Australian approvals rose, with THC products more common in older youth

ABSTRACT: To describe patterns of Special Access Scheme Category B (SAS-B) medicinal cannabis approvals among children and young people aged 25 years or younger in Australia using national regulatory data. DESIGN: National descriptive analysis of Therapeutic Goods Administration (TGA) SAS-B approvals for medicinal cannabis. SETTING: Australian national regulatory setting, using SAS-B approval data, through which registered medical and nurse practitioners may obtain TGA approval before prescribing unapproved medicinal cannabis products to individual patients. PARTICIPANTS: Individuals aged 25 years or younger with approved TGA SAS-B applications for medicinal cannabis from February 2016 to May 2024. MAIN OUTCOME MEASURES: Number and distribution of medicinal cannabis approvals by age, sex, indication, product category, formulation and practitioner characteristics. RESULTS: A total of 52 419 approved applications were included. SAS-B approvals increased substantially over time, with a more marked increase observed from 2021. Approvals were concentrated in older adolescents and young adults, with 71% of approvals in those aged 20–25 years. Overall, 62.6% of approvals were for males. Anxiety (43%), chronic pain (28%), neurodevelopmental conditions (10%) and sleep disorders (9%) were the most common indications. Approvals for younger children more commonly involved cannabidiol-dominant products and oil formulations, whereas approvals in older age groups more frequently involved THC-dominant product categories and inhaled formulations. Among approvals with a recorded prescriber specialty, general practice was the most frequently identified specialty. CONCLUSIONS: Medicinal cannabis SAS-B approvals for young people in Australia have expanded substantially and are concentrated in older adolescents and young adults. Approvals are occurring for conditions with limited evidence, with THC product categories predominating among approvals for older adolescents and young adults. These findings highlight the need for improved clinical guidance, age-specific oversight and systematic monitoring of outcomes to support safer, evidence-based use.