An accredited medical officer engaged in clinical practice at Sydney Adventist Hospital will only prescribe unapproved therapeutic goods under section 19(5) of the Therapeutic Goods Act to patients under their care, after receiving endorsement as an Authorised Prescriber, from the Hospital’s Ethics Committee. The Committee will provide a letter of endorsement as part of the practitioner’s application to the Therapeutic Goods Administration (TGA).
The Hospital’s pharmacy will only dispense unapproved therapeutic goods to an accredited medical officer engaged in clinical practice at Sydney Adventist Hospital who has received endorsement as an Authorised Prescriber from the Hospital’s Ethics Committee and the TGA.
Procedure
An accredited medical officer will comply with the Human Research Ethics Committee Standard Operating Procedures when requesting endorsement as an Authorised Prescriber.
• For endorsement to supply a medical device a written request must be submitted to the HREC which includes the following:
• Indication – Condition for which the product will be prescribed
• Clinical Justification
• Product details: Name of medical device / supplier
• Dosage / route or method of administration and duration of treatment
• Efficacy and safety data
• Prescriber’s name, postal address, phone number / qualifications
• Site/s at which the product is to be used
• Anticipated patient numbers
• Anticipated commencement date
• Proposed method of tracking devices
For endorsement to supply medicine a written request must be submitted to the HREC which includes the following:
• Indication – Condition for which the product will be prescribed
• Clinical Justification
• Product details: Class of drug / trade name / generic name / supplier
• Dosage / route or method of administration and duration of treatment
• Efficacy and safety data
• Prescriber’s name, postal address, phone number / qualifications
• Site/s at which the product is to be used
• Anticipated patient numbers
• Anticipated commencement date
A Participant Information Statement must be submitted to the HREC which includes the following information:
• That the product is not approved for marketing in Australia
• Identify any benefits of treatment
• Identify any known risks and side effects of treatment
• Alternative treatment using approved products, if available
Participants are required to give written Consent to receive unapproved therapeutic goods. The form of Consent - Authorised Prescriber Use must comply with the standard Hospital template.
If the application is to supply unapproved products derived from biological tissue including human blood or plasma, the Consent must advise that the TGA offers no guarantee as to its quality, safety or efficacy, particularly in regards to prion or viral inactivation. The TGA template Consent to Treatment for use of Products Derived from Biological Tissue Including Human Blood or Plasma must be used.
