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FRENCH IT SYSTEM FOR REPORTING ADVERSE
REACTIONS AND EVENTS IN HAEMOVIGILANCE
I. Sandid, N. Ounnoughene, K. Boudjedir, R. Adda , A. Gautier , L. Aoustin , E. Pouchol, N. Ferry
The French National Agency for Medicines and Health Products Safety (ANSM), 143-147 boulevard Anatole France, 93285 Saint Denis Cedex, France
BACKGROUND
Figure 4. e-FIT homepage – access with HPC
The French haemovigilance (HV) system is organised by the ANSM (former
Afssaps), French Competent Authority for health products, in a network
(Figure 1) integrating different levels: national (French national blood service
(EFS), Army blood centre (CTSA)), regional (regional coordinators (RHC) and
HV correspondents (HvC) of regional blood establishments) and local levels
(HV correspondents (HvC) of hospitals and clinics and sites of blood
establishments).
The epidemiological follow-up of blood donors is carried out by the French
institute for public health surveillance (InVS).
Figure 1. French haemovigilance network
Ministry of health
National
ANSM
InVS*
Donors epidemiology
CTSA Military Blood
Transfusion Centre
EFS National Blood Service
Regional haemovigilance coordinators: 29 RHC
Regional
Regional blood establishments: 17 HvC
Local blood centers:
140 HcV
Local
Hospitals, clinics and
hospital blood banks: 1,692 HcV
Healthcare professionals
e-FIT reporting is based on 4 templates (donor’s SAR, recipient’s AR, SAE,
and PDI). (Figure 5).
Figure 5. e-FIT homepage – access to notification templates
* InVS: French Institute for Public Health Surveillance
This system was set up (Figure 2) in 1994 to collect, supervise and evaluate
all the adverse reactions occurring at the patients (rAR) and to collect
denominators. The others notifications templates were added successively
in 2002 for PDI, in 2003 for recipient SAEs, in 2007 for all transfusion chain
SAE and dSAR.
From 1994 to 1998, reporting was made in paper form sent by fax. And in a
2nd time via the 1st generation of national HV database, called GIFIT.
In 2003, the ANSM has developed an IT system for reporting, called e-FIT to
improve collection, supervision and evaluation of the HV reports. This system
was available for the HV network in 2004.
Figure 2. Time table of the implementation of the French
Haemovigilance in e-FIT IT system
rAR (paperGIFIT)
rAR (e-FIT)
Recipient SAE (e-FIT)
All transfusion
chain SAE
(paper)
All transfusion chain SAE
(e-FIT)
dSAR (paper)
dSAR (e-FIT)
PDI (e-FIT)
PDI (paper)
Denominators
(e-FIT)
Denominators (several regional and national databases)
1994-1999
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
2016
rAR: recipient Adverse Reaction; e-FIT: electronic Format Incident Transfusion; SAE: Serious Adverse Events; dSAR: donor
Seripus Adverse reaction; PDI: Post Donation Informations
e-FIT is a secure IT system with access restricted to health care professionals
(Figures 3, 4). Every user of the French HV network is registered by the e-FIT
administrator via his personal details and his establishment (BE, hospital or
clinic, regional health agencies, ANSM, EFS, CTSA). The access to the data is
governed by the profiles of each member.
Figure 3. e-FIT/Architecture
e-FIT
Administrator
Access
Control
system
Library
Health
professional
card (HPC)
For each report initiated in the system by the local correspondent, the
authorized individuals receive an e-mail message at the different steps of
the procedure. The report file can be modified by the various professionals
until the report is finally validated and locked.
In order to help the reporters, several guidelines were developed and are
available on-line in e-FIT.
The annual data on blood collection and recipients are also collected, and
this allows calculation of incidence rate events per 100,000 donations or
blood components.
WHAT IS E-FIT? HOW IT WORKS?
Desktop /
Laptop
e-FIT allows real-time sharing of information between authorized members
and thus a rapid analysis at each level, and implementation of corrective
measures if needed, and It’s a quick alert system for serious and rare reactions
and events.
Discussion
Forum
HPS
reader
Complementary
notification
format
Validation
Contact
details
e-FIT database contains more than 165,000 reports. Among these, 77% are
reports of rARs, 15% of dSARs, 5% of SAEs and 3% of PDIs.
SUMMARY
The e-FIT system is continuously evolving to meet the needs of national and
international users.
e-FIT allows real-time sharing of information and thus a rapid analysis and
It’s a quick alert system for serious and rare reactions and events.
It also serves to prepare the annual HV reports (national, European (EC,
EDQM) and international (ISTARE, WHO)) and to participate to several
surveys.
Authors are acknowledging all the members of the HV network for their
continuous involvement and their prompt and efficient cooperation.