Latest online version of the Criteria
During the BloodSTAR transition period (July to December 2016), the addition of ‘new’ Criteria ‘evidence items’ fields does not change the basis for approval of authorisation of Ig product. Authorisers will evaluate authorisation requests with the same approach that applies to authorisation based on the use of previous paper forms.
The National Blood Authority (NBA), on behalf of all Australian governments, commissioned a review of the adequacy of the existing intravenous immunoglobulin (IVIg) authorisation and clinical governance arrangements, with a view to recommending options for improvements to deliver governments’ goals for the management of IVIg. The review also analysed the issues, benefits and risks of potentially including normal human immunoglobulin (NHIg) and subcutaneous immunoglobulin (SCIg) in the IVIg management framework.
The review highlighted significant variation in IVIg use, management and processes nationally, with a number of inefficiencies being described. Improvements recommended by Ernst and Young in review included short term and long terms improvement projects.
The following recommended short term projects targeted five areas identified for improvement of the existing arrangements:
- Describe the functional model for the current authorisation and clinical governance arrangements, and formally allocate responsibility and authority in each jurisdiction;
- Introduce new management processes to include NIg and SCIg in IVIg authorisation process;
- Improve patient information to ensure patients are aware of the Criteria requirements for eligibility and ongoing therapy;
- Centralise hospital ordering and product management at the blood bank or pharmacy for improved management; define when and how emergency stock should be managed; and
- Define and deliver a package of information concerning current IVIg products and arrangements, particularly for junior medical and nursing staff.
The longer term strategic projects recommended by Ernst and Young included projects to establish the knowledge base and decision making processes to allow further improvement, and strategic projects targeted at transitioning arrangements to a more self‐supporting and continuously improving mode. Further work is continuing to consider these recommendations within the proposed centralised model and provide more detailed advice to governments. Any proposed structural changes to the current IVIg arrangements would require governments’ endorsement.
More information about the completion of the review:
- Completion of the Review of the Authorisation and Clinical Governance Framework for IVIg (pdf) (102.21 KB)
- Completion of the Review of the Authorisation and Clinical Governance Framework for IVIg (docx) (32.7 KB)
Executive Summary: Review of the Clinical Governance and Authorisation Process for IVIg
For further information, please contact the National Blood Authority on 13 000 IG GOV (13 000 44 468) or email IgGovernance [at] blood.gov.au