A regional hemovigilance study of transfusion-related adverse events at a tertiary care hospital

Abstract

Background: Blood transfusion is a routine, life-saving medical intervention which is generally regarded as safe when done appropriately. Hemovigilance is systemic surveillance of adverse transfusion reactions (ATRs). Aims and Objective: The aim of the study was to analyze the ATRs as a part of Haemovigilance Programme of India under the broad ambit of Pharmacovigilance Programme of India (PvPI). Materials and Methods: A retrospective review of all ATRs reported to the department of immuno haematology and blood transfusion, Victoria Hospital attached to Bangalore Medical College and Research Institute (BMC and RI), Bengaluru, between December 2012 and November 2017 was done. All the reactions were reported in a pre-designed transfusion reaction (TR) reporting form for blood and blood products as per the haemovigilance, PvPI. TR workup was done for all TRs. The frequency and distribution of ATRs year wise over a period of 5 years were assessed. ATRs were also analyzed with respect to age, gender, and types of blood products implicated in ATRs. Results: Total blood components issued by our blood bank to various departments and total ATRs during the study period were 48,576 and 89 respectively. ATRs were experienced by all age groups with a male preponderance (56.18%). Majority of the reactions occurred with whole blood (0.46%) followed by packed red cells (0.19%). The most common ATR observed was febrile nonhemolytic TR (88.76%) followed by anaphylaxis (2.25%). Most of the ATRs were acute reactions and transfusion siderosis being the only delayed reaction. Conclusion: The study emphasizes the continuous need to implement hemovigilance to improve the quality and safety of transfusion therapy.