How to access Medicinal Cannabis

Information for medical practitioners
Date:  2020-01-01
Author:   Medlab
How to access Medicinal Cannabis

In most states and territories in Australia, approval or permission is required by a medical practitioner in order to prescribe medicinal cannabis products to their patient(s).

Additionally, Medicinal cannabis products may be scheduled differently under the Schedule of Medicines and Poisons (SUSMP or 'Poisons Standard'). The adoption of the SUSMP may vary between different states and territories.

The Australian Government provides a number of educational articles and links around Medical Cannabis which can be viewed here.

Medicinal cannabis may be accessed through the Special Access Scheme (SAS) Online System, by an Authorised Prescriber or for use in a Clinical Trial, unless registered in the Australian Register of Therapeutic Goods (ARTG).


Requirements in each Australian state for prescribers to gain access to Schedule 8 Medicinal Cannabis

Select your state



 

Australian Capital Territory (ACT)

In the ACT, prescribers must have approval from the ACT Chief Health Officer (CHO) and from the TGA to prescribe medicinal cannabis as a controlled medicine.

Prescribers may now apply for both ACT and TGA approvals to prescribe medicinal cannabis concurrently via the TGA’s online application pathway. This single online pathway has been developed to streamline the application process for prescribers and facilitate more timely patient access to medicinal cannabis products.

Applications can now be submitted through the TGA’s Special Access Scheme Application website. For more information about the Special Access Scheme, please visit the TGA website.

The TGA and ACT Health will each conduct their own evaluation processes on the information submitted via the online application system. It is important to note that as part of these evaluation processes, the TGA and ACT Health may contact the prescriber seeking further information in support of the application.

The TGA will evaluate the application under the requirements of the Therapeutic Goods Act 1989 and ACT Health will evaluate the application against the requirements of the ACT Controlled Medicines Prescribing Standards. Both the TGA and ACT Health must approve the application prior to a prescriber being permitted to prescribe medicinal cannabis.

Under the ACT Controlled Medicines Prescribing Standards, medicinal cannabis can be approved for patients with the following conditions:

  • spasticity in Multiple Sclerosis
  • nausea and vomiting from Cancer chemotherapy
  • pain and anxiety related to active malignancy from a life limiting disease with a prognosis of 12 months or less
  • refractory paediatric epilepsy

Applications will also be considered on a case by case basis for other conditions. ACT Health may refer these applications to the Medicinal Cannabis Medical Advisory Panel for advice

Links

 


New South Wales (NSW)

The Poisons and Therapeutic Goods Amendment (Cannabis Medicines) Regulation 2019 commenced on 30 September 2019.

From 30 September 2019 an application to NSW Health for a Schedule 8 cannabis medicine is required where it is for:

  • prescribing or supplying to a drug dependent person*, or
  • prescribing or supplying for a clinical trial (if it is an unregistered cannabis medicine), or
  • prescribing or supplying to treat a child (aged under 16 years).

* A drug dependent person means a person who has acquired, as a result of repeated administration of any of the following drugs an overpowering desire for the continued administration of a drug of addiction (Schedule 8), or a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985 (including but not limited to heroin, methylamphetamine or cocaine). A person treated under the Opioid Treatment Program is a drug dependent person.

NSW Authorities issued before 30 September 2019 are valid until they expire (unless they are cancelled).

Prescriptions for Schedule 8 cannabis medicines issued from 30 September 2019 do not require a NSW Authority number.

The changes described above do not affect the requirement for a Commonwealth approval to prescribe an unregistered cannabis medicine.

 

Links

 


Northern Territory (NT)

A patient living in the Northern Territory must access medicines containing cannabinoids through an Australian doctor who is authorised under the Special Access or Authorised Prescriber Scheme administered by the Therapeutic Goods Administration.

Authorisation from NT Chief Health Officer (CHO) is not required for all goods in Schedule 8 other than the ones declared as restricted (see link for a full list). However, a prescriber needs to send a notification to the NT CHO if the patient is going to be on the unrestricted S8 medicine for more than 8 weeks, or has already been on the medicine for 8 weeks with another prescriber (notification form on the NTG website).

Links

 


Tasmania (TAS)

The Tasmanian Government has developed a medical cannabis controlled access scheme (CAS). The scheme will allow only relevant medical specialists to be authorised to prescribe medical cannabis (unregistered cannabinoid products) in limited circumstances where conventional treatment has been unsuccessful. Please note that only public hospital consultants or visiting medical officers/VMOs (medical practitioners in private practice who also provide medical services in a public hospital) can be approved to prescribe these products. If a GP believes an unregistered medical cannabis product is indicated based on a risk/benefit assessment, referral to a relevant specialist medical practitioner in the relevant field of medicine is required. The Relevant Specialist Medical Practitioner must then apply to the Secretary of the Tasmanian Department of Health and Human Services (DHHS), for authorisation to prescribe unregistered medicinal cannabis products. Please note that the application form is available on the Tasmanian Health System (THS) intranet page (it is not a public document). The application is reviewed by a delegate of the Secretary of DHHS under the Poisons Act 1971. Application or notification to the TGA and/or the Office of Drug Control is required in parallel.

Once the authority to prescribe unregistered medicinal cannabis products is issued, the Relevant Specialist Medical Practitioner prescribes a product for a patient in accordance with their authority and the product is dispensed by a Tasmanian Health Service (THS) Hospital Pharmacy.

Links

 


Queensland (QLD)

A medical practitioner must apply to the Chief Executive (CE), Department of Health, for a medicinal cannabis approval in Queensland. This approval authorises the medical practitioner to treat an individual patient with a specified medicinal cannabis product. The CE may request advice from the Queensland Medicinal Cannabis Expert Advisory Panel. Specialists that wish to become a patient-class prescriber will need patient-class approval.

Once the medicinal cannabis approval is granted, it is valid for up to one year. The prescriber must then apply to the TGA for the supply of the product under SAS scheme or AP scheme before the medicinal cannabis product can be prescribed (medical practitioner) and dispensed (pharmacist) to the patient.

Links

 


South Australia (SA)

Patients in South Australia can access medicinal cannabis on prescription from their authorised medical practitioner and dispensed by a pharmacist.

The decision to consider medicinal cannabis as a treatment option is a matter for discussion between a medical practitioner and their patient, enabling consideration of the patient’s clinical information and the safety and efficacy of medicinal cannabis in the particular condition to be treated.

Importantly, medical practitioners must notify or apply for approval to the Commonwealth TGA to prescribe an unregistered medicinal cannabis product.

Note, there is not a restricted list of medical conditions for which medicinal cannabis may be prescribed in South Australia.

Consistent with the requirements for Schedule 4 medicines in South Australia, there is no requirement for a medical practitioner to obtain State approval to prescribe a Schedule 4 cannabidiol (CBD) medicine.

The South Australian Controlled Substances Act 1984 regulates the prescribing and supply of medicines in South Australia and applies to medicinal cannabis products.

A section 18A authority to prescribe a medicinal cannabis product that is a Schedule 8 controlled drug (drug of dependence) is required:

  • after 2 months of treatment or before commencing treatment where the person has already been prescribed a Schedule 8 drug for a period exceeding 2 months
  • before commencing treatment for any person the medical practitioner reasonably believes to be dependent on drugs.

However, a section 18A authority is not required for patients:

  • Patients aged 70 years or older
  • Notified Palliative Care Patients (notification must be made to the Drugs of Dependence Unit)

Links

 


Victoria (VIC)

Due to Covid-19, Schedule 8 permits are no longer required to prescribe medicinal cannabis in non-drug dependent persons until 27 September 2020, or until otherwise revoked.

In Victoria, any medical practitioner can prescribe a medicinal cannabis product for their patient, if they believe it is clinically appropriate to do so. Medical practitioners do not need to gain accreditation, nor be specialists in a particular field.

Depending on the product being prescribed, approvals may be required from the Commonwealth and/or Victorian government prior to prescribing.

All Medicinal Cannabis products not registered on the ARTG require approval from the Therapeutic Goods Administration (TGA) to be prescribed. This approval can be obtained through the TGA's Special Access Scheme, or by becoming an Authorised Prescriber.

Irrespective of registration on the ARTG, most medicinal cannabis products (other than pure cannabidiol (CBD) will require a Victorian Schedule 8 treatment permit. Exemptions from the requirement for treatment permits exist if the patient is in hospital, an aged care service or prison, or the indication for treatment is palliative care.

Victorian (Schedule 8) and Commonwealth (TGA) approvals required to prescribe Schedule 8 medicinal cannabis products not listed on the ARTG can now be sought together via the TGA's single online application.

Depending on the product being prescribed, approvals may be required from the Commonwealth and/or Victorian government prior to prescribing.

No Victorian permit/approvals are required if a prescriber is seeking to prescribe a Schedule 4 medicinal cannabis product.

Links

 


Western Australia (WA)

All medical practitioners in WA are eligible to prescribe medicinal cannabis products. For most patients, a general practitioner may initiate treatment. For some patients, including those with a history of drug dependency, children and young adults, the support of a suitable specialist will be required.

Before prescribing medicinal cannabis in Schedule 8, authorisation is required from the Department of Health, for each individual patient.

There are no requirements for Department of Health authorisation for cannabidiol only products in Schedule 4. However, as these products are unapproved therapeutic goods, TGA requirements must still be met.

The TGA Online System is available to apply for Western Australian Department of Health authorisation whilst simultaneously complying with the TGA requirements. Turnaround time for approval is generally 48 hours (two business days).

Links

 



Further information

You can reach out to the Australian Government, Therapeutic Goods Administration (TGA)  

Or seek further information available on the following websites:

COMMENTS 0

Tell us what you think login to share your thoughts.

ABOUT THE AUTHOR

Medlab Author
Medlab Author
Medlab

Medlab in-house Editor.