3_Recording & reporting Adverse events following immunisation.pptx
- 1. AEFI RECORDING AND REPORTING IN INDIA Dr. Krishna Kumar, Zonal AEFI Senior Consultant-South, National AEFI Secretariat, MoHFW, New Delhi
- 2. Outline of the presentation AEFI Surveillance reporting system Channels of reporting AEFI Reporting of minor and serious/severe AEFI cases Steps to strengthen AEFI reporting
- 4. Introduction • Vaccination is one of the greatest public health achievements of human history. • Vaccines used in national immunization programmes (NIPs) are considered safe and effective when used correctly. • However vaccines are not risk-free and adverse events will occasionally occur following vaccination. • AEFI surveillance is key component to ensure vaccine safety.
- 5. AEFI reporting system Why do we need an AEFI surveillance system? 1. To capture rare, serious AEFIs undetectable during clinical trials 2. To recognise programme errors (improper storage, handling, administration of vaccines) and take corrective action 3. To ensure vaccine safety 4. To investigate known coincidental events causing concern to parents/community, document and convey cause to parents/community to maintain vaccine confidence
- 6. AEFI system is NOT meant to blame field staff but rather to improve the overall quality of immunization services AEFI reporting system
- 7. AEFI reporting system • Rural areas: ANM, MO-PHC • Urban areas: ANM, MO-UPHC • Reporting through ADR monitoring centres in the network of PvPI (Pharmaco-vigilance Program of India). • Both public / private vaccinations • Not only for UIP but also all vaccines (Exm- PCV, Rabies)
- 8. CHANNELS OF REPORTING AEFI Section 2
- 9. Channels of reporting AEFI • Monthly routine reporting ( monthly immunization reporting format in HMIS M9 Child Immunization 9.6.1- AEFI injection site abscess; 9.6.2- AEFI death; 9.6.3- AEFI others- high grade fever 102<, persistent inconsolable cry >3hrs, seizure, HHE) • Immediate serious/ severe AEFI cases reporting through CRF – Identification/ notification/ reporting/ investigation / causality assessment
- 10. AEFI Monthly Reporting - Data Flow Sub Centre National State HQ District HQ PHC / Block Urban Centres* 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
- 11. Important Terminology in AEFI Surveillance • Notification: AEFI becoming aware by the health care system. Usually by ANM to the MO. • Reporting: Informing of the AEFI to the district and documentation of the same in the Case Reporting Form (CRF). Usually by MO to the district. • Investigation: Site visit and documentation in the Preliminary Case Investigation Form (PCIF) & Final Case Investigation Form (FCIF) by the district AEFI committee. • Causality Assessment: Systematic assessment of information to determine the likelihood of the vaccine/s causing the event. Conducted by state/ national AEFI committee
- 12. 1. Immediate AEFI case notification by the health worker in person or phone 2. Case visit for confirmation and reporting by the medical officer 3. Decision on investigation by the District 4. Preliminary AEFI case investigation, report submission and action at the local level 5. Final AEFI case investigation and report submission 6. Causality assessment by the State AEFI committee and conclusion of the investigation 7. Submission of Causality assessment report by state AEFI Committee 8. Taking action at state and national level Steps Following AEFI Case Detection
- 13. CASES TO BE REPORTED Serious AEFI Severe AEFI Minor AEFI
- 15. Minor AEFIs • Minor reactions following immunization are common • They include pain & swelling at the site of injection, fever, irritability, malaise, etc • They are self-limiting, hardly requiring even symptomatic treatment • But it is important to inform and assure parents about such events.
- 16. Reporting Minor AEFI • Information of all minor AEFI brought to the notice of the health staff by parents and/ or guardian should be recorded weekly at PHC in an AEFI register and submitted in the monthly HMIS* reports. • Monitoring crude numbers is helpful to record and compare with background rates that could identify product quality defects immunization errors increased susceptibility of vaccine reactions among the given population It is necessary for the ANM to submit NIL report in case no AEFI case is detected in the area during the week *Health Management Information System
- 17. Format For Block/ PHC Planning unit AEFI Register
- 18. Minor AEFI Monthly Report- Block / PHC level
- 19. SEVERE AND SERIOUS AEFI REPORTING Section 3
- 20. Serious and severe reactions Severe reactions Any untoward medical occurrence that at any dose: Results in death Requires inpatient hospitalization Results in persistent or significant disability AEFI cluster Serious reactions • Can be disabling and, rarely, life threatening • Most do not lead to long-term problems • Severe reactions include serious reactions but also include other severe reactions • Must be reported Examples of severe reactions include non-hospitalized cases of: anaphylaxis that has recovered, high fever( >102 degree F), hypotonic hyporesponsive episodes, Sepsis, etc
- 21. Reportable AEFI Onset time interval if vaccine/vaccination is implicated Anaphylactoid reaction (acute hypersensitivity reaction) Anaphylaxis Persistent (more than 3 hours) inconsolable screaming Hypotonic hypo responsive episode (HHE) Toxic shock syndrome (TSS) Within 24 to 48 hours of immunization Severe local reaction Sepsis Injection site abscess (bacterial/sterile) Within 7 days of immunization Seizures, including febrile seizures (6-12 days for measles/MMR; 0-2 days for DTP) Encephalopathy (6-12 days for measles/MMR; 0-2 days for DTP) Within 14 days of immunization Acute flaccid paralysis (4-30 days for OPV recipient; 4-75 days for contact) Brachial neuritis (2-28 days after tetanus containing vaccine) Intussusception (commonly within 21 days after rotavirus vaccines) Thrombocytopaenia (15-35 days after measles/MMR) Within 3 months of immunization Lymphadenitis Disseminated BCG infection Osteitis /Osteomyelitis Between 1 and 12 months after BCG immunization Death Hospitalization Disability Any other severe and unusual events that are thought by health workers or the public to be related to immunization No time limit Examples of reportable AEFI
- 22. Reporting formats Case Reporting Form (CRF) Preliminary Case Investigation Form (PCIF) Final Case Investigation Form (PCIF) Hospital Records- discharge summary, clinical lab/ diagnostic reports Verbal Autopsy in case of death Postmortem Reports in case of PM done Reporting channels email to aefiindia@gmail.com Serious/severe AEFIs
- 23. AEFI Case Investigation • DIO should review CRF and conduct detailed investigation • Investigate patient information prior to vaccination, details of vaccine provided at vaccination site, details of first clinical examination, medical treatment records, immunization practice at place of event, cold chain & transport mechanism, community investigation, other key findings. • Initiate to collect relevant immunization documents, sample/ specimen collection used unused vials, diluents, syringes, lab request for samples / biological specimens.
- 24. AEFI Case Investigation • Investigation of reported sudden unexplained deaths following immunization • Cause of death not known – Post-mortem / verbal autopsy form
- 25. Case Reporting Form- Routing, timeline, actions Medical Officer Pvt Practitioner District Immunization Officer State Immunization Officer DC Immunization Division MoHFW, Govt.of India State District National 24 Hours 24 Hours Site Immediate Health Worker • Confirm AEFI • Complete Case Reporting Form • Assign EPID number, complete additional details • Dist level planning meeting on investigation • Send copy of CRF to local drug inspector, team conducting autopsy & other stakeholders • Initiate collection of vaccine, logistic samples, CSF, Serum (or biological products), if indicated • Start collecting data for completing CIF • Inform if necessary State/regional AEFI committee State Drug Controller • If necessary, convene State AEFI Committee Meeting to plan course of action
- 26. Case Investigation Form- Routing, timeline, actions District Immunization Officer Preliminary CIF State Immunization Officer DC Immunization Division MoHFW, Govt.of India Final CIF 10 days of Notification State National District 70 days of Notification Inform DCG(I) & senior officers in the MoH&FW Inform the Vaccine manufacturers and review GMP • Convene district AEFI committee meeting and finalize action •If indicated and recommended, ship specimens to appropriate labs • Site (s) visit and investigation • Collect additional details Vaccine/logistic distribution and utilization Other AEFI in the area Other details such as pre-existing health, medical and environmental condition • Inform state AEFI committee & State Drug Controller • Request for additional information if necessary • Do a causality assessment within 100 days of notification
- 27. Serious/Severe AEFI Cases (formats and timelines) Type of Report Responsible Time line CASE REPORTING FORM(CRF) MO 24 hours of notification DIO 48 hours of notification INVESTIGATION FORM (CIF) Preliminary DIO 10 days of notification Final AEFI investigation team 70 days of notification
- 28. 24 hrs 48 hrs Day 10 Day 70 Day 100 Day 0 State Causality Assessment Report Final case Investigation form (FCIF) Preliminary Case Investigation Form ( PCIF) Case Reporting Form (CRF) Causality Assessment SEVERE & SERIOUS AEFI CASES AEFI GUIDELINES Final investigation –district reports to state Preliminary investigation – district reports to state District decision on investigation and informs state Medical officer visits and reports to district Case Notification Revised AEFI Guidelines – Timelines & Reporting Compared
- 29. District to share the same in VPD -D-001 with the state, and record in the line- list to be maintained with the District Immunization Officer ( DIO) Information on serious and severe AEFI to be submitted to district in weekly VPD -H002 form Cumulative numbers of all AEFIs to be entered by the block in the monthly HMIS data ANM( and other sources) to submit information on serious, severe and minor AEFIs- to be entered in the AEFI register at the block on weekly basis Besides serious AEFIs, other severe AEFI to be reported as well Key Highlights
- 30. Form VPD-H002 Name: ________________________________________________________________________________________ Address: ______________________________________________________________________________________ Fax: ____________________________ Name of Reporting Hospital:____________________________ Year: Week No. Period included in the report: From: To: Number of cases Identified: AFP* Suspected Measles** AEFI If no cases were identified, write Zero (0) Write the case details of AFP cases identified and reported this week Patient's name and Father's name Age in months Sex Block name Fill up information on all Measles cases below: Patient's name and Father's name Age in months Sex Received measles vaccine (Y/N/U) # Village name and landmark PHC name Block name District name Outcome: Died? (Y/N/U) # # Y=Yes, N=No, U=unknown Name of person filling this report: ____________________________ Date report sent to District: _________________________________ Approval of Medical Director:________________________________ ACUTE FLACCID PARALYSIS AND MEASLES SURVEILLANCE SYSTEM - WEEKLY HOSPITAL REPORT Address / Village name and landmark After review of all wards and registry books, please send this report to the following person every Monday. District name * All cases of AFP in children under 15 years of age should be reported and investigated per guidelines. ** All cases of suspected measles of any age should be reported and investigated per guidelines. Serious Severe
- 31. Form VPD-D001 Please send this report to the following person every Tuesday: Name:_____________________ Address:_____________________________________________________ Fax:_______________________ Name of reporting district:________________________ Year: Week No: Period included in the report: From: To: Number of units expected to report: __________ Number of units reporting on time: __________ Number of cases Identified: AFP* Suspected Measles** AEFI If no cases were identified, write Zero (0) Names of Reporting Units not reported on time this week: Write EPID numbers of AFP cases identified and reported this week: Y / N If Yes, allot Outbreak ID (#) Blocks outside of reporting district Y/N If Yes, date cross-notified to the concerned District Note: The number of measles deaths should be counted as measles cases also. Name of person filling out report: ________________________________ Date report sent to State: ______________________ Approval of District Immunization Officer________________________________ All districts should report weekly even if no cases of AFP or suspected measles were identified 4 - suspected measles cases or death due to measles reported in this week belongs to an already investigated outbreak, In this case mention the outbreak Id. already allotted (#) Cross-notified to the concerned District? If No, give reason Number of Deaths 1 - there are less than 5 suspected measles cases and no deaths in a block in a Cases from previous week should also be considered while flagging for preliminary investigation. Similarly deaths in cases reported from previous weeks should be considered. District name The reasons for not flagging for preliminary investigation are: Number of Cases Block name ACUTE FLACCID PARALYSIS AND MEASLES SURVEILLANCE SYSTEM - WEEKLY DISTRICT REPORT Fill up information on all suspected measles cases below Blocks within the reporting district Block name Number of Cases District total: Flagged for preliminary investigation Number of Deaths If No, give reason Serious Severe
- 32. Minor AEFI Severe AEFI Serious AEFI Weekly H-002 Report FLOW OF INFORMATION ON AEFI CASES FROM BLOCK AEFI REGISTER Monthly HMIS report District D-001 Report
- 34. Improve AEFI surveillance • AEFI reporting by private health provider/ practitioner • Sensitize AEFI to IAP/ IMA professional bodies • AEFI reporting by ADR monitoring centres • Include Pharmaco-Vigilance experts (PvPI from ADR monitoring centres) as district / state AEFI committee member. • Report Non UIP vaccines AEFIs • Training & encourage, support AEFI reporting • Share investigation results & corrective actions taken • Public trust in vaccine safety is key to the success of vaccination programmes.
- 35. District AEFI Surveillance: Reports 2015-18 District Name No of AEFI District Name No of AEFI District Name No of AEFI Chennai 151Tiruvannamalai 9Trichy 0 Kanchipuram 49Madurai 5Ariyalur 0 Thiruvallur 48Tirunelvel 4Karur 0 Vellore 25Tirupur 3Nagapattinam 0 Salem 25Thanjavur 3Thiruvarur 0 Namakkal 16Perambalur 2Dharmapuri 0 Tuticorin 2Krishnagiri 0 Villupuram 2Erode 0 Kanyakumari 1Coimbatore 0 Pudukottai 1Nilgiri 0 Virudhunagar 1 Dindugul 0 Theni 1 Ramanathapuram 0 Sivaganga 0 Cuddalore 0
- 36. THANK YOU AEFI reports to aefiindia@gmail.com, Any queries aeficonsultantsouth@gmail.com, To contact Mobile: 96297 44220