Dr. Pradeep Haldar
Assistant Commissioner (I)
ADVERSE EVENT FOLLOWING IMMUNIZATION SURVEILLANCE AND RESPONSE
SEPIO meeting 18-20 May 2011
A medical incident that takes place after an immunization, causes concern and is believed to be caused by immunization
Adverse Event Following Immunization
Adverse Event Following Immunization
Revised AEFI Surveillance and Response
Operational Guidelines
Released in September 2010
By
Ministry of Health and FW, Government of
India, New Delhi
Content of these guidelines• AEFI : Concepts• Types of AEFIs• Recording and reporting• Case investigation• Sample collection• Operational aspects• AEFI Committees• Communication• Various formats• Technical information sheets as annex
A separate workshop to be conducted
for training in these guidelines
AEFI Surveillance-Reporting system
Immediate reporting with FIR/PIR/DIR: Serious AEFIs• Deaths• Hospitalization• Cluster• Disability
Routine Monthly report: - Abscesses - Deaths - Others
Non serious AEFIs• Minor reactions following immunization are common
• They include pain & swelling at the site of injection, fever, irritability, malaise
• They are self-limiting, hardly requiring even symptomatic treatment
• But it is important to reassure parents about such events so that they know about it
Common non serious reactions
•Rate of local reactions likely to increase with booster doses, up to 50-85%** Symptoms include diarrhoea, headache, and/or muscle pains
Vaccine Local reaction(pain, swelling,
redness) Fever > 38oC
Irritability, malaise &non specificsymptoms
BCG Common -- --
Hib 5% - 15% 2% - 10% --
Hepatitis BAdult up to 15%Children up to 5%
1% - 6% --
Measles/MMR Up to 10% 5% - 15% Up to 5% (rash)
Polio (OPV) -- Less than 1% Less than 1% *
Tetanus/DT/Td Up to 10% ** Up to 10% Up to 25%
Pertussis (DPT - whole cell) c Up to 50% Up to 50% Up to 60%
AEFI Monthly Reporting - Data Flow
Sub Centre
National
State HQ
District HQ
PHC/ Block
Urban Centres*
Depending on location
* Monthly reports to be sent to the respective district OR state HQ through the Asst Health Officer (EPI)/ Corporation Immunization Officer I/C
Serious AEFIs:Case investigation;
Reporting formats and channels
1. FIR2. PIR3. DIR
Serious AEFI Case investigation
• All serious AEFI cases need to be investigated by Distt. AEFI committee
• Standard reporting formats to be used for collecting information;
• Lab samples need to be sent as per guidelines
• Complete PIR and DIR on time
• State committee to do causality assessment
Serious AEFI Cases (formats and timelines)
Type of Report Responsible Time line
FIR First Information
Report
MO 24 hours
PIRPreliminary
Investigation Report
DIO 7 days
DIRDetailed
Investigation Report
AEFI investigation team 90 days
DIO 24 hours
FIR (Ref. page 93)
AC (Imm.) MoHFW, Govt of
India
• Confirm AEFI• Complete First Investigation Report (FIR).
•Assign EPID number, complete addl details• Dist level planning meeting on investigation
Send copy of FIR to local drug inspector, team conducting autopsy & other stakeholders
Initiate collection of vaccine, logistic samples, CSF, Serum (or biological products)
• Start collecting data for completing PIR
•Inform if necessary State/ regional AEFI committee State Drug Controller
•If necessary, convene State AEFI Committee Meeting to plan course of action
District Immunization
officer
State Immunization
officer
Site
District
State
National
First Information Report – Routing, Timeline and Actions
24 Hours
24 Hours
Medical Officer
Health Worker
Immediate
Pvt Practitioner
PIR (Ref. page 95)
Preliminary Investigation Report Routing, Timeline and Actions
AC (Imm.) MoHFW, Govt of
India
District Immunization
officer
Complete PIR
State Immunization
officer
•Complete FIR•Convene district AEFI committee meeting and finalize action plan•If indicated and recommended, ship specimens to appropriate labs• Collect additional details
Vaccine/ logistic distribution and utilization Other AEFI in the area Other details such as preexisting health, medical and
environmental conditions•Site(s) visit and investigation
•Inform State AEFI committee & State Drug Controller Do a provisional causality assessment Request for addl information if necessary
District
State
National
7 Days of FIR
Inform the Vaccine manufacturers and review GMP
Inform DCG(I) & senior officers in the MoH&FW
DIR (Ref. page 103)
Detailed Information ReportRouting, Timeline and Actions
AC (Imm.) MoHFW, Govt of
India
District Immunization
officer
State Immunization
officer
90 Days of FIR
• Complete FIR and PIR• Compile ALL available reports (including district reports, health
centre reports, field reports, hospital records, laboratory results, post mortem reports & results of any tests conducted) as relevant
Convene State AEFI Committee and determine the cause for the AEFI. Finalize the DIR
• Review of causality by National AEFI Committee• Feedback of review to all stakeholders
Complete DIR
District
State
National
within 30 days of DIR with causality assessment
AEFI - LRF (Ref. page 109)
Unreported, undetected
AEFIs
AEFIs identified by existing surveillance
AEFI Surveillance
Steps to encourage reporting
Staff should be encouraged to report AEFI without fear of penalty. Reporting can be enhanced by
Training. Positive feedback. Ensuring there are enough support available at
all levels Sharing results of the investigation and any
corrective action taken.
AEFI Committees
• Are these formed in all districts?
• When was the last time district AEFI committee met in your district?
• Do you know, who all are the members of AEFI committee in your district?
Action points
• Revive District AEFI committee
• Send the information to state
• Make sure every district AEFI committee meets regularly
To summarize ………
• AEFI surveillance is an important aspect of UIP service delivery
• National AEFI surveillance guidelines have been updated in India
• District AEFI committees may exist but must be made fully functional
Thanks