In Australia, the use and possession of non-medicinal cannabis remain illegal in most states and territories. However, patients with specific medical conditions may be eligible for medicinal cannabis under strict regulations. The Therapeutic Goods Administration (TGA) oversees prescribing, allowing access only when conventional treatments have failed or caused intolerable side effects. To prescribe medicinal cannabis, healthcare providers must navigate regulatory pathways such as the Special Access Scheme (SAS) or obtain Authorised Prescriber status, as most cannabis-based products are not registered on the Australian Register of Therapeutic Goods (ARTG).
Medical cannabis usage in Australia is skyrocketing.
Today it is estimated that roughly 2.7% of the population (of ~30 million) is using legally prescribed medicinal cannabis products¹.
Medicinal cannabis may be prescribed for conditions such as
Prescribing decisions must consider patient-specific factors, including potential contraindications like age, psychiatric disorders, cardiovascular conditions, and pregnancy. Ongoing patient monitoring, informed consent, and compliance with state and territory regulations are essential components of the prescribing process.
Online prescribing of cannabis varies considerably among different providers. Below is a summary of the main points…
This stage is conducted before a prescriber is consulted. It is intended to exclude high-risk and contraindicated patients. Steps within this stage include:
Additional risk factors include:
Enzyme | Interaction and Effect | Drugs |
---|---|---|
CYP 3A4 |
Inducers: May decrease THC and/or CBD Inhibitors: May increase THC and/or CBD Substrates: CBD is a potential inhibitor of CYP3A4 and could increase 3A4 substrates. Caution with medications with a smaller therapeutic index (e.g., tacrolimus). Unlikely to have an effect on THC. |
Inducers: Carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s wort Inhibitors: Azole antifungals, clarithromycin, diltiazem, erythromycin, grapefruit, HIV protease inhibitors, macrolides, mifepristone, verapamil Substrates: Alprazolam, atorvastatin, carbamazepine, clobazam, cyclosporine, diltiazem, HIV protease inhibitors, buprenorphine, tacrolimus, cyclosporine, phenytoin, sildenafil, simvastatin, sirolimus, verapamil, zopiclone |
CYP 2C9 |
Inducers: May decrease THC concentration. Unlikely to have effect on CBD. Inhibitors: May increase THC concentration. Unlikely to have effect on CBD. Substrates: THC and/or CBD may increase drug levels; should monitor for toxicity. |
Inducers: Carbamazepine, rifampin Inhibitors: Amiodarone, fluconazole, fluoxetine, metronidazole, valproic acid, sulfamethoxazole Substrates: Warfarin, rosuvastatin, phenytoin |
CYP 2C19 |
Inducers: May decrease CBD and THC. Inhibitors: May increase CBD and THC. Substrates: CBD may increase the level of medications metabolized by 2C19 such as norclobazam (active metabolite in clobazam). CBD may also prevent clopidogrel from being activated. Unlikely to have an effect on THC. |
Inducers: Carbamazepine, rifampin, St. John’s wort Inhibitors: Cimetidine, omeprazole, esomeprazole, ticlopidine, fluconazole, fluoxetine, isoniazid Substrates: Aripiprazole, citalopram, clopidogrel, diazepam, escitalopram, moclobemide, norclobazam, omeprazole, pantoprazole, sertraline |
CYP 1A1 and 1A2 | Substrates: Smoking cannabis can stimulate these isoenzymes and increase the metabolism of these medications. | Amitriptyline, caffeine, clozapine, duloxetine, estrogens, fluvoxamine, imipramine, melatonin, mirtazapine, olanzapine, theophylline |
p-Glycoprotein | Substrates: CBD may inhibit p-glycoprotein drug transport. Should monitor for toxicity. No effect from use of THC. | Dabigatran, digoxin, loperamide |
Double check:
References
¹ Medical cannabis treating at least 2.7 percent of population (no date) The University of Sydney. Available at: https://www.sydney.edu.au/news-opinion/news/2022/12/16/medical-cannabis-treating-population.html (Accessed: 13 February 2025).
² MacCallum CA, Lo LA, Boivin M. “Is medical cannabis safe for my patients?” A practical review of cannabis safety considerations. European Journal of Internal Medicine. 2021;89:10-18. doi:https://doi.org/10.1016/j.ejim.2021.05.002
]]>The General Pharmaceutical Council (GPhC) has recently published updated guidance for registered pharmacies providing services remotely. This guidance, issued in February 2025, underscores the importance of maintaining high standards of patient care while addressing the unique challenges associated with distance pharmacy services. In this blog post, we’ll break down the key elements of the guidance and explore what it means for pharmacies, pharmacists, and patients.
With the rise of online pharmacies and remote healthcare services, the need for clear regulations has become paramount. Distance pharmacy services offer convenience and accessibility, but they also bring risks such as the potential for improper medication use, data breaches, and reduced patient engagement. The GPhC’s updated guidance aims to mitigate these risks by ensuring that registered pharmacies uphold their responsibilities, even when services are delivered remotely.
Here are the primary aspects covered in the GPhC’s guidance:
Pharmacies must prioritize patient safety in all aspects of their operations. This includes ensuring that:
Pharmacies providing distance services must have robust systems to verify the identity of patients. This helps prevent fraudulent activities and ensures that medications are supplied to the correct individuals.
Pharmacies must take extra care when serving vulnerable patients. This includes:
Pharmacies are required to verify the validity and authenticity of prescriptions before dispensing medications. This step is crucial in combating the misuse of online platforms for obtaining prescription medicines.
The guidance goes on to highlight that online pharmacies need to follow the law and guidance on the advertising and promotion of medicines.
With sensitive patient information being handled electronically, pharmacies must adhere to data protection laws and ensure robust cybersecurity measures are in place.
Pharmacies must provide clear and accessible information about their services, including:
Registered pharmacies providing distance services must review their policies and processes to ensure compliance with the GPhC’s updated guidance. Key steps include:
The GPhC’s updated guidance on distance pharmacy services is a significant step toward ensuring the safe and effective delivery of pharmacy services in an increasingly digital world. By prioritizing patient safety, data protection, and operational transparency, the guidance sets a robust framework for the future of remote pharmacy care. However, implementing these changes is often costly and difficult to achieve.
If you would like more information about how to achieve these new standards, get in contact with our distance-selling pharmacy consultant here.
]]>Ibogaine is classified as a psychoactive alkaloid, primarily known for its hallucinogenic and anti-addictive properties. It has been used traditionally in West African spiritual ceremonies and more recently in alternative medicine to treat opioid, alcohol, and other substance dependencies. Despite anecdotal reports of success, its safety profile and efficacy remain topics of ongoing scientific investigation.
In Australia, ibogaine is classified as a Schedule 9 substance under the Poisons Standard. Substances in this category are considered prohibited and are only available for research purposes under strict regulatory control. Schedule 9 substances are deemed to have a high potential for abuse or cause harm, and their use is not approved for medical treatments outside of specific clinical trials or research programs.
This classification means that the possession, sale, importation, or distribution of ibogaine without proper authorization is illegal in Australia. Even therapeutic use in private settings or clinics is not permitted under current regulations.
Several factors contribute to the restricted status of ibogaine in Australia:
Although ibogaine is prohibited for general use, there are avenues for authorized research. Researchers and institutions can apply for approval to study ibogaine under tightly controlled conditions. This pathway is crucial for advancing scientific understanding and potentially revisiting its legal classification in the future.
For those seeking ibogaine treatment, an alternative option is travelling to New Zealand, where ibogaine is legally available through registered medical practitioners. New Zealand has established a regulatory framework that allows licensed professionals to administer ibogaine in controlled clinical settings. This ensures that patients receive proper medical supervision, reducing the risks associated with unregulated treatments. Anyone considering this option should consult with qualified healthcare providers to assess their suitability for the treatment and ensure a safe and legal approach.
]]>Ibogaine, a psychoactive indole alkaloid found in the West African shrub Tabernanthe iboga, has gained recognition for its potential in treating substance use disorders (SUDs). It has a historical background in Western medicine, initially used as a neuromuscular stimulant and later for its unique properties in attenuating cravings and withdrawal symptoms in addiction cases.
The scientific research on ibogaine provides insights into its potential effectiveness and safety concerns in treating drug dependence. Here are key findings from various studies:
Ibogaine has received considerable scrutiny in Australian media, largely due to concerns over its potential cardiotoxicity. However, when you look at the scientific research, ibogaine shows a more favorable mortality profile compared to methadone—a widely used treatment for opioid addiction. Despite this, ibogaine is classified as a Schedule 9 substance under the Therapeutic Goods Administration’s Poisons Standard, meaning it is prohibited in Australia. Possession, use, sale, or importation is illegal without a specific research exemption or special authorization. Currently, there are no legally operating ibogaine clinics in the country. That said, recent years have seen the rise of psychedelic integration communities supporting individuals with substance use disorders. One particularly active group is The Transparent Company, which focuses on holistic approaches to recovery and integration.
The New Zealand Experience
In New Zealand, Ibogaine has been a subject of significant interest, especially after legislative changes in 2010 that allowed its prescription as a non-approved medicine for therapeutic use. The New Zealand model of Ibogaine treatment involves comprehensive assessment, the development of a treatment plan, and post-treatment support, emphasizing the importance of aftercare and continued counselling.
MDMA-assisted therapy has shown significant promise in the treatment of various psychiatric disorders, including post-traumatic stress disorder (PTSD), depression, and anxiety. This article provides an overview of the best practices in MDMA-assisted therapy, synthesized from recent scientific research.
MDMA, commonly known as ecstasy, when used in a controlled therapeutic setting, has been shown to enhance the effectiveness of psychotherapy for certain mental health conditions.
MDMA-assisted therapy represents a breakthrough in the treatment of certain psychiatric disorders, offering a unique combination of pharmacological and psychotherapeutic interventions. The controlled use of MDMA in therapeutic settings has shown significant efficacy and safety, making it a promising option for patients who are resistant to traditional treatments.
The information presented in this article is based on current scientific research and is subject to change as new studies emerge. Always consult with a healthcare professional for medical advice and treatment.
]]>Remember, the specifics of the plan will vary based on the size of the pharmacy, the complexity of its IT systems, and the types of data handled. It’s also important to stay updated with NHS and GPhC guidelines, as they may change over time.
]]>There has been a recent increase in interest in MDMA therapy as Lykos Therapeutics intends to launch MDMA as a licensed medicine towards the end of 2024. This marks a significant milestone in the evolving landscape of psychedelic-assisted therapy, particularly for conditions like post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD).
MDMA-assisted psychotherapy represents a novel approach to mental health treatment. Its efficacy primarily revolves around its ability to enhance the therapeutic process by fostering a sense of openness, empathy, and reduced fear response during psychotherapy sessions. This environment is conducive for patients to process and integrate challenging emotions and memories, particularly those related to traumatic experiences.
The safety and tolerability of MDMA therapy have been major points of consideration. Recent studies indicate that when administered in a controlled clinical setting, MDMA treatment is well-tolerated by participants. Adverse events have been rare and non-life-threatening, emphasizing the controlled use of MDMA in clinical environments as a key factor for safety. Research shows that MDMA therapy for PTSD is entering the final phase of drug development, with an aim for FDA and EMA licensing in the near future. This progress indicates the potential for MDMA to become a medicine, assuming clinical efficacy criteria are achieved (Sessa, Higbed, & Nutt, 2019).
Further, MDMA-assisted therapy has shown promising results in treating social anxiety in autistic adults and anxiety associated with life-threatening illnesses. Unlike conventional drug treatments, MDMA-assisted therapy is not intended for ongoing administration. It is used on one to several occasions within a psychotherapy protocol, potentially reducing the frequency of adverse events and improving the risk/benefit ratio. This aspect may present a significant advantage over medications that require daily dosing (Danforth, Struble, Yazar-Klosinski, & Grob, 2016).
As such, there are lots of ongoing clinical research on the subject, the most important of which include:
Other MDMA studies include:
Study Type | Trial ID or DOI | Condition | Year Registered | n | Intervention |
Phase 2 | ACTRN12619001334190 | Late-stage cancer patients, mood and anxiety | 2019 | 32 | 120mg MDMA (supplemented 60mg) with psychotherapy |
Phase 1/2 | ACTRN12621001078842 | PTSD | 2021 | 4 | 80 or 120mg MDMA (supplemented 40 or 60mg) with psychotherapy |
Phase 1 | No ID yet | Mechanism | 2021 | 100 | n = 100 for MDMA arm |
Phase 0 | ACTRN12613000685718 | Tinnitus | 2013 | 40 | 30 or 70mg MDMA |
Observational | ACTRN12620001068954 | Attitudes of psychotherapists towards MDMA-assisted psychotherapy | 2020 | 200 | MDMA-assisted psychotherapy questionnaire |
Phase 3 / Phase 2 | ACTRN12622000883718p | Brain Activity in Healthy Adults | 2022 | 200 | 80 or 120mg MDMA; or 25, 30, 35mg psilocybin |
Phase 2 | ACTRN12623000838617 | PTSD | 2023 | 5 | 87 + 43.5 mg |
Phase 1 | ACTRN12622001335785 | Healthy | 2023 | 5 | 75; 125; 175; 225 mg EMP-01 (MDMA analogue) |
Phase 2 | ACTRN12623000971639 | PTSD, veterans | 2023 | 24 | 120 + 40 mg |
Phase 2 | ACTRN126220 01525774 | TR-OCD | 2023 | 40 | 100 mg |
Alongside this, there is a wide range of small investigator-led MDMA trials including:
The development of MDMA-assisted psychotherapy heralds a new era in mental health treatment, promising a potentially transformative approach for patients with conditions resistant to current treatments. As Lykos Therapeutics prepares to introduce MDMA as a licensed medicine, the medical community and patients alike await with anticipation the outcomes and broader implications of this novel therapeutic approach.
]]>i. What their key operational services are,
ii. What technologies and services their operational services rely on to remain available and secure,
iii. What other dependencies the operational services have (power, cooling, data, people etc.),
iv. The impact of loss of availability of the service.
Understanding Health and Care Services Provided by [Organization Name]
I. Key Operational Services:
[Provide a comprehensive list of the key operational services offered by the organization. These services are at the core of the organization’s mission and activities. For example:]
II. Technologies and Services Dependencies:
[Detail the technologies and services that are crucial for the availability and security of the key operational services. For example:]
III. Other Dependencies:
[Identify other dependencies beyond technology that are critical for operational services. These may include power, cooling, personnel, and more. For example:]
IV. Impact of Loss of Availability of the Service:
[Describe the potential consequences and impact on patients, staff, and the organization if the key operational services become unavailable. This may include:]
[Include any additional information specific to your organization’s services and dependencies.]
This document serves as a foundational understanding of the critical elements related to health and care services provided by [Organization Name]. It highlights the importance of safeguarding these services, their dependencies, and the potential impact of service unavailability on patient care and the organization’s overall performance.
]]>2. Objectives:
3. Data Collection:
A. Staff Roles and Responsibilities:
B. Skill Assessment:
4. Identify Training Needs:
A. Training Objectives:
B. Training Topics:
C. Training Gaps:
D. Prioritize Training Needs:
5. Training Methods:
6. Training Plan:
A. Training Schedule:
B. Training Materials:
C. Trainers or Facilitators:
7. Evaluation:
A. Pre-Training Assessment:
B. Training Delivery:
C. Post-Training Assessment:
D. Feedback and Improvement:
8. Monitoring and Continuous Improvement:
9. Conclusion:
10. Approval and Implementation:
We process your personal data, which includes your name, contact details, prescription medicines and data from other pharmacy and health care services we provide to you (for example pharmacy medicines, pharmacy services, flu vaccinations) for the purposes of:
Your care: providing pharmacy services and care to you and, as appropriate, sharing your information with your GP and others in the wider NHS
Our payments: sharing your information with the NHS Business Services Authority, others in the wider NHS and sometimes local authorities, and only limited information to those external to the NHS who negotiate and check the accuracy of our payments
Management: sharing only limited information with the NHS Business Services Authority and others in the wider NHS and sometimes local authorities, as well as those external to the NHS who ensure we maintain appropriate professional and service standards and that your declarations and ours are accurate.
We hold your information for as long as advised by the NHS. You have a right to a copy of the information we hold about you, generally without charge. You may seek to correct any inaccurate information.
We process your personal data in the performance of a task in the public interest, for the provision of healthcare and treatment and the management of healthcare systems. A pharmacist is responsible for the confidentiality of your information. You may object to us holding your information. You may also lodge a complaint with the Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF. Please ask if you want more information.
Our Data Protection Officer is (name and contact details)
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