January 2019 Ig Governance Criteria and Progress Updates

January 2019

Version 3 Criteria are here!

Version 3 of the Criteria has been released!

Version 3 of the Criteria was successfully released into BloodSTAR on 22 October 2018.

Developed by clinical working groups and in collaboration with relevant clinical colleges and societies, Version 3 of the Criteria aims to more clearly articulate and standardise diagnostic, qualifying and review requirements. More comprehensive justification and evidence from clinicians will be required to confirm patient eligibility and so will strengthen the capacity to direct Ig product to those who most require it. National funding of Ig products is no longer supported for a small number of low-use conditions as better alternative treatments are available.

The Criteria is available at www.criteria.blood.gov.au

The Criteria for each medical condition can now be printed from BloodSTAR or from www.criteria.blood.gov.au if required, but any printed version must regularly be checked for currency. The NBA will no longer publish the Criteria in hard-copy.

BloodSTAR is now live Australia-wide!

BloodSTAR is now a national system following implementation in NSW from 22 October 2018.

BloodSTAR is the sole channel for doctors in Australia to seek authorisation for the prescription of Ig products in accordance with the Criteria.

The key benefits of BloodSTAR as a national system are:

  • ensuring the consistency of processes and application of the Criteria so that Ig products are directed, based on best evidence and clinical opinion, to patients who are most likely to benefit and for whom there are no safe and effective alternative treatments
  • consistently promoting the clinical review of ongoing patients, and consideration of alternative therapies, where appropriate as identified in the Criteria
  • support for patients across multiple sites
  • better flexibility for managing mobile or remote patients, and
  • generation of information for:
    • supply planning and management
    • supply risk management
    • process and system governance and improvement
    • potential linkage with research, and
    • further development of the Criteria to ensure Ig is directed to where there is evidence of greatest benefit.

BloodSTAR statistics

There are currently over 13,900 patients in BloodSTAR with active authorisations and approximately 12,800 users as Authorisers, Medical Officers, Nurses or Facility Administrators. The system continues to have high use with 857 initial authorisation requests and 16,251 dispense episodes of Ig in BloodSTAR nationally during October 2018.

National Policy: access to government funded Ig products in Australia

The National Policy: Access to Government-Funded Immunoglobulin (Ig) in Australia (National Policy) sets out the process that must be followed and describes the rules and requirements that must be complied with to access Ig products under the National Blood Agreement. Together with the Criteria and BloodSTAR, the National Policy has standardised processes nationally to improve equitable access to government funded Ig products.

The policy is undergoing revision to align with changes that have been made to BloodSTAR since its implementation in 2016, and Version 3 of the Criteria. It also aims to make more direct statements of responsibilities, and corrects guidance that has become outdated including changes to external document titles and web links.

The updated National Policy will be available soon.

Module 2 of the Managing Blood and Blood Product Inventory Guidelines

Module 2 of the Managing Blood and Blood Product Inventory Guidelines (managing IVIg and SCIg) has been updated, and is available at https://www.blood.gov.au/module-2-ig-inventory-management-guidelines.

The purpose of this Module is to assist health providers in meeting the requirements of the National Policy by:

  • describing how to establish and manage stock levels
  • outlining the Ig product ordering models
  • identifying different methods to determine ordering requirements/trigger
  • providing recommendations for good practice

Performance Improvement and Knowledge Development

The implementation of BloodSTAR and Version 3 of the Criteria are significant achievements and have been the main focus for the Ig Governance Program for some time. Focus can now shift to other Ig Governance Program activities, including progressing the development of a Performance Improvement Strategy. The strategy promotes a nationally consistent approach to the management and use of immunoglobulin. One way this can be done is by analysing BloodSTAR data and providing useful reports to doctors, nurses and other BloodSTAR users. These reports will also help to establish benchmarking activities, to encourage greater review of prescribing and/or product management practices.

The Ig Governance Program will also work with doctors, nurses, patients and other relevant stakeholders to develop a suite of educational materials for clinicians and patients.

Keep an eye out on the website for further news on future Ig Governance Program activities.    

National Immunoglobulin Interest Group

The NBA has established the National Immunoglobulin Interest Group (NIIG). The main aim of this national group is to provide the NBA with ongoing feedback and input in relation to updates and proposed changes to the Ig Governance Program and the BloodSTAR system from stakeholders involved in the use of immunoglobulin across Australia. Thank you to those who have already expressed their interest in participating in this group. The NBA would like to ensure widespread representation for this group including medical officers, nurses, dispensers (pathology and/or pharmacy) and facility administrators.

The NBA intends to engage regularly with the NIIG and email updates on Ig Governance Program activities. The NBA will also seek input into various Ig Governance matters as appropriate. When there is a specific need, the Ig interest group will be contacted via email with issues being discussed via teleconference if necessary.

The NIIG will complement the national network of committees involved in the Ig Governance Program, including jurisdictional Ig ‘user groups’, Specialist Working Groups for Immunology, Neurology, Haematology and Transplantation, the National Immunoglobulin Governance Advisory Committee and the Jurisdictional Blood Committee. The NIIG will also facilitate the circulation of updates, analysis and news of better practice initiatives within this overall network.

If you would like to participate please let us know by providing your full name, facility name, position, contact phone number and email address to support@blood.gov.au.

Keep up to date

Keep up to date with the latest Immunoglobulin Governance updates - create a BloodPortal account and from the home page click on ‘My Subscriptions’ and ‘Subscribe’ to Immunoglobulin. The latest update is available at Ig Governance Criteria and Progress Updates.

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