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In 2016, the Australian Government legislated to allow cannabis to be prescribed to patients as an unapproved medicine under the special access provisions of the Therapeutic Goods Act. This paper compares the Australian regulatory approach with other national approaches, outlines the main provisions of the Special Access Scheme for medical cannabis, describes how the program has evolved since 2017, includes an analysis of adverse events reported to the Therapeutic Goods Administration, and discusses the barriers that remain for patients who wish to access medical cannabis. It assesses how well the Australian program has addressed the challenges of providing patients with easier access to medical cannabis while ensuring that high-quality products are used safely and effectively under medical guidance., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Wayne Hall has advised the World Health Organization (WHO) on the health effects of cannabis (2016–2023); reviewed evidence on the medical uses of cannabis for the Australian Government (2017–2018); served as a member of the Australian Advisory Council on the Medical Uses of Cannabis (2017–2020); and served as an unpaid Chair of the International Scientific Advisory Board to the NHMRC-funded center for Excellence in Clinical Research on Medical Uses of Cannabinoids (2019–2022). The views expressed in this paper are his personal views and do not reflect the views of any of these bodies. Myfanwy Graham contributed to the United Nations Office on Drugs and Crime (UNODC) 2023 World Drug Report chapter on medical cannabis regulation; is a Fulbright Scholar Alumna in medical cannabis public health policy, University of Southern California (2022-2023); an Associate Investigator of the NHMRC-funded Australian Centre for Cannabinoid Clinical and Research Excellence (2019-2023); and received funding from the NSW Clinical Cannabis Medicines Program (2018-2022). The views expressed in this paper are her personal views and do not reflect the views of any of these bodies., (Copyright © 2023. Published by Elsevier B.V.)

Purpose: Interest in the use of cannabis as a medicine has markedly increased during the last decade, with an unprecedented number of patients now seeking advice or prescriptions for medicinal cannabis. Unlike other medicines prescribed by physicians, many medicinal cannabis products have not undergone standard clinical trial development required by regulatory authorities. Different formulations with varying strengths and ratios of tetrahydrocannabinol and cannabidiol are available, and this diversity of medicinal cannabis products available for a myriad of therapeutic indications adds to the complexity. Physicians face challenges and barriers in their clinical decision making with medicinal cannabis because of current evidence limitations. Research efforts to address evidence limitations are ongoing; in the interim, educational resources and clinical guidance are being developed to address the gap in clinical information and support the needs of health professionals., Methods: This article provides an overview of various resources that health professionals may use when seeking information about medicinal cannabis in the absence of high-quality evidence and clinical guidelines. It also identifies examples of international evidence-based resources that support clinical decision making with medicinal cannabis., Findings: Similarities and differences between international examples of guidance and guideline documents are identified and summarized., Implications: Guidance can help guide physicians in the individualized choice and dose of medicinal cannabis. Before quality clinical trials and regulator-approved products with risk management programs, safety data require clinical and academic collaborative pharmacovigilance., Competing Interests: Declaration of Interest None declared., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Patient interest in the use of cannabis-based medicines (CBMs) has increased in Australia. While recent policy and legislative changes have enabled health practitioners to prescribe CBMs for their patients, many patients still struggle to access CBMs. This paper employed a thematic analysis to submissions made to a 2019 Australian government inquiry into current barriers of patient access to medical cannabis., Methods: We identified 121 submissions from patients or family members (n = 63), government bodies (n = 5), non-government organisations (i.e., professional health bodies, charities, consumer organisations or advocacy groups; n = 25), medical cannabis and pharmaceutical industry (n = 16), and individual health professionals, academics, or research centres (n = 12). Data were coded using NVivo 12 software and thematically analysed. The findings were presented narratively using a modified Levesque's patient-centred access to care framework which includes: i) appropriateness; ii) availability and geographic accessibility; iii) acceptability; and iv) affordability., Results: Submissions from government agencies and professional health bodies consistently supported maintaining the current regulatory frameworks and access pathways, whereas an overwhelming majority of patients, advocacy groups and the medical cannabis industry described the current regulatory and access models as 'not fit for purpose'. These differing views seem to arise from divergent persepctives on (i) what and how much evidence is needed for policy and practice, and (ii) how patients should be given access to medical cannabis products amidst empirical uncertainty. Notwithstanding these differences, there were commonalities among some stakeholders regarding the various supply, regulatory, legislative, financial, and dispensing challenges that hindered timely access to CBMs., Conclusions: Progress in addressing the fundamental barriers that determine if and how a patient accesses and uses CBMs needs i) a 'system-level' reform that gives due consideration to the geographic disparity in access to prescribers and medical cannabis, and ii) reframing societal and health professional's views of CBMs by decoupling recreational vs medical cannabis., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Erku et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

There is international interest for consensus advice for prescribers working in the field of drug resistant epilepsy intending to trial potential therapies that are nonregistered or off-label. Cannabinoids are one such therapy. In 2017, the New South Wales State Government (Australia) set up a cannabinoid prescribing guidance service for a wide variety of indications, based on known pharmacology together with the relevant new literature as it became available. Increasing interest in cannabis medicines use outside this State over the following 5 years together with a paucity of registration-standard clinical trials, lack of information around dosing issues, drug interactions and biological plausibility meant there remained a large unmet need for such advice. To address the unmet need in epilepsy, and until medicines were registered or regulator quality data were available, it was agreed to bring together a working group comprising paediatric and adult epilepsy specialists, clinical pharmacists., clinical pharmacologists and cannabis researchers from across Australia to develop interim consensus advice for prescribers. Although interim, this consensus advice addresses much of the current practice gap by providing an informed overview of the different cannabis medicines currently available for use in the treatment of epilepsy in paediatric and adult settings, with information on dose, drug interactions, toxicity, type of seizure and frequency of symptom relief. As such it supplements the limited evidence currently available from clinical trials with experience from front-line practice. It is expected that this consensus advice will be updated as new evidence emerges and will provide guidance for a subsequent Guideline., (© 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Amidst growing global acceptance of medicinal cannabinoids as a potential therapeutic interest in cannabidiol (CBD) is increasing. In Australia in 2020, a government inquiry examined the barriers that the public are experiencing in accessing medicinal cannabis. A number of recommendations to improve access were made. In response to these recommendations, the Australian therapeutics regulatory authority down-scheduled CBD from Prescription Only (Schedule 4) to Pharmacist Only (Schedule 3). As a group of early to mid-career researchers of the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), we propose some considerations in relation to over-the-counter availability of CBD and opportunities to improve knowledge about its potential therapeutic benefits alongside its increased uptake.

Background: In 2018, an innovative, State government-funded cannabis medicines drug information service was established for health professionals in New South Wales (NSW). The NSW Cannabis Medicines Advisory Service (CMAS) provides expert clinical guidance and support to medical practitioners considering prescribing a cannabis medicine to their patient(s)., Aims: This research examines quality assurance and patient outcomes related to enquirers' experience with NSW CMAS., Methods: Data collection involved an online, anonymous survey with two components. Following a health professional enquiry, quality assurance data were collected about the enquirers' experience with NSW CMAS. The second survey focussed on patient outcomes and provides real-world observational data about cannabis medicines safety and effectiveness across a wide range of indications., Results: Data collection occurred between January 2020 and June 2021. Preliminary analyses were based on 68 quality assurance and 50 patient outcomes survey responses. General practitioners represented the highest proportion of survey responses (n = 33; 49%). The most common enquiry involved 'patient-specific advice' (n = 50; 74%). Patient-specific information provided by the service was mainly used for prescribing decision support (n = 45; 90%)., Conclusions: Preliminary findings highlight the impact of an innovative cannabis medicines drug information service in supporting health professional clinical practice in an area of rapid knowledge translation. Quality assurance data indicate that the service is perceived well by the majority of enquirers. Patient outcomes data across a wide range of indications suggest some effectiveness and a reasonable safety profile for prescribed cannabis medicines for most patients., (© 2021 State of New South Wales. Internal Medicine Journal published by John Wiley & Sons Australia, Ltd on behalf of Royal Australasian College of Physicians.)