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While well-known systems like the sympathetic nervous system are widely understood, doctors may be less familiar with the more recently identified endocannabinoid system (ECS).1,2 The ECS is thought to be involved in regulating pain, immunity, stress, appetite, weight, and nausea, yet it remains largely absent from traditional medical education in Australia.3 What will you learn?This module aims to equip you with the skills and confidence to integrate medical cannabis into patient care when clinically appropriate. Drawing on current evidence and theoretical case studies, the module explores the ECS, cannabinoid pharmacology, proposed therapeutic effects, and the clinical implications of both ECS function and use of medical cannabis. Through interactive scenarios and evidence summaries, you’ll explore how this knowledge may be relevant to clinical applications—ranging from the potential involvement of the ECS in patient presentations to identifying possible treatment approaches. Estimated Duration: 4 hours Access Duration: 12 months from date of purchase Learning Outcomes Upon completion of this module, you’ll be able to: Identify the endocannabinoid system’s components, role and functions, as currently understood Describe how endocannabinoid system function and dysfunction may contribute to symptoms such as pain, anxiety, sleep disturbance and inflammation Interpret how the mechanism of the endocannabinoid system may inform the therapeutic potential of medical cannabis Explain the pharmacological effects of THC and CBD Identify clinical features suggestive of cannabinoid tolerance or receptor desensitisation Describe the limitations and uncertainties in the current evidence relating to the endocannabinoid system References Harvard Health Publishing. The endocannabinoid system: Essential and mysterious. https://www.health.harvard.edu/blog/the-endocannabinoid-system-essential-and-mysterious-202108112569 (accessed Aug 2025). Parliament of Australia. Current barriers to patient access to medicinal cannabis in Australia. https://parlinfo.aph.gov.au/parlInfo/download/committees/reportsen/024403/toc_pdf/CurrentbarrierstopatientaccesstomedicinalcannabisinAustralia.pdf (accessed Aug 2025). Hillard CJ. Circulating Endocannabinoids: From Whence Do They Come and Where are They Going? Neuropsychopharmacology. 2018;43:155–172.

As medicinal cannabis becomes increasingly encountered in clinical practice,1 healthcare professionals are navigating a growing range of products alongside evolving regulatory requirements.2 In this 5-part video series, learn about the different forms of medicinal cannabis products currently available in Australia, including formulations, administration methods, pharmacokinetic and pharmacodynamic profiles and how these factors influence prescribing considerations. Additionally, explore the five categories of medicinal cannabis products relevant to prescribing via the TGA's Special Access Scheme and Authorised Prescriber access pathways. With a focus on foundational understanding and practical implications, this video series is suitable for beginner to intermediate prescribers and those wishing to broaden their understanding of the range of medicinal cannabis products available in Australia today. Estimated Duration: 15 minutes Access Duration: 12 months from date of purchase References Hallinan et al. Implementation of medicinal cannabis in Australia: innovation or upheaval? Perspectives from physicians as key informants, a qualitative analysis. BMJ Open. 2021;11:e054044. Martin et al. Exploring access to medicinal cannabis through general practitioners in Australia. Aust J Gen Pract. 2025;54:101–108.

Understanding Medical Cannabis Formulations: A Primer for GPs Published: August 2025 Australian general practitioners (GPs) who prescribe medical cannabis are faced with a diverse and rapidly evolving range of formulations to choose from. Beyond selecting a product with the appropriate cannabinoid profile for their patient's presentation, GPs must also consider the route of administration and formulation type, which could significantly impact onset, duration, tolerability, and patient adherence.1,2 This primer explores the key medical cannabis dosage forms currently available, their pharmacokinetic profiles, patient considerations, and practical prescribing tips to help guide formulation decisions. Overview of medical cannabis formulations The two primary active compounds in medical cannabis, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), are available as various dosage forms.1,3 Each has distinct benefits and limitations, depending on the therapeutic goal and patient-specific factors.1 The most commonly available forms include: 1. Oral formulations: oils, pastilles, capsules Oral formulations, including oils, and softgel capsules, are the most commonly prescribed medical cannabis products in Australia.4 Oils typically come in bottles with graduated droppers, allowing for flexible dosing. Capsules and pastilles offer convenience and fixed doses.1 Pharmacokinetics: Onset: 60 -180 minutes1Peak effect: 2-4 hours5Duration: 6-8 hours1 Pros and Cons: Pros Cons Discreet and convenient to administer1 Patients with dexterity challenges may find oils difficult to administer9 Suitable for chronic conditions requiring longer-lasting relief1,5 Delayed onset may limit use for acute symptom control1 Slower onset and lower peak concentrations may potentially reduce risk of intoxication6,7,8 Low bioavailability due to first pass metabolism5 Prescribing tips: Start with a low dose, titrate slowly (e.g. “start low and go slow”).1 Oral absorption can be enhanced by administering in the presence of fats and oils thus ideally taken with food.1 2. Inhaled formulations: vaporised dried flower or inhalation oils Medical cannabis can be inhaled via a medical vaporiser device which delivers vapour containing cannabinoids and terpenes to the lungs.9 Smoking is not an approved method for medical cannabis administration in Australia.5 Use of a registered medical vaporizer device reduces exposure to potentially toxic compounds of cannabis smoke and helps to reduce variability in the cannabinoid content delivered.9 Pharmacokinetics: Onset: 5-10 minutes1Peak effect: 15-30 minutes5Duration: 2-4 hours1 Pros and Cons: Pros Cons Rapid onset may be useful for episodic or breakthrough symptoms1 Shorter duration of action than oral formulations with variable bioavailability7 Dose titration is patient-guided - patients stop when symptom relief is achieved (within daily THC limits)9 Not suitable for patients with respiratory disease (e.g. asthma, chronic obstructive pulmonary disease)2 Lack of first-pass metabolism may improve cannabinoid absorption6 May be associated with compliance issues10 Prescribing tips: Inhaled forms may be useful as an adjunct to oral formulations for conditions like chronic pain with breakthrough flares.1 Ensure patients have access to a TGA-approved vaporiser (details: TGA website).5,6 3. Oromucosal sprays These sprays are administered under the tongue or inside the cheek for mucosal absorption.10 Currently there is only one such product available in Australia (nabiximols THC 27mg: CBD 25mg oral spray), which is TGA-approved for spasticity in multiple sclerosis.12 Pharmacokinetics: Onset: 15-45 minutes1Peak effect: 1-2 hours10Duration: 6-8 hours1 Pros and Cons: Pros Cons Faster onset than oral ingestion1 May cause local irritation (dry mouth, oral ulcers) 12 Suitable for patients with swallowing difficulties 8 Can be more expensive than other forms 1 Fixed metred dosing facilitates dose titration and may be easier to administer than some oral formulations 5 TGA-approved for patients with multiple sclerosis only.12 * *Patients may be able to access via Special Access or Authorised Prescriber scheme for other conditions Prescribing tips: Consider oromucosal sprays when rapid symptom relief is needed but inhalation is contraindicated, such as in patients with respiratory disease.2,10 Six to eight sprays of nabiximols are generally required for symptomatic relief with a daily limit of 12 sprays.11 4. Topical preparations Topical formulations such as creams, ointments, or gels are suitable for localised symptoms such as dermatological conditions or arthritis pain.1 They exert their actions locally rather than systemically.1 THC is not well absorbed via the skin however CBD and the minor cannabinoid cannabinol (CBN) are much more permeable than THC.5 Pharmacokinetics: Onset: 5-120 minutes13Peak effect: variable 13Duration: variable13 Pros and Cons: Pros Cons May be useful for localised pain or inflammation 13 Limited clinical evidence to support efficacy1 Low risk of intoxication or systemic side effects13 Local side effects such as contact dermatitis13 Steady delivery of active compounds over prolonged period13 Variable absorption through the skin barrier13 Administration tips: Topical preparations should not be applied to broken skin.14 Advise patients not to rub the topical preparation into the skin vigorously.14 Factors to consider when choosing a formulation 1. Symptom profile and onset requirements Acute symptoms → inhaled or oromucosal.1 Chronic conditions → oral formulations.1 Mixed profiles → combination therapy.1 2. Patient preference and practicality Some prefer oils, capsules for discretion. Others prefer inhaled forms for feedback. Consider dexterity, cognition, access to devices. 3. Safety and contraindications Avoid inhaled in respiratory disease.2 Avoid THC in pregnancy, unstable CV disease, psychiatric history.5 Watch drug interactions with hepatic enzymes.5 4. Dosing control and titration Oral oils: flexible but delayed onset.1,10 Capsules/pastilles/sprays: consistent dosing.1,13 Inhaled: rapid but variable.1,8 Summary Clinicians prescribing medical cannabis have a considerable array of dosage forms to choose from. Understanding the factors that influence formulation selection may be central to safer more effective patient care.1,2 Choosing the most appropriate dosage form may enhance therapeutic outcomes, minimise side effects, and improve adherence.1,2 By familiarising themselves with the available formats (oral, inhaled, oromucosal, topical) and considering patient-specific needs and preferences, GPs may be better positioned to deliver personalised and evidence-informed care in this emerging therapeutic area. This article is intended for educational purposes and does not replace clinical judgment or regulatory requirements. Disclaimer: Medical cannabis products may be associated with adverse events. For more information please contact medinfo@saged.com.au. Medical cannabis products are not suitable for use during pregnancy or breastfeeding, for anyone with a history with psychotic disorders, or for those with unstable cardiovascular disease. Treatment for patients under 18 years is recommended under the guidance of a paediatrician. Patients should not drive or operate machinery while being treated with some forms of medical cannabis.

Understanding Medical Cannabis Strength: A Guide for Healthcare Professionals Published: July 2025 When prescribing medical cannabis, it’s essential to understand and accurately communicate the “strength” of the product. However, the lack of standardisation in the way cannabis strength is represented can lead to confusion, complicating safe prescribing, patient education, and effective transitions between products.1 In this article, we will simplify the key concepts used to describe medical cannabis strength and highlight how these terms impact clinical practice. Methods of Describing Medical Cannabis Strength Current methods for expressing medical cannabis strength are determined by the amount of the two primary cannabinoids, CBD (cannabidiol) and THC (tetrahydrocannabinol) in a product. THC is considered the primary psychoactive component, whilst CBD is thought to modulate THC’s effects.2 The dose at which THC’s psychoactive properties become clinically apparent is generally regarded to be 5 mg.3 Medical cannabis strength can be described in different ways, each with its unique meaning: Total Cannabinoid Content (mg) This measurement describes the actual amount of THC and/or CBD per unit, such as per capsule, gummy, or spray. For example, a capsule might contain 5 mg of THC and 5 mg of CBD. Total cannabinoid content is the most clinically meaningful way to describe cannabis product strength and aligns with the dosing nomenclature used for other medications. For example, a drug may be prescribed with a specific dose in milligrams (such as 5 mg of morphine), and cannabis dosing follows this same principle. Cannabinoid Ratios (e.g. CBD:THC) This ratio describes the balance of two primary cannabinoids in a product. For example, a product with a 20:1 ratio has 20 parts CBD for every 1 part THC. The ratio can help you quickly compare products but doesn’t indicate the actual dose of THC or CBD. For instance, both a 1:1 product containing 2.5 mg of each cannabinoid and one containing 25 mg of each would have the same ratio but differ in dose. Therefore, clinical decisions must reference the exact quantities or percentages of the cannabinoids, not just the ratio. Potency (%) Potency refers to the percentage of a product’s weight that consists of THC or CBD. For instance, a product labeled as 15% THC means each gram of dried flower contains 150 mg of THC. Potency is often used to describe the strength of products like oils, tinctures, and flower, helping to compare their strength quickly. This is especially helpful when assessing products used for inhalation or topical application. Patient tolerance - a key factor affecting dosage and strength Tolerance to cannabis varies significantly from patient to patient.4 Cannabis-naïve patients (first-time users or those with limited experience) are much more sensitive to cannabinoids.4 Therefore, it’s essential to start with a low dose and gradually increase as needed.1 Conversely, experienced users may require higher doses to achieve the desired effect and may benefit from short breaks in therapy to reduce the likelihood of developing tolerance.4 Prescribers should always consider the patient's history when determining dosage.1 TGA Categorisation In Australia, the Therapeutic Goods Administration (TGA) classifies medical cannabis products based on their CBD content.5 This classification can be confusing as it reflects only the proportion of CBD in the product, not its THC or other cannabinoid content. For example, products in the "CBD dominant" category may still contain significant amounts of THC, which could have psychoactive effects. The TGA categorises products into five categories based on CBD percentage: Category 1: ≥98% CBD (Schedule 4) Category 2: ≥60% and <98% CBD (Schedule 8) Category 3: ≥40% and <60% CBD (Schedule 8) Category 4: CBD 2%-<40% (Schedule 8) Category 5: <2% CBD (Schedule 8)5 The categorisation system does not indicate the total strength or amount of THC, which can lead to misunderstandings in clinical practice. Standardising Cannabis Dosing Unlike opioids, where doses are standardised using measures such as oral morphine equivalents (OME), medical cannabis currently lacks a universally accepted standard dosing unit. Researchers have proposed using THC content as a common measure, such as defining a “standard THC unit” as 5 mg of THC6, which is considered a typical psychoactive dose.3 However, this concept is not yet universally adopted, as cannabis contains multiple active compounds, and individual factors (such as patient tolerance) play a significant role in how patients respond to cannabis.6 Clinical Implications and Best Practices Healthcare professionals should focus on the actual quantities of THC and CBD when determining dosages. This ensures safe and effective prescribing. When prescribing, always refer to the total milligrams (mg) of THC and CBD in the product, as this reflects the actual dose a patient will receive. Consider the patient’s tolerance when determining the appropriate dose. Cannabis-naïve patients should start with low doses and increase gradually. Be cautious with TGA categorisation: A product in the "CBD dominant" category may still have enough THC to cause psychoactive effects, so it’s essential to check the cannabinoid breakdown, not just the CBD percentage. Summary The strength of medical cannabis is described in multiple ways - through ratios, potency percentages, and total milligrams - making it vital for healthcare professionals to understand the clinical implications of each. To ensure accurate dosing and patient safety, always refer to the total amount of THC and CBD in the product, and consider patient factors such as experience and tolerance. As the medical cannabis market evolves, the need for clearer and more standardised labeling becomes increasingly important for effective prescribing and patient education. By adhering to these best practices, healthcare professionals can reduce medication errors, improve patient outcomes, and promote best practices in prescribing and dispensing medical cannabis.

A Closer Look at Medical Cannabis & Chronic Pain An evidence-based webinar exploring the role medical cannabis could play in the treatment of chronic pain. Date: Tuesday 30th September  |  Time: 7–8pm (AEST)  |  Format: Online (Zoom) Hosted by SAGED & Dr Joel Wren, GP Have you experienced challenges in managing patients with chronic pain? This webinar aims to provide you with evidence, case studies, and practical tools you can use right away. SAGED invites you to attend a free, RACGP- and ACRRM-accredited webinar, designed for Australian GPs interested in the evolving role of medical cannabis in chronic non-cancer pain (CNCP). Led by Dr Joel Wren, a GP with experience in prescribing medical cannabis, this 60-minute session will cover: Current evidence on medical cannabis in chronic non-cancer pain management Clinical insights on medical cannabis and neuropathic pain Practical case studies, dosing, and product selection Don’t miss your chance to hear from one of Australia’s leading medical cannabis practitioners on chronic pain. Designed for Australian GPs, this session aims to support safe, evidence-based prescribing in general practice. Learning Outcomes By attending this webinar, you will be able to: Identify when and why medical cannabis may be appropriate in CNCP management Understand the current evidence base supporting the use of medical cannabis in CNCP, with a focus on neuropathic pain Apply clinical insights to case examples, including product selection, dosing, and safety considerations

‘Unapproved’ products: Prescriber access pathways explained Published: October 2025 Accessing medical cannabis in Australia can feel complex—for both patients and healthcare practitioners.1 While demand for medical cannabis has grown steadily, it is still considered an ‘unapproved’ therapeutic good under the Therapeutic Goods Administration (TGA) for most conditions.1 This means that, in most cases, practitioners must first demonstrate that conventional, registered medicines have been tried or deemed unsuitable before turning to medical cannabis.2 Yet for many patients, especially those living with chronic pain, conventional treatments provide limited relief3—highlighting the importance of clear, workable access pathways to ‘unapproved’ products. So how does this work in practice? How do Australian practitioners access medical cannabis for their patients? Accessing medical cannabis in Australia There are two primary pathways for accessing medical cannabis in Australia, each with two sub-categories:4 Special Access Scheme Category A notification pathway Category B application pathway Authorised Prescriber Established History of Use pathway Standard pathway Each of these pathways is designed for different clinical scenarios and levels of oversight. Let’s break them down. 1: Special Access Scheme (SAS) Through the SAS, Australian-registered practitioners can apply to use an ‘unapproved’ medicine—such as medical cannabis—for an individual patient on a case-by-case basis.2 1.1: SAS-A – notification for a seriously ill patient SAS-A allows practitioners to prescribe an ‘unapproved’ medicine, such as medical cannabis, for patients who are seriously ill*.2 This is a notification pathway – which means prior approval from the TGA is not required.2 Compared with SAS-B applications, SAS-A notifications are submitted less frequently.5,6 *Seriously ill is defined as: someone who is ‘seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment’.2 1.2: SAS-B – application for all other patients SAS-B allows qualified practitioners to prescribe an ‘unapproved’ medicine for patients who don’t meet the Category A definition.2 When seeking approval to prescribe an unapproved medical cannabis product under the SAS-B pathway, the practitioner must provide clinical justification.4 This justification should be succinct yet comprehensive, and include:4 A summary of the patient’s symptoms and/or diagnosis Details of prior treatments or procedures that have been trialled or considered, with reasons why therapeutic goods currently included in the Australian Register of Therapeutic Goods (ARTG) are not clinically appropriate An appraisal of the anticipated clinical benefits of the proposed treatment weighed against the potential risks The SAS does not limit applications to specific medical conditions.4 The key requirement is that the prescriber has the necessary knowledge of the patient’s condition and of the product they wish to use.4 SAS-B is an application pathway – which means an approval letter must be obtained from the TGA before the product can be supplied to the patient.2 2: Authorised Prescriber (AP) Registered practitioners can apply to the TGA to become APs of certain medical cannabis products for groups of patients they care for.7 Approval lasts up to five years, and while practitioners don’t need to notify the TGA each time they prescribe, they must provide reports every six months.7 Additional approvals are only needed if the product isn’t already on the Established History of Use list.7 2.1: AP – Established History of Use pathway The TGA’s Established History of Use lists set out which medical cannabis products and conditions have a recognised track record.4 This applies only to Category 1 (CBD ≥98%), Category 2 (CBD ≥60% and <98%), and Category 3 (CBD <60% and ≥40%) oral liquids or capsules for a select few conditions, including refractory chronic pain, anxiety, cancer pain, sleep disorders and autism spectrum disorder.8 For these, doctors can become APs without needing Human Research Ethics Committee (HREC) approval or specialist college endorsement.4 2.2: AP – Standard pathway For medical cannabis products not included on the TGA’s Established History of Use lists, doctors can apply to become APs via the Standard pathway.4 To do so, doctors must first obtain approval from an HREC or endorsement from a specialist college, before lodging their application with the TGA.4 HREC approval or specialist college endorsement includes:9 Applying in writing to an HREC or specialist college for endorsement Providing evidence to justify use of the unapproved therapeutic good Details about the doctors’ training and experience Description of the unapproved therapeutic good the doctor intends to prescribe Clinical justification for use of the unapproved therapeutic good To find an HREC, check the list of HRECs registered with the National Health and Medical Research Council.9 If an HREC is unavailable, endorsement can be sought from a specialist college.9 The specialist college must have expertise relevant to the condition being treated. The list of specialist colleges can be found here.9 The infographic below summarises medical cannabis access pathways most commonly accessed in Australia. Download this infographic here To apply for the SAS or AP pathway, visit: https://compliance.health.gov.au/sas/ Need help deciding which pathway suits your practice needs? Get step-by-step assistance with your SAS-B or AP application from a SAGED Prescriber Support Specialist. Click here for support. Use of the SAS and AP pathway Despite being labelled as complex and time-consuming,1 the TGA’s dashboard shows that the SAS and AP pathway are well utilised, highlighting ongoing patient demand. In 2024 alone, registered practitioners submitted 177,751 SAS-B applications,6 although the SAS-A pathway was less frequently used with 376 SAS-A notifications.5 Over the same period, the TGA granted 22,066 AP approvals, with 407,434 treatments initiated under these approvals between July and December 2024.10,11 Leading conditions for medical cannabis prescription According to the SAS-A and SAS-B dashboards, chronic pain is the leading condition for which medical cannabis is accessed in Australia, followed by anxiety,5,6 reflecting their significant health burden. The Australian Institute of Health and Welfare reported that in 2016, 1.6 million (1 in 5) Australians aged ≥45 years were living with chronic pain.12 Current pharmacological treatments are often limited in effectiveness, with fewer than 20% of patients achieving ≥50% pain relief.3 In light of these limitations, it is estimated that around 600,000 Australians self-medicate with medical cannabis—most commonly for chronic pain.3 The most common conditions for SAS-A notifications and SAS-B applications in 20245,6 Summary Although the regulatory framework for accessing medical cannabis is perceived as complex time-consuming,1 the SAS and AP pathways provide routes for doctors to access unapproved products for their patients.4 The SAS enables case-by-case approvals, with SAS-A reserved for seriously ill patients2 and SAS-B requiring a clinical justification for all other patients.2,4 The AP pathway allows longer-term prescribing for groups of patients, with applications made via either the Established History of Use pathway or the more rigorous Standard pathway, which requires ethics or specialist college approval.4,9 Despite perceptions of complexity,1 these mechanisms are being used extensively.5,6,10 With 1 in 5 Australians over 45 living with chronic pain—and conventional treatments often falling short—medical cannabis may offer an additional therapeutic option, particularly when conventional treatments provide limited relief.3,12