Medicinal Cannabis Prescribing in Australia: An Analysis of Trends Over the First Five Years

Abstract

A regulatory framework allowing legal access to medicinal cannabis (MC) products has operated in Australia since November 2016. MC prescribing by healthcare practitioners (HCPs) is primarily conducted through the Special Access Scheme - Category B (SAS-B) pathway, through which prescribers apply to the Therapeutic Goods Administration (TGA–the federal regulator) for approval to prescribe a category of product to an individual patient suffering from a specific indication. The dataset collected by the TGA provides a unique opportunity to examine MC prescribing trends over time in the Australian population. Here we analysed this TGA SAS-B dataset since inception with respect to age, gender, product type (e.g., oil, flower, etc.), CBD content, indication treated, and prescriber location. Results are presented descriptively as well as being analysed using non-linear regression models. Relationship between variables were explored via correspondence analyses. Indications were classified with reference to the International Statistical Classification of Diseases and Related Health Problems (10th Revision). As of 31 August 2021, a total of 159,665 SAS-B approvals had been issued for MC products, 82.4% of were since January 2020. Leading indications for approvals were for pain, anxiety, and sleep disorders. Oil products were the most popular product type, while CBD-dominant products (≥98% CBD) accounted for 25.1% of total approvals. Approvals for flower products increased markedly during 2020–2021, as did approvals involving younger age groups (18–31 years old), male patients, and non-CBD dominant products. A disproportionate number of SAS-B MC applications (around 50%) came from HCPs in the state of Queensland. Associations between patient gender and age and/or indication with product type were found. For example, approvals for oil products were commonly associated with approvals for pain. While, overall prescribing increased dramatically over the last 2 years of analysis, stabilization of approval numbers is evident for some indications, such as pain. Current prescribing practices do not always reflect provided TGA guidance documents for MC prescribing. While acknowledging some limitations around the SAS-B dataset, it provides a unique and valuable resource with which to better understand current prescribing practices and utilisation of MC products within Australia.

Medical cannabis use in Australia: consumer experiences from the online cannabis as medicine survey 2020 (CAMS-20)

“…Only 3.9% of respondents using cannabis for medical purposes obtained their cannabis by prescription. This is consistent with our earlier 2018–2019 online survey [ 9 ] in which only 2.4% of 1044 respondents indicated that they had accessed MC via prescription, with most using illicit cannabis. Both surveys hinted at demographic and clinical differences between people using prescribed versus illicit MC, but the small numbers of participants in the former category limited any meaningful analysis.…”

“…Online surveys employing convenience sampling are also likely to encounter selection bias towards recruiting people with favourable experiences of MC. Nevertheless, comparison of demographic data for the prescribed participants in our sample is comparable (mean age = 45.8 years; male gender 51.4%) with regulatory data of medicinal cannabis approvals [ 9 ] (median age group reported 45–52, male gender in 46.3% of approvals in 2020). Furthermore, our design does not allow us to confidently estimate the proportion of people using prescribed versus illicit MC products, nor the number of people using MC in Australia.…”

“…Our findings indicate a substantial increase in the use of prescribed MC products in Australia in 2020 compared to our earlier surveys, consistent with recent regulatory data [ 11 ]. Use of a prescribed product was reported by 37.5% of respondents, a dramatic increase relative to our CAMS in 2016 [ 13 ] (< 1%) and 2018 [ 9 ] (< 3%).…”

“…chronic pain, palliative care, chemotherapy, epilepsy); however, in practice, doctors may prescribe for any clinical indication as long as they can justify prescribing to the regulating body based on the available evidence. A recent analysis of Australian regulatory data suggests the majority of patients are treated for the indications of pain, anxiety or sleep disorders, and that the majority of prescriptions involve THC-based medications rather than CBD-only products [ 9 ]. While prices vary between different products, at the time of writing, THC-predominant herb products often cost the consumer between $AUD 15–20 per gram (not dissimilar to prices reported by many consumers for illicit cannabis).…”

A large Australian longitudinal cohort registry demonstrates sustained safety and efficacy of oral medicinal cannabis for at least two years

“…[1] Australians can access a prescription for MC from their treating physician for a wide range of clinical conditions via a Special Access Scheme. [1,2] Recreational cannabis (RC) remains illegal in nearly all State and Territories. This provides a unique environment in Australia to evaluate oral MC where efficacy and safety can be assessed by Real World Data (RWD) without conflation with privately consumed unregulated and indeterminate dosed RC or inhaled MC.…”