Clarification of requirements to access unapproved medicinal cannabis medicines for paediatric patients

This communique clarifies requirements for Special Access Scheme (SAS) and Authorised Prescriber (AP) applications for healthcare practitioners to access Category 2, 3, 4 and/or 5 (i.e. Schedule 8) medicinal cannabis medicines for their patients under the age of 18 years (paediatric patients). For the purposes of this communique, the term ‘specialist’ means a medical practitioner with a specialty other than general practice.

Health practitioners are reminded that caution is advised when prescribing unapproved medicinal cannabis products containing tetrahydrocannabinol (THC) to paediatric patients. Research shows that exposure to THC-containing medicinal cannabis products carries potential risks for developing brains.

Due to the potential risks, the Therapeutic Goods Administration (TGA) Delegates reviewing SAS or AP applications for Schedule 8 medicinal cannabis medicines need assurance that there is regular and continued specialist involvement in the clinical decision to treat a paediatric patient with these products. This includes products that contain other Schedule 8 cannabinoids such as cannabigerol (CBG).

Clarification on requirements

New SAS B applications

SAS B applications for Category 2, 3, 4 and/or 5 medicinal cannabis medicines to treat paediatric patients, must include evidence of support from a ‘specialist’ medical practitioner (not a general practitioner (GP)) with a specialty relevant to the indication/use in the application.

The letter of support must:

• Be dated within 12 months before the date of the SAS B submission; and
• Be addressed directly to the prescriber submitting the SAS B application; and
• State endorsement for prescribing a Category 2-5 medicinal cannabis product for the specific patient in the application who must be named. For example, “I endorse the prescribing of a Category 2, 3, 4, and/or 5 medicinal cannabis medicine for John Smith, DOB: DD/MM/YY”

Applications submitted by ‘specialist’ medical practitioners (who are not GPs) with a specialty relevant to the indication in the application do not need a letter of support.

To renew a SAS B approval for the same patient

• A new application must be made; and
• A new letter of support is required for every new application.

AP scheme applications

To access Category 2, 3, 4 and/or 5 medicinal cannabis products to treat paediatric patients under the AP pathway, you must:

• Be a ‘specialist’ medical practitioner (not a GP) with a specialty relevant to the paediatric indication(s)/use(s) you are requesting approval for; and 
• provide approval from a Human Research Ethics Committee (HREC) specific to patients under 18 years.

GPs can access Category 1 (Schedule 4) medicinal cannabis products for paediatric patients under the AP pathway with relevant HREC approval.

SAS B approval period

Currently, SAS B applications for Category 2, 3, 4 and 5 medicinal cannabis products for paediatric patients (less than 18 years of age) are approved for a maximum period of 24 months. Please note that this timeframe is currently under consideration to determine if it is appropriate to ensure regular and continued involvement of a ‘specialist’ medical practitioner (in addition to a GP). 

Nurse Practitioners

For patients under the age of 18 years, a nurse practitioner can apply to access Category 1 medicinal cannabis products with a letter of support from a medical practitioner or proof that their scope of practice is child and adolescent health, neurology or psychiatry.