THIRUVANANTHAPURAM: Blood transfusion saves lives and plays a key role in improving the health status of any community. In order to improve the standards of blood and its components, the Central Government through Drugs Controller General of India, has formulated a comprehensive legislation to ensure better quality control system on collection, storage, testing and distribution of blood and its components. It is in this context that the term Hemovigilance becomes important.
Haemovigilance which has Latin and Greek roots is a tool to improve the quality of the blood transfusion chain, primarily focusing on safety. There are 2,757 licensed blood banks in India and the average annual blood collection is around 7- 8 million units . Our country still faces a deficit in terms of the availability of blood or blood components as the gap of demand and supply of safe blood is wide. A Hemovigilance program as an integral part of pharmacovigilance program of India at a national level was launched on December 10, 2012 with a road map of 5 years. The activities of hemovigilance between the blood banks and National Coordinating Centre at National Institute of biologicals(NIB) are co-ordinated by a core group. The advisory committee introduced Transfusion Reaction Reporting Form (TRRF) and gives expert opinion for collection, collation, and analysis of hemovigilance. A software ‘Haemovigil’ was also developed for reporting the adverse reactions. They also monitor the functioning and quality of the data collected.
Characteristics of haemovigilance programme
The main characteristics of HvPI are developed in accordance with WHO guidelines for adverse event reporting. The reporting and learning systems are adopted. Medical Colleges/ institutes/ hospitals/ blood banks of India can enroll under HvPI. The head/ incharge of Transfusion Medicine Department / blood bank provides necessary details to the National Coordinating Centre (NCC) - Haemovigilance Programme of India (HvPI) by sending the duly filled Enrolment Form either to NCC at National Institute of Biologicals, Ministry of Health & Family Welfare, Plot No. A-32, Sector-62, Institutional Area, NOIDA - 201 309 (U.P.) or via E-mail to NCC at haemovigilance@nib.gov.in. NCC verifies the details provided by the Center.
Challenges in the implementation of HV system
The major challenges faced in the implementation of HV system include enrolment of reporting centres, fear of punitive action, sense of additional work and responsibility especially for clinicians, shortage of staff, limited availability of computers and lack of easy access of internet facility, lack of perception of immediate benefit of reporting.Better haemovigilance can be achieved by ensuring better national blood quality and safety initiatives, reducing or minimizing human errors, imparting training, generating data standards, improving reporting capacity, designing and implementing motivational programmes.
P K Sreekumar,
Assistant Drugs Controller,Thiruvananthapuram,Kerala.