National Blood Authority Australia

Annual Report 2010–11

Part 5: Performance: Supporting Appropriate and Safe Use of Bloof and Blood Products

National Guidelines and Criteria for Use

The involvement of stakeholders and other interested individuals is a key strategy for the NBA in its role in developing and updating guidelines for the use and management of blood and blood products. In particular, our capacity to mobilise the expertise of the clinical community continues to guarantee the quality, and assist in the uptake, of the advice that our published material contains.

Evidence-based patient blood management guidelines

Internationally, PBM is an approach which helps patients to avoid unnecessary transfusions and the associated risks, by reducing blood loss and optimising the patient's own blood.

The World Health Assembly recently resolved (63.12) to encourage the implementation of PBM in all World Health Organization member states. The NBA's wide-ranging program to implement these objectives, which includes developing PBM guidelines, developing national outcome and performance measures, and implementing effective strategies to promote our initiatives has gained considerable momentum during 2011-12.

The NBA is continuing to manage the development of evidence-based PBM guidelines. Interest monies approved by the JBC support the costs of systematic reviewers, publication and promulgation of the guidelines, and clinical meetings. The NBA procures and manages contractors, liaises with all government agencies including the NHMRC, coordinates all project related activities including clinical meetings, and conducts extensive quality assurance of technical reports and the guidelines throughout all stages of development. Clinical/consumer reference groups have been established to provide valuable oversight of the development of each module.

The guidelines will comprise a set of six separate modules each focusing on different patient populations: critical bleeding/massive transfusion; perioperative; medical; critical care; obstetrics; and paediatrics/neonates. NHMRC approval is being sought on completion of each module in order to ensure credibility within the clinical community. Together, the suite of six modules will replace the NHMRC/Australian and New Zealand Society for Blood Transfusion Clinical practice guidelines on the use of blood components (2001). The guidelines align with other national strategic initiatives such as the Statement on National Stewardship Expectations for the Supply of Blood and Blood Products (see pages 77-78) and the NSQHS Standards (see page 91).

The cost of the systematic reviews and overall production expenses for the modules, in particular the Medical module, has been higher than estimated, because of the number and complexity of the questions and the volume of the body of evidence to be reviewed. For this reason, in 2011-12 the NBA commissioned an independent assessment of the project management processes to examine and suggest better ways of managing systematic review projects, including estimating costs. In 2012 the JBC approved additional funding from interest monies, to enable the existing contractor to complete work on the remaining two modules.

Our aim is to ensure that the modules are well known, well received, sought after and used by clinicians, other health care professionals and patients involved with transfusion. It is evident from many studies that it is not enough to just publish new guidelines. It is also essential to publicise the availability and significance of the new information and to develop a comprehensive implementation strategy. In 2012 the NBA appointed a dedicated communications and marketing officer to manage the development and implementation of a range of communications strategies to support the promotion of the guidelines. Our PBM program includes a comprehensive implementation strategy (described in further detail in this chapter).

By June 2012 it was clear that the guidelines are well regarded, with endorsement from national colleges and societies, regular presentation at national and international conferences, strong demand for copies of the published modules, and continued requests for updates by individuals received on the NBA website.

Module 1-Critical Bleeding/Massive Transfusion

The first module of the PBM guidelines, on Critical Bleeding/Massive Transfusion, was released in March 2011. The module is intended to assist and guide healthcare professionals in making clinical decisions when managing patients who require, or are likely to require, massive transfusions. Uptake of the document has been high throughout 2011-12, with a resurgence of interest following the release of the second module. As at 30 June 2012 the module had 5088 copies downloaded from the NBA website and the quick reference guide had 3250 downloads. 1776 hard copies of the module and 3326 copies of the quick reference guide were sent out in the last twelve months. In addition, the module has frequently been presented at clinical meetings in Australia and overseas.

Module 2-Perioperative

This module is intended to inform healthcare practitioners, health educators and health service managers about the care of patients before, during and after surgery or invasive procedures, particularly those in which blood loss is anticipated.

Public consultation on this module closed on 1 April 2011. An external and independent peer review reported very favourably and the module was finalised and submitted in August 2011 for NHMRC approval; the module was approved in November 2011 and released in March 2012. As at 30 June 2012 the module had 3275 copies downloaded, the quick reference guide 1085 copies downloaded, and 2366 hard copies of the module and 4305 copies of the quick reference guide had been ordered, and this guide had also been presented many times at clinical meetings in Australia and overseas.

Module 3-Medical

This module is intended to assist and guide clinical decisions and coordination of healthcare across the health sector, from the local general practitioner to the hospital operating theatre, for patients with acute or chronic medical conditions requiring haematological intervention. Work on this module continued, with the reference group reviewing relevant literature, and completing the evidence statements and clinical guidance sections of the guide. The systematic review process for this module was also completed during the year and a public consultation process for the draft document commenced on 23 January 2012 for an eight week period. Nine formal submissions were received, including two letters of congratulation on the high quality of the guidelines. The module was submitted for NHMRC approval in June 2012. An abstract on this module was invited for oral presentation at the 32nd Congress of the International Society of Blood Transfusion to be held in Cancun, Mexico in July 2012.

Module 4-Critical Care

This module is intended to assist and guide clinical decisions relating to blood management in patients suffering life-threatening illness or injury in an intensive care environment. During the year the systematic review of this module was completed and a public consultation process ended on 18 May 2012. Twelve submissions were received (using the submission template provided on the NBA website), of which nine were on behalf of an organisation. Three of the submissions acknowledged their endorsement of the draft guidelines but did not include any specific feedback. The clinical reference group met on 12 June 2012 to consider all responses to the public consultation process and make revisions where necessary.

The NBA anticipates submitting the module to the NHMRC in July for approval later in 2012.

Module 5-Obstetrics and Module 6- Paediatrics/Neonates

These modules were placed on hold until all other modules to the NHMRC have been submitted and the outcomes of the independent assessment of project management processes were completed.

NBA guidelines set to improve patient care and reduce transfusions

Patient health will be improved and the number of blood transfusions will be reduced if clinicians follow new guidelines developed by clinical experts working with the National Blood Authority.

The Perioperative module is one of six modules, covering different patient populations, which make up the Patient Blood Management Guidelines. The module has been approved by the National Health and Medical Research Council and provides evidence-based recommendations that help reduce the need for transfusions, avoid infections and reduce hospital stays for patients undergoing surgery.

The Perioperative module is based on an extensive systematic review of the highest quality evidence available from trials in the perioperative setting throughout the world.

A key finding from the evidence is that diagnosis and treatment of anaemia before surgery, particularly in patients at risk of blood loss, reduces risks and improves patients' recovery and health.

Anaemia in patients is not routinely diagnosed or treated prior to admission for surgery, even though patients with anaemia have poorer outcomes when they undergo surgery and are more likely to require a transfusion.

The module includes an easy-to-use preoperative haemoglobin assessment and optimisation template which aids in the identification, diagnosis and treatment of anaemia prior to surgery.

The approach recommended has been tested in the Australian setting-Western Australia became the first jurisdiction in the world to adopt a system-wide program of patient blood management.

It did this by assessing and managing preoperative anaemia, adopting surgical techniques that minimise blood loss and introducing a policy of transfusing one unit at a time. As a result, the state's issues of red blood cells for transfusion per 1000 of the population fell from 30.5 in 2007-08 to 27.5 in 2011-12 (the national average was 35.6 per 1000 in 2011-12).

Work will resume in July 2012.

Criteria for the clinical use of intravenous immunoglobulin (IVIg)

IVIg is used to replace or modify a person's immune response. It is used to treat many different indications across immunology, neurology, haematology and other specialty areas, for these two purposes.

Many of the indications for which IVIg is used are extremely rare, and in these circumstances, evidence of IVIg efficacy is limited.

The Criteria for the clinical use of intravenous immunoglobulin in Australia (the Criteria) identifies the indications for which IVIg is funded under the national blood arrangements by all Australian governments; the book is not a medical or clinical guideline on treatment of the indications listed. Regular review of the Criteria is needed to align funded access to IVIg with the latest evidence, or in the case of limited evidence, a consensus of expert opinion. In the last twelve months, the Criteria has had 8446 copies downloaded from the NBA website and the quick reference guide 3247 copies downloaded, with 312 and 368 hard copies distributed respectively.

The NBA published the initial Criteria in December 2007, with a number of clarifications published in February 2009. A triennial review of the document commenced in 2010 and a public consultation on the recommended changes closed in August 2011. The draft second edition of the Criteria was endorsed by JBC in December 2011 and approved by health ministers in June 2012. We estimate that the overall impact of the proposed changes to the Criteria is likely to stem the rate of growth in demand for IVIg.

The NBA has also developed a communications plan to accompany the release of the second edition of the Criteria. While the new Criteria will apply from 10 August 2012 for all new patients, a transition period of six months will be allowed for existing patients affected by changes to the Criteria.