key: cord-0730412-hcp4ngbg
authors: Seifried, E.; Mueller, M. M.
title: I08 Development of transfusion medicine in Europe A challenge for physicians, scientists and politicians
date: 2007-08-31
journal: Blood Reviews
DOI: 10.1016/s0268-960x(07)70009-7
sha: b29748a3f4b081a7ffa8b12b8439d4941486b43d
doc_id: 730412
cord_uid: hcp4ngbg

nan

Modern transfusion medicine in Europe has successfully handled the major threats to a safe blood supply by "classical viral" transfusion-transmitted pathogens like HCV and HIV. However, this was only managed by utilizing major financial and expert resources. Today, European harmonisation of optimal use of blood components in clinical hemotherapy, uniform quality standards for blood donations, testing and component production as well as an increasing cost pressure in clinical care are tasks, which need our full attention. Modern cellular therapies and regenerative medicine are novel treatment options, which can only be handled by a close cooperation between clinicians and transfusion medicine specialists. Future challenges comprise proactive measures like pathogen inactivation for all blood components in order to diminish threats to blood safety by (re-)emerging pathogens, an adequate blood supply bearing in mind the ongoing ageing of most European populations and political decisions regarding a potential open "blood market" in Europe, which in our opinion should not be supported by the European Union. History: When after World War II the needs of modern medicine called for well organized blood donor services, most European governments handed this task over to their respective national Red Cross organizations. With increasing demand for blood components, encouragement and mobilization of the healthy population to donate blood became one of the prominent tasks of these new organizations in the 50s of the last century. The aging of most European populations nowadays demands great efforts to provide blood donations from healthy volunteers since most surgical procedures on elderly patients require more blood products than the same procedure on young people does.

Providing an adequate amount of safe blood components is vital for modern societies in Europe and it remains to be decided, whether this important task will be handled by the national Red Cross organizations, hospitals, private pharmaceutical companies, governmental organizations or even possibly a combination of those. For hemophilia patients, who in former times died in early adulthood due to bleedings or other complications, the introduction of self-treatment at home with factor VIII or factor XI concentrates helped these patients to achieve a normal life expectancy. However, most of the hemophiliacs treated suffered from hepatitis B or hepatitis C in the last decades of the last century. In the 80s of the last century, the first AIDS scandal helped to accelerate the development of heat-inactivated factor VIII concentrates. Later on, in the 90s of the last century, a second AIDS scandal in blood products shocked Germany: Following this, public authorities were closed and the Paul-Ehrlich-Institute took over responsibility for granting marketing authorizations for blood and plasma products. New institutions like the "Arbeitskreis Blut" at the German Ministry of Health with experts from transfusion medicine, hemostaseology and patient care were established and new laws like the transfusion law were inaugurated as well.

Since then, safety of blood products has become one of the highest priorities in Germany as well as in most other European countries.

Quality and safety of blood components have increased dramatically since the beginning of the 90s of last century: Registration of blood donor services as pharmaceutical companies, manufacturing licenses and marketing authorizations for blood products, in-line filtration of whole blood donations in order to diminish leucocyte contamination of the final blood components, quality control and quality management as well as inspections by Proactive measures to reduce threats to a safe blood supply from (re-)emerging pathogens: Apart from the "classical" hepatitis viruses, HI virus and bacteria as potential transfusion transmitted pathogens, new threats from (re-)emerging pathogens have developed over the last few decades: Variant Creutzfeldt-Jacob Disease (vCJD) caused by prions [3, 4] , viral infections like Severe Acute Respiratory Syndrom (SARS), Avian Influenza, West-Nile-Virus and Chikungunya fever are all examples of (re-)emerging pathogens (see also Table 1 ). These pose an acute and more dangerous threat to safe blood transfusions than the "classical" viral pathogens such as hepatitis viruses and HIV, which today are almost negligible transfusion risks as has already been described above. The new threats from (re-)emerging pathogens require constant hemovigilance and acute decisions regarding new test procedures for these pathogens or the introduction of pathogen inactivation measures for blood products as they become available in Europe.

Increasing costs and economic pressure on the European health care systems: Modern medicine in Europe has to deal with an ageing population and a decline in (altruistic) blood donations while facing an increasing cost pressure on the health care systems in Europe at the same time. Clinical hemotherapy and transfusion medicine have to deal with these backgrounds: Questions arise, whether it is more suitable to establish smaller, hospital-based blood donor services which are able to work closely with the hospital staff versus bigger entities working like pharmaceutical companies, which are able to reduce costs through economies of scale.

Research and development: Modern clinical transfusion medicine and hemotherapy are essential parts of today's medicine. Close cooperation and scientific networking with industrial and clinical partners in tissue transplantation, cell therapy and other new fields of medicine are vital to the future of our field. However, funding for R&D, competition with the pharmaceutical industry regarding blood donor screening and new blood substitutes, as well as growth factors like erythropoietin or thrombopoietin provide some examples of the more problematic fields in this competition. Many experts are calling for a trend to "bloodless medicine". However, evidence of any true benefit from "bloodless medicine" is lacking. Growth factors like erythropoietin show adverse events like a potential increase in tumor growth and their use has not led to the mortality reduction hoped for in several patient populations. Optimal use of blood products is a worthwhile goal to aim for; however, the risk of undertransfusion in some patients has to be taken into account. In some European countries, strategies to reduce allogenic blood transfusion led to less advertising for healthy volunteer blood donors which finally resulted in the dramatic reduction in blood donations now endangering the blood supply in these countries. Future challenges in transfusion medicine: Medical: Maintaining and increasing blood transfusion safety: With the successful containment of the transmission of the "classical" viruses like hepatitis and HIV by transfusion, the focus has shifted to sources of lower risks to blood transfusion safety: Screening of blood donations for prions, bacterial screening (especially in platelet concentrates), pathogen inactivation of all blood products and testing for new and emerging pathogens [5] are examples of ongoing challenges in transfusion medicine. Transplantation medicine: Transplantation of solid organs and hematopoietic stem cells require complex diagnostic and procedural logistics: HLAtesting, stem cells apheresis and storage as well as new cell therapies like stem cells in acute myocardial infarction and chronic heart diseases are examples of the vast developments in this field [6, 7] . New blood products and regenerative medicine: Hematopoietic stem cells from bone marrow are nowadays almost completely replaced by peripheral hematopoietic stem cells obtained via apheresis procedures. Umbilical cord stem cells are a promising source of hematopoietic stem cells also in adult patients nowadays. Cellular therapeutics and gene therapy as well as immunotherapy are novel

Fax: +49 69 6782 231. E-mail address: e.seifried@ blutspende

Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in an blood-bank setting

Transfusion medicine: looking to the future

Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion

vCJD tissue distribution and transmission by transfusion a worst-case scenario coming true?

NAT screening of blood donors for severe acute respiratory syndrome coronavirus can potentially prevent transfusion associated transmissions

Transcoronary transplantation of progenitor cells in patients with persistent left ventricular dysfunction after myocardial infarction: a randomized controlled trial (TOPCARE-CHD)

Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction

Population biology of emerging and reemerging pathogens

European Parliamentary Public Hearing on 'The Impact of SARS and Other Emerging Pathogens on Transfusion Medicine

 Table 1 : (Re-)Emerging infectious diseases recently discovered [8, 9] Year Pathogen