06 introduction to guidelines
TRANSCRIPT
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