Articles and Case Studies

Prescribing Medicinal Cannabis

12 Dec 2019

Dr Kiely Kim

by Dr Kiely Kim

medicinal cannabis

On 1 November 2016, following a decision by the Therapeutic Goods Administration (TGA), medicinal cannabis became a controlled drug (Schedule 8) in the Poisons Standard.

As a result, medicinal cannabis can be prescribed. There are legislative requirements however at both a federal and state/territory level that medical practitioners will need to be aware of when prescribing.

[This article was last updated on 12 December 2019]

In general, medicines supplied in Australia must be assessed by the Australian Government’s Therapeutic Goods Administration (TGA) for quality, safety and efficacy, and registered on the Australian Register of Therapeutic Goods (ARTG).

Most medicinal cannabis products are unregistered and practitioners will need to apply to the TGA who may approve the supply of unregistered cannabis medicines under the following pathways:

  • the Special Access Scheme (SAS)
  • the Authorised Prescriber Scheme 
  • a clinical trial

It is expected that medical practitioners will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access an unapproved medicinal cannabis product.

There is no pre-determined list of conditions for which a cannabis medicine can be prescribed and applications to prescribe unregistered medicines are assessed by the TGA on a case-by-case basis. The TGA provides further information on the clinical evidence for medicinal cannabis and cannabis products in their medicinal cannabis guidance documents.

In addition to the need to obtain TGA approval before prescribing unregistered medicinal cannabis medical practitioners will need to check the prescribing requirements of their state or territory.

The TGA has been working with the State and Territory health departments to streamline the application process and have introduced a SAS online system which will allow prescribers in certain States and Territories to apply to both the Commonwealth and the relevant State/Territory Health department simultaneously.

Here is a step by step guide to apply for approval to prescribe medicinal cannabis via the SAS or Authorised prescriber schemes

Step 1: Determine your state or territory prescribing requirements

Medicinal cannabis – state and territory prescribing requirements

New South Wales

 

NSW medical practitioners can legally prescribe a cannabis medicine for a patient if they believe it is an appropriate treatment option for their patient's health condition and they have obtained the relevant authorities. 

Medical practitioners are encouraged to use the TGA's online system for SAS applications to NSW to prescribe or supply unregistered Schedule 8 cannabis medicines. 

A NSW Health authority is only needed when prescribing or supplying a Schedule 8 cannabis medicine either: 

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

(apply directly to NSW Health)

* A drug dependent person is 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. 

Contact details

NSW Cannabis Medicines Advisory Service - prescribing advice

Phone: 02 4923 6200 (9.00am - 5.00pm, Monday to Friday)

Email: HNELHD-CMAS@health.nsw.gov.au

Pharmaceutical Regulatory Unit, NSW Ministry of Health - authorisation enquiries 

Phone: 02 9391 9944

Email: MOH-CannabisMedicinesApplicationsNSW@health.nsw.gov.au

NSW Health website: http://www.health.nsw.gov.au/pharmaceutical/cannabismedicines

Queensland

Doctors who hold a specialist registration (including specialist general practitioners) can prescribe Schedule 8 - products containing tetrahydrocannabinol (THC) without a Queensland Health approval except when treating a drug-dependent person.

Doctors who do not hold a specialist registration:

Schedule 8 Medicinal cannabis not registered on the ARTG

Doctors who do not hold a specialist registration need approval from Queensland Health if prescribing a Schedule 8 medicinal cannabis product that is not registered on the ARTG. 

Schedule 8 medicinal cannabis registered on the ARTG

To prescribe the registered medicine nabiximols (Sativex), all non-specialist medical practitioners need to apply to the Director-General Queensland Health for a Section 18 approval under the Health Drugs and Poisons Regulation 1996 (HDPR).

Queensland doctors can prescribe Schedule 4 - cannabidiol (CBD) only products without a Queensland Health approval. 

Contact details

Phone: 07 3708 5283

Fax: 07 3708 5431

Email: MCTeam@health.qld.gov.au

Website: https://www.health.qld.gov.au/public-health/topics/medicinal-cannabis

Victoria

In Victoria, any registered medical practitioner can prescribe medicinal cannabis for any patient with any condition, if they believe it is clinically appropriate and have obtained the required Commonwealth and/or state approvals. 

Summary of approvals required before prescribing a medicinal cannabis product in Victoria

S4-S8 Medicinal Cannabis 

Contact details

Phone: 03 9069 7768, 1300 364 545 (medical practitioners only)

Email: medicinal.cannabis@dhhs.vic.gov.au

Medical practitioners only: dpcs@dhhs.vic.gov.au

Website: http://www2.health.vic.gov.au/public-health/drugs-and-poisons/medicinal-cannabis

Australian Capital Territory

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 apply for both ACT and TGA approvals to prescribe medicinal cannabis concurrently via the TGA's online application pathway. 

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.

Contact details

Phone: 02 6205 0998

Email: hps@act.gov.au

Website: https://www.health.act.gov.au/health-professionals/pharmaceutical-services

Northern Territory

A patient living in the Northern Territory must access medicines containing cannabinoids through a Northern Territory doctor who is authorised under the Special Access or Authorised Prescriber Schemes administered by the TGA. 

Contact details

Phone: 08 8999 2633

Email: chiefhealthofficer.DoH@nt.gov.au

Western Australia

The Schedule 8 Medicines Prescribing Code governs the prescribing of Schedule 8 medicines in WA.

All medical practitioners in Western Australia (WA) can prescribe medicinal cannabis products. For most patients, a general practitioner (GP) can initiate treatment. Specialist endorsement is required before a GP can prescribe medicinal cannabis for a person with drug dependency (current or history) or products containing tetrahydrocannabinol (THC) for children and young people. 

Approval to prescribe is required for each individual patient. State approval is not required for cannabidiol only products. 

Prescribers may apply for both WA Department of Health and TGA approvals to prescribe medicinal cannabis concurrently via the TGA's online application pathway.

Contact details

Phone: 08 9222 6883

Email: MPRB@health.wa.gov.au

Website: http://ww2.health.wa.gov.au/Articles/A_E/Cannabis-based-products

South Australia

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

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. 

Exemptions

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)

There is no requirement for a medical practitioner to obtain State approval to prescribe a Schedule 4 cannabidiol (CBD) medicine. 

Contact details

Phone: 1300 652 584 (medical practitioners only)

Email: HealthDrugsofDependenceUnit@sa.gov.au

Website: SA Health

Tasmania

The Tasmanian Government has developed a medical cannabis controlled access scheme (CAS).

The scheme allows relevant medical specialists to be authorised to prescribe medical cannabis (unregistered cannabinoid products) in limited circumstances where conventional treatment has been unsuccessful. 

The Controlled Access Scheme (CAS) will allow authorised medical specialists to prescribe medicinal cannabis products to their patients in certain circumstances. The CAS will impose conditions to ensure safety, including review of applications by a skilled panel of specialist medical practitioners. 

Unregistered medical cannabis products require all usual Commonwealth exemptions, authorisations or approvals in addition to a Tasmanian authority being issued. 

Contact details 

Phone: 03 6166 0400

Email: pharm.services@dhhs.tas.gov.au

Website: https://www.dhhs.tas.gov.au/psbtas

Step 2: Submit an application, or notification under the Special Access Scheme or an application under the Authorised Prescriber Scheme

Special Access Scheme (SAS)

The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case-by-case basis.

 

Authorised Prescriber Scheme

Authorised Prescribers are medical practitioners who are approved to prescribe unapproved therapeutic goods for a particular condition or class of patients in their immediate care without further TGA approval.

To be an Authorised Prescriber, the medical practitioner must:

  • have the training and expertise appropriate for the condition being treated and the proposed use of the product;

  • be able to best determine the needs of the patient; and

  • be able to monitor the outcome of therapy.

Applications or notifications for both schemes can be made via the TGA SAS and AP online system.

 

Step 3: Apply for a licence and permission to import, if necessary

Practitioners can obtain information about available products, formulations, strengths and dosing from manufacturers and importers. A list of suppliers is available from the Commonwealth Office of Drug Control (ODC).

If stock is available in Australia, medical practitioners can contact the supplier and provide TGA authorisation and state/territory approval (if required).

If a medicinal cannabis product has not already been imported by the sponsor, a medical practitioner, or pharmacist acting on behalf of the medical practitioner, can apply for a licence and permission to import.

Licence and permit application forms and guidance are available on the ODC website.

Step 4: Comply with conditions of approval or authorisation and ongoing regulatory requirements

Each state and territory has its own ongoing prescribing requirements. Members can contact our Medico-legal Advisory Service for further information regarding ongoing regulatory requirements.

 

Doctors can call the TGA on 1800 020 653 during weekdays, 9.00am–5.00pm (AEST), or email medicinal.cannabis@health.gov.au for queries about access to medicinal cannabis including information about licensed suppliers. 

Dr Kiely Kim
Medico-legal Adviser
MDA National


References

  1. Medicinal Cannabis Products: Overview of Regulation. Available at: tga.gov.au/access-medicinal-cannabis-products-1
Clinical, Anaesthesia, Dermatology, Emergency Medicine, General Practice, Intensive Care Medicine, Obstetrics and Gynaecology, Ophthalmology, Pathology, Psychiatry, Radiology, Sports Medicine, Surgery, Physician, Geriatric Medicine, Cardiology, Plastic And Reconstructive Surgery, Radiation Oncology, Paediatrics, Independent Medical Assessor - IME
 

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