinalcannabisreforms@health.gov.au