Accessing unapproved medications

The Australian Therapeutic Goods Administration (TGA) allows patient and prescriber access to unapproved medications not included in the Australian Register of Therapeutic Goods (ARTG), through 2 schemes—through the Special Access Scheme (SAS) and or by becoming an Authorised Prescriber.

Informed patient consent is required when starting an unapproved medication. The prescriber takes responsibility for monitoring the effectiveness and adverse effects, and reporting these to the TGA. They may also need to provide written information about the medication for the patient. Unapproved medications are not subsidised on the Pharmaceutical Benefits Scheme (PBS), and cost implications for the patient should be considered.

Unapproved medications can be accessed for a specific patient on a case-by-case basis via the Special Access Scheme (SAS). For the purpose of this scheme, the application pathways are:

• Category A—patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment
• Category C—a defined list of unapproved medications that have an established history of use; prescribing is restricted by indication and practitioner types
• Category B—all other patients who do not fit under the Category A definition and the medication is not listed under Category C.

Patients with palliative care needs generally fulfil the requirements of Category A. The SAS application process is different for each category; for Categories A and C, an unapproved medication can be prescribed and supplied before needing to notify the TGA, which needs to be done within 28 days of supply. For Category B, supply cannot occur until an approval letter has been received. Application is via The SAS and Authorised Prescriber Online System as described on the TGA website.

As an Authorised Prescriber, a healthcare professional can be authorised by the TGA to prescribe an unapproved medication for a particular indication for patients under their immediate care. This authorisation is linked to the prescriber rather than a specific patient and can be useful if the same unapproved medication is being prescribed for multiple patients. Application to become an Authorised Prescriber is described on the TGA website.

For further advice on using unapproved medications, contact a specialist palliative care service or a Medicines Information Service.