Applications
To obtain a drug through the Special Access Scheme, an application or notification needs to be made to the TGA. Forms are available from the TGA website, and completed forms are emailed or faxed to the TGA.2
For category A patients, the prescriber does not need to seek approval from the TGA in advance. A completed ‘Special Access Scheme – Category A’ form is sent to the supplier (which provides them with the legal authority to supply the product), with a copy of the form to be forwarded to the TGA within four weeks.3
For a category B patient, an application to the TGA needs to be completed in advance. An unregistered drug cannot be supplied before the TGA has evaluated and approved the application.3
When assessing applications, the TGA takes into consideration whether there is sufficient justification to approve supply of the drug. This includes whether there are registered products already available to treat the patient’s condition, whether these products have been tried by the patient in the past, and the seriousness of the patient’s condition.3 In addition, the TGA considers the degree and quality of evidence to support the drug’s efficacy and safety. For example, greater credence is placed on evidence from published randomised trials over individual case reports or expert opinion.3 The TGA also considers the relevance of the qualifications of the requesting prescriber in relation to the drug being requested.
For the drugs listed in category C, such as melatonin modified-release tablets for the treatment of sleep disorders, preapproval is not necessary. However, the category C form must be used to notify the TGA within four weeks of supplying the drug.
Supply
Unregistered drugs may be available from suppliers within Australia, in which case the prescriber (or pharmacy) needs to contact the supplier directly. However, if the drugs are unavailable, the requesting doctor may need to source them from overseas. When this is the case, the prescriber needs to check whether the importation of a drug is controlled by customs regulations.3,5 Examples of drugs that are subject to these regulations include:3,5
- drugs of abuse, for example narcotics, amphetamines, psychotropic substances
- substances that may be considered performance enhancing for athletes, for example anabolic steroids, erythropoietin, growth hormones
- antibiotics.
Drugs subject to these regulations cannot be imported without permission. It is important to note that the import permit and, when required, an import licence for drugs such as narcotics and medical cannabis are obtained through the Office of Drug Control. This process is separate from the TGA’s approval.5
Consent
The use of unregistered drugs should be considered experimental. It is a condition of the Special Access Scheme that the patient (or their legal guardian) provides written informed consent.3 This needs to be provided freely and the patient must understand the nature of their condition (including its natural history) and have appropriate knowledge of the treatment options. Specifically, the patient must be informed about:
- the product not being approved in Australia
- the possible benefits of treatment and any known risks and adverse effects
- the possibility of unknown risks and late adverse effects
- any available alternative treatments using registered products.3
It is important for both the patient and prescriber to understand that the Australian Government does not accept responsibility for any adverse consequences of treatment, including any defects in the product related to manufacture. In addition, the prescriber of an unregistered drug is required to report the details of any actual or suspected adverse drug reactions to the TGA within 15 days.3 Specific information about the unregistered drug may not be readily available, as the product information for the unregistered drug will not be in MIMS and may be limited in the Australian Medicines Handbook. If the drug is registered in another jurisdiction, product information may be available from the US Food and Drug Administration or the European Medicines Agency.