Under subsections 19(5-9) of the Act and Regulation 12B, the TGA is able to grant a medical practitioner authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients (identified by their medical condition). An Authorised prescriber can then prescribe that product for that condition (also known as ‘the indication’) and no approval from the TGA is required for each individual patient. The legislation requires:
When reviewing applications to become an Authorised Prescriber, the HREC needs to assess not only the safety of the product in relation to its proposed use, but also the suitability of the medical practitioner. The HREC considers:
The applicant must provide the following documentation to the HREC:
-Details of the named prescriber to support the application. This should include information about whether the practitioner is seeking to treat a condition in his/her area of specialty or training and expertise. In general, endorsement will only be given when the practitioner has training and expertise appropriate for the proposed use of the product. A CV will normally demonstrate this training and expertise but the prescriber may submit other information to support his/her request such as past experience in prescribing the drug (attach CV of intended prescriber)
-Information about the drug and its use for the indication for which it will be prescribed, including the route of administration, dosage form, a clinical justification for its use, an assessment of the efficacy and safety of the product in relation to its proposed use, information about its previous use in humans and associated adverse events (attach an investigator brochure or equivalent if available)
-A patient information and consent form
-Any other material to support your request.
If endorsed, the HREC provides a letter to the applicant in the format suggested by the TGA. The HREC may impose conditions on the endorsement, if required, such as:
Where the HREC is satisfied that the welfare and/or rights of patients are not or will not be protected, it will:
To review access to unapproved therapeutic goods via Authorised Prescribers, the HREC and SWSLHD will determine the best process for considering applications. This process may consist of:
Final responsibility for the use of an unapproved product within an institution always rests with that institution. Medical practitioners working in a NSW Public Health Organisation should discuss the use of the unapproved therapeutic product and identify the approval process with the institution before applying for authorisation.