Objective 2. Improve risk management and blood sector performance

In 2015-16, the NBA achieved a range of objectives to improve blood sector performance and risk management, particularly in the areas of Ig governance, evaluation of new products, ICT developments, data availability and analysis and risk and knowledge management.

Ig Governance

The NBA continued to implement new Ig authorisation and clinical governance arrangements. These arrangements address a range of deficiencies identified in the 2012-13 review of the management and authorisation of Ig, including:

• significant variations and inefficiencies in Ig management processes nationally
• variation in dosing
• high prescription rates in some conditions compared to international rates of use
• limited transparency of price implications
• no accountability for cost with the prescriber.

Key 2015-16 achievements included:

• holding five meetings of the National Immunoglobulin Governance Advisory Committee (NIGAC), and approval by NIGAC of Specialist Working Group three year work plans for achieving key governance outcomes
• implementation of the National Ig Governance framework processes in Western Australia
• publication and implementation of the second edition of the Ig Governance policy to support the implementation of BloodSTAR
• finalisation of the online adaptation of Criteria for BloodSTAR
• commencement of a further review of the Criteria for the clinical use of intravenous immunoglobulin in Australia (the Criteria) with a view to implement Version Three in 2017
• Specialist Working Groups for Neurology, Immunology, Haematology and Transplantation Medicine finalised the review of the medical conditions in Chapters 5 & 6 of the Criteria through regular teleconference meetings.

 

Evaluation of new products

The working group established by the JBC, including NBA and jurisdictional representatives, progressed work on the requirements and processes for evaluations to be undertaken under Schedule 4 of the National Blood Agreement.

The NBA undertook an evaluation of a Schedule 4 proposal for the inclusion of C1 Esterase Inhibitor Concentrate as a new product under the national blood arrangements. The Medical Services Advisory Committee (MSAC) provided advice on the proposal on 30 July 2015.

On 11 December 2015 the JBC agreed to recommend the inclusion of C1 Esterase Inhibitor Concentrate in the National Products and Services List and the 2016-17 NSP&B for Type I or II hereditary angioedema for the following indications:

• treatment of acute attacks
• pre-procedural (short term) prophylaxis for high risk procedures such as dental work, head or neck surgery, or surgery requiring intubation
• routine (long term) prophylaxis for patients who experience the equivalent of eight or more acute attacks per month.

The NBA is working with the Australasian Society of Clinical Immunology and Allergy (ASCIA) to develop guidance and governance arrangements for use of C1 Esterase Inhibitor Concentrate for the clinical circumstances which reflect JBC's approval.

The NSP&B was subsequently approved by Health Ministers in April 2016. Supply of C1 Esterase Inhibitor Concentrate is expected to commence in late 2016.

Data developments

In 2015–16, the NBA continued to build its data capture and analysis capabilities across all aspects of the supply chain. This area of activity is a key strategy to improve the overall efficiency and sustainability of the sector by providing a measurement for improvement.

A significant amount of data and information exists within the blood sector, however, the extent to which this data is currently available to the parties that need it, the quality of the data, and the capacity of the systems that hold it, varies widely. During 2015-16, the NBA progressed the following activities identified in the National Blood Sector Data and Information Strategy and Scorecard 2013-2016:

• Continued to develop the list of BloodNet and ABDR reports to be provided to stakeholders and developed specifications to assist in their development
• Discard Data
  • Collected, analysed and distributed discard data from the BloodNet Fate Module to support the establishment of targets for discard rates in 2016-17 under the National Blood and Blood Product Wastage Reduction Strategy 2013-2017
  • Specified further BloodNet discard reports on red blood cell ABO groups.
• Haemovigilance
  • Published the National Haemovigilance Report 2016 based on data for 2013-14 collected by states and territories
  • Developed a work plan to support implementation of the Strategic Framework for the National Haemovigilance Program approved in 2014-15
  • Supported Queensland and Western Australia with their haemovigilance tools and templates for their haemovigilance programs
  • Developed revised haemovigilance tools and templates to support haemovigilance programs in Queensland
  • Published the standards and minimum data sets for haemovigilance reporting.
• Australian Bleeding Disorders Registry (ABDR)
  • Published the ABDR Annual Report for 2014-15
  • Provided to AHCDO the 2014-15 ABDR Benchmarking Report
  • Developed a draft set of data standards as part of the data integrity process for the ABDR for review by AHCDO Executive and the Data Managers.
• In 2014-15 the NBA signed an Information Framework Agreement with SA and with NT, TAS, and WA in 2015-16. These agreements are required as part of the National Blood Sector Data and Information Governance Framework
• Published the Ig Annual Report for 2014-15
• Responded to 75 data requests from internal and external stakeholders.

Risk management

The management of blood sector risk remains a core element of ensuring the safety, security and availability of the blood supply.

2015-16 saw the NBA continue a focus on the strengthening of risk management arrangements relating to:

• the National Blood Supply Contingency Plan
• blood sector risks, particularly as they relate to liability provisions under the Deed with the
  Blood Service
• revision and testing of supply risk mitigation arrangements for fresh blood products.

National Blood Supply Contingency Plan (NBSCP)

The NBSCP is a cornerstone measure to manage risks to the blood supply. In 2015-16 a range of activities were undertaken to further strengthen contingency management arrangements, including the following:

• A complete revision of existing annexes covering plasma and recombinant products, red cells and the addition of a support document covering transfusion transmitted infections as well as revision of the NBSCP master document which will take into account a range of contingency management enhancements. The revised NBSCP will be considered for endorsement by the JBC in 2016
• Conducting a NBSCP contingency exercise with an imported products supplier to test arrangements for the management of a national shortage of supply of a nominated product.

Review of Risk Management in the Blood Sector

The NBA continued to progress a range of recommendations resulting from an independent comprehensive Review of Risk Management in the Blood Sector, previously known as the National Managed Fund (NMF) Action Plan Review. This included approval of strategic level recommendations by all Health Ministers through the COAG Health Council. The Review concluded that the overall level of risk in the blood sector has reduced over the last decade due to a range of factors, including supply security improvements undertaken by the NBA. The negotiation between the NBA and the Red Cross for the new Deed of Agreement signed in 2016 addressed a number of these recommendations together with a range of operational improvements for implementation in consultation with the Blood Service.

Supply Risk Mitigation for Plasma Derived and Recombinant Products

Ensuring security of supply is a primary policy objective of the National Blood Agreement and a requirement of the National Blood Authority Act 2003 (NBA Act 2003). Specific risk management strategies have been developed and implemented for individual plasma and recombinant products. The plasma and recombinant supply risk assessment is updated annually. The NBA completed an update of the plasma and recombinant risk assessment in June 2016. This update included the validation of existing stock and contractual supply reserves.

Information Communication Technology (ICT) developments

ICT systems development and operations continue as a key enabler of both data collection/analysis and business process reform across the sector.

The NBA continued to pursue outcomes identified in the JBC - approved National Blood Sector ICT Strategy 2013-16 designed to:

• deliver ICT capabilities to drive performance improvement
• deliver ICT capabilities to enhance collaboration and training across the sector
• increase the resilience of existing ICT capabilities
• improve ICT governance and management.

Australian Bleeding Disorders Registry

The ABDR and the associated patient portal (MyABDR) is a clinical tool in use on a daily basis by clinicians in all Australian haemophilia treatment centres to assist in the management and treatment of people with bleeding disorders. The NBA delivered a number of updates and improvements to the Registry in 2015-16 to enhance the functionality and the user experience with both ABDR and MyABDR. These changes included the ability for patients to place an order for their own emergency patient card, additional and updated reports and multiple minor functionality updates as requested by users.

The NBA was also able to attend the Haemophilia Foundation Australia Conference in October 2015 where face to face meetings were held with users of ABDR and MyABDR. The NBA was able to discuss future functionality plans and requests in detail and receive feedback from a wide number of users.

The NBA was recognised for the dedication in developing MyABDR as the recipients of two awards, the 2016 Excellence in eGovernment overall winner – MyABDR and the 2016 Excellence in eGovernment – Government 2.0 – MyABDR.

BloodNet

The implementation of BloodNet across smaller health providers, in particular pharmacies continued throughout 2015-16, with 98 per cent of volume issued by the Blood Service nationally processed through BloodNet as at 30 June 2016. Significant BloodNet enhancements delivered in 2015-16 included:

• the ability to place 'Ad-hoc' orders for infrequently ordered products that do not require a patient identifier
• the introduction of the Authorisation tab in preparation for the rollout of BloodSTAR
• the development and release of a range of BloodNet reports that improve the management utility of the system for users, specifically the Fresh Blood Management report that provides the users' detail on their wastage statistics, age at issue, and transfer information.

For their work on BloodSTAR, which included the integration with BloodNet, the team were awarded three Australian Information Industry iAwards, the 2016 Public Sector Award, the 2016 Government Award and the 2016 Victorian Government Inspiration Award.

In February 2016 we held a face to face meeting with all the members of the BloodNet User Reference Group in Canberra. At this full day meeting we discussed a wide range of issues and future plans for BloodNet and introduced BloodSTAR with indepth discussion on how BloodSTAR and BloodNet will work and when the implementation would begin.

Image: BloodNet User Reference Group Meeting February 2016

2015-16 Sector monitoring

In 2015-16, the NBA continued its horizon scanning of international experience that may influence the management of blood and blood products in Australia. This monitoring activity informs the provision of current and proactive analysis to governments to enable the NBA to fulfil its functions under the National Blood Agreement.

Our focus in 2015-16 was:

• new product developments and applications
• global regulatory and blood practice trends
• scientific and clinical research with implications for future supply or demand in the sector
• business events that may have an impact on global supply, demand and pricing, such as changes in company structure, financial outlook, production capacity, organisation, ownership, and marketing and contractual arrangements
• diseases or pandemics that may have an impact on supply or risks to the safety of products
• developments in testing methods, vaccines and disease control strategies that could potentially mitigate risks to supply
• any other emerging risks that could potentially put financial or other pressures of any kind on the Australian sector.

NBA regularly posts to its website a selection of items from this horizon scanning process, illustrating the wide range of factors which may influence industry operations and patient outcomes. This information is available from www.blood.gov.au/monitoring-international-trends-blood-sector.

During 2015-16, key developments included:

• increased availability of longer acting clotting factors for patient convenience
• further progress on an investigational humanised bispecific monoclonal antibody engineered to mimic the function of factor VIII, and simultaneously bind factors IXa and X
• research of variable success on gene therapies directed at disorders such as haemophilia, sickle cell disease and beta thalassemia, and continued interest in the treatment of haemophilia with RNAi therapeutics
• the transfer of Baxter International's haemophilia treatments and pipeline to spinoff company Baxalta, which then became the subject of a successful bid by Shire PLC
• CSL Behring's announcement of an increase in the global supply of immunoglobulin as it shipped its first export of Privigen to the US from its new Australian manufacturing facility
• new haemostasis products, and new ways of assessing blood loss
• a suggested relationship between whole blood processing methods and patient outcomes
• interest in a variety of ways of storing/preserving blood and blood products
• continuing endorsement of a restrictive transfusion policy, as the body of clinical experience grows in a range of surgical contexts
• increased acceptance of the benefits of treating anaemia pre-operatively
• further clinical experience of novel anticoagulants and reversing their effects when required
• further stem cell research relevant to the blood sector, both on producing transfusible product and on modifying the surgical contexts in which transfusion may be considered
• the winding down of the Ebola epidemic in West Africa, which did not completely stop efforts around the world to develop rapid tests, vaccines and treatments
• declaration by the World Health Organization of a public health emergency, the spread of the Zika virus in and from South America. Women who contracted Zika in the first trimester of pregnancy were found to face a significant risk of delivering microcephalic babies. The mosquito-borne Zika virus was also found to be transmissible through blood transfusions and sex
• continuing reports of cases of Middle East Respiratory Syndrome-Coronavirus (MERS-CoV), primarily in Saudi Arabia
• continuing reports of avian influenza A (H7N9) by the Chinese mainland health authorities.
  While temporary poultry market closures reduced environmental levels of H7N9 and other avian flu viruses, contamination returned to pre closure levels when markets re-opened.