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National Guidelines Dr Pradeep Haldar Assistant Commissioner GoI
Why monitor AEFI? <ul><ul><li>No vaccines are 100% safe and without any risks </li></ul></ul><ul><ul><li>It is important t...
What to Report <ul><li>Serious events </li></ul><ul><ul><li>Deaths </li></ul></ul><ul><ul><li>Hospitalizations </li></ul><...
HOW , WHOM & WHEN TO REPORT <ul><li>PHC level </li></ul><ul><li>Minor Events </li></ul><ul><li>By ANM to MO PHC In Monthly...
HOW , WHOM & WHEN TO REPORT <ul><li>Serious events   </li></ul><ul><li>PHC level </li></ul><ul><ul><li>ANM to the MO (PHC)...
HOW , WHOM & WHEN TO REPORT <ul><li>Serious events </li></ul><ul><li>District Level </li></ul><ul><ul><li>DIO informs AC (...
HOW , WHOM & WHEN TO REPORT <ul><ul><li>Detailed Investigation (DIR) </li></ul></ul><ul><ul><li>The DIO with team/ Regiona...
 
Role & Responsibilities of key players……1(ANM)  <ul><li>ANM responsibilities include: </li></ul><ul><ul><li>Detection  </l...
Role & Responsibilities of key players……2 (ANM) <ul><li>Help in preliminary investigation </li></ul><ul><li>Communication ...
Role & Responsibilities of key players……3 (HS) <ul><li>Health Supervisors  </li></ul><ul><ul><li>Monitor </li></ul></ul><u...
Role & Responsibilities of key players……4 (MO) <ul><li>MO PHC responsibilities include: </li></ul><ul><ul><li>Management  ...
Role & Responsibilities of key players……5 (MO) <ul><li>Training </li></ul><ul><li>Communication  </li></ul><ul><ul><li>Hea...
Role & Responsibilities of key players……6 (District level staff) <ul><li>District (Players: CMO/CS, DM&HO, DIO, RIT, MO at...
Role & Responsibilities of key players……7 (District level staff) <ul><ul><li>Investigate serious AEFI and deaths (RIT in c...
Role & Responsibilities of key players……8 (District level staff) <ul><li>Compilation and dissemination of data </li></ul><...
Role & Responsibilities of key players……9 (District level staff) <ul><li>Communication  </li></ul><ul><ul><li>With the hea...
Role & Responsibilities of key players……10 (State level staff) <ul><li>State Level (Players: Dept of FW, SEPIO, and State ...
Role & Responsibilities of key players……11 (State level staff) <ul><ul><li>Corrective (programmatic) action </li></ul></ul...
Role & Responsibilities of key players……12 (State level staff) <ul><ul><li>Share reports and communicate with key players,...
Role & Responsibilities of key players……13 (State level staff) <ul><ul><li>Give positive feedback for reporting. </li></ul...
Role of State Regulatory Authority (SRA), NRA and NCL <ul><li>Technical point of contact for vaccine testing (receive vacc...
Regional Investigation Teams <ul><li>Regional Investigation Teams if required is composed of a pediatrician, an epidemiolo...
State Expert Committee on AEFI <ul><li>A state-level AEFI Committee with two subgroups:  </li></ul><ul><ul><li>An Expert P...
State Expert Committee on AEFI <ul><li>A Technical/Implementation Group; this subgroup will </li></ul><ul><ul><li>Oversee ...
State Expert Committee on AEFI <ul><ul><li>Review of aggregate reports,  </li></ul></ul><ul><ul><li>Recommending cases for...
National Expert committee on AEFI <ul><li>Composed of NRA representative, AC (UIP), Senior Paediatrician,  infectious  dis...
National Expert committee on AEFI <ul><li>The AC (UIP) will be the overall in-charge and will coordinate the following:  <...
National Expert committee on AEFI <ul><ul><li>Maintaining a National AEFI database.  </li></ul></ul><ul><ul><li>Arrange an...
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06 introduction to guidelines

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06 introduction to guidelines

  1. 1. National Guidelines Dr Pradeep Haldar Assistant Commissioner GoI
  2. 2. Why monitor AEFI? <ul><ul><li>No vaccines are 100% safe and without any risks </li></ul></ul><ul><ul><li>It is important to know the risks and how to handle such an event when it occurs </li></ul></ul><ul><ul><li>Informing people correctly on AEFI helps keep public’s confidence in the immunization programmes </li></ul></ul><ul><ul><li>Monitoring AEFI also helps improve the quality of service </li></ul></ul>
  3. 3. What to Report <ul><li>Serious events </li></ul><ul><ul><li>Deaths </li></ul></ul><ul><ul><li>Hospitalizations </li></ul></ul><ul><ul><li>Vaccine quality suspicious </li></ul></ul><ul><li>Minor events </li></ul>
  4. 4. HOW , WHOM & WHEN TO REPORT <ul><li>PHC level </li></ul><ul><li>Minor Events </li></ul><ul><li>By ANM to MO PHC In Monthly Report </li></ul><ul><li>By MO PHC to DIO in Monthly Report </li></ul><ul><li>District Level </li></ul><ul><li> By DIO to SEPIO in Monthly Report </li></ul><ul><li>State level </li></ul><ul><li> By SEPIO to GoI in Monthly Report </li></ul>
  5. 5. HOW , WHOM & WHEN TO REPORT <ul><li>Serious events </li></ul><ul><li>PHC level </li></ul><ul><ul><li>ANM to the MO (PHC) immediately by telephone. </li></ul></ul><ul><ul><li>The MO (PHC) </li></ul></ul><ul><ul><ul><li>First Information Report (FIR): to DIO in 24 hrs </li></ul></ul></ul>
  6. 6. HOW , WHOM & WHEN TO REPORT <ul><li>Serious events </li></ul><ul><li>District Level </li></ul><ul><ul><li>DIO informs AC (UIP), GoI & SEPIO within next 24 hrs. </li></ul></ul><ul><ul><li>Preliminary Investigation (PIR) </li></ul></ul><ul><ul><li>PIR to AC (UIP) & SEPIO within 7 days of the AE. </li></ul></ul><ul><ul><ul><li>This report will include the probable cause of death and also mention the further investigation planned for the case </li></ul></ul></ul>
  7. 7. HOW , WHOM & WHEN TO REPORT <ul><ul><li>Detailed Investigation (DIR) </li></ul></ul><ul><ul><li>The DIO with team/ Regional investigation team/ State investigation team </li></ul></ul><ul><ul><ul><li>Prepare & Forward DIR, Post mortem report, vaccine test report, medical documents etc of the case to the AC (UIP) within 90 days </li></ul></ul></ul><ul><ul><li>Field workers are encouraged to report AEFIs </li></ul></ul>
  8. 9. Role & Responsibilities of key players……1(ANM) <ul><li>ANM responsibilities include: </li></ul><ul><ul><li>Detection </li></ul></ul><ul><ul><li>Treatment of mild symptoms </li></ul></ul><ul><ul><li>Reporting of serious events immediately </li></ul></ul><ul><ul><li>Reporting of minor events monthly </li></ul></ul>
  9. 10. Role & Responsibilities of key players……2 (ANM) <ul><li>Help in preliminary investigation </li></ul><ul><li>Communication </li></ul><ul><li>Corrective action </li></ul><ul><ul><li>May initiate action themselves </li></ul></ul><ul><ul><li>In response to the guidance from the MO (PHC) </li></ul></ul>
  10. 11. Role & Responsibilities of key players……3 (HS) <ul><li>Health Supervisors </li></ul><ul><ul><li>Monitor </li></ul></ul><ul><ul><li>On job training </li></ul></ul><ul><ul><li>Assist in collecting and compiling report from the ANM </li></ul></ul><ul><ul><li>Assist in conducting the investigation </li></ul></ul>
  11. 12. Role & Responsibilities of key players……4 (MO) <ul><li>MO PHC responsibilities include: </li></ul><ul><ul><li>Management </li></ul></ul><ul><ul><li>Initiating investigation when required </li></ul></ul><ul><ul><li>Completing case report forms- FIR, PIR and DIR if required. </li></ul></ul><ul><ul><li>Inform DIO immediately of serious cases and deaths </li></ul></ul><ul><ul><li>Reports all DPT site abscesses </li></ul></ul>
  12. 13. Role & Responsibilities of key players……5 (MO) <ul><li>Training </li></ul><ul><li>Communication </li></ul><ul><ul><li>Health workers and Community </li></ul></ul><ul><li>Correction of the problem: </li></ul><ul><ul><li>Logistics: Improving/arranging logistics in case programme errors are due to lack of appropriate supplies or equipment, or failure in the cold chain </li></ul></ul><ul><li>Supervision </li></ul><ul><ul><li>Site visits and immediate feedback to the health worker. </li></ul></ul>
  13. 14. Role & Responsibilities of key players……6 (District level staff) <ul><li>District (Players: CMO/CS, DM&HO, DIO, RIT, MO at the district hospital) </li></ul><ul><ul><li>Detection of AEFIs + Management (district hospitals) </li></ul></ul><ul><ul><li>Inform SEPIO immediately of serious cases and deaths (DIO) </li></ul></ul><ul><ul><li>Reviews case forms for completeness and forward to State level (DIO) </li></ul></ul>
  14. 15. Role & Responsibilities of key players……7 (District level staff) <ul><ul><li>Investigate serious AEFI and deaths (RIT in collaboration with State-level Investigation Teams) </li></ul></ul><ul><ul><li>Supervisory role for Health workers & Medical officers </li></ul></ul><ul><li>Sentinel Surveillance </li></ul><ul><ul><li>DIO to monitor that the Sentinel surveillance is carried out for all AEFI using existing sentinel sites for vaccine-preventable diseases. </li></ul></ul>
  15. 16. Role & Responsibilities of key players……8 (District level staff) <ul><li>Compilation and dissemination of data </li></ul><ul><ul><li>. DIO must mention in the report non-occurrence of these events in the district (A NIL REPORT IS ALSO AS IMPORTANT) </li></ul></ul><ul><li>Training of MO PHC </li></ul>
  16. 17. Role & Responsibilities of key players……9 (District level staff) <ul><li>Communication </li></ul><ul><ul><li>With the health workers, community, media. </li></ul></ul><ul><ul><li>Correction of the problem </li></ul></ul><ul><ul><li>Supervision </li></ul></ul>
  17. 18. Role & Responsibilities of key players……10 (State level staff) <ul><li>State Level (Players: Dept of FW, SEPIO, and State level Investigation Teams) </li></ul><ul><ul><li>Training: District level staff </li></ul></ul><ul><ul><li>Ensuring investigation of clusters, serious events, unusual events </li></ul></ul><ul><ul><li>Inform AC (UIP) immediately of serious cases and deaths (SEPIO) </li></ul></ul><ul><ul><li>Regulatory action, if required </li></ul></ul>
  18. 19. Role & Responsibilities of key players……11 (State level staff) <ul><ul><li>Corrective (programmatic) action </li></ul></ul><ul><ul><li>Point of contact for state AEFI surveillance (SEPIO). </li></ul></ul><ul><ul><li>Receive, analyze and report on AEFI case reports (SEPIO) </li></ul></ul><ul><ul><ul><li>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) </li></ul></ul></ul><ul><ul><ul><li>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 </li></ul></ul></ul>
  19. 20. Role & Responsibilities of key players……12 (State level staff) <ul><ul><li>Share reports and communicate with key players, including SRA when needed </li></ul></ul><ul><ul><li>Increase awareness of health staff (DIOs & MOs) on the importance of reporting </li></ul></ul><ul><ul><li>Ensure that sufficient copies of the appropriate guidelines and reporting tools are available to staff </li></ul></ul>
  20. 21. Role & Responsibilities of key players……13 (State level staff) <ul><ul><li>Give positive feedback for reporting. </li></ul></ul><ul><ul><li>Communication </li></ul></ul><ul><ul><li>Arrange and co-ordinate the meeting of the State AEFI committee on regular basis. </li></ul></ul>
  21. 22. Role of State Regulatory Authority (SRA), NRA and NCL <ul><li>Technical point of contact for vaccine testing (receive vaccine samples or initiate collection of samples) (SRA/NRA) </li></ul><ul><li>Advise on vaccine quality and testing (NRA/NCL) </li></ul><ul><li>Controlling and releasing each batch of vaccine individually, including recalling if necessary </li></ul><ul><li>Evaluating & monitoring vaccine performance (including safety) </li></ul>
  22. 23. Regional Investigation Teams <ul><li>Regional Investigation Teams if required is composed of a pediatrician, an epidemiologist and a microbiologist. </li></ul><ul><li>Function: investigate serious AEFIs and deaths (investigation will be initiated within 24 hours of being reported to the team). </li></ul>
  23. 24. State Expert Committee on AEFI <ul><li>A state-level AEFI Committee with two subgroups: </li></ul><ul><ul><li>An Expert Panel which will review serious and unusual AEFI. </li></ul></ul><ul><ul><ul><li>Broad expertise, including pediatrician/neurologist, physician, microbiologist, epidemiologist, SEPIO, State FDA </li></ul></ul></ul><ul><ul><ul><li>Meet at-least twice a year to review the serious and unusual AEFI. </li></ul></ul></ul>
  24. 25. State Expert Committee on AEFI <ul><li>A Technical/Implementation Group; this subgroup will </li></ul><ul><ul><li>Oversee the functioning of the system, including planning and carrying out training activities and review. </li></ul></ul><ul><ul><li>Development of training materials in local language if required, </li></ul></ul><ul><ul><li>Advising on development & maintenance of a state database, </li></ul></ul>
  25. 26. State Expert Committee on AEFI <ul><ul><li>Review of aggregate reports, </li></ul></ul><ul><ul><li>Recommending cases for review by the Expert Panel, and </li></ul></ul><ul><ul><li>Carrying out regular evaluations of the surveillance system of the state </li></ul></ul>
  26. 27. National Expert committee on AEFI <ul><li>Composed of NRA representative, AC (UIP), Senior Paediatrician, infectious disease physician, neurologist, Immunologist, Epidemiologist, and possibly a pharmacologist /toxicologist </li></ul><ul><li>Meet at least twice a year </li></ul><ul><li>Causality assessment on investigations which have not reached conclusions; provides quality control on system </li></ul><ul><li>Investigating AE when requested by the state </li></ul>
  27. 28. National Expert committee on AEFI <ul><li>The AC (UIP) will be the overall in-charge and will coordinate the following: </li></ul><ul><ul><li>Reviews overall pattern of reports and investigations </li></ul></ul><ul><ul><li>Developing or revising, as needed, appropriate guidelines/SOPs on AEFIs </li></ul></ul><ul><ul><li>Provide feedback to the states on the functioning of the AEFI system </li></ul></ul><ul><ul><li>Conduct periodic evaluation of the AEFI surveillance system of the country </li></ul></ul>
  28. 29. National Expert committee on AEFI <ul><ul><li>Maintaining a National AEFI database. </li></ul></ul><ul><ul><li>Arrange and co-ordinate the meeting of the National expert committee on AEFI on regular basis. </li></ul></ul>
  29. 30. Thank You

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