How to access overseas products in the absence of an Australian registered product
Background
A national medicine shortage occurs when the supply of a medicine is not likely to meet the normal or projected consumer demand within Australia at any point during the next six months. The Therapeutic Goods Administration (TGA) publishes information about national medicine shortages for reportable medicines in the medicine shortage reports database on the TGA website.
There are processes for the supply of medicines that have not been approved for use in Australia by the TGA (i.e. not registered on the Australian Register of Therapeutic Goods - ARTG) that may be accessed at times of medicines shortages. Sometimes these medicines are required for emergency use, and shortages can place patients at risk. It is therefore vital these medicines are available immediately, and there is facility to prescribe 'unapproved' medicines from overseas in a clinical setting, as outlined in the case study below. Understandably, part of this process is formal notification to the TGA of ANY use of these vital non-approved medicines.
Case Study: nifedipine immediate release (IR)Nifedipine IR was discontinued in the Australian market. Its ongoing, off-label use in the management of tocolysis (the suppression of premature labour) is critical, particularly in rural and remote regions of Australia. Supplies are needed to be kept in obstetric emergency kits so that it is available when needed. |
Alternative supply options
Prescribers can use the Special Access Scheme (SAS) Category A pathway and the Authorised Prescriber (AP) scheme to access 'unapproved' medicines from overseas.
Special Access Scheme (SAS) Category A pathway - Using the medicine
The Special Access Scheme (SAS) allows certain health practitioners to access an 'unapproved' therapeutic good for an individual patient on a case-by-case basis. There are three SAS pathways however, the Category A pathway would be most suitable for emergency medicines and does not require the prescriber to wait for approval from the TGA.
The SAS Category A is a notification pathway. Prescribers must submit (online or by email) a completed Category A form to the TGA within 28 days of giving the medicine to the patient. This pathway may be used by a medical practitioner whose patient meets the Category A definition:
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
How to submit a SAS Category A formThe Category A form is a single page form available on the TGA SAS webpage. It must be completed by a prescribing medical practitioner or by a health practitioner on behalf of a prescribing medical practitioner within 28 days of giving the medicine to the patient and submitted via
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