In Australia, almost all prescription medicines supplied to patients are ‘registered’. This means that the Therapeutic Goods Administration (TGA) has assessed them for safety, quality and effectiveness. Patients need to know that the medicines they are taking are safe and should help them.
Sometimes, however, registered medicines are not suitable for a particular medical condition. In these cases, doctors may seek approval to use an unregistered medicine. This is a medicine that has not been assessed for safety or effectiveness. The TGA has a number of schemes to allow doctors to prescribe unregistered medicines. These are: the Special Access Scheme Category A and Category B and the Authorised Prescriber Scheme.
The Special Access Scheme Category B and the Authorised Prescriber Scheme require approval from the TGA before the unregistered medicine can be used. The Special Access Scheme is a prescription by prescription approval for a single patient; Authorised Prescribers can prescribe a specific unregistered medicine (or a number of unregistered medicines) to specific patients with a specific condition (for example, children with epilepsy resistant to other treatments).
The Special Access Scheme Category A is for the use of unregistered medicines in terminally ill patients where the patient might die without early treatment. Doctors notify the TGA after they have used the unregistered medicine.
Doctors have always been able to seek approval to prescribe unregistered medicinal cannabis products under the Special Access Scheme Category B and the Authorised Prescriber Scheme. They have never been able to prescribe unregistered medicinal cannabis products under the Special Access Scheme Category A.
It is appropriate that unregistered medicinal cannabis products are not prescribed under the Special Access Scheme Category A. These are poorly characterised and poorly understood products that must be used with caution. For example, it has been shown that cannabis might accelerate the growth of some forms of cancer.
The TGA assesses the clinical reasons for using any unregistered medicine under the Special Access Scheme Category B and Authorised Prescriber Scheme, to help ensure that the doctor does not actually cause harm to the patient. In addition, for an applicant to be an Authorised Prescriber they must get endorsement from an Ethics Committee for their proposed treatment approach.
When the Government announced the scheme to allow the cultivation of cannabis for medicinal purposes in October 2015, it said that prescription would be in accordance with the existing arrangements, that is, Special Access Scheme Category B, Authorised Prescriber, clinical trials or as a registered medicine.
These requirements are in the Narcotic Drugs Act 1967, which says that a manufacture licence cannot be granted unless the Department of Health is satisfied that the product will be used in one of these four ways.
When cannabis was rescheduled from Schedule 9 to Schedule 8 of the Poisons Standard, it was necessary to makes some changes to the Therapeutic Goods Regulations to ensure that imported medicinal cannabis products are treated the same as domestically produced medicinal cannabis products.