HvPI generates 2303 adverse transfusion reaction reports through its reporting system
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Shardul Nautiyal, Mumbai
July 24 , 2015
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Taking forward the centralised programme of monitoring transfusion
reactions, Haemovigilance Programme of India (HvPI) launched on December
10, 2012 by National Institute of Biologicals has till date reported
2303 adverse transfusion reaction reports.
Presently, 207
centres located in blood banks, medical colleges, government and private
hospitals are enrolled under this programme. Data in transfusion
reaction reporting form (TRRF) from various centres across the country
enrolled under HvPI is being collected through a software, Haemo-Vigil
indigenously developed by IT division of NIB.
Aimed at generating
evidence based recommendations and advising CDSCO for safety related
regulatory decisions, Dr Surinder Singh, director, NIB further explains
that among the key attributes of the HvPI, the reporting system deployed
is independent of any authority with NIB/Indian Pharmacopoeia
Commission (IPC) being the co- ordinating centre between the reporters
and regulators. Therefore, the other attributes of the system are that
it is confidential, independent, offers expert analysis, is systems
oriented and responsive.
He further says reports are evaluated by
experts who understand the clinical circumstances and are trained to
recognise underlying systems causes through a Haemovigilance Advisory
Committee (HAC). Besides this, the identities of the patient, reporter
and institution are never revealed to third party going by the clause
for confidentiality.
As per the programme, traceability of
events is done through proper documentation which in turn leads to
effective recommendations to be accepted and acted upon and also by
defining systematic documentation process.
HvPI, which was
launched at the national level by NIB aims to identify trends in adverse
reactions and events, thereby to form transfusion policy, target areas
for improvement in practice, stimulate research, raise awareness of
transfusion hazards, give an early warning of new complications to
improve safety of transfusion for patients.
Such information is
also key to introduce required changes in the applicable policies,
improve standards, systems and processes, assist in the formulation of
guidelines, and increase the safety and quality of the entire process
from donation to transfusion. It is a boon for hospital deans and
directors, major blood users among the clinicians and blood bank
officers from all government, municipal and private hospitals, drug
regulators, officials from other government and municipal agencies.
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