06 introduction to guidelines
Download as PPT, PDF0 likes693 views
The document outlines guidelines for monitoring and reporting adverse events following immunization (AEFI) in India. It describes who should report AEFIs at different levels (ANM, MO, DIO, SEPIO), what types of events to report (serious vs. minor), and reporting timelines. It also defines the roles and responsibilities of key players in AEFI surveillance and investigation at the primary health center, district, state, and national levels. The goal is to monitor vaccine safety, maintain public confidence in immunization programs, and help improve service quality.
06 introduction to guidelines
- 1. National Guidelines Dr Pradeep Haldar Assistant Commissioner GoI
- 2. 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
- 3. What to Report Serious events Deaths Hospitalizations Vaccine quality suspicious Minor events
- 4. HOW , WHOM & WHEN TO REPORT PHC level Minor 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
- 5. HOW , WHOM & WHEN TO REPORT Serious events PHC level ANM to the MO (PHC) immediately by telephone. The MO (PHC) First Information Report (FIR): to DIO in 24 hrs
- 6. HOW , WHOM & WHEN TO REPORT Serious 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
- 7. 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
- 9. 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
- 10. 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)
- 11. 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
- 12. 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
- 13. 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.
- 14. 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)
- 15. 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.
- 16. 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
- 17. Role & Responsibilities of key players……9 (District level staff) Communication With the health workers, community, media. Correction of the problem Supervision
- 18. 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
- 19. 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
- 20. 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
- 21. 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.
- 22. 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)
- 23. 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).
- 24. 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.
- 25. 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,
- 26. 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
- 27. 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
- 28. 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
- 29. 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.
- 30. Thank You
Editor's Notes
- #5: Minor AEFI are to be reported by the ANM to the MO PHC in the monthly reports who will include the report from all ANM in the monthly report to the District. The DIO reports this in the monthly report to the state and the state to the GoI as per the timeline for monthly report.
- #6: The serious events are to be reported by the ANM to the MO (PHC) immediately by telephone or any other fastest means of communication. The MO (PHC) will fill the First Information Report (FIR) and forward a copy to the DIO immediately (maximum within 24 hrs). The DIO will forward the copy of the AC (UIP), GoI and to the SEPIO within next 24 hrs. The DIO will then conduct the preliminary investigation and forward a PIR to be the AC (UIP) and the 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.
- #8: The DIO along with the Regional investigation team or the state investigation team will conduct the detailed investigation. This team will forward the report (DIR) along with all relevant documents like Post mortem report, vaccine test report, any other medical documents of the case to the AC (UIP) within 90 days of the AE. Field workers are encouraged to report AEFIs even if there is uncertainty about whether the event was caused by the vaccine and even if there is a delay in the submission of the report.
- #10: Detection of AEFIs Treatment of mild symptoms like fever Reporting of serious events immediately to the MO (PHC) Reporting of minor events (e.g. local abscesses at the site of DPT immunization; occurrence of draining lymphadenitis of the BCG vaccinated limb etc) in the regular monthly reporting system.
- #11: Help the MO (PHC) in preliminary investigation of AEFI. Communication with parents and other members of the community, specially rumors or public enquiries. Corrective action: They may initiate action themselves if it is clear what to do (e.g. improve injection practices in case of an abscess). Corrective action in response to the guidance from the MO (PHC)
- #12: Health Supervisors He/ She should monitor the community for adverse events during their supervisory visits to immunization sites/ SC. Provide on job training to the field staff on the safe injection practices. Assist the MO in collecting and compiling report from the ANM Assist the MO in conducting the investigation
- #13: MO PHC responsibilities include: Management of AEFIs and referral to next higher level if required. 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 that occur within 2 weeks of immunization and draining lymphadenitis at any time after immunization in the monthly report form to DIO. The MO must mention in the report non-occurrence of these events in the PHC (A NIL REPORT IS ALSO AS IMPORTANT)
- #14: Training: Staff to be trained in diagnosing, treating and reporting of AEFIs and differentiating between minor, non significant reactions and more serious events. Solving operational problems through training in order to improve the skills & knowledge of the workers. Communication with the health workers and the community. The public should be informed about what is being done in the investigation and when over the conclusions and results should be shared with the workers and the 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: Non serious events reported should be supervised by site visits and immediate feedback should be given to the health worker on their AEFI activities. Regular supervisory visits for monitoring the routine immunization program should be utilized to detect problems in reporting or identifying the programme errors. Intensified supervision in cases of serious/ cluster of AEFIs to correct the programme errors.
- #16: DIO to monitor that the Sentinel surveillance is carried out for all AEFI using existing sentinel sites for vaccine-preventable diseases. It is carried out through those hospitals having large paediatric outpatient & inpatient departments and MCH clinics where children with adverse events are more likely to report. Appropriate record maintenance and reporting of non-occurrence of such cases is an integral part of the sentinel surveillance. Sentinel surveillance will attempt to highlight whether the AEFI is due to vaccine or programmatic errors or coincidental
- #17: DIO will compile these data centrally for each diagnostic type of AEFI and disseminate this information to field personnel, state government. 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 in diagnosing, treating and reporting of AEFI and differentiating between mild, non significant reactions and more serious events.
- #18: Communication with the health workers and the community and the media if required. They should be informed about what is being done in the investigation and the conclusions and results should be shared with them at the end of the investigation. Correction of the problem: By arranging logistics in case of lack of supplies; Training; Supervision as detailed above.
- #19: State Level (Players: Dept of FW, SEPIO, and State level Investigation Teams) Training: They will train the district level staff in diagnosis, treatment and reporting AEFIs and differentiating between minor, non significant reactions and more serious ones. Ensuring investigation of clusters, serious events, unusual events: following a report of serious AEFI, the manager will investigate, collect & report data. This may be under supervision of national team, if required Inform AC (UIP) immediately of serious cases and deaths (SEPIO) Regulatory action, if required
- #20: Corrective (programmatic) action as detailed above Point of contact for state AEFI surveillance (SEPIO). Receive, analyze and report on AEFI case reports (SEPIO) SEPIO will 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
- #22: Communication with the health workers and the community and the media if required. They should be informed about what is being done in the investigation and the conclusions and results should be shared with them when the investigation is over.
- #24: Regional Investigation Teams if required and established (based on large geographical area or population and the expertise available) is composed of a pediatrician, an epidemiologist and a microbiologist. The teams will function primarily to investigate serious AEFIs and deaths (investigation will be initiated within 24 hours of being reported to the team).
- #28: Composed of NRA representative, AC (UIP), Senior Paediatrician, infectious disease physician, neurologist, Immunologist, Epidemiologist, and possibly a pharmacologist/toxicologist,- The committee will meet at least twice a year Provides the causality assessment on investigations which have not reached conclusions; provides quality control on system Help in investigating AE when requested by the state.