National Blood Authority
AUSTRALIAN HAEMOVIGILANCE REPORT
A report by the National Blood Authority Haemovigilance Advisory Committee
The first haemovigilance system in Europe was initiated in France in 1994[58], in large part as a reaction to the human immunodeficiency virus scandal in the 1980s and early 1990s. Other European countries followed this initiative, notably the SHOT program in the UK in 1996. The French and UK systems are the most mature and continue to provide insightful data and contribute to the global improvement of quality of care. Subsequent to the adoption and implementation of the European Blood Directive (2002/98/EC) and three additional implementing directives (2004/33/EC, 2005/61/EC and 2005/62/EC), nearly all European Union countries, and many other countries internationally, have established haemovigilance systems.
Communication between haemovigilance systems is organised through the IHN[59], previously the European Haemovigilance Network founded in 1997. The network started with five member countries from Europe and grew to 28, including seven from outside Europe.[60] It now has 32 international members and six more countries are in the application stage. The NBA participates in and reports on Australian haemovigilance data to the IHN.
The IHN holds annual haemovigilance seminars for member countries and researchers. The 15th International Haemovigilance Seminar was held in Brussels in February 2013.[61] The seminar highlighted the achievements of mature haemovigilance systems and provided an opportunity for developing countries to actively participate in the haemovigilance program and present the specific aspects and challenges in those countries.
The IHN has established an international haemovigilance database. A recent pilot study on 12 haemovigilance systems showed that the establishment of such a database is possible and already yields relatively valid and comparable information.[60]
The WHO supports haemovigilance at a global level, particularly in developing countries. The recent data from the WHO Global Database on Blood Safety showed that the number of countries having a national haemovigilance system increased from 42 in 2004-05 to 57 in 2011.[62]
A WHO Global Consultation on Haemovigilance was held in Dubai, United Arab Emirates, in November 2012. This consultation involved around 150 participants from over 50 countries.[63] The consultation:
The International Society of Blood Transfusion (ISBT) also contributes to haemovigilance at a global level, through its Working Party on Haemovigilance, consisting of individual members of ISBT. ISBT and IHN collaborate on development of definitions, surveys and other educational activities.
In most of the countries conducting haemovigilance, reporting is obligatory, and in all European countries the reporting of serious transfusion reactions and events became mandatory after the EU Blood Directive implementation in November 2005. There is a minority of countries in which reporting is restricted to adverse reactions that occur after the transfusion of blood products. In most countries, additional reporting is required, or desired, ranging from reporting the misuse of blood products (such as not based on the proper indications), to reporting data on virtually the whole blood transfusion chain.
The majority of the serious adverse reactions and events that are reported internationally happen in the hospital part of the blood transfusion chain. Data from the UK SHOT program have drawn attention to the fact that about 50% of these are due to administrative errors. Mature haemovigilance systems have documented the success of various measures to further improve the safety of blood products. Two key examples are:
These examples have been demonstrated to result in significant decreases of serious adverse reactions due to bacterial contamination of blood components (particularly platelets) and TRALI reactions respectively.
With reliable mature data streams and proven clinical benefits, many countries are seeking to install and improve haemovigilance systems. One notable recent addition is the USA.
The situation in the USA is complex. It is obligatory to report all fatal transfusion reactions to the FDA, but no official national haemovigilance system was used until 2009. Initiated in 2006, the US Biovigilance Network is a public-private collaboration between the USA Department of Health and Human Services, including the Centers for Disease Control and Prevention, and organisations involved in blood collection, transfusion, tissue and organ transplantation.[64] The first component of the network, the Haemovigilance Module or Haemovigilance System to monitor adverse events associated with transfusions, was launched in February 2010. Another network component, the Donor Haemovigilance System, was launched in October 2010 to track and reduce the occurrence of adverse events associated with blood donation.[65] Due to advances in donor screening, improved testing, automated data systems, and changes in transfusion medicine practices, the risks associated with blood transfusion have decreased in the USA. The latest FDA annual report of transfusion fatalities indicates that the blood supply is safer today than any previous time in history and transfusion-related deaths appear to be declining.[50]