It is the 5th anniversary of my authorised prescriber status and I want to take the opportunity to provide an update on this subject. Medicinal cannabis products now come in a plethora of combinations of active ingredients and formulations ranging from inhaled, ingested and topical preparations. There are creams, oils, capsules, gummies, wafers , vapes and whole flowers that can be vaporised and an expanded range of clinical indications for use.
Medicinal cannabis is no longer unconventional with more prescribing doctors and is widely accepted in the Australian community. Increased competition in the market means these products are also no longer unaffordable.
Schedule 3 medicinal cannabis encompasses low dose cannabidiol (CBD) products that do not require a prescription and can be dispensed by pharmacists but as there are no TGA registered products available in Australia, this is not an option for consumers.
Schedule 4 medicinal cannabis products contain CBD and do not contain any significant tetrahydrocannabinol (THC), which is the psychoactive component that is more stringently regulated. CBD preparations can be isolates (only CBD) or full spectrum (CBD with minor cannabinoids, flavonoids and terpenes) and do not have any cognitive effects. They are commonly used to manage pain, anxiety, seizure disorders, spasticity and movement disorders and modify inflammation in the body. CBD can be used safely in quite high doses as the side effects are minimal and there is no issue with safety critical work or driving. CBD use does not result in a positive drug test.
Schedule 8 products usually contain THC and CBD in varying concentrations. The THC component is very useful to manage chronic pain, insomnia, anxiety, appetite and management of palliative care patients. It can cause some undesirable side effects on balance, cognition and precludes any safety critical tasks and driving.
There is now uniformity in the approach throughout Australia with Schedule 4 products, however every State still has different regulations for the Schedule 8 products. For example, unlike WA, in Tasmania medicinal cannabis products with THC are able to be legally used while driving.
There are always risks and downsides with these medications and one size does not fit all. There are no medicinal cannabis products on the PBS and in my experience, cost is the main deterrent in finding the right product combination and dose for the patient. DVA is the only organisation that will cover the cost in specific patients if there is specialist support for the use of the product.
These products are a game changer in patients where conventional medicines have either failed or caused too many undesirable effects such as tolerance with opioid and benzodiazepine medications. Why use opioids for chronic pain when we know they do not work long term, can cause terrible effects on physical and mental health and result in overdose fatalities when we have an option of an effective medication that does not cause tolerance effects or fatalities.
If a patient wants to book in for an appointment to discuss the use of medicinal cannabis with me, please note the first appointment should be for 45 minutes and will not be bulk billed. I do not usually consult patients outside WA due to the different regulations pertaining to the use of Schedule 8 medicinal cannabis products in each state.
Clinical indications for Dr Aparna Hegde’s approval as Authorised Prescriber:
1. Chronic Non-Cancer Pain (CNCP)
a. Neuropathic pain
b. Arthropathic pain
c. Fibromyalgia
2. Cancer Pain and/or Palliation
3. Insomnia
4. Anxiety (including PTSD)
5. Autism Spectrum Disorder (ASD)
6. Movement disorders
a. Parkinson’s Disease
b. Multiple Sclerosis (MS)
When all other standard therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
Chronic pain to include, but not limited to conditions below:
Neuropathic pain when all other standard therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
Musculo-skeletal and inflammatory pain (Arthropathies) when all other standard care therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
Fibromyalgia associated generalised pain and muscle stiffness severe enough to interfere with daily activities of living where standard therapies have failed to adequately control clinical symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
Any other non-nociceptive chronic pain where:
– the medical practitioner believes that standard therapies have been inadequate in controlling clinical symptoms and/or
– if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications and/or
– the medical practitioner believes that medical cannabis may be beneficial to the patient.
1. Cancer Pain and/or Palliation, including CINV
When all other standard care therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
Inclusive of cancer pain, chemotherapy or cancer associated nausea and vomiting, anorexia, insomnia, cachexia related to cancer treatment when standard treatments have failed to adequately control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care therapies or medications.
2. Insomnia
When all other standard care therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
One of the most common reasons that patients report the use of cannabis for medical purposes is to reduce pain and improve sleep. Despite this repeated association, it is not clear whether the effects of cannabis use on pain are mediated by the effect of improved sleep, or vice versa.
A recent review of the current scientific findings was published in 2017 (Babson KA, Sottile J, Morabito D. Cannabis, Cannabinoids, and Sleep: a Review of the Literature. Curr Psychiatry Rep. 2017;19(4):23.) which show that early findings indicate that cannabidiol (CBD) may have therapeutic potential for the treatment of insomnia.
3. Anxiety (including PTSD)
Where standard therapies have failed to adequately control clinical symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
In human trials, CBD has shown to reduce subjective anxiety in cannabis-naive patients with Social Anxiety Disorder (SAD), (Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. Crippa JA et al). Trials such as this, as with much of the research into anxiety and cannabis, have small patient populations. However, in the case of this study and some others, evidence may be held in high regard as it is one of the few that have been conducted with high-quality research methods (double-blind, placebo-controlled, crossover trial).
4. Autism Spectrum Disorder (ASD)
When all other standard care therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
The researchers from Ben-Gurion University of the Negev (BGU) and Soroka University Medical Center looked at the link between the use of medical cannabis and autism behavioural improvements in children with autism, who are 18 years old and under, and found cannabis to be a well-tolerated, safe and effective option to relieve symptoms including seizures, tics, depression, restlessness, and rage attacks.
The researchers reported that after six months of treatment that 80% of participants reported some level of improvement.
5. Movement disorders (incl. Parkinson’s Disease and Multiple Sclerosis)
When all other standard care therapies have proven inadequate to control symptoms and/or if the patient suffers intolerable adverse reactions or side-effects to standard care treatment or medications.
For a comprehensive clinical management plan for the patient, relevant specialist(s) will be consulted where deemed necessary.low prescription of Cannabis Based Products (CBP’s), by GPs for certain specific medical reasons. There is a lot of confusion amongst both doctors and patients about medical cannabis, and I’m hoping this article will clarify the situation for you.
Each State in Australia is different in its requirements and legislation. I’m going to concentrate on WA as this is where I practice.
No CBP’s are listed on the PBS (Pharmaceutical Benefit Scheme), meaning there is no subsidy for their cost and this means they can be expensive. DVA patients with specialist support may be eligible to have CBP costs covered by the organisation.
Why bother with a CBP prescription instead of getting an online product or using cannabis bought off the street? CBPs are legal – which means you won’t be in trouble with the law for using them and they are controlled by regulations so you know exactly what you are getting. In some cases, such as with chronic pain, when we have run out of other therapeutic options, they might be worth considering.
The first type of CBP is classified as a Schedule 4 (prescription only) medication. This is not psychoactive, as it contains less than 2% THC (tetrahydrocannabinol is the part that gives the “high” of cannabis). As at present there are no Schedule 4 CBPs registered as therapeutic goods in Australia, even these medications require the appropriate paperwork and approval under the Special Access Scheme from the Therapeutic Goods Administration (TGA). A doctor can register to submit the information for patients online https://www.tga.gov.au/special-access-scheme-and-authorised-prescriber-online-system and the process is much more streamlined that when it started 2 years ago.
As per the TGA, approvals for Schedule 4 CBDs may be given for:
• chemotherapy induced nausea and vomiting;
• refractory paediatric epilepsy;
• palliative care;
• cancer pain;
• neuropathic pain;
• spasticity from neurological conditions;
• anorexia causing wasting, due to chronic illness such as cancer.
The TGA is a federal organisation and approvals for indications other than mentioned will require justification such as a specialist letter indicating the CBD was not being used as first line treatment (i.e. conventional treatments must be tried first), that it was correctly indicated as treatment for the condition, and that there were medical studies backing up it’s appropriate usage. This is a little time consuming for the doctor requesting the approval at present. Once there is a Schedule 4 CBD product that is registered in Australia with the TGA, this process should become a simple matter of the doctor writing a script and the patient getting it filled at the pharmacy, as with any other medication.
The second type of CBPs are listed as Schedule 8 medications (controlled drugs) as they are mainly THC (and therefore may be psychoactive). These require WA Department of Health approval. There are Schedule 8 CBPs that are already registered with the TGA, and so further approval from the TGA is not needed if these are prescribed in accordance with Department of Health rules. The paperwork and approval process is more straight forward if there is a supporting specialist letter. If a Schedule 8 medication that is not registered in Australia is being used such as a THC10:CBD10 product as is most commonly prescribed, the TGA online site is used to apply for both TGA and DOH WA with the documentation of specialist reports, consent, proposed monitoring and justification able to be uploaded – just follow the prompts appropriately https://www.tga.gov.au/special-access-scheme-and-authorised-prescriber-online-system
Indications for Schedule 8 CBDs are:
• chronic pain and spasticity
• sleep disorders
• nausea and vomiting due to chemotherapy
• weight gain in HIV infection
• seizure disorders.
My approach to the use of CBPs is to first establish if the condition can be helped by their use, referring to studies in the medical literature; discuss other options available on the PBS for the condition (as these will always be easier to obtain and more affordable), assess if there are any excluding conditions (such as heart disease, liver problems or history of illicit drug use), decide on which type of CBP would be indicated, go through the paperwork requirements with the patient including trying to obtain a supportive specialist letter, agree on a written treatment plan and then submit the paperwork through the appropriate pathway for approval. Once approval is received, I review the patient every 2 weeks to check for therapeutic effect, such as a pain score, as well as for side effects and order investigations as clinically indicated. After the 3-month trial period has been completed, I discuss with the patient as to the efficacy and willingness for ongoing treatment, and either cease the CBP or apply for ongoing approval as appropriate. I always try to handover ongoing care to the treating GP at any stage and most seem happy to take over the ongoing prescription once the approvals are in place.
Not many doctors, in particular specialists are familiar with the use of CBPs and it is important to establish contact with a GP who is experienced in this field.
Please note consultations for Medicinal Cannabis are not bulk billed at The Age Less Clinic and General Practice.
