Haemovigilance

1. HAEMOVIGILANCE
Dr. Rupendra K. Bharti,
Department of Pharmacology,
IGMC Shimla

2. INTRODUCTION
• Haemovigilance is a continuous process of
data collection and analysis of blood
transfusion related adverse reactions in order
to investigate their causes and outcomes and
prevent their occurrence or recurrence.

3. HISTORY
• Hemovigilance was first introduced in France in
1993 with mandatory reporting and in United
Kingdom (UK) with first voluntary reporting
system in 1996.
• Most of the developed countries like Canada,
Ireland, Netherlands, and Denmark have a
voluntary reporting requirement. Hemovigilance
program in these countries is linked to
International Hemovigilance Network, which
presently has 28 members.

4. Hemovigilance systems, depending upon the
country, are governed either
by regulators (e.g., France, Germany,
Switzerland),
 blood manufacturers (e.g., Japan, Singapore,
South Africa),
medical societies (e.g., Netherlands, UK), or
 public health authorities including regulators
(e.g., Canada).

5. • Among the Asian countries, a well-established
hemovigilance system is lacking and there is
paucity of data on hemovigilance except for
Japan, which has published a report on adverse
reactions.
• Hemovigilance system is required in the country
to have a comprehensive approach to address the
issues of adverse reaction following blood
transfusion and blood product administration.

6. Hemovigilance program of India
• A Hemovigilance program as an integral part
of pharmacovigilance program of India at a
national level has been launched on
December 10, 2012 with a road map of 5
years, i.e., year 2012–17, with four phases,
i.e.,
• initiation phase, expansion and
consolidation phase, expansion and
maintenance phase, and optimization phase.

7. • A core group to coordinate the activities of
hemovigilance between the medical colleges
and National Coordinating Centre at IPC has
been constituted.

8. • An advisory committee has also been
constituted to
• a) finalize hemovigilance—Transfusion
Reaction Reporting Form (TRRF) to be
introduced in the country,
• b) give expert opinion for collection, collation,
and analysis of hemovigilance data and
development of the software for the same,

9. • c) monitor the functioning and quality of the
data collected by the Adverse Transfusion
Reaction Reporting Centres, i.e., ADR
Monitoring Centres of PvPI,
• d) develop training modules and guidelines for
implementation of hemovigilance program
under PvPI,

10. • e) develop a roadmap for linking
hemovigilance program under PvPI with
International Haemovigilance Network.

11. • Initially, 60 medical colleges that are already
enrolled under pharmacovigilance program of
India have been brought under the ambit of
this program.This number has increased to
153.

12. • The National Institute Of Biologicals, Noida is
the National Coordinating Centre for
Haemovigilance programme of India.

14. OBJECTIVES of HvPI.
• Monitor transfusion reactions
• Create awareness among health care
professionals
• Generate evidence-based recommendations
• Advise Central drugs standard control
organization (CDSCO) for safety related regulatory
decisions
• Communicate findings to all key stakeholders
• Create national and international linkages

15. Centers under HvPI.
• Those medical colleges, institutes, hospitals,
blood banks in India that are registered with
the National Coordinating Centre for HvPI for
reporting the adverse reactions that occurs
during blood/blood component transfusion or
blood product administration.

16. Enrolment of Centres under HvPI.
• Head/Incharge of transfusion medicine
department/ Blood bank sends request via e-
mail to haemovigilance.nib.gov.in
• In response to the request, NCC sends the
enrolment forms to collect the necessary
details of the centre.
• Centre provides the necessary details by
sending the completely filled enrolment form.

17. • NCC verifies the received details.
• After verification, NCC issues the user Id and
password to access the Haemo-vigil Software
to start reporting transfusion reactions.

18. HAEMO-VIGIL SOFTWARE.
• It is a software which is being used by HvPI to
collect and collate Transfusion Reaction
Reports from Centres under HvPI for onward
transmission of data to NCC.
• This software was indigenously developed by
IT team NIB-IPC, and was launched on 24th of
January,2013.

19. Privacy and Security of Data.
• It is the intention of the NCC of HvPI that the
reports received will be held in strict
confidence and protected to the fullest extent.
• Programme staff is not expected to and will
not disclose the reporter’s identity in response
to a request from the public.

20. Documentation and Reporting.
• Responsibilities of the hospitals/ medical
colleges/institutes/blood banks (Centres)
under HvPI- to enter the information
regarding Transfusion Reactions in the Haemo-
Vigil Software for onward transmission of data
to NIB-NCC of HvPI.

21. Responsibilities of the medical and nursing staff
of the centres under HvPI-
 Report suspected transfusion reaction
immediately to the attending physician.
 Document the details of the patient as well as
the implicated units/products in the FORM
NO.1 and retain it in the patient’s file.

22. • Send the details of the transfusion reaction to
the department of transfusion
medicine/blood bank in the FORM NO.2.
• Protocol for investigation is there.
• Assess the imputability levels of the adverse
reaction in coordination with the department
of transfusion medicine/blood bank.

23. • Responsibilities of the department of
Transfusion medicine/Blood Bank-
• Reporting the details of the clinical and
laboratory investigations to the respective
medical ward and to the Hospital Transfusion
Committee.
• To do the investigations as per the work-up
form and documenting the results in the
work-up form.

24. • To enter the necessary details as per the
documentation required in the transfusion
reaction-traceability document(TR-TD) record.
• To assess the imputability levels of the adverse
reactions in coordination with the attending
physician.

25. • Custodian of the TR-TD record.
• To ensure the completeness of the TR-TD
document record.
• Report the details of the transfusion reaction
as per the TRRF form in the Haemo-Vigil
Software.

26. • Responsibilities of the Hospital Transfusion
Committee:
• To review the reported transfusion reactions
for improving hospital transfusion practices.

27. • Responsibilities of NCC:
• Collection, collation and analysis of
haemovigilance data and forwarding it to IPC.
• Monitor functioning of centres under HvPI.
• Review completeness,quality check,causality
assessment.

28. • Preparation of SOPs,guidance documents and
training manuals.
• Providing training to the centres under HvPI.
• Publishing of haemovigilance newsletter.
• Communicate recommendation of
Haemovigilance advisory committee to
NCC,IPC,Ghaziabad.

29. • Responsibilities of IPC,NCC,PvPI:
• Forward recommendations of haemovigilance
advisory committee to DCGI-CDSCO.

30. • Responsibilities of CDSCO:
• Formulate safety related regulatory decisions.
• Communications of blood and blood products
transfusion safety related decisions to
stakeholders.

31. IMPUTABILITY LEVELS
• DEFINITE(CERTAIN): When there is conclusive
evidence beyond reasonable doubt that the
adverse event can be attributed to the
transfusion.
• PROBABLE(LIKELY): When the evidence is
clearly in favour of attributing the adverse
event to the transfusion.

32. • POSSIBLE: When the evidence is indeterminate
for attributing the adverse event to the
transfusion.
• UNLIKELY: When the evidence is clearly in favour
of attributing the adverse event to causes other
than the transfusion.
• EXCLUDED: When there is conclusive evidence
beyond reasonable doubt that the adverse event
can be attributed to causes other than the
transfusion.

33. CONCLUSION
• Hemovigilance program is an integral part of
pharmacovigilance program of India and is a
comprehensive, centralized, and a well-
structured approach to collect, collate, and
analyze data to address the issues of adverse
reactions associated with blood transfusion
and blood product administration by
generating evidence-based recommendations
for transfusion safety and preventive
measures.