Transfusionsassoziierte Risiken – Update 2014

Gemäß §16 Abs. 2 TFG (Transfusionsgesetz) bzw. §63c AMG (Arzneimittelgesetz) ist jeder transfundierende Arzt verpflichtet, schwerwiegende Transfusionsreaktionen der Bundesoberbehörde PEI zu melden. Die Zahlen in den letzten Jahre belegen, dass das Risiko der Übertragung einer HIV- oder Hepatitis-Infektion durch die Transfusionen von Blutpräparaten dank der sensitiven Nachweismethoden derart in den Hintergrund gedrängt worden ist, dass akute Transfusionsreaktionen inzwischen die Hauptrisiken einer Transfusion darstellen, hierzu gehören Fehltransfusionen (durch Verwechslungen/Fehlbestimmungen), allergische Reaktionen, hämolytische Transfusionsreaktionen (HTR) und die transfusionsassoziierte Lungeninsuffizienz (TRALI). Fehltransfusionen mussten bis 2012 dem PEI nur auf freiwilliger Basis mitgeteilt werden. Seit Oktober 2012 besteht durch die 16. Novelle des Arzneimittelgesetzes (AMG) auch für diesen nicht bestimmungsgemäßen Gebrauch eine Meldepflicht. Im britischen Hämovigilanzsystem „Serious Hazards of Transfusion“ (SHOT) werden schon seit Jahren die Fehlanwendungen von Blutprodukten systematisch erfasst. Der SHOT-Report zeigt, dass die Kategorien Fehltransfusionen (IBCT), allergische (ATR) und hämolytische (HTR) Transfusionsreaktionen in der Statistik unerwünschter Ereignisse an der Spitze stehen.

According to §16 para 2 TFG (German transfusion law) or, respectively, §63c AMG (German drug law), every physician who performs transfusions is obliged to report severe transfusion reactions to the Federal agency PEI. The figures for the past years confirm that the risks for transmission of an HIV or hepatitis infection through transfusions of blood products have been so markedly lowered thanks to the modern sensitive methods of detection that in the meantime acute transfusion reactions now constitute the major risks from transfusions, these include erroneous transfusions (due to mix ups/false determinations), allergic reactions, hemolytic transfusion reactions (HTR) and transfusion-associated pulmonary insufficiency (TRAPI). Up to 2012 erroneous transfusions were reported to PEI on a voluntary basis. Since October 2012 there is now an obligation to report this incorrect usage according to the 16^th amendment of the drug laws (AMG). In the British hemovigilance system “serious hazards of transfusion” (SHOT) the incorrect usage of blood products has been systematically recorded for several years. The SHOT report reveals that the categories erroneous transfusions (IBCT), allergic (ATR) and hemolytic (HTR) transfusion reactions are at the top of the statistics on unwanted events.

Key words:

Transfusion reactions - transfusion-associated risks - erroneous transfusions - transfusion laws - „serious hazards of transfusion“ (SHOT)

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