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