No 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.

Objective: Evidence is accumulating that components of the Cannabis sativa plant may have therapeutic potential in treating psychiatric disorders. Medicinal cannabis (MC) products are legally available for prescription in Australia, primarily through the Therapeutic Goods Administration (TGA) Special Access Scheme B (SAS-B). Here we investigated recent prescribing practices for psychiatric indications under SAS-B by Australian doctors.Methods: The dataset, obtained from the TGA, included information on MC applications made by doctors through the SAS-B process between 1st November 2016 and 30th September 2022 inclusive. Details included the primary conditions treated, patient demographics, prescriber location, product type (e.g., oil, flower or capsule) and the general cannabinoid content of products. The conditions treated were categorized according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, text revision (DSM-5-TR). Trends in prescribing for conditions over time were analyzed via polynomial regression, and relationships between categorical variables determined via correspondence analyses.Results: Approximately 300,000 SAS-B approvals to prescribe MC had been issued in the time period under investigation. This included approvals for 38 different DSM-5-TR defined psychiatric conditions (33.9% of total approvals). The majority of approvals were for anxiety disorders (66.7% of psychiatry-related prescribing), sleep-wake disorders (18.2%), trauma- and stressor-related disorders (5.8%), and neurodevelopmental disorders (4.4%). Oil products were most prescribed (53.0%), followed by flower (31.2%) and other inhaled products (12.4%). CBD-dominant products comprised around 20% of total prescribing and were particularly prevalent in the treatment of autism spectrum disorder. The largest proportion of approvals was for patients aged 25–39 years (46.2% of approvals). Recent dramatic increases in prescribing for attention deficit hyperactivity disorder were identified.Conclusion: A significant proportion of MC prescribing in Australia is for psychiatry-related indications. This prescribing often appears somewhat “experimental”, given it involves conditions (e.g., ADHD, depression) for which definitive clinical evidence of MC efficacy is lacking. The high prevalence of THC-containing products being prescribed is of possible concern given the psychiatric problems associated with this drug. Evidence-based clinical guidance around the use of MC products in psychiatry is lacking and would clearly be of benefit to prescribers.