Review of the Authorisation and Clinical Governance Framework for Intravenous Immunoglobulin (2011 – 2012)
The National Blood Authority (NBA), on behalf of all Australian governments, commissioned a review of the adequacy of the current Intravenous Immunoglobulin (IVIg) authorisation and clinical governance arrangements, with a view to recommending options for improvements to delivering governments’ goals for the management of IVIg. The review also analysed the issues, benefits and risks of potentially including Normal Immunoglobulin (NIg) and Subcutaneous Immunoglobulin (ScIg) in the IVIg management framework.
In March 2013 the Jurisdictional Blood Committee considered the final report of the review and endorsed the NBA commencing work to implement five short term improvement projects recommended by the review. These will be undertaken within 2013, and further updates will be available as this work unfolds. The five projects are to:
- 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.
Work will continue to consider longer term strategic projects recommended by the review, and implementation of any further projects will require further approval from governments under the national blood arrangements.
More detail on the completion of the review is available:
Completion of the Review of the Authorisation and Clinical Governance Framework for IVIg (pdf) (102 KB)
Completion of the Review of the Authorisation and Clinical Governance Framework for IVIg (docx) (33 KB)
The Executive Summary of the review is also available:
Review of the Clinical Governance and Authorisation Process for IVIg - Executive Summary (pdf) (737 KB)
The NBA intends to keep all stakeholders informed and involved in the implementation of any of the agreed recommendations of the review. For further information or to provide any feedback, please contact IVIgReview [at] blood [dot] gov [dot] au.