AEFI guidelines


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AEFI guidelines

  1. 1. Adverse Events Following Immunization Current Status & National Guidelines State EPI Officers Meeting 8 July 2005
  2. 2. INDIA (1999-2005) Serious AEFI Case(s) 72 Cases 1 Dot= 1 Case
  3. 3. INDIA
  4. 4. 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>
  5. 5. Steps in AEFI surveillance <ul><li>Detection and reporting </li></ul><ul><li>Investigation </li></ul><ul><li>Data analysis </li></ul><ul><li>Corrective and other actions </li></ul><ul><li>Evaluation </li></ul>
  6. 6. AEFI <ul><li>Detection and reporting </li></ul><ul><ul><li>Every individual that administers an immunization injection should know about AEFI </li></ul></ul><ul><ul><li>The following are events need to be reported and investigated immediately (Serious Events) </li></ul></ul><ul><ul><ul><li>All deaths suspected to be related to immunization </li></ul></ul></ul><ul><ul><ul><li>All hospitalisation suspected to be related to immunization </li></ul></ul></ul><ul><ul><ul><li>Any other event in which vaccine quality is suspected </li></ul></ul></ul>
  7. 7. AEFI <ul><li>Detection and reporting </li></ul><ul><ul><li>The above basic categories act as “ trigger ” mechanisms for further course of action </li></ul></ul><ul><ul><li>Minor events </li></ul></ul><ul><ul><li>Sudden, unexplained deaths or large scale hospitalisation or a cluster of events reported following immunisation warrants immediate investigation </li></ul></ul>
  8. 8. 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>
  9. 9. 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>
  10. 10. 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>
  11. 11. 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>
  12. 13. AEFI <ul><li>Investigation </li></ul><ul><ul><li>AEFI investigation will attempt to </li></ul></ul><ul><ul><ul><li>confirm or propose alternative diagnosis of the reported event </li></ul></ul></ul><ul><ul><ul><li>identify the specifications of the vaccine incriminated </li></ul></ul></ul><ul><ul><ul><li>examine the operational aspects of the programme </li></ul></ul></ul><ul><ul><ul><li>identify whether it was an isolated event or a cluster of events and, if a cluster, where the immunization was given and what vaccines were used </li></ul></ul></ul><ul><ul><li>Preliminary investigation may be carried out by the local health worker, but serious AEFIs or clusters of AEFIs should be investigated from district or state/central level </li></ul></ul>
  13. 14. AEFI <ul><li>Investigation </li></ul><ul><ul><li>Data on the patient(s) </li></ul></ul><ul><ul><li>Vaccine (lot number, expiry, manufacturer, lab results if any), storage, reconstitution practice, diluent used, </li></ul></ul><ul><ul><li>General disease information </li></ul></ul><ul><ul><li>Similar disease episodes </li></ul></ul><ul><ul><li>Collect samples of vaccines and diluents used (make sure vaccine sample collected are kept in the cold chain) </li></ul></ul>
  14. 15. FORMS USED FOR INVESTIGATION <ul><li>The reporting of the minor events is done on monthly basis in the form 6-9 of RCH </li></ul><ul><li>The reporting for severe cases is done using First Information report (FIR) in 48 hrs </li></ul><ul><li>Followed by Preliminary investigation report (PIR) within 7 days </li></ul><ul><li>And a Final report in form of Detailed investigation report (DIR) within 90 days </li></ul>
  15. 16. AEFI <ul><li>Data analysis </li></ul><ul><ul><li>Quickly to determine whether the AEFI is </li></ul></ul><ul><ul><ul><li>Programme related (incorrect dose of vaccine, wrong site, wrong diluent, improper storage & handling, use of other medicines as diluent, etc.) </li></ul></ul></ul><ul><ul><ul><li>Vaccine induced AEFI </li></ul></ul></ul><ul><ul><ul><li>Coincidental AEFIs (caused by something other than vaccine or programme errors) </li></ul></ul></ul><ul><ul><ul><li>Unknown </li></ul></ul></ul>
  16. 17. <ul><ul><li>Laboratory support </li></ul></ul><ul><ul><ul><li>If patient hospitalised, tests may confirm diagnosis </li></ul></ul></ul><ul><ul><ul><li>Testing vaccines </li></ul></ul></ul><ul><ul><ul><ul><li>Send Vaccine & Diluents in reverse cold chain to CRI Kasauli </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Send case investigation report with vaccine for test </li></ul></ul></ul></ul>
  17. 18. AEFI <ul><li>Corrective and other actions </li></ul><ul><ul><li>Action must not wait for investigation to be completed </li></ul></ul><ul><ul><li>Treat </li></ul></ul><ul><ul><li>Communicate </li></ul></ul><ul><ul><li>Publicise the results </li></ul></ul><ul><ul><li>Take corrective actions, where necessary </li></ul></ul><ul><ul><li>Training of health workers & supervision to prevent avoidable AEFIs in future </li></ul></ul>
  18. 19. AEFI <ul><li>Avoiding Programme Errors </li></ul><ul><ul><li>Use sterile needle & syringe for every injection </li></ul></ul><ul><ul><li>Reconstitute only with specific diluent </li></ul></ul><ul><ul><li>Discard reconstituted vaccines after Four hours </li></ul></ul><ul><ul><li>Do not store drugs & other medicines in the same fridge as the vaccines and diluents </li></ul></ul><ul><ul><li>Train & supervise health workers to ensure safe injection practices </li></ul></ul><ul><ul><li>Monitor, Investigate and Act when AEFIs occur </li></ul></ul>
  19. 20. AEFI <ul><li>Evaluation </li></ul><ul><ul><li>Periodically to examine its usefulness and to modify it if necessary </li></ul></ul><ul><ul><li>Issues to consider when evaluating a surveillance system are </li></ul></ul><ul><ul><ul><li>timeliness, completeness, accuracy of the system </li></ul></ul></ul><ul><ul><ul><li>swiftness with which response was effected when a trigger event was reported </li></ul></ul></ul><ul><ul><ul><li>appropriateness of actions taken </li></ul></ul></ul><ul><ul><ul><li>potential for strengthening of immunization system </li></ul></ul></ul>