How to get medicinal cannabis
There are several ways that patients can gain access to products such as medicinal cannabis that have not been approved for use in Australia
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Access medical cannabis in Australia
All medicinal cannabis products in Australia, bar one, nabiximols, are currently classified as unapproved products are not available as registered prescription medicines. For a product to be approved and listed on the Australian Registry of Therapeutic Goods (ARTG) a company must submit clinical research which shows their product has proven therapeutic benefit for a specific condition. This is a lengthy process that can take years.
Despite medicinal cannabis not being listed on the ARTG, there are several ways that patients can still access medicinal cannabis even though it is an approved product in Australia. This site will focus on the following three access pathways:
- Special access scheme (SAS)
- Authorised prescribers
- Clinical trials
For further information we suggest you refer to the TGA site: https://www.tga.gov.au/accessing-unapproved-products
Before you consider medicinal cannabis as a treatment in Australia, you should be aware of the following:
Medical Cannabis: Not a first line treatment
The TGA, is currently recommending cannabinoid therapy only be used after conventional treatments have been unsuccessful. This is because medicinal cannabis is an unapproved product and requires further research to enable clinicians to understand if there are conditions or therapeutic areas where cannabis may be definitively useful.
A doctor can prescribe medicinal cannabis (upon approval from the TGA) only after established treatments have been trialled and or have been unsuccessful, with the exception of palliative care. If a patient would like to try medical marijuana before other approved treatments, an application to the TGA may be rejected unless approved conventional therapies have not worked or have given the patient adverse side effects.
As supporting evidence for the use of cannabinoid products develops through robust clinical trials, the TGA will update its guidelines and expand the clinical settings and conditions for which medical cannabis may be considered for approval.
STEP 1: Doctor consultation with patient
An Australian-registered medical practitioner with appropriate qualifications and/or expertise for the condition requiring treatment will assess a patient to decide if cannabinoid therapy is appropriate for their condition and circumstances. Currently the advice from the TGA, Australia's regulatory authority, is that medical cannabis should be used only when approved treatments (medical cannabis is still an unapproved product) have been tried and have failed to manage conditions and or symptoms. There is one exception, patients with terminal conditions are able to access medicinal cannabis through a separate avenue.
For a patient's medical practitioner to be successful in applying for medical cannabis they will need to:
- have confirmed your medical condition and relevant medical history,
- submit documentation outlining which medications for your condition have been attempted and are not working or have adverse effects,
- submit clinical evidence or research showing therapeutic benefit from the use of medical cannabis has show benefit in patients with a similar medical condition.
TGA applications (excluding those for SAS A – palliative care) need to state if the medical practitioner making the application is the patient’s usual doctor.
A patient's current treating medical practitioner should have a good understanding of the patient's medical condition(s) AND access to their medical records. Information regarding the patient's relevant medical history may need to be submitted if an application is made to the TGA. If the patient visits a new medical practitioner to access medical cannabis for their condition, the new clinician may need to access to your medical records and explain why they are making the application. It is preferable for patients to use their regular medical practitioner to access medicinal cannabis if they feel it will be beneficial for their condition.
Does your doctor need assistance?
Medical practitioners can find assistance compiling these applications to the TGA via our GreenChoices HCP Portal.
STEP 2: Product consideration
If the medical practitioner decides that cannabinoid therapy is an appropriate treatment they will then need to determine exactly which product is suitable. They are likely to consider the following;
- product availability by supplier / sponsor
- the cost to the patient,
- if there is compassionate access or clinincal trials available (to potentially reduce product costs for patients),
- a dispensing pharmacy, and
- if it is a ‘Schedule 4’ medicine (Prescription Only) or ‘Schedule 8’ medicine (Controlled Drug) as the approval process and product delivery can differ between the two.
Choosing a product for a patient is the responsibility of the doctor. They will research and compare products which are best suited for their patient's condition. It is also a requirement for each TGA application to include documentation confirming the product meets the safety and quality requirements set out in Therapeutic Goods Order No 93 (TGO93). This information is normally supplied to the doctor by the manufacturer.
Detailed product information is available only to medical practitioners and can be obtained via product suppliers or via the GreenChoices HCP Portal.
STEP 3: Decide on pathway to access
The medical practitioner will need to determine if SAS Category A or B is most suitable for the patient, or consider becoming an Authorised Prescriber (AP) – Category C. With the patient’s consent, the practitioner can apply for federal approval from the Therapeutic Goods Administration (TGA) citing relevant scientific research around the use of medicinal cannabis for the relevant medical condition, and the patient’s medical history.
Who can apply?
This varies depending on the state/territory. Some states stipulate a specialist must apply. In other states General Practitioners can apply but may require a Specialist’s support or expertise in the area for which the medication is being prescribed. Specialist support is required if they do not have the relevant expertise or qualification to treat the patient's condition.
Special Access Scheme (SAS)
In Australia, therapeutic goods (e.g. prescription medicines) are required to be evaluated for quality, safety and efficacy before they can be supplied or listed on the Australian Register of Therapeutic Goods (ARTG).
If patients require access to medicines that are not listed on the ARTG, such as medical marijuana, the TGA can provide access via the Special Access Scheme (SAS) or other programs. In such cases, the SAS allows for the import and/or supply of this unapproved medicine to a single patient on a case-by-case basis or to a number of patients with a similar condition for doctors who have been approved as Authorised Prescribers.
The TGA expects that the prescribing doctor will have considered all appropriate treatment options that are included on the ARTG and available in Australia prior to considering access to an unapproved medicine like cannabis via the SAS.
SAS Category A – for terminal patients
Category A is a notification pathway which can be accessed by a prescribing medical practitioner for patients who are seriously ill with a condition from which death is reasonably likely to occur within months, or from which premature death is reasonably likely to occur in the absence of early treatment. Supply of unapproved medicines to patients under Category A does not require TGA approval therefore it ensures timely access to effective therapy under the supervision of a dedicated medical practitioner. This is the only mechanism under the Therapeutic Goods Act and Regulations whereby terminally ill patients can access medicines “immediately” without the requirement of approvals.
SAS Category B – application pathway (most common)
SAS B is an application pathway accessible by health practitioners for patients who do not fit the Category A definition and where the unapproved good is not deemed to have an established usage history. An approval letter from the TGA is required before the therapeutic good may be prescribed by a doctor.
A medical practitioner can apply to prescribe a medicinal cannabis product to a single patient through the Special Access Scheme (SAS) Category B.
Health practitioners wanting to conduct a clinical trial involving the use of an unapproved medicines should consider the CTN or CTX pathways. Health practitioners wanting to enrol a patient into a clinical trial or compassionate access program are normally encouraged to contact the sponsor.
The regulatory controls placed on clinical trials conducted through the CTN and CTX pathways provide sufficient assurance that high quality, credible data that contribute to the answering of specific scientific questions is collected, while also protecting the rights, safety and well-being of clinical trial participants.
STEP 4: TGA Approval
SAS Category B
If your doctor is successful applying via SAS A you can go to Step 6.
SAS Category B – application pathway (most common)
Under current legislation if you are situated in NSW, upon receiving TGA approval a practitioner can then prescribe medicinal cannabis to the patient – Go to Step 6.
For Schedule 8 medicines, other states and territories must then take a second step* to obtain prescribing approval which is to submit a second application to the state health department – Go to Step 5.
In all areas except Queensland, Schedule 4 medicines can be prescribed once the TGA has approved the application. Go to Step 6 (unless you apply in Queenland).
*This two-step process will change to reflect NSW’s single-access pathway in the near future, with all states committing to a single access pathway in April 2018. We will update this information as the regulations are updated.
Upon receiving TGA approval to become an Authorised Prescriber, a practitioner can go to Step 5 or 6 (depending on your state).
STEP 5: State / Territory Approval (excluding NSW & VIC)
Each Australian State and Territory has different requirements for patients accessing medicinal cannabis depending on which schedule listing the medical cannabis products are classified as (Schedule 4 or 8).
For Schedule 8 medicines, once approval is given from the TGA, the doctor will receive an approval certificate that must be provided as part of a separate application to the relevant State Health Department.
For Schedule 4 cannabinoid therapy medicines, no State Health Department approvals are required, except in Qld.
STEP 6: Product availability
Upon approval, the patient can receive a script for medicinal cannabis which is to be presented at the nominated pharmacy with the approved TGA and State Health approvals (if required.) If stock is available in Australia, the supplier can release product to the pharmacy who will then dispense the product to the patient. However, if the product needs to be imported there are additional steps involved to supply product and the supplier must hold an import licence from the ODC. In all states/territories except Queensland, Schedule 4 medicines can be prescribed once the TGA has approved the application – Go to Step 7.
STEP 7: Patient Access
A pharmacist can dispense product to a patient only on receipt of a hard copy written prescription (Emergency supply provisions do not apply). Hospital pharmacies may supply for inpatients on a copy of a medication chart order.