Haemovigilance in developing countries

Abstract

The word haemovigilance is derived from the word pharmacovigilance, which covers activities and systems to collect information in medicinal products, especially for adverse drug reactions in humans. Haemovigilance, initially created in France in the begining of 90s has Greek and Latin roots: ‘‘haema’’: blood and ‘‘vigilans’’: paying special attention. Haemovigilance concerns blood components. Pharmacovigilance concerns plasma derivatives such as clotting factor oncentrates, immunoglobulins, albumin and other fractionated products. Since 1993, in European legislation plasma derivatives are considered to be pharmaceuticals, and the manufactures have to comply with the European regulations on pharmacovigilance. Transfusion reports from US and United Kingdom showed that most of the incidents were caused by clerical errors. Not only identification but also administrative errors also plays an important role. In France, by a law in 1994, the first definition of hemovigilance was introduced. Various number of definitions have been written since then. In the European Blood Directive, it is defined as a group of organized surveillance procedures relating to serious, adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors. The definition given by the European Haemovigilance Network (EHN) is the one most widely used. ‘‘Haemovigilance is a set of surveillance procedures covering the entire transfusion chain (from the donation of blood and its components to the follow-up of recipients of transfusions), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent the occurrence or recurrence of such incidents’’ [1]. Haemovigilance and the European Blood Directive