Hemovigilance in India: Corrective action towards safety of blood transfusion

Hemovigilance is defined as the surveillance procedures covering the blood transfusion chain (from the collection of blood and its components to the follow-up of its recipients), intended to collect and assess information on unexpected or undesirable effects. The word hemovigilance is derived from the word pharmacovigilance, which encompasses activities and systems to collect information useful in supervising medicinal products, with particular reference to adverse drug reactions in human beings, and to evaluate such information scientifically. An adverse drug reaction is a response to a drug which is noxious and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function. The aim of hemovigilance is to detect and to analyze all untoward effects of blood transfusion in order to correct their cause and to prevent recurrence, and to improve the safety of blood transfusion. Although several reports have been published on adverse events, including transfusion-associated deaths, the relative risk based on the number of actual cases divided by the number of units of blood products issued or transfused, is relatively low. Scope of different hemovigilance systems varies due to differences in spectrum of reporting. Ideally, the hemovigilance system should cover processes throughout the entire transfusion chain, from blood donation, processing, and transfusion to patients for the monitoring, reporting, and investigation of adverse events and reactions and near misses related to blood transfusion. Keywords: Serious Hazards of Transfusion (SHOT), European Hemovigilance Network (EHN), Pharmacovigilance Program of India (PVPI), Hemovigilance Program of India (HvPI), International Hemovigilance Network (IHN).