Authorised Prescriber Scheme

Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors

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3 July 2017

Information for HRECs and specialist colleges

HRECs and specialist colleges provide the initial assessment of a medical practitioner's application to become an Authorised Prescriber. Details of what should be reviewed are outlined above under Applying for HREC or specialist college approval or endorsement. By undertaking this assessment, you are determining that the use of the product is suitable for the proposed indication and that the medical practitioner has the appropriate expertise or qualifications for the proposed use of the product. The medical practitioner is ultimately responsible for determining whether it is appropriate to prescribe the unapproved goods for each patient that they treat.

HRECs and specialist colleges can approve or endorse a medical practitioner's application for Authorised Prescriber status. As an HREC or specialist college, you need to determine what level of evidence is appropriate to support an application based on a number of factors, including those described below under Clinical justification for the use of the goods.

Specialist colleges may decide to develop a protocol by which they will evaluate a medical practitioner's submission. Potential protocols include:

  • establishing clinical justification through the use of a clinical practice guideline which you will require the medical practitioner to follow
  • seeking advice from a specialist society which you will consider in your assessment

The medical practitioner may want to discuss their application with you before they submit it, to determine what level of evidence you will require.

Less serious conditions require stronger evidence than more serious medical conditions.

Clinical justification for the use of the goods

TGA encourages the use of approved therapeutic goods which have been assessed for safety, quality and efficacy. You need to evaluate the clinical justification the medical practitioner provides to determine whether the use of the unapproved good is appropriate, considering the availability of any approved goods.

The medical practitioner must supply you with:

  • details of the indication for which the good will be used
  • a clinical justification for its use

Consider whether the clinical justification is appropriate with regards to:

  • the seriousness of the condition
  • expected benefits of the proposed treatment versus the potential risks
  • approved treatments for the same indication:
    • have they been attempted?
    • why are they inappropriate?
    • will they be attempted prior to prescribing the unapproved good?
    • why is the proposed unapproved good a more appropriate treatment?
  • how the risk associated with the use of an unapproved good will be managed
    • the monitoring that will be undertaken
    • the process of investigating and reporting adverse events

The following are not justifications for the use of an unapproved good:

  • that the unapproved good is less expensive than any approved treatment
  • personal preference for an unapproved good

Providing approval or endorsement

If you support the medical practitioner's application, provide the medical practitioner with an approval letter if you are a HREC or a letter of endorsement if you are a specialist college. This letter must declare that you have reviewed all the necessary documentation.

The letter of approval must be personally signed by the chair of the HREC. Specialist colleges must determine who the most appropriate person to sign the letter of endorsement and declaration is.

You may apply conditions to the approval or endorsement. If the medical practitioner does not meet these conditions, you may revoke your approval or endorsement. Past conditions have included requirements to:

  • provide regular reports on how the unapproved good is used, such as the periodic report the medical practitioner submits to the TGA, which outlines the number of patients that have been treated in a six month period
  • report suspected adverse events to you within a specified timeframe

The medical practitioner must provide us with a copy of the letter of approval or endorsement so we can determine if it is appropriate to approve them as an Authorised Prescriber. They will also supply these documents to the unapproved good's sponsor, thereby authorising them to supply the goods.

Applications not approved or endorsed

If you do not approve or endorse an application, provide the medical practitioner with the reason for your decision in writing.

Withdrawal of approval or endorsement

You may withdraw your approval or endorsement of a medical practitioner if it is no longer appropriate. This could include, but is not limited to circumstances where:

  • the medical practitioner has not met the conditions that you have applied to their approval or endorsement
  • you become aware that the medical practitioner is using the unapproved good inappropriately
  • a suitable alternative good becomes available on the ARTG
  • you become aware of significant concerns about the good's safety

If you withdraw your approval or endorsement of a medical practitioner, inform us of this decision.

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