06 introduction to guidelines

National Guidelines

Dr Pradeep Haldar

Assistant Commissioner

GoI

Why monitor AEFI?

No vaccines are 100% safe and without any risks

It is important to know the risks and how to handle such an event when it occurs

Informing people correctly on AEFI helps keep public’s confidence in the immunization programmes

Monitoring AEFI also helps improve the quality of service

What to Report

Serious events Deaths Hospitalizations Vaccine quality suspicious

Minor events

HOW , WHOM & WHEN TO REPORT

PHC levelMinor Events

By ANM to MO PHC In Monthly Report

By MO PHC to DIO in Monthly Report

District Level By DIO to SEPIO in Monthly Report

State level By SEPIO to GoI in Monthly Report

HOW , WHOM & WHEN TO REPORTSerious events

PHC level ANM to the MO (PHC) immediately by

telephone. The MO (PHC)

First Information Report (FIR): to DIO in 24 hrs

HOW , WHOM & WHEN TO REPORTSerious events District Level

DIO informs AC (UIP), GoI & SEPIO within next 24 hrs.

Preliminary Investigation (PIR) PIR to AC (UIP) & SEPIO within 7 days of

the AE. This report will include the probable

cause of death and also mention the further investigation planned for the case

HOW , WHOM & WHEN TO REPORT

Detailed Investigation (DIR) The DIO with team/ Regional investigation

team/ State investigation team Prepare & Forward DIR, Post mortem report,

vaccine test report, medical documents etc of the case to the AC (UIP) within 90 days

Field workers are encouraged to report AEFIs

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CHANNELS AND TIMELINE FORREPORTING SERIOUS AEFI CASES

Role & Responsibilities of key players……1(ANM) ANM responsibilities include:

Detection Treatment of mild symptoms Reporting of serious events immediately Reporting of minor events monthly

Role & Responsibilities of key players……2 (ANM) Help in preliminary investigation Communication Corrective action

May initiate action themselves In response to the guidance from the MO (PHC)

Role & Responsibilities of key players……3 (HS) Health Supervisors

Monitor On job training Assist in collecting and compiling report from

the ANM Assist in conducting the investigation

Role & Responsibilities of key players……4 (MO) MO PHC responsibilities include:

Management Initiating investigation when required Completing case report forms- FIR, PIR and

DIR if required. Inform DIO immediately of serious cases and

deaths Reports all DPT site abscesses

Role & Responsibilities of key players……5 (MO) Training Communication

Health workers and Community Correction of the problem:

Logistics: Improving/arranging logistics in case programme errors are due to lack of appropriate supplies or equipment, or failure in the cold chain

Supervision Site visits and immediate feedback to the health

worker.

Role & Responsibilities of key players……6 (District level staff) District (Players: CMO/CS, DM&HO, DIO,

RIT, MO at the district hospital) Detection of AEFIs + Management (district

hospitals) Inform SEPIO immediately of serious cases

and deaths (DIO) Reviews case forms for completeness and

forward to State level (DIO)

Role & Responsibilities of key players……7 (District level staff)

Investigate serious AEFI and deaths (RIT in collaboration with State-level Investigation Teams)

Supervisory role for Health workers & Medical officers

Sentinel Surveillance DIO to monitor that the Sentinel surveillance is

carried out for all AEFI using existing sentinel sites for vaccine-preventable diseases.

Role & Responsibilities of key players……8 (District level staff) Compilation and dissemination of data

. DIO must mention in the report non-occurrence of these events in the district (A NIL REPORT IS ALSO AS IMPORTANT)

Training of MO PHC

Role & Responsibilities of key players……9 (District level staff) Communication

With the health workers, community, media. Correction of the problem Supervision

Role & Responsibilities of key players……10 (State level staff) State Level (Players: Dept of FW, SEPIO,

and State level Investigation Teams) Training: District level staff Ensuring investigation of clusters, serious

events, unusual events Inform AC (UIP) immediately of serious cases

and deaths (SEPIO) Regulatory action, if required

Role & Responsibilities of key players……11 (State level staff)

Corrective (programmatic) action Point of contact for state AEFI surveillance

(SEPIO). Receive, analyze and report on AEFI case

reports (SEPIO) Compile these data at state level for the districts for each

diagnostic type of AEFI and disseminate this information to Government of India. SEPIO must mention in the report non-occurrence of these events in the state (A NIL REPORT IS ALSO AS IMPORTANT)

Produces a regular line listing of the reports received, and the conclusion of the investigation and send these reports to the AC (UIP) on regular and timely basis

Role & Responsibilities of key players……12 (State level staff)

Share reports and communicate with key players, including SRA when needed

Increase awareness of health staff (DIOs & MOs) on the importance of reporting

Ensure that sufficient copies of the appropriate guidelines and reporting tools are available to staff

Role & Responsibilities of key players……13 (State level staff)

Give positive feedback for reporting. Communication Arrange and co-ordinate the meeting of the

State AEFI committee on regular basis.

Role of State Regulatory Authority (SRA), NRA and NCL

Technical point of contact for vaccine testing (receive vaccine samples or initiate collection of samples) (SRA/NRA)

Advise on vaccine quality and testing (NRA/NCL)

Controlling and releasing each batch of vaccine individually, including recalling if necessary

Evaluating & monitoring vaccine performance (including safety)

Regional Investigation Teams

Regional Investigation Teams if required is composed of a pediatrician, an epidemiologist and a microbiologist.

Function: investigate serious AEFIs and deaths (investigation will be initiated within 24 hours of being reported to the team).

State Expert Committee on AEFI

A state-level AEFI Committee with two subgroups: An Expert Panel which will review serious and

unusual AEFI. Broad expertise, including

pediatrician/neurologist, physician, microbiologist, epidemiologist, SEPIO, State FDA

Meet at-least twice a year to review the serious and unusual AEFI.

State Expert Committee on AEFI

A Technical/Implementation Group; this subgroup will Oversee the functioning of the system,

including planning and carrying out training activities and review.

Development of training materials in local language if required,

Advising on development & maintenance of a state database,

State Expert Committee on AEFI

Review of aggregate reports, Recommending cases for review by the Expert

Panel, and Carrying out regular evaluations of the

surveillance system of the state

National Expert committee on AEFI

Composed of NRA representative, AC (UIP), Senior Paediatrician, infectious disease physician, neurologist, Immunologist, Epidemiologist, and possibly a pharmacologist /toxicologist

Meet at least twice a year Causality assessment on investigations which

have not reached conclusions; provides quality control on system

Investigating AE when requested by the state

National Expert committee on AEFI

The AC (UIP) will be the overall in-charge and will coordinate the following: Reviews overall pattern of reports

and investigations Developing or revising, as needed,

appropriate guidelines/SOPs on AEFIs Provide feedback to the states on the

functioning of the AEFI system Conduct periodic evaluation of the AEFI

surveillance system of the country

National Expert committee on AEFI

Maintaining a National AEFI database. Arrange and co-ordinate the meeting of the

National expert committee on AEFI on regular basis.

Thank You