​Product requirements

Epidyolex® (cannabidiol) and Sativex® (nabiximols) are the only cannabis medicines currently registered in Australia on the Australian Register of Therapeutic Goods (ARTG). Epidyolex® is approved for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older. Sativex® is approved for the treatment, for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.

Other cannabis medicines that have been registered by regulators outside of Australia, but are not registered in Australia, include:

  • Marinol® (dronabinol) synthetically manufactured, and registered in the US by the Food and Drug Administration (FDA) for the treatment of anorexia in patients with AIDS, and for the management of chemotherapy-induced nausea and vomiting where standard anti-nausea treatments have failed.
  • Cesamet® (nabilone) synthetically manufactured, and registered in the US by the FDA for the management of chemotherapy-induced nausea and vomiting.

Applications to prescribe or supply cannabis medicines are not limited to such products. However the product applied for must be legally produced and manufactured to appropriate quality standards.

The product applied for must have been lawfully manufactured or imported, i.e. under a Commonwealth licence or an approval, unless exempted.

The Commonwealth’s Office of Drug Control (ODC) license cultivation, production and manufacture of cannabis for medicinal use. A NSW based manufacturer must also hold a licence issued by NSW Health to manufacture and supply a cannabis medicine.

Products that might be accessed from unregulated sources, including oils, tinctures and plant material, are of unknown safety and efficacy and may include harmful substances and contaminants. Use of these will not be authorised and may be unlawful.

A cannabidiol preparation for therapeutic use, where cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation, and which contains no more than 2% of other naturally-derived cannabinoids as impurities in the cannabidiol component, is a Schedule 4 medicine.

Currently, Epidyolex® is the only registered cannabidiol preparations in Australia. Whilst a NSW Authority is not required to prescribe an unregistered Schedule 4 medicine, the other requirements for unregistered cannabis medicines apply, e.g. Commonwealth licences to import/manufacture and TGA approval (under SAS Category B, Authorised Prescriber or Clinical Trial schemes) are still required.

Prescribing

Prescriptions for any Schedule 8 medicine can be provided using either a paper prescription (handwritten or computer generated) with handwritten details in compliance with  Criteria for Issuing Non-Handwritten (Computer Generated) Prescriptions (TG184), or a conformant electronic prescription.

For paper prescriptions (handwritten or computer generated), the medical practitioner must specify, on the prescription for a Schedule 8 cannabis medicine, all the usual requirements for a Schedule 8 prescription, such as adequate directions for use, handwritten quantity in words and figures and repeat intervals if repeat supplies are ordered (for details see  Guide to Poisons and Therapeutic Goods Legislation for Medical, Nurse and Midwife Practitioners and Dentists).

For conformant electronic prescriptions, the prescriber must ensure the Schedule 8 cannabis medicine prescription is created where all systems participating in the prescribing, transmission and dispensing of the prescription conform under the national Electronic Prescribing Conformance Assessment Scheme. See Electronic Prescribing webpage.

The medical practitioner must make a prescribing record as for any Schedule 8 prescription.

The Information Bulletin Schedule 8 Cannabis Medicines and Unregistered Schedule 8 Medicines provides guidance for NSW public health facilities on prescribing registered and unregistered Schedule 8 cannabis medicines.

 

Dispensing

A pharmacist can dispense a prescription for a cannabis medicine (other than a registered medicine listed on the ARTG – currently only Sativex® and Epidyolex®) only if the prescriber holds an approval by the TGA to prescribe it, or (if in Schedule 8) if it is a prescription for a compounded medicine bearing the NSW Health Authority number issued to and written by the prescriber.

A pharmacist can dispense a Schedule 8 cannabis medicine only on receipt of a paper prescription (handwritten or computer generated  in compliance with  Criteria for Issuing Non-Handwritten (Computer Generated) Prescriptions (TG184) or a conformant electronic prescription, via receipt of a paper or electronic token presented to the pharmacy.

The electronic prescription needs to be created, transmitted or dispensed from a conformant prescribing electronic system, see Electronic Prescribing. Hospital pharmacies may supply a cannabis medicine for inpatients on a valid medication chart order.

Emergency supply provisions do not apply.

When dispensing from a paper Schedule 8 prescription, the other usual Schedule 8 requirements apply, e.g. the pharmacist must verify the prescriber, must report any apparently forged or fraudulently altered prescriptions, and must retain the dispensed prescription, separately from other prescriptions. When dispensing from an electronic prescription, the patient date of birth must be recorded in the dispensing system.

Cannabis medicines supplied to a patient (by a pharmacy or medical practitioner) must be labelled with a dispensing label with the usual details required for any dispensed medicine.

A pharmacy (or medical practitioner) cannot hold stock of any unregistered medicine unless it has been approved for supply, to a particular patient, by the Commonwealth.

All supplies and receipts of Schedule 8 cannabis medicines (whether dispensed on prescription or supplied directly by a medical practitioner) must be recorded in a drug register. If used in a clinical trial, a record of the NSW Authority number must be made in the clinical trial records.

For further information see the  Guide to Poisons and Therapeutic Goods Legislation for Pharmacists.

The Information Bulletin  Schedule 8 Cannabis Medicines and Unregistered Schedule 8 Medicines provides guidance for NSW public health facilities on dispensing registered and unregistered Schedule 8 cannabis medicines.

Any loss or theft of Schedule 8 cannabis medicines must be reported to the Secretary, NSW Health, on the  Notification of Loss or Theft of Accountable Drugs (S8 and S4D substances) form as for all Schedule 8 drugs. Unwanted cannabis medicines may not be destroyed except by a person authorised to destroy Schedule 8 drugs.
 

Storage

Schedule 8 cannabis medicines must be stored separately and securely, as is required for any Schedule 8 medicine. All current cannabis medicines are Schedule 8 other than those that are Schedule 4 cannabidiol only.

In a retail pharmacy or hospital pharmacy, a Schedule 8 medicine that requires refrigeration may be kept in a refrigerator rather than a safe if all of the following requirements are met:
 
  • the refrigerator must be in a room (which includes a part of a room or an enclosure) to which the public does not have access,
  • the refrigerator, or any cupboard or receptacle in which the refrigerator is kept, must be securely attached to a part of the premises,
  • the refrigerator, or the room, cupboard or receptacle in which the refrigerator is kept, must be kept securely locked when not in immediate use,
  • a device (including a key) that is used to securely lock anything under this subclause must:
    • be kept on the person of a pharmacist who is at the premises, or
    • be securely locked in a safe that can be unlocked only by a pharmacist,
  • a code or combination that is used to securely lock anything under this subclause must not be disclosed to any person who is not a pharmacist,
  • the refrigerator must not be used to store any other item that is not a substance listed in Schedule 2, 3, 4 or 8 of the Poisons List or is not a therapeutic good.

Packaging and labelling

Cannabis medicines supplied in or from NSW (other than when dispensed to a patient) must be packaged and labelled as Schedule 8 medicines (unless a Schedule 4 cannabidiol), unless otherwise exempted by the Secretary, NSW Health.
 
It is illegal to label a product suggesting it is a cannabis product if it is not.
Current as at: Monday 21 June 2021
Contact page owner: Pharmaceutical Services