How to Apply to the SLHD HREC

GUIDELINES TO APPLY TO BECOME AN AUTHORISED PRESCRIBER OF UNAPPROVED PRODUCTS FOR MULTIPLE PATIENTS AT CONCORD HOSPITAL

The Therapeutic Goods Act indicates that the TGA can authorise individual medical practitioners to prescribe unapproved products to specific patients with a particular medical condition. The medical practitioner becomes an Authorised Prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to a specific class of recipients. An Authorised Prescriber is allowed to supply the product directly to patients in their immediate care without requiring separate approval for individual patients.

1. Refer to the detailed Authorised Prescriber Information from the TGA to assist with your application. See: Unapproved products for multiple patients (Authorised Prescriber) | Therapeutic Goods Administration (TGA)

2. Write to both Concord Hospital Drug Committee and Concord Hospital Human Research Ethics Committee (HREC) requesting endorsement to become an authorised prescriber of an unregistered drug.

The following documentation should be submitted for review:

Cover letter – requesting to become an authorised prescriber. It should include information on each of the criteria:

o The recipients: Indication and clinical justification

o The product: dosage, route/method of administration, duration of treatment, any safety data (if drug)

o Details of the prescriber(s) (name, position, department, qualifications, specialty, training and experience etc.)

Completed online TGA Authorised Prescriber Form- one must be submitted for each clinician wanting to become an authorised prescriber See: https://compliance.health.gov.au/sas/

Information sheet and consent form for patients (template)

Relevant literature reference(s) supporting its use (if available)

Any other information you intend to give patients (brochures, flyers etc. if applicable)

Contact the Research Office for more information: SLHD-ConcordEthics@health.nsw.gov.au

GUIDELINES TO APPLY FOR SPECIAL ACCESS SCHEME (SAS) FOR INDIVIDUAL PATIENTS

When prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS), HREC endorsement is not required. Any relevant submissions should be made through the TGA website. See further information here.

The applicant must contact the Pharmacy department of the relevant SLHD site to discuss drug supply and determine whether the application requires review by their Drug Committee.

CRGH: SLHD-ConcordPharmacyTrials@health.nsw.gov.au

If there is an associated legal agreement with the suppler of the unapproved good, the Research Office must be contacted so that they can seek further advice on whether legal review is required by the SLHD Legal Team.

If the SAS submission involves any research components, the applicant should advise the Research Office who may then seek further advice from the HREC.