AEFI p haldar presentation for sepio meet


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  • Two types of reporting. Routine monthly for the Minor AEFIs and Immediate reporting for the Serious AEFIs.
  • Common, minor reactions These occur within a day or two of immunization (except for measles/MMR - 6 to 12 days after immunization) and they only last one to a few days. Local reactions include pain, swelling and/or redness at the injection site and can be expected in about 10% of vaccinees, except for those injected with DTP, or tetanus boosters, where up to half can be affected. BCG causes a specific local reaction that starts as a papule (lump) two or more weeks after immunization that then becomes ulcerated and heals after several months, leaving a scar. Individuals with dormant tuberculosis infection often have an accelerated response to BCG. Keloid (thickened scar tissue) from the BCG lesion is more common among Asian and African populations. Systemic reactions include fever and occur in about 10% or less of vaccinees, except for DTP where it is again about half. Other common systemic reactions (e.g., irritability, malaise, ‘off-colour’, anorexia) can also occur after DTP. For measles/MMR and OPV the systemic reactions arise from vaccine virus infection. Measles’ vaccine causes fever, rash and/or conjunctivitis, and affects 5-15% of vaccinees. It is very mild compared to ‘wild’ measles, but for severely immunocompromised individuals, it can be severe, even fatal. Vaccine reactions for mumps (swollen parotid gland) and rubella (arthralgia and swollen lymph nodes) affect less than 1% of children. Rubella vaccine causes symptoms more often in adults, with 15% suffering from arthralgia. Systemic reactions from OPV affect less than 1% of vaccinees with diarrhoea, headache, and/or muscle pain.
  • Undetected disease Example: False Negative (C ulture Negative)
  • AEFI p haldar presentation for sepio meet

    1. 1. Dr. Pradeep Haldar Assistant Commissioner (I) ADVERSE EVENT FOLLOWING IMMUNIZATION SURVEILLANCE AND RESPONSE SEPIO meeting 18-20 May 2011
    2. 2. A medical incident that takes place after an immunization, causes concern and is believed to be caused by immunization Adverse Event Following Immunization
    3. 3. Revised AEFI Surveillance and Response Operational Guidelines Released in September 2010 By Ministry of Health and FW, Government of India, New Delhi
    4. 4. Content of these guidelines <ul><ul><ul><li>AEFI : Concepts </li></ul></ul></ul><ul><ul><ul><li>Types of AEFIs </li></ul></ul></ul><ul><ul><ul><li>Recording and reporting </li></ul></ul></ul><ul><ul><ul><li>Case investigation </li></ul></ul></ul><ul><ul><ul><li>Sample collection </li></ul></ul></ul><ul><ul><ul><li>Operational aspects </li></ul></ul></ul><ul><ul><ul><li>AEFI Committees </li></ul></ul></ul><ul><ul><ul><li>Communication </li></ul></ul></ul><ul><ul><ul><li>Various formats </li></ul></ul></ul><ul><ul><ul><li>Technical information sheets as annex </li></ul></ul></ul>A separate workshop to be conducted for training in these guidelines
    5. 5. AEFI Surveillance- Reporting system <ul><li>Immediate reporting with FIR/PIR/DIR: Serious AEFIs </li></ul><ul><ul><ul><li>Deaths </li></ul></ul></ul><ul><ul><ul><li>Hospitalization </li></ul></ul></ul><ul><ul><ul><li>Cluster </li></ul></ul></ul><ul><ul><ul><li>Disability </li></ul></ul></ul>Routine Monthly report: - Abscesses - Deaths - Others
    6. 6. Non serious AEFIs <ul><li>Minor reactions following immunization are common </li></ul><ul><li>They include pain & swelling at the site of injection, fever, irritability, malaise </li></ul><ul><li>They are self-limiting, hardly requiring even symptomatic treatment </li></ul><ul><li>But it is important to reassure parents about such events so that they know about it </li></ul>
    7. 7. Common non serious reactions <ul><li>Rate of local reactions likely to increase with booster doses, </li></ul><ul><li>up to 50-85% </li></ul><ul><li>** Symptoms include diarrhoea, headache, and/or muscle pains </li></ul>Vaccine Local reaction (pain, swelling, redness) Fever > 38 o C Irritability, malaise & non specific symptoms BCG Common -- -- Hib 5% - 15% 2% - 10% -- Hepatitis B Adult 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%
    8. 8. AEFI Monthly Reporting - Data Flow 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 Sub Centre National State HQ District HQ PHC/ Block Urban Centres*
    9. 9. Serious AEFIs: Case investigation; Reporting formats and channels 1. FIR 2. PIR 3. DIR
    10. 10. Serious AEFI Case investigation <ul><li>All serious AEFI cases need to be investigated by Distt. AEFI committee </li></ul><ul><li>Standard reporting formats to be used for collecting information; </li></ul><ul><li>Lab samples need to be sent as per guidelines </li></ul><ul><li>Complete PIR and DIR on time </li></ul><ul><li>State committee to do causality assessment </li></ul>
    11. 11. Serious AEFI Cases (formats and timelines) DIO 24 hours Type of Report Responsible Time line FIR First Information Report MO 24 hours PIR Preliminary Investigation Report DIO 7 days DIR Detailed Investigation Report AEFI investigation team 90 days
    12. 12. FIR (Ref. page 93)
    13. 13. First Information Report – Routing, Timeline and Actions AC (Imm.) MoHFW, Govt of India <ul><li>Confirm AEFI </li></ul><ul><li>Complete First Investigation Report (FIR). </li></ul><ul><li>Assign EPID number, complete addl details </li></ul><ul><li>Dist level planning meeting on investigation </li></ul><ul><ul><li>Send copy of FIR to local drug inspector, team conducting autopsy & other stakeholders </li></ul></ul><ul><ul><li>Initiate collection of vaccine, logistic samples, CSF, Serum (or biological products) </li></ul></ul><ul><li>Start collecting data for completing PIR </li></ul><ul><li>Inform if necessary </li></ul><ul><ul><li>State/ regional AEFI committee </li></ul></ul><ul><ul><li>State Drug Controller </li></ul></ul><ul><li>If necessary, convene State AEFI Committee Meeting to plan course of action </li></ul>District Immunization officer State Immunization officer Site District State National 24 Hours 24 Hours Medical Officer Health Worker Immediate Pvt Practitioner
    14. 14. PIR (Ref. page 95)
    15. 15. Preliminary Investigation Report Routing, Timeline and Actions AC (Imm.) MoHFW, Govt of India District Immunization officer Complete PIR State Immunization officer <ul><li>Complete FIR </li></ul><ul><li>Convene district AEFI committee meeting and finalize action plan </li></ul><ul><li>If indicated and recommended, ship specimens to appropriate labs </li></ul><ul><li>Collect additional details </li></ul><ul><ul><li>Vaccine/ logistic distribution and utilization </li></ul></ul><ul><ul><li>Other AEFI in the area </li></ul></ul><ul><ul><li>Other details such as preexisting health, medical and environmental conditions </li></ul></ul><ul><li>Site(s) visit and investigation </li></ul><ul><li>Inform </li></ul><ul><ul><li>State AEFI committee & State Drug Controller </li></ul></ul><ul><ul><li>Do a provisional causality assessment </li></ul></ul><ul><ul><li>Request for addl information if necessary </li></ul></ul>District State National 7 Days of FIR Inform the Vaccine manufacturers and review GMP Inform DCG(I) & senior officers in the MoH&FW
    16. 16. DIR (Ref. page 103)
    17. 17. Detailed Information Report Routing, Timeline and Actions AC (Imm.) MoHFW, Govt of India District Immunization officer State Immunization officer 90 Days of FIR <ul><li>Complete FIR and PIR </li></ul><ul><li>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 </li></ul>Convene State AEFI Committee and determine the cause for the AEFI. Finalize the DIR <ul><li>Review of causality by National AEFI Committee </li></ul><ul><li>Feedback of review to all stakeholders </li></ul>Complete DIR District State National within 30 days of DIR with causality assessment
    18. 18. AEFI - LRF (Ref. page 109)
    19. 19. Unreported, undetected AEFIs AEFIs identified by existing surveillance AEFI Surveillance
    20. 20. Steps to encourage reporting <ul><li>Staff should be encouraged to report AEFI without fear of penalty . Reporting can be enhanced by </li></ul><ul><li>Training. </li></ul><ul><li>Positive feedback. </li></ul><ul><li>Ensuring there are enough support available at all levels </li></ul><ul><li>Sharing results of the investigation and any corrective action taken. </li></ul>
    21. 21. AEFI Committees <ul><li>Are these formed in all districts? </li></ul><ul><li>When was the last time district AEFI committee met in your district? </li></ul><ul><li>Do you know, who all are the members of AEFI committee in your district? </li></ul>
    22. 22. Action points <ul><li>Revive District AEFI committee </li></ul><ul><li>Send the information to state </li></ul><ul><li>Make sure every district AEFI committee meets regularly </li></ul>
    23. 23. <ul><li>AEFI system is NOT meant to blame field staff </li></ul><ul><li>It is know the facts , identify the gaps and </li></ul><ul><li>to improve the overall Quality of </li></ul><ul><li>Immunization Services </li></ul>
    24. 24. To summarize ……… <ul><li>AEFI surveillance is an important aspect of UIP service delivery </li></ul><ul><li>National AEFI surveillance guidelines have been updated in India </li></ul><ul><li>District AEFI committees may exist but must be made fully functional </li></ul>
    25. 25. Thanks