mmunization against vaccine preventable diseases
is one of the safest and the most cost effective interventions to
improve child survival [1]. The advent and growing availability of new
vaccines which target major childhood diseases such as pneumonia,
meningitis and rotavirus have the potential to save an additional 1.7
million child lives. In India, with approximately 26 million infants
born each year, hundreds of millions doses of vaccines are administered
annually [2]. Although vaccines are proven to be extremely safe, there
is a potential risk of a adverse reaction, as with any other drug or
medication. Adverse Event Following Immunization (AEFI) is defined as ‘a
medical incident that takes place after immunization, causes concern and
is believed to be caused by the immunization’ [4-5]. This risk of AEFI
with vaccination is always weighed against the risk of not immunizing a
child. It is only when the benefit outweigh the risk, a vaccine is
considered safe. However, even at a relatively low rate, because of the
high absolute number of beneficiaries, there is risk of a few serious
adverse events in the vaccinated children. This paper provides
guidelines to practitioners both in private and government sector
(including pediatricians) on how to report cases, and outline the steps
needed to improve AEFI surveillance and reporting by strengthening
public private partnership in India.
Importance of AEFI
The vaccines are foreign for human bodies, given to
healthy infants and children. In the natural process of developing
immunity, a vaccine may cause fever, erythema, local pain etc. Besides,
there is a slight risk of foreign body reaction to the components in the
vaccines. These factors are likely to cause some concerns in the
caregivers/parents. Whatever the cause, an AEFI may upset people to the
extent that they may refuse further vaccination for their children. This
may lead to the children much more likely to get a vaccine preventable
disease, become seriously ill, disabled, and risk death. AEFI
surveillance, therefore, helps to preserve public confidence in the
immunization program [4]. Though, the majorities of AEFIs are mild,
settle without treatment, and have no long term consequences; very
rarely, serious adverse reaction can occur. The vaccination programs
work in a ‘paradox’ meaning thereby that the focus of attention changes
with the implementation of immunization program—when the vaccination
coverage increases and disease burden reduces drastically, more cases of
AEFI attract the attention of the people than the disease in the
community [6].
AEFI Surveillance Strengthening in India
AEFI surveillance in India started with the launch of
Universal Immunization Program (UIP) in 1985. However, the AEFI
reporting remained suboptimal for long in the country. In 2005/2006, the
Government of India, with technical assistance from the World Health
Organization/National Polio Surveillance Project India and other
development partners, prepared the National AEFI Surveillance and
Response Operational Guidelines [7]. These guidelines were widely
disseminated across the country among medical officers in Government
sector. Since then many national, state and district level AEFI
surveillance workshops for immunization program managers have been
conducted. The national guidelines were further revised and updated in
2010. These efforts have contributed in improving AEFI surveillance in
India and the country reported the highest ever number of serious AEFI
in 2010 (395 vs. 55 in 2006).
National AEFI Guidelines in India
There are two sets of national guidelines available
in India. The detailed version is called ‘Operational Guidelines’, and a
shorter version is for ‘Standard Operating Procedures’ [8,9]. These
guidelines, based upon World Health Organization suggested framework
[4], were developed through a consultative process with various
stakeholders, including various Government departments involved in
immunization program, state government program managers, academic
institutions, independent subject experts, Drug Controller General of
India (DCGI) officials, development partners etc.
The AEFI reactions can broadly be classified as
‘serious AEFIs’ (death, disability, cluster and hospitalization) which
need to be reported immediately and investigated as per the laid down
procedures. The other, i.e. ‘minor AEFIs’ are reported through monthly
reporting systems in UIP in Government of India. For the programmatic
purpose, the AEFIs are classified in five broad categories of
programmatic error, vaccine reaction, injection reactions, coincidental,
and unknown [8,9].
How to Report AEFI From Private Sector?
The majority of children in India receive
immunization through public health facilities. However, it is estimated
that approximately 10-20% of total immunization is provided through
private sector and by pediatricians [10]. Moreover, the vaccines not
part of the UIP in India are provided by the private sector only. There
is an evolving AEFI surveillance system in India for UIP vaccines from
government sector; however, the reporting from private sector is limited
so far. It is important that AEFI from this sector are also reported and
investigated, as per the laid down national guidelines, which are
applicable to private sector also. Additionally, the AEFI reporting from
private sector will provide vital information on the safety of new and
underutilized vaccines in India. Once a serious AEFI happens in the
private sector at a clinic of pediatricians, in the rural area, she/he
should immediately inform medical officer incharge of nearest primary
health centre or other health facility. In the urban area, either she/he
can inform medical officer In charge of nearest urban health centre or
to the ‘District Immunization Officer’ (DIO). By all channel, the
information should reach DIO as soon as possible.
The private practitioners (including pediatricians)
should use the ‘First Information Report’ (FIR) form for reporting
serious AEFI cases to the district officials. Once an AEFI is reported
from private sector, the DIO and district AEFI committee members would
then investigate the reported AEFI case. The pediatricians should help
the investigation team in collection of all the related information.
It has come out from various interactions at
different forums that the pediatricians, in general, are not aware and
apprehensive about the existing AEFI reporting system and national
guidelines on AEFI surveillance and response in India.
The Way Forward
Based upon the understanding of the AEFI surveillance
and case investigation in India and a series of interactions with
members of professional bodies, there are a few possible ways to
strengthen AEFI reporting from private sector in India:
• Stronger collaboration: Considering a
large number of pediatricians provide immunization service, their
involvement in AEFI surveillance is crucial. A stronger
collaboration between Government of India and Indian Academy of
Pediatrics (IAP) will be a right platform to strengthen AEFI
surveillance in India. The possible role of IAP can be as follows:
• Sensitizing members about AEFI surveillance in
monthly IAP meetings and through their state and national level
conferences
• Disseminating information through IAP
publications
• Reporting AEFIs and supporting case
investigation
• IAP members actively participating in district
and state AEFI committee activities
• Supporting causality assessment at the state
level.
• Conduct short sensitization meetings
specifically targeted at new /underutilized vaccines at district
level through IAP/IMA network.
Online AEFI Reporting Platform for Private Practitioners
A possible solution for AEFI reporting from private
sector is providing online platform through which practitioners can
report from the comfort of their clinic. This platform may ask for First
investigation report to be provided by private practitioner and then
government counterpart can take lead and collaborate for further
investigating and taking up the AEFI case investigation and reporting.
• IAP through its IAP Advisory Committee on
Vaccines and Immunization Practices (ACVIP) has resolved to
collaborate with the National AEFI program by suggesting the
following measures:
- Integrate IAP disease surveillance project
(IDSURV) with AEFI reporting for a web based and integrated
voice recording (IVR) reporting (already incorporated:
www.idsurv.org).
- The IDSURV program is fine-tuned to
automatically send information to the concerned DIO/state
immunization officer for prompt action.
- In due course, SMS reporting shall also be
integrated within the program for preliminary reporting but
shall have to be followed up by proper FIR.
• The proposed ‘public-private partnership’ has
been enthusiastically received by Ministry of Health, Government of
India for prompt implementation.
• The public-private partnership envisages
continuous monitoring by all the stake holders for a meaningful
outcome.
• Bringing the confidence amongst private
practitioners: Once the practitioners are sensitized about the
AEFI surveillance, they might have higher confidence to report the
cases. Inculcating confidence in the private practitioners will
contribute to strengthen AEFI surveillance in India.
Conclusions
The immunization coverage in India is slowly
increasing and additional new and underutilized vaccines are being
administered to the children by private practitioners. While there is a
system for AEFI reporting from government sector in India based on the
operational guidelines, there is limited awareness about the reporting
system in the private sector resulting in inadequate reporting. There
is, thus, a perceived need for improving AEFI surveillance in the
private sector. This is possible through information dissemination and
better collaboration with professional bodies and Government of India.
The improved AEFI surveillance and reporting system in India will go in
a long way to increase and retain the faith of the community in the
existing and new vaccines and increasing the immunization coverage in
India.
References
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