Haemovigilance programme faces roadblocks as blood banks reluctant to enroll
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Arun Srinivasan, New Delhi
January 25 , 2018
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The Haemovigilance Programme of India (HvPI), which aims at improving
the quality of blood transfusion chain to ensure the safety of donors
and recipients, is facing hurdles as many blood banks and medical
institutions across the country remain reluctant to enroll in it.
Blood
banks, hospitals and medical institutions are expected to enroll in
HvPI, which is an indispensable part of pharmacovigilance programme at
the national level. However, according to sources, even after five
years, only 900 out of around 3,000 licensed blood banks in the country
are registered.
“The number of enrollments is limited as it is
voluntary at present. The solution is to make it mandatory under Drugs
and Cosmetics Act,” the source added.
National Institute of
Biologicals (NIB) is the nodal agency implementing the HvPI. An
autonomous institution under the ministry of health and family welfare,
it acts as the national control laboratory for assuring the availability
of good quality biological products. When asked about the need for a
regulatory mechanism to make the programme more effective, an NIB
official said “the institute is also working along similar lines.”
The
average annual blood collection in India is around 7-8 million units.
The availability of safe blood is crucial as the country is facing a
shortage of blood and blood components.
Ensuring blood safety is
just one aspect of the programme. Haemovigilance system is beneficial
for surveillance of treatment with other human products such as cells,
tissues and organs. It also focuses on donor selection and biological
control, labile blood component processing, qualification, transport and
conditioning and follow-up of transfused patient.
“The main
characteristics of HvPI are developed in accordance with WHO guidelines
for adverse event reporting. The reporting and learning systems are
non-punitive and independent of public authority. So framing a
regulatory mechanism may not be easy,” another official pointed out.
The
activities of blood banks and the National Coordinating Centre at NIB
are guided by a core group. The group has introduced a transfusion
reaction reporting form and gives expert opinion on collection and
analysis of haemovigilance. HaemoVigil, a software developed for
reporting adverse reactions, also helps keep an eye on the data
collected.
Official figures show that until January 2017, more
than 2,000 transfusion reaction reports have been received by the
HaemoVigil software at 71 centres. If all blood banks are enrolled, the
adverse reaction count may rise substantially and more experts and
supporting staff will be needed to review the reports. Moreover, blood
bank medical officers, clinicians, nurses and technicians need to be
sensitised with these adverse reactions to make sure that the project
will achieve its stated goals.
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