ipc aefi surveillance_program_in_india
TRANSCRIPT
Adverse Events Following Immunization (AEFI) Surveillance program in India
Dr Jyoti JoshiSenior Advisor-AEFI Management, vaccine safety and quality
Immunization Technical Support Unit, MoHFW
22 Aug 2015IPC Ghaziabad
Presentation Outline
1. AEFI Surveillance Program 2. Milestones
3. Program Progress
4. Initiatives Undertaken
5. Future Plans
• ~27 million new born targeted each year
• ~ 9 million immunization sessions held annually( 57% outreach, 37% Health facilities,9% in private)
• ~27,000 cold chain points • Vaccines against 7 VPDs (T.B,
Diphtheria, Whooping cough, Tetanus, Hepatitis B, Measles, Polio)
• Polio SIAs since 1995, 800 million children vaccinated each year
• Measles & JE campaign completed (measles 135 M, JE 15 M ) and second dose measles introduced
• Hib containing Pentavalent vaccine introduced in 12 states in 2014 (total 20 states).
• Introduction of IPV, MR and Rotavirus vaccine approved by the NTAGI in 2014
61 % full immunization coverageWide Geographical variations (Kerala 82%, Haryana 72%)Polio-free for last 3 years
Immunization program in India : A Snapshot
SIGNIFICANCE OF AEFI SURVEILLANCE IN INDIA
• AEFI surveillance program demonstrates the country’s intent of delivering quality immunization services with safe vaccines and ensure vaccine confidence
• Globally, India is the largest developing country manufacturer of vaccines and vaccines manufactured in India are used in all continents
• As a large consumer, leading manufacturer and exporter of vaccines, India is expected to have a well-developed AEFI surveillance system
• With the largest birth cohort of approx. 27 million infants in the country the immunization program administers approx. 460 million doses annually yet reported serious AEFI are approx. 500 serious AEFIs annually
5
Milestones in AEFI Program implementation in India
1988 2005 2007 2008 2010 2011 2012 2015
AEFI Program
established
National AEFI Guidelines
District and State AEFI Committee established
National AEFI
Committee established
Revised National
AEFI Guidelines
Standard Operating
Procedures of AEFI issued
AEFI Secretariat established
at ITSU
Revised National
AEFI Guidelines launched
Identify problems ,if any, with vaccine lots/brands leading to vaccine reactions caused by vaccine.
Detect, correct and prevent immunization errors.
Prevent false blame arising from coincidental adverse events.
Reduce incidence of injection reactions from anxiety or pain through education and messaging.
Maintain confidence by addressing parent/community concerns, and raising awareness about vaccine risks.
Estimate rates of AEFI occurrence in local population compared with trial and international data
Objectives of AEFI surveillance
AEFI Case Definition
Earlier used-
An adverse event following immunization is a medical incident that takes place after an immunization, causes concern and is believed to be caused by the immunization.
Revised Definition-An AEFI is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage
of the vaccine.
The adverse event may be any unfavorable or unintended sign, abnormal
laboratory finding, symptom or disease.
Data sources for AEFI surveillance program
Immediate Direct reporting:• Serious AEFIs
– Death– Hospitalization– Cluster– Disability– Significant parent/community concern
• Severe AEFIs– Injection site swelling beyond nearest
joint– Fever >102 degrees
Monthly routine reporting in HMIS– Death----(selected Serious AEFI) – Abscess---(selected non serious
AEFI)– Others----All other serious and
non serious AEFIs are reported in this category
Dedicated email address: [email protected] sector paediatricians (IAP) can report AEFIs through www.idsurv.org
new
Previous forms
• FIR (First Information Report)
• PIR (Preliminary Investigation report)
• DIR (Detailed Investigation Report)
• Lab investigation form
New Forms• CRF (Case Reporting Form)
• PCIF (Preliminary Case Investigation Form)
• FCIF (Final Case Investigation Form)• State Causality Assessment Form
• Lab investigation form
• Verbal autopsy form• Guidelines for conducting
autopsy in reported AEFI deaths
AEFI REPORTING FORMATS
new
The DIO sends CRF
within next 24 hours and
PCIF in 10 days. The
FCIF is submitted within next
60 days
Immunization Division, MOHFW
NATIONAL AEFI COMMITTEE
State Immunization Office
District Immunization Office
Health facilities and outreach sessions
State AEFI Committee
District AEFI Committee
Report AEFI within 24 hours of
Notification through CRF
Pvt Practitioner
AEFI Organizational Structure
Severe and serious AEFI
AEFI Secretariat,ITSU
+
4 Zonal AEFI Consultants
Natl. AEFI Technical Collaborating Centre (LHMC, New Delhi)
AEFI COMMITTEES : Roles and Responsibilities
Terms of reference (National/ State/District)
– Strengthen and validate AEFI reporting at all levels
– Ensure implementation of uniform standards and formats.
– Prompt & thorough investigation of serious AEFIs and periodic review of non serious AEFIs
– Timely classification of cases – Causality assessment (Brighton
Classification)– Support spokesperson for media
interface and management.
Composition • Epidemiologist/Public Health Specialist• Representative from Drug Authority• Pediatrician, Microbiologist, Neurologist• Pathologist, Forensic Expert, Cold Chain
officer• Member Infectious Disease Surveillance
Program(IDSP)• Representative from local bodies like
corporations• Representatives from professional
bodies like IAP,IMA• Representatives from partners agencies
Member Secretary : Imm. Program Manager
NATIONAL AEFI SURVEILLANCE PROGRAM PROGRESS
12
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 20150
100
200
300
400
500
600
700
800
900
0 9 29 48 80170
219 199
303
410321
398
593
780
64
National AEFI Guidelines
Printed and Cir-culated
Trends in reporting of serious AEFIs (2001-2015)
AEFI Sect.established at
ITSU
Revised National AEFI
Guidelines circulated
Data as on 17-02-15
State trainings and sensitization on AEFI
Surveillance
A&N
ISLA
NDS
ANDH
RA P
RADE
SH
ARUN
ACHA
L PR
.
ASSA
M
BIHA
R
CHAN
DIGA
RH
CHHA
TTIS
GARH
D&N
HAV
ELI
DAM
AN &
DIU
DELH
I
GOA
GUJA
RAT
HARY
ANA
HIM
ACHA
L PR
ADES
H
JAM
MU
& K
ASHM
IR
JHAR
KHAN
D
KARN
ATAK
A
KERA
LA
0
5000000
10000000
15000000
20000000
25000000
30000000
35000000
40000000
45000000
0 8 0 106
33 1 3 0 0 21 28 15 35 2 17 4 20 126
0 7 0 13 20 0 3 0 0 1 0 7 15 1 3 3 7 8
DOSES 2014 TOTAL 2014 DEATH 2014
State-wise distribution of serious AEFIs (2014)
Data as on 10-01-15
N – 772
1.1Lacs
209.8 Lacs
3.2Lacs
119.7 Lacs
444.2 Lacs
3.5 Lacs
116.8Lacs
1.5 Lacs
0.8 Lakh
51.4 Lacs 4.4
Lacs
226. Lacs
90.4 Lacs
23.2 Lacs
34.4 Lacs
120.3 Lacs
210.8 Lacs
78.6 Lacs
Variable sensitivity in serious AEFI reporting from states.
LAKS
HADW
EEP
MAD
HYA
PRAD
ESH
MAH
ARAS
HTRA
MAN
IPUR
MEG
HALA
YA
MIZ
ORA
M
NAG
ALAN
D
ODI
SHA
PUDD
UCHE
RRY
PUN
JAB
RAJA
STHA
N
SIKK
IM
TAM
IL N
ADU
TELA
NGA
NA
TRIP
URA
UTTA
R PR
ADES
H
UTTA
RAKH
AND
WES
T BE
NGA
L
0
10000000
20000000
30000000
40000000
50000000
60000000
70000000
80000000
0 50 32 0 1 9 1 17 4 8 9 0 61 3 10 76 0 720 16 4 0 1 7 1 6 0 2 8 0 13 3 9 41 0 31
DOSES 2014 TOTAL 2014 DEATH 2014
State-wise distribution of serious AEFIs (2014)
Data as on 10-01-15
N – 772
0.2Lakh
315.7Lacs
420.2Lacs
8.5Lacs
13.7Lacs
4.2Lacs
4.6Lacs
148.2Lacs
3.7Lacs
95.7Lacs
273.2Lacs
1.8Lacs
206.2Lacs
100Lacs
274.4Lacs
702.5Lacs
109.4Lacs
238.5Lacs
Variable sensitivity in serious AEFI reporting from states.
DISTRIBUTION OF SERIOUS AEFI CASES
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
100 100
0
100 10083.33
5748
29
56
37.293729372937334.634146341463442.767295597484340.7035175879397
31.216931216931229
0 0
0
0 016.57
4352
71
44
62.706270627062764.146341463414657.232704402515859.0452261306533
68.606701940035371
% Death % Hospitalized
Data as on 10-01-15
Increased reporting of hospitalized cases in recent years indicates enhanced sensitivity of AEFI Surveillance
State Level AEFI Committee not formedState Level AEFI Committee formed
Status of State AEFI Committee formation
2013 2014
Data as on 01-12-14
Status of District AEFI Committee formation
RAJASTHAN
ODISHA
GUJARAT
MAHARASHTRA
MADHYA PRADESH
BIHARUTTAR PRADESH
KARNATAKA
ANDHRA PRADESH
JAMMU & KASHMIR
ASSAM
TAMIL NADU
CHHATTISGARH
PUNJAB
JHARKHANDWEST BENGAL
ARUNACHAL PR.HARYANA
KERALA
UTTARAKHAND
HIMACHAL PRADESH
MANIPUR
MIZORAM
MEGHALAYANAGALAND
TRIPURA
SIKKIM
GOA
A&N ISLANDS
D&N HAVELI
PONDICHERRY
LAKSHADWEEP
DELHI
CHANDIGARH
DAMAN & DIU
District AEFI Committee yet to be formed
District AEFI Committee formed
2014 (616 – 92%)2013 (502 - 75%)
Data as on 01-12-14
NUMBER OF REPORTING DISTRICTS AND STATUS OF AEFI COMMITTEES
2011 2012 2013 2014
125142 148
209
No. of reporting districtsdistricts
Data as on 17-02-15
Fig: Map of districts reporting serious AEFIs (2014)
LegendCASES (1 Dot = One Case)Silent District
Reporting District
REASON FOR REPORTING OF SERIOUS AEFI (2013-2014)
Data as on 17-02-15
CLUSTER CASE; 19; 3%CLUSTER CASE (DEATH);
11; 2%
CLUSTER CASE (HOSPITAL-IZED); 133;
22%
DEATH; 169; 28%
DISABILITY; 4; 1%
HOSPITAL-IZED, 253,
43%
LAMA; 1; 0%OTHERS; 1; 0%NOT MENTIONED; 2; 0%CLUSTER CASE; 38; 5%
CLUSTER CASE (DEATH); 16; 2%CLUSTER
CASE (HOSPITAL-IZED); 152;
19%DEATH; 215; 28%
DISABILITY; 1; 0%
HOSPITALIZED, 329, 42%
RECOVERED; 4; 1% NOT MENTIONED; 25; 3%
2013 (593) 2014 (780)
Data review for trends
Year Doses administered
(MoHFW)
Reported serious AEFIs
by direct reporting
Serious AEFI reporting rate per 100,000
doses
2011 40,58,52,482 321 0.079
2012 42,86,76,755 398 0.093
2013 45,19,02,620 574 0.127
2014 41,01,61,680 708 0.173
Data as on 01-12-14
Reporting rate for serious AEFIs has almost
doubled over the last 3 years
YEAR 2011 YEAR 2012 YEAR 2013 YEAR 20140
100
200
300
400
500
600
700
800
900
321398
593
780
229289
400327
TOTAL COMPLETE
COMPLETENESS OF REPORTING ( FIR+PIR+DIR ,2011-2014)
Data as on 17-02-15
71 %73 %
67 %
42 %
Completeness of cases means not only submission of FIR/ PIR/ DIR, but other documents such as hospital records, post mortem reports, lab reports, etc. and opinion regarding causality by State AEFI Committee. Most common cause for unclassified cases is incomplete documentation.
Causality Assessment of reported AEFIdeaths following Pentavalent Vaccination ( 2011-14)
Data as on 15-09-2014
UNCLASSIFIABLE; 12; 22%
IN-DE-TERMI-NATE; 5; 9%
CO-IN-CIDEN-TAL; 37; 69%
B1, 3, 60%
B2, 2, 40%
N - 54
Following detailed causality assessment by the National AEFI Committee, none of the reported AEFI deaths have been
found to be causally related to the vaccine
• Changes in – Reporting and investigation formats and timelines – Reporting of serious and severe AEFIs. Examples of severe AEFIs – high
grade fever, extensive limb swelling post vaccination, etc.– Reporting adverse events with any vaccines (not just pediatric
vaccines/UIP vaccines)– weekly zero reporting formats for serious AEFI– AEFI register at block level to report minor and severe/serious AEFIs– introduce new verbal autopsy formats and Guidance for conducting
specialized autopsy to investigate cause of death (for deaths which occur at home/inadequate information available/brought dead to hospital/ lack of medical information regarding circumstances of death etc.)
– Action points and tools to improve communication response during AEFI crisis and advocate for vaccines in routine circumstances
– Use of WHO algorithm for causality assessment (state AEFI committees)
SALIENT FEATURES OF REVISED NAT. AEFI GUIDELINES
INITIATIVES TO STRENGTHEN AEFI SURVEILLANCE
• Establishment of AEFI Secretariat for techno-managerial support to National AEFI Committee and Immunization Division, MoHFW
• 4 zonal AEFI Consultants to work closely with states and provide support to states.
• Partnership with Lady Hardinge Medical College as National AEFI Technical Collaborating Centre for technical oversight and support
• Involvement of WHO SMO network in improving AEFI surveillance in the country
• Formation of panel of experts to support states( technical as well as risk communication related) for supporting introducing pentavalent vaccine in the country
INITIATIVES FOR HEALTH SYSTEMS STRENGTHENING
!OT
I
West Zone East Zone
South Zone
North Zone
LegendNorth ZoneWest ZoneEast ZoneSouth Zone
Network of National AEFI Technical Collaborating Centres
• Revision of National AEFI Guidelines based on WHO Guidelines with improved investigation of reported deaths
• Training of frontline health workers in 9 states with WHO country office support
• Improved reporting from the private sector with collaboration with IAP, IDSurv.org portal
IMPROVED AEFI DETECTION AND REPORTING
• Support to states in rapid field investigations of reported serious AEFI(J&K, Kerala, Punjab, Assam)
• Special Investigation Protocol for supporting national team in investigation of serious AEFIs
• Improving investigations for reported AEFI deaths through trained resource pool of experts &verbal autopsy form for gathering information about reported AEFI deaths
• Training workshops for orientation and Capacity building of State and District officials
IMPROVED AEFI INVESTIGATIONS
Special investigation protocol
Training workshops
Supporting field investigation
• Timely regular meetings:•
o National AEFI Committee as per calendar
o Causality Assessment subcommittee
• Quality Management System for AEFI Program
• Establishment of National AEFI Technical Collaborating Centre
IMPROVED CAUSALITY ASSESSMENT
!OT
I
West Zone East Zone
South Zone
North Zone
LegendNorth ZoneWest ZoneEast ZoneSouth Zone
Network of AEFI Collaborating Centres
Quality Managemen
t Systems
• Strengthening communication around AEFI: o Establishing spokespersons at
national and state levelo RI & AEFI response protocol with
tools and media templates for use at district and state level
• Revitalization of state AEFI committees
• Greater coordination with vaccine safety stakeholders for response to community and media
• Feedback to states (AEFI dashboard) for surveillance program performance
IMPROVED AEFI FEEDBACK AND RESPONSE
AEFI Surveillance program of National
Immunization Program
ICSRs reported to Indian
Pharmacopoeia Commission (IPC)
PSURs from MAH to Central Drug
Standards and Control Organization
(CDSCO)
VACCINE SAFETY DATABASE
AEFI edition of PvPI newsletter
Communication Guidelines for AEFI
• Improved reporting of AEFIs for all vaccines (not just vaccines used in paediatric practice or given in UIP)
• Involvement of Medical college to support State AEFI committees in all aspects of AEFI surveillance
• Piloting of electronic database and AEFI reporting system in the country
• Strengthening AEFI communication response• Involvement of SMOs of NPSP in supporting AEFI program• Research to advance vaccine safety: Pilot of a multi centric
hospital based active AEFI sentinel surveillance system, qualitative studies
• Increased participation of the private sector in AEFI reporting – collaboration with professional bodies such as IAP
Future plans
Thank YouReport AEFIs in India : [email protected] or