AEF Adverse Event Following Immunization Surveillance and Response OPERATIONAL GUIDELINES Ministry of Health and Family Welfare a Govermentof india Dalhi wow,a OT K. SUJATHARAO 4d a Health & FW Seoreiary tate ee feet chert ‘Tel.: 29061863 Feoc 23061252 bape emak atcyniwenicin cee MPA BHAVAN, NEW DELICTOOHY Foreword Universal Immunization Programme is one of the largest vaccination programme in the world; there are 2.7 crore children and 3.0 crore pregnant women eligible for recetving the primary series of vaccines in the country. In order to reach these beneficiaries, around &- S lakh sessions are conducted every month across the country both in rural as well as in urban areas with aver crores of doses of vaccine being administered, The 700,000 villages inthe country are mostly covered through outreach approach. Therefore, itis evident that monitoring of the Adverse Events Following Immunization (AEFI) in the country is a challenging task nonetheless essential. ‘The AEFI Surveillance System in the country has come a long way since its inception in 1988. Intensive efforts are being made by Govemment of India to strengthen Surveillance and Monitoring of AEFI in the country and facilitated in establishing State and District Level AEFI committees were established to streamline the AEF! Surveillance and Monitoring System. National and State Level workshops were conducted by Ministry of Health & Family Welfare further to intensify the system. Jam happy that the Operational Guidelines for Surveillance and Response to AEF] have been revised incorporating the lessons learned. These guidelines will enable the health system to effectively respond to any AEF! in the field by clearly defining the roles and responsibilities of the various health staff. These ACI! guidelines are meant to provide tools for the field functionaries to enable them to detect, report and monitor the adverse ‘events in a timely manner as wall as help to pravent AEFis dus to programme errors. This document would further strengthen the AEFI Surveillance and Response System in the country and would help build public confidence in the immunization programme. These guidelines reinforce the commitment of the Govt. of India to provide safe immunization servicas in the country. ha mae (Sujatha Rac) National Rural Health Mission_ @): arene tar ’ ‘frader see, vf fered 110011 ANMIT MOHAN PRASAD, las. Saaecici te HERE Chee ia Joint Secretary are NIRMAN BHAVAN, NEW DELH110011 ‘Tel: 23061195 Fax: 23061842 e-mait am.prasad@nic.in Preface Universal mmunization Programme aims vaccinating 2.7 crores children's and 3.0 crores pregnant women, being the largest cohort of eligible beneficiaries in the world. The services are provided through network of fixed centres and outreach session covering urban and rural areas with reach to every village in the country. Monitoring AEFI and exacuting such large scale program correctly with diverse and large geographical areas is a challenge to gain the public confidence. Inorderto ensure the safety and efficacy, vaccines are being pre-tested every batch before release for public use. However, due to intrinsic property of the vaccine and its constituents like stabilizers, adjuvant, antibiotics, diluents etc. added to the vaccine, some of the individuals may be hyper-sensitive to one component or other and can manitest as Adverse Event Following Immunization (AEFI), Such incidents are rare but may become apparent interms of number when vaccinating large cohort. AEF! could also be due to programmatic errors as a result of inappropriate storage, improper handling, preparation and administration etc. Itis extremely important that these AEFis are reported, investigated and treated at the earliest, They will not only build the public confidence but will also prevent additional clustering of cases if due to programmatic error. Quick response in case of AEFI is extremely important. Government of India has been making efforts to strengthen the ACT | ‘Surveillance System in the country through constitution of AEFI committees at National, ‘State and district levels. Inorder to strengthen the system further, the National AEF! Guidelines, which were released in 2005, have been revised based on the fiekd experience and development inthe field. This revised Operational Guidelines for Surveillance and Response to Adverse Events Following Immunization (AEF!) enable the health system to detect, report and monitor the adverse events in a timely manner as well as help to prevent AEFIs due to programme errors. Itis fervently hoped that this document will guide the program managers at all levels to further strengthen the AEFI surveillance system in the country. Oar (Amit Mohan Prasad)2.1.4 Injection Resection 21.5 Uniown... 2.2. Isolated and Clusters of AEFI .. 3. Recording and Reporting AEFI 3.1. AEFI reporting System 8.2 Channels of reporting AEFIS 3.2.1 Monthly routine reporting, 3.2.2 Immediate natification of Serious AEFI by the first person ‘who identifies the event. Conditions warranting immediate notification and investigation 3.3. The process of reporting serious AEFI . 3.3.1 First Information Report (Annex 1) 33.2 Preliminary Investigation Report (Annex2). 33.3 Detailed Investigation Report (Annex:3) 3.3.4 Maintenance of data and records 3.3.5 AEFI reporting by a private heatth facility / practitioner. 8.4. Steps to encourage reporting ..4, AEFI Investigatio 4.1 Objectives of investigating AEFI ca 4.2. Serious events that should trigger immediate investigation 4.3. Stepsin investigating AEFI... 4.3.1 _ Initial evaluation and First Information Reporting (FIR) by the health worker. 432 Confirming the FIR and First Investigation 43.3 Decision on Preliminary Investigation by the District 43.4 Preliminary Investigation 43.5 Detailed investigation, formulation of a probable hypatheala and action at local level. 43.8 Causality assessment by the state AEF! committes and ‘conclusion of the investigation 43.7 Submission of Investigation report 43.8 TekingAction 43.9 Challenges and pitfalls to causality assessment 4.4 Investigating an AEFI Cluster . en collection and handling for AEFI .. 5.1. Testing ot Biological specimens. 5.1.1 Biological specimens from AEFI cases 5.1.2 Autopsy specimens in an AEFI case resulting in death 5.2 Testing of vacoine/ diluents at CDL Kasauli 52.1 Sample collection .. 522 Packing of samples 5.23 Documentation and transportation of sample to laboratory .. 5.2.4 Dos and Don'ts for collection of vaccine/ diluent samples ‘and transportation .. 5.3 Testing of syringes, needles and vitamin A samples at CDL Kolkata ........ 61 53.1 Samplecollection .. 53.2 Packing, documentation and shipment 6. Operational aspecta of AEFI Survelllance 6.1 Thegoals of AEFI surveillance. 6.2 The objectives of AEFI surveillance 83. Key elements of the AEFI surveillance system 6.4 Roles and Responsibilities of Key Player 6.4.1 Sub centre Level... Health Supervisors (HS)64.2 Block PHC/CHC/CorporationWard/ Urban Health post. 6.4.3 Roleof the private sector 64.4 64.5 646 6.5 National Regulatory Authority (NRA), State Regulatory Authority (SRA), & Central Drug Laboratory (CDL- Kasauli and Kolkata) 6.6 Performance of the AEFI surveillance system 66.1 Performance indicators 6.6.2 Analysis of AEFI reports 8.7 AEFI secretariat... 6.8 Liaison with the police and the district administration 7. AEFI Committees ... 7.1 Composition of the AEFI Committee .. 7.2 Termsof reference for AEFI commitiee at various levels 7.2.1 District AEFI Committee. 722 StateAEFI Committee 7.2.3 National AEFI Committee .. 8. Vaccine risk communication and handling of the media, 8.1 Advance preparedness .. B2 Media Management when an AEF! has occurred . 8.3 Post-AEFI actions Annexure - © Annex1-FIR ‘Annex2-PIR ‘Annex-DIR ‘Annex 4—AEFI Laboratory Request Form ‘Annex5— Line listform for AEFI ‘Annex 6- Treatment guidelines for reportable AEFI ‘Annex7 — Event reduction during vaccination campaigns ‘Annex 8 — Causaltly Assessment (Aide Memoires) ‘Annex 9—Communication and Media Management ‘Annex 10 - Conducting Autopsies - Important Considerations ‘Annex 11 - Checkiist for prograrr/ district managers ‘Annex 12—List of kay functionaries and important addresses Further Reading ‘Acknowledgment weer err eee seeAbbreviations AC Assistant Commissioner AEFL Adverse Event Following Immunization AE Adverse Event AFP Acute Flaccid Paralysis AMS All India Institute of Medical Sciences ANM. Auxiliary Nurse Midwite BCG Bacillus Calmette-Guerin cpsco Central Drug Standard Control Organization CHC ‘Community Health Center Commissioner FW Commissioner Family Welfare cMo/cs Chief Medical Officer/ Civil Surgeon DEG (!) Drug Controller General of India DF Deep Freezer DIO District Immunization Officer DIR Detalled Investigation Report DM&HO District Medical and Health Officer oT Diphtheria-Tetanus vaccine DPT Diphtheria -Pertussis (whole-cell) Tetanus vaccine EPI Expanded Programme on Immunization FDA Food & Drugs Administration FIR First Information Report Gol Goverment india HA Health Assistant HepB Hepatitis B vaccine HIV Human Immunodeficiency Virus HMIS. Health Management Information System lop 10 International Classification of Diseases 10th editionA MOC MoHFW MO (PHC) Nop NCL NRA opv PHC PIR, AT UNICEF ur VAPP_ vPD wM WHO Ice Lined Refrigerator Medical Officer Incharge Ministry of Health & Family Welfare Medical Officer (Primary Health Center) National Centres for Disease Control National Control Laboratory National Regulatory Authority, Oral Polio vaccine: Primary Health Canter Preliminary Investigation Report Regional investigation Taam ‘Sub Center ‘State Immunization Officer/State EP| Officer ‘State Regulatory Authority Standard Operating Procedures Tetanus Toxoid vaceine Urban Health Center Universal Immunization Programme United Nations Children's Fund Union Territory Vaccine-Associated Paralytic Poliomyelitis Vaccine Preventable Disease Vaccine Vial Monitor World Health OrganizationGlossary, Adverse event following immunization (AEFI): A medical incident that takes place after an immunization causes concem andis believed to be caused by immunization. AEFI surveillance: monitoring, detecting and rasponding to adverse events following immunization (AEFI); Implementing appropriate and immediate action to correct any unsafe practices detected through the AEF! surveillance system, in order to lessen the negative impact on the health of individuals and the reputation of the immunization programme, Causal assoclatlon/ link: An AEF! which is caused by administration of a particular vaccine. Causally associated avents are also temporally associated, but events which are temporally associated may not necessarily be causally associated. Causaliy is usually based on Laboratory findings (6.g. Isolation of vaccine virus strain), and/or Unique clinical syndrome (e.g. anaphylaxis), and/or Epidemiological studies showing an increased incidence in vaccinated groups as compared with unvaccinated groups, (Cluster: Two or more cases of the same or similar events, which are related in time, and have occurred within specific geographical area, or associated with the same vaccine, the same batch number orthe same vaccinator. ‘Colncidental adverse event: A medical event that occurs after immunization but is not caused by the vaccine. This is due to a chance temporal association. Immunization safety: Includes vaccine safety and quality, Safe injections and waste disposal and AEFI surveillance. Injection safety: Injection safety is the safe handling of all injection equipment, routine ™onitoring of the availability and use of safe injection equipment, and correct disposal of contaminated injection equipment. Live viral vaccines (e.g. poliomyelitis, measles) contain attenuated (weakened) version of the disease-causing virus. The vaccine virus causes a mild infection, usually with no or minimal symptoms, that creates immunity against that virus. ee ee‘Non serlous AEFI: A reaction that is not “serious”. Programme Error: An event caused by an error in the transportation, storage, handing, or administration of vaccine. Serious AEFis: AEFis that are lite threatening and those that result in hospitalization, disabllty or death. ‘Temporal association: If the putative (presumed) causal event precedes the onset of the suspected adverse event then they are temporally associated. Temporal association is independent of causal association, and an event which is temporally associated with vaccine administration may or may not be caused by the vaccine. ‘Trigger event: A medical incident that stimulates a response, usually a case investigation. Vaccine: Biological substance that is administered to individuals to elicit immunity (protection) against a specific disease. Combination vaccines (8.9. DTP) protect against more than one disease. ‘Vaccine reaction: An event caused or precipitated by the active componentor one of the other components of the vaccine (e.g. adjuvant, preservative of stabilizer). This is due to inherent properties of the vaccine,Chapter 1 IntroductionIntroduction Chapter] Anadverse event following immunization (AEFI) is defined as a medical incident that takes place afterimmunization, causes concern and is believed to be caused by immunization Some AEFIs are inevitable, however its impact can be minimized by providing quality Immunization services, appropriate case management and communication strategies. Health care providers at all lavels should be equipped with technical and communication skills to address public concems about vaccination and respond rapidly, clearly and effectively to protect the beneficiaries and preserve the integrity of the immunization programme. AEFI surveillance monitors immunization safety, detects and responds toadverse events following immunization; corrects unsafe immunization practices, reduces the negative impact of the event on health and contributes to the quallty of immunization activities. Immunization safety has a wide spectrum ranging from vaccine manufacturing & regulation, vaccine safety & quality, safe injections & waste disposal and AEFI surveillance. Presently this guideline is mainly related to AEFI cases related to vaccines included in the National Immunization Programme. Issues of ea)vaccine manufacturing, safety & quality control and AEFI cases are handled by the Central Drug Control Standards Organization (CDSCO), headed by the Drug Controller General of India (DCG (|)). National Immunization Programme vaccines are those approved vaccines, for which license to its manufacture Is issued by the State Licensing Authority. For new vaccine, manufacturers have to furnish Periodic Safety Update Reports (PSURs) tothe CDSCO every six months for the first two years and then annually for next two years as per Drugs and Cosmetics Rules . The National Pharmacovigllance Center, at All India Institute of Medical Sciences (AIIMS), which Is assisting CDSCO to detect, assess and prevent adverse drug reactions in humans by monitoring effects, assessing risks & benefts, providing information and monitoring the Impact of any action taken. Post-marketing surveillance (PMS) is the practice of monitoring a vaccine after ithas been releasad on the market. AEFI surveillance needs to be sustained by the health care providers at all levels. Safe injections, vaccine vials in cold-chain and waste disposal are managed at the immunization session site by the service provider as per the guideline laid down by the Immunization Division of Ministry of Health & Family Welfare (MoHFW) and Central Pollution Control Board/ Pollution committee, ‘These AEFI surveillance guidelines provide information to program managers at national, state, district, block and PHC levels on establishing a sensitive AEFI surveillance system capable of detecting, notifying, investigating and responding to an AEFI for vaccines supplied by Government of India. It also briefly outiines a communication strategy on immunization safety to respond to inquires by the public and media.Chapter AEFI — The BasicsAEFI - The Basics Chapter2 The majority of events thought to be related to the administration of a vaccine are actually not due to the vaccine itself - many are simply coincidental events, others are due to human, or programme error. AEFIs can be classified into five types (Table2.1) 1. Vaccine Reaction 2. Program error 3. Coincidental reactions 4. Injection reaction 5. Unknown Table 2.1: Types of AEFis Vaccine reaction ‘An event caused or precipitated by the active: ‘ther component or ane of the components of the vaccine (6.9, adjuvant, presarvatho and stabilizer). This is due to the inherent properties of the vaccine, — Program Error ‘An event caused by an ettor In vaccine SUSE preparation, handling or administration, Coineidental ‘An event that occurs ater inmuntaton but ts not caveed by the vaccine. Tis ie due to a chance temporal association Injection Reaction Event caused by anxioly about, or pain from ‘he injection itsolf rather than the vaccine Unknown ‘The cause of the event cannot be determined ea) High grace fever following OPT vaccination + Anaphylaxis Bacterial abscess ue urstotio Injection / wrong diluent Pheumenia after oral pollo vaccine ‘administration Fainting spel ater Immunization Does not ft Into any of ‘he above four types,2.1 Types of AEFI 2.1.1 Vaccine Reaction Most vaceine reactions are minor and settle on their awn. More serious reactions are very rare andin general do not resuttin long term problems. An ideal vaccine maintains reactions to a minimum while producing the best possible immunity. Vaccine reactions can be classified into common, minor or non serious and rare serious reactions. Non sarlour vaccine reactions: ‘These include common mild side-effects, such as local reactions (pain, swelling and/or redness), fever and systemic symptoms (e.g. vornting, diarrhea, malaise), which can result as part of the normal immune response to the vaccine. Some of the nor-antigenic vaccine components (e.g. adjuvant, stabilizers or preservatives) can also cause some of these reactions. The frequency and nature of common non serious vaccine reactions are outlined in table 2.2 ‘Table 2.2: Frequency and nature of non serlous vaccine reactions Bca ‘Common -* Hepatts B Adults up to 30% (Children up 0 5% 170% Hy Up 20% - Measles/MMR. Up to 10% 515% Up to 5(cash) opy = Less than 1% Less than 1% Totanvs/DT Td Up to 10% Upto 10% Up to 25% Pertussis Up t 50% Upto 50% Up to 60% (OPT-Whole cel}? Management ‘+ Cold ofoth at Give extra fids = Symptomatic Injection site ‘+ Wear light clothing ‘+ Paracetamol ‘+ Tepid sponge of bath Paracotamal Dias, headache andor muscle pains ‘no ol ran iy oreo wh boon ogee upto 60-05% ¢ Acallar Peruels vescne caus lower rns of ncn.‘Oocurrence of non serious AEFI with any change in nature, severtty or frequency should be reported. ‘While mid fever is a common reaction, high (39 - 40.4° C/ 102 - 104.8°F) to extreme fevers (> 40.5 *7 105° F) may indicate the possibilty of sepsis or Toxic Shock Syndrome (TSS) resulting from a rogram error ot a coexisting iliness. Serious vaccine reactions Serious vaccine reactions are rare and may or may not have long term sequelae. For example serious reactions such as anaphylaxis though potentially fatal are treatable without leaving any long-term effects. An increase in the expected frequency of rare, serious reactions may indicate a problem with a specific batch of vaccine or a programme error. Itis important to reiterate that not all AEFIs are actually caused by vaccines. Table 2.3 summarizes serious vaccine reactions, thelr time of onset and frequency. Table 2.3: Frequency and nature of serious vaccine reactions, “sisuae ance 2 moms mom BCG Osteitis Up to several years: Dinning Ben 12 mot Hib ‘None known : : Hep B Anaphylaxis: (0-1 hour 12 Measlee/MMR* Febrile seizures 512 days 330, ‘Thrombocytopenia (low platelets) 80 days 30 ‘Anaphylaxis 04 hour 1 oPy Vaccino-Assooiated Paralytic Poliomyelitis” 4-30 days Up to.4* Tetanus Brachial Neuritis 228 days, 510 Anaphylaxis (0-1 hour 16 Sterile abscess 1-6 weeks 6-10 DPT Persistent (>3hours) inconsolable screaming —_ 0-48 hours: 1,000-60,000, Seizures 03 days 600 Hypotonie Hypo Responsive Episode (HHE) 0-24 hours 30-990 -Anaphylaxis/Shock 01 hour 16 Japanese Serious allergic reaction 0-2 weeks: 10- 1000 Encephale Houle ot 0 Ble 128 Rega erie ane areas eermmeaae So eh So et car wen nea2.1.2 Programme Errors Programme errors occur as a result of inappropriate transport, storage, handling, preparation and administration of vaccines. They must be immediately reported and Investigated to ensure rapid response and corrective measures instituted quickly to prevent additional cases. Aprogramme error often occurs when a vaccinator does not follow the standard immunization policies and practices. Table 2.4 outlines the most common programme errors leading to AEFI ‘Table 2.4: Common program errors leading to AEFIs Nom-stetle Injection © Coninct of needle with unsterle surface eg. finger, swab, table ets. * Contaminated vaccine or divent + Administering Injection over clothes + Improper hanting of vaccine vel he touching of soptum * Use of reconstituted vaccines beyond the Stipulated time (4 brs for BCG and Meastes, 2 Hrs for JE) Reuse of reconsttuted vaccine at ‘subsequent sessions "Reuse of disposable syringe & needle proper sionaye ad Iai of syringes ‘and needs leading to loss of serity "Syringes and needles used ater expiry dats Reconstitution error Wrong vaccine preperation * Reconstitution with incorrect vent = Reuse of the recanstiution syringe = Uso of expired vaccine or diluents * Drug subattuted for dliuent "Inadequate shaking of T-series vaccines on) Infection e.g. local abscess at aio of injocton, saps. ‘Toxle shock syndrome or death. Blood-bome infections 4.9. Hep B, HIV, Hep C ete, oy) Less vaccine effectiveness Toxic sheok Syndrome Drug reaction; Death Sterile abscossInjection at incorrect sterouts = * Injection into gluteal region (buttocks) = BCGIT series vaccine given subcutaneously ‘Vaccine ransportatonistorage incorrect * Improper storage of vaccines ike freezing of T-series vaccines and subsequent ‘administration of frozen and thewad {reeze-sonsitive vaccine Contraindlcations Ignored 'DPT2 givan after history of convulsions with DPTi ‘Sciatic nerve damage, Local reaction or abscess Increased local reaction such as storle abscess, Logs Vaccine otfectiveness More severe convulsions Programme errors may lead to cluster of events (2 or more cases) associated with a particular provider, health facility, single or muttiple vials (e.g. freezing of T series vaccine during storage/ transport) of vaccine, Symptoms arising from a programme error such as local tendemess, tissue infiltration, vomiting, diarthea, cyanosis and high temperature may help to identify the likely cause such as toxic shock syndrome. Programme errors can be avoided by training health workers, proper supervision and supply of adequate equipment. 2.1.3 Coincidental Events In general, coincidental events are clearly unrelated to the vaccination but stil require investigation to confirm and classify the event (e.g. pneumonia after OPV). In general, If the same or similar event also affected others in the same age group around the same time, but they did not receive the suspect vaccine(s), then a coincidental event is more likely. There may also be clinical or laboratory evidence showing that the event is not related to immunization. However, certain serious events may be blamed on the vaccine by the parents or community because of the close temporal association with immunization, on)especially if the vaccinated individual was previously healthy. Such cases need to be investigated, to allay public fear and maintain credibility and confidence in the immunization programme. 2.1.4 Injection Reaction Some vaccinated children or adults may develop reactions such as fainting, light-headedness, dizziness, tingling aroundmouth and in hands and breath-holding (sometimes even leading to unconsciousness especially in younger children) in anticipation to or as a result of an injection of any kind. This reaction is unrelated to the content of the vaccine. In group or outreach situations, overcrowding could increase the risk of injection reactions as well as programme errors. Mass hysteria is also possible, especially ita beneficiary is observed by others to faint or have some other reaction. Where possible, care givers should be allowed to accompany the child being vaccinated to reassure the child and to feel reassured about the vaccination process. Overcrowding should be avoided by proper planning of the sessions, The vaccinator should provide parents and the community with clear explanations about the immunization in a calm and confident manner. 2.1.5 Unknown The cause of the event cannot be determined. All efforts must be made to rule outall the above mentioned causes before reaching this conclusion. 2.2 Isolated and Clusters of AEFI 2.2.1 Isolated AEFI: This is a solitary medical incident that takes place after immunization, causes concern and Is believed to be caused by immunization 2.2.2 Cluster AEFI Acluster is defined as two or more cases of the same or similar event, which is related in time, and has occurred within the game district or geographical unit, or associated with the same vaccine, same batch number administered or same vaccinator. on) cf2.3 Reportable adverse events Itis essential to ramember that the health staff should identify and report all serious and nan setios adverse events. The system of reporting may vary from state to state. However as outlined in section 3.2, Non Serious AEF! should be reported “routinely” on a monthly basis and the serious AEFI should be reported immediately and also included in the monthly report and the linelist. The case definitions of some of the reportable AEFI are described in Table 2.5. ‘Table 2.5 Case definitions of some reportable adverse events. Vaccine associalad paralytic poliomyelitie (presenting as AFP) ‘Anaphyfactold reaction (ecute hypersensitivity reaction) Disseminated BCG infections, Encephalopathy on) ‘An acule flaccid paralys's 4-30 days folowing raceipt of oral ‘vaccine (OPV), or win 4-76 days after contact with a recipient of ‘OPV, wth neurologlcal cefits remalring 60 cays after onset, or death, Exaggerated aoute allorgla reaction, ooaurtng within 2 hours after Immunization, characterized by one oF more of the folowing: = wheating and ahorinees of broth due to bronchoopaam = laryngospasmvlaryngeal edema "One or mors skin maniestaions, 6.9. hives, facial edema, or generalized edema. Do not report less severe allergic reactions ‘Severe Immedate within + hout) ellergc reaction leadng to rcuatory failure with or without bronchospasm andor laryngospasmlaryngoal edema. ‘Widespread infection occuring within 1 to 12 months after BCG ‘vaccination and confirmed by isolation of Mycobacterium bovis, BCG strain. Usuelly in immuno-compromised individuals ‘Acute onset of malorlness characterized by any two of the following three conditions: Seizures severe alteration In level of consciousness lasting for ‘ne aay oF mare ‘= Distnt change in behavior lasting one dey ot more, Needs to oocur within 48 hours cf DPT vaccine or from 7 to 12 daye after measles vaccine, to be relatad to immunization, All All Measles, PertussisFover Hypotonie, hypo: responsive episode (HHE or shook- collapse) Injection site abscess Lymphaderits (Includes Suppurativs lymphadenitis) Osteitis’ Osteomyelitis Porsitontinconsolebla screaming Seizures, Sepals on) ‘The fovar con be claseifed (bated on temperature) such a Mii fover: 1004 °F to 102 (38 to 38.900), High fever: 102 °F 12 104.7 (39 to 404°C) and Extreme fever: 104.7 or higher (>40 °C). Event of succen onset occurring within 48 [usually les than 12] toute of vaccination and Issting rom one minute to several hours, in hin younger than 10 years af aga. Alt he fofowing must be present * impress (rypotoniz) * reduced responsiveness (hypo responsive) * pallor or cyanosis or fers to cbeerva! recall Fluctuant or draining fui filed lesion at the site of injection Bacterial i evidence of infection (@.g. puruint, inflammatory ‘signs, fever, culture), Sterile abscess if ro evidence of bacterial Infecon on cute, Serle abscesses are usualy due tothe Inherent properties ofthe vaccina. ier ls one yp es eng Ww >1.8 ain sige (one adult inger width) oF & draining sinus over @ lymph node. ‘Aimast exclusively caused by BCG and then occuring within 2 {tp 6 months afer receipt of BOG vaccine, on the seme side as inoculation (mostly axilary). Inflammation of the bone with isolation of Mycobacterium bovis BCG strain. Inconsolable continuous eying lasting 9 hours or lengor ‘eccompanied by high pitched screaming, ‘Occurrence of generalized convulsions that are not sccompanied by focal neurological signs or eymptoms. Febrila seizures: i ‘Temperature elevated >100.4 °F oF 38 °C (rectal) ‘Aerio seizures: If temperature Is normal ‘Acute onset of severe generalized lines due to bacterial Infection and confirmed (If possible) by postive blood culture. Needs to be reported as possible indicator of Program err All Mainly OPT, rarely others All injectable ‘vaccines DPT, Pertu AN, especially Pertussis, Al Injectable vaccinesSovere local reaction Toxic shock syndrome (TSS) Redness andlor swoling centered atthe sit of injection and ‘one oF more of the folowing: = Sweling beyond the nearest joint Pain, rechess, and sweling of more than 3 days, = Requires hosptaization, ‘Local reactions of lesser intensity ocaur commonly ‘and are tivial and do not noed to be reported. ‘Abrupt onset of fever, vomiting and watery iarhea within a {ew hours of mmuraaton, Often leading to death within 24 to 48, hours. Report as a possible indicator of program eror Al injectable ‘vaccines Al injectable vaccines on)Chapterd Recording and Reporting AEFI Se ee eeRecording and Reporting AEFI Chapter3 3.1 AEFI reporting System The main service provider for childhood immunization in India is the government sector. However, utilization of private sector for childhood immunization is increasing. Sessions in the government run centres are conducted on fixed immunization days at least once a week. The outreach sessions are conducted in a planned manner at regular interval on need basis. It is ‘therefore important that all levels providing immunizations are sensitized to detect, Investigate and report AEFls. Therefore the responsibility of primary reporting of AEF! depends upon the places where vaccines are administered. In Rural areas: The primary responsibility of AEFI reporting is with the Auxillary Nurse Midwife (ANM) at each sub centre who provides immunization services to approximately 3000 to 5000 people. Also the medical officers of the Primary Health Centres (PHC) that provides health care to a population of 20,000 to 30,000 as well as the Community Health Centre (CHC) or Block PHC that targets a population of 80,000-120,000. In Urban areas: AEFI reporting is primarily the responsiblity of the health workers and the medical officers of the Corporations, Municipalities and ‘Towns who provide immunization services through urban health faciities in underserved areas, maternal and child health centers and district hospitals. Itis also important that private practitioners both in rural and urban areas who administer vaccines report AEFI to the district health authorities. Recording and Reporting AEFI ar)3.2 Channels of reporting AEFIs ‘There are two channels of reporting AEFIs 1. Monthly routine reporting 2, Immediate serious AEFI reporting 3.2.1 Monthly routine reporting This includes reporting of all Non Serious and Serious AEFIs outlined in table 2.2 and table 2.3 from the level of Health worker (ANM) up to the National level (ooordinated by the district) through monthly progress reports (fig 3.1) using existingimmunization monthly progress reports /forms (vary from state to state) such as NRHM, HMIS, and RIMS ete. It is necessary for the ANM to submit “Nil” report in case no AEFI case detected from her area during the month This information is collated and compiled by health workers in monthly reporting formats under the heading of “Any untoward reactions or reportable AEFis” and forwarded to the next level. They include, Deaths Injection site Abscesses High Grade Fever (> 102° F) Persistent inconsolable screaming (> hours) Seizure 6. Hypotonic Hypo reaponaive cpisode (HHE) 7. Other complications (including the ‘cases not listed above such as severe local reaction, brachial neuritis, thrombocytopenia, lymphadenitis, disseminated BCG infection, osteitis! osteomyelitis and any untoward incident the vaccinator, ANM, Medical (Officer think is a resutt of Immunization —both immediate and/or delayed.) Ae PD Figure 3.1: AEFIMonthly Reporting = Data Flow National ‘State HQ. District HO Urban Centres* DDepencing on lection PHC/Block. ‘Sub Centro RO P ncenesreen3.2.2 Immediate notification of Serious AEFI by the first person who identifies the event Allserious AEFI are to be immediately notified by the first person who identifies the event. This “first person should notify the case to the nearest government PHC,CHC and/or the District immunization Officer (DIO)/ by quickest means of communication e.g. telephone, messenger etc. All persons involved in reporting AEFI should be aware of the timeline and channels of reporting. Notification should be followed up with a First Information Report (FIR—Annex 1). {tis important to intiate case management as a priority over AEFI reporting. The health authorities need to Immediately respond to ALL reported AEFI. Conditions warranting immediate notification and investigation ‘These are serious AEF! defined as “any untoward medical occurrence that results in death, hospitalization or prolongation of hospitalization, persistent or significant disability’ incapacity, or is life threatening”. All serious AEFis require systematic causality assessment. Additional AEFIs that need systematic causality assessment are: + AEFis that may be causad by a programme error, @.9., a cluster of bacterial abscesses; * serious unexplained AEFI occurting within 30 days after vaccination and not listed in productlabet; * events causing significant parental or community concem. ‘These are described in tables 2.3 and 2.5, 3.3 The process of reporting serious AEFI ‘These events are an emergency and need to be immediately investigated, managed and reported on standardized AEFI formats. Each serious event(s) should be followed up to datermine the cause for its occurrence (causality assessment). In India, the following reporting reports are used to guide AEFI investigation and causality assessment ‘pba rn, 0 court wu be he Mada a Haat) hare of nmurzaon such se Conran maton ‘Oar, Muna! Heal Ofer tz, Tha volo at Yasponsbllty of the uiben counterparts ll bathe tame ab the DIO for datcten ahd reopening to AEF Penner1. First Information Report (FIR) 2. Preliminary Investigation Report (PIA) 3. Detailed Investigation Report (DIR) 3.3.1 First Information Report (Annex 1) Purpose: Provides the most basic information of the event all levels and becomes the reference pointfor further investigations in a time bound manner Routing and Reporting Timeline (Fig 3.2) Figure 3.2 First Information Report - Routing, Timeline and Actions ‘Health Worker Site immediate | aaa Confirm Medical Oficer +*Compleie First Investigation Report (FIR) 24 Hours > Pvt Practitioner District + Assign EPID nubs, complet aul Uelats * Dit level lanning meeting on investigation District = Send copy of FIF to local drug Inspector, Immunization team conducting autopsy & other stakeholders ~ Initiate collection of vaceine, logistic samples CSF, Serum (or biological products) * Start collecting data for completing PIR. * Inform it necessary ~ Stateregional AEFI committee = State Drug Convoler * Hfnecessary, convene State AEFI Comm Meeting to plan course of action fl ; Covtoringa 1. ‘Thereporting can ocour using the FIR form from any lavel in the government or private sector. The primary reporting (notification) will usually be done by completing “section ‘A’, first information of the FIR form by any health worker including the ANM, AWW,ASHA, ICDS, Health Supervisor, community mobiliser, private practitioner, RMP etc and submitting the same to the Medical Officer (the MO can also be the first person ‘to report the case) of the nearest Government rural or urban Health Centre as soon as the event is brought to their notice. 2. The Medical officer should complete “section B”, first investigation of the FIR and ‘submit the same to the DIO within 24 hours of notification of the event. 3. The DIO should complete the final details in “section C” in the FIR and subrritto the State Immunization Officer and Assistant Commissioner of Immunization Division, MOHFW. Govt of India within next 24 hours. Steps In completing FIR. Role of health facility MO © Ensure that the notified adverse event fulfls the criterla of a serious AEFI. Medical officer (MO) should examine the patient and Immediately submit the FIR (within 24 hours of notification) to the DIO. Role of DIO 1. Within the next 24 hours, the DIO should review the FIR sentby the MO and provide district specific information like the EPID number, contact details, initiate sample collection and a tentative plan for further investigation and forward this copy to the ‘State immunization officer and AC of Immunization Division, MoHFW, Government of india. ‘Specimens for testing must be collected as soon as possible as outlined in the chapter “AEFI - laboratory aspects”. The collected samples may be sent only if specified by the district AEFI committe. 2. DIO should convene a meeting of the district AEFI committee and determine the need for conducting a time bound investigation and deciding the further course of action. 3. The MO in consultation with the DIO should prepare a list of items relevant to that particular event that would assist the investigation team such as the relevant registers, ‘ANM diarias, session tally sheets, indent records, used and unused vials, diluents and syringes . 4, The MO and DIO should ensure that such articles and items are kept secure, safe and are available at the time of preliminary and detalled investigation by the District AEFI team.5. Copies of the FIR should be shared with * District AEF! committee + Drug Inspector{who is also a part of the AEFI committee) * Incase a post mortem (autopsy) is planned, a copy should be provided to the concemed officer «The testing laboratory along with Laboratory Request Form (LRF) and other documents (as outlinedin chapter § “Laboratory aspects of AEFI’), in case the district AEFI committee decides to send the samples of implicated vaccine/ diluents/ logistics or biological products for testing. Role of State Immunization officer 1. On receipt of FIR at state level, the state immunization officer should decide on the gravity of the AEFI case and can take a decision to involve state/ regional AEFI committee at this stage or wait for the report of the PIR and involve the State/ Regional AEFI committee (including State drug controller) and chalk out further course of action. Role of Assistant Commissioner AC of Immunization Division MoHFW, government of India 1. _Atthe national level, the Assistant Commissioner of Immunization Division, MoHFW, government of India should decide on the gravity of the AEFI case and can take a decision to involve DCG() at this stage or wait for the report of the PIR and involve the DCG(I) (National AEFI Committee, if required) and chalk out further course of action. 3.3.2 Preliminary Investigation Report (Annex 2) Purpose: The PIR will guide the investigating team to collect important information required for final categorization of the adverse event. Routing and Reporting Timeline (Fig 3.3) 1. FromDIO to the State immunization officer and AC (UIP) MOHFW, Govt of India as early as possible or within 7 days of submitting the FIR Responsibility: 1. DO assisted by the district AEFI committee and the area medical officer / staff. PreeFigure : 3.3 Preliminary Investigation Report — Routing, Timeline and Actions Diawict District + Convene dlsttct AEFI committse meeting and finalize acon ireireeeer + ifindeated and recommended, ship speomens to ‘Ofloer propriate + Collect addtional detata lope cetbuon and uitaton 2 Other AEFI Inthe area = Other detais such as preexisting heath, medical and ‘onvironmanial conditans. ear * Sita (S) vii and Investigation nl + Completa PIR. State * Inform = Do a provisional causality assessment ini = State AEFI commit & State Drug Controller a ~ Request for addl information if necessary ‘AG of Immunization Inform DCG) & senior offers In the MOHEFW Division MoHFW, acioiacet Inform the Vceina manuacturam and raew GMP Steps In completing PIR. Role of the DIO 1. DIO should discuss and coordinate with the district AEFI committee to plan the preliminary Investigation using the PIR. 2. He should first ensure that he has the relevant documents this includes © Complete FIR * Vaccine, cold chain, logistic distribution and utilization (including batch number, lotnumber etc) © Other AEFI inthe area * Other details such as preexisting health, medical and environmental conditions both in the case(s) as well as the area 3. Organize an AEF! investigation in the field as outlined in chapter 4 4, Once the preliminary investigation is completed the district AEFI committee should raview the findings and attempt to confirm the AEF! as per definition and categorize the type of the adverse event. Pn5. The completed PIR along with copies of supporting documents should be sentto the ‘State Immunization Officer and Assistant Commissioner of Immunization Division, MoHFW, Government of India. Copies of the same should be shared with member of the district AEFI committee, the autopsy team (only in case of death) and laboratories to which implicated samples sent. Itis essential that the DIO should periodically update the State Immunization Officer on the status of the investigation and seek assistance if required Role of State Immunization Officer ‘The state immunization officer will coordinate with the state AEFI committee which includes the state drug controller for review of the PIR and copies of the supporting documents, categorize the AEF! and decide the further course of action. Deaths and clusters should be taken up as a priority for review. The state AEFI committee should attempt to undertake a preliminary causality assessment for the event taking into consideration the state experience with the vaccine(s) and if necessary request for additional information such as laboratory tests, field level information etc. Role of AC of Immunization Division MoHFW, Government of India At the national level the Assistant Commissioner of Immunization Division, MoHFW, Government of India should share the available information in the PIR with the DCG (I) and other senior officers in the Ministry of Health and Family Welfare. The DCG (|) may inform the drug manufacturers and review Good Manufacturing Practices if required. 3.3.3 Detalled Investigation Report (Annex 3) Purpose: The DIR is to guide the program managers at all levels to review the comprehensive data and information of the AEF'(s) to arrive at a possible cause for the occurence (causality assessment) of this event. ‘The state/ regional AEFI committee will review and monitor quality of investigation and final assessment based on the investigation reports submitted by the district committees and arrive at a final conclusion on causality. State AEFI committee could request for assistance from the national AEF! committee if necessary. PerensRouting and Reporting Timeline (Fig 3.4) + Section A to be completed by the DIO with help of the district AEFI committee and forwarded with copies of supporting documents to State Immunization Officer not later than 90 days of submitting the FIR. + This 90 day period has been provided to the district to ensure the processing of ‘samples and collection of reports. /f the documents are available earlier the same should be sent with the completed DIR immediately. + The state immunization officer should convene a state AEF! committee meeting and conduct a causality assessment and complete the final documentation (section B) and forward the completed DIR with (causality) assessment and copies of documents tothe AC of Immunization Division, MoHFW, Govt of India within 20 days of receipt of DiRatthe state level. Responsibility = DIO = State Immunization officer. Figure 3.4 : Detaled Information Report — Routing, Timeline and Actions District District + Complete FIA PIR Immuntzation + Compile ALL availabye report (including district repor's, heath Oicer contre reports, eld reporta, hospital records, laboratory result, ost mortem roporis & rosults of any taste conducted) as relevant ‘State ‘Convene Stata AEFI Committee and determine Immunization the cause for the AEFI. Finalize the DIR Officer within 30 days of DIR with ‘assessment ‘National AC of immunization Aes ‘Review of causallty by National AEF] Committee ae ee eee + Feedback of review to all stakeholders Govtof India PennerSteps in completing DIR. The DIO should compile all the relevant documents including o Complete FIR and PIR © _ District reports, health centre reports, field reports, hospital records, laboratory tesults, post mortem reports and results of tests conducted and any other records: as relevant * The DIO should complete the DIR with assistance of the district AEFI committee, obtain the committee's endorsement and forward the same with a case summary report (as outlined in section 3.3.3) o the state immunization officer within 90 days of submitting the FIR. The state immunization officer should ensure that the final (causality) assessmentis conducted by the state AEF! committee and results incorporated in the DIR within 30 days of receipt of the DIR at the state level. A copy of this along with the completed case summary should be sent to AC (Imm) as indicated above. The final report should include the diagnosis, type of adverse event and the key remarks/inputs of the district and state AEF! committe. * Timely submission of completed DIR is a good indicator of AEFI surveillance. © ALL serious AEFIs should be reported in standard forms (FIA, PIR and DIR) through the fastest available means For EVERY reported serious AEFI case, the district / state program officer has to ensure: that allthe 3 forms FIR, PIR, DIFLandease summary are completed on ime and submitted as outlined. 3.3.4 Maintenance of data and records: ‘State level: In addition to a copy of the FIR, PIR and DIA of all the AEFIs reported, the State Immunization officer should maintain a database ofall reported AEFIs in the form of aline list (Annex 5). An quarterly review of data of all serious AEF! should be done by the state AEFI committee. This will help the state to take appropriate action and improve AEFI surveillance. Feedback should be provided to all stakeholders. National level: The National level AEF! database is maintained in MoHFW. itis regularly updated following receipt of FIR, PIR and DIR.Periodic routine data analysis should be carried out at the district, state, and the national level. The monitoring of reported data includes the following information: © Number of AEFIs reported * Geographic and temporal distribution of AEFIs reported (look for clustering) and epidemiological analysis of the same ‘* Number and type of adverse events reported by antigen (e.g. Injection site abscess, seizures, HHE, et). * Geographic distribution of possible programme related adverse events like abscesses * Clustering of adverse events according to batch * Timeliness and completeness of reporting * Silent blocks/corporation/districts/states not reporting AEFI data MoHFW has developed software (tool) for recording data of reported serious AEFs. This generates basic (Time, Place and Person) analysis. All states need to maintain an AEFI database using this tool. 3.3.5 AEFI reporting by a private health facillty / practitioner. Itis never appropriate to discontinue immunization while awaiting the completion of the ‘AEFI investigation. The district authorities (D1O/ CMO or the Block MO) should ensure that the key private health facilities and focal persons are identfied and are sensitized about the AEF | reporting system for vaccines supplied by Govemment of India. Reporting of an AEFI from any private health facility or a practitioner should trigger an investigation by the district health authortties. Feedback of AEFI investigation and causality assessment should be provided. ‘The reporting channels, documentation and timelines ramain the same. Professional bodies like IAP, IMA, IPHA, Medical Colleges, Partner agencies like WHO/NPSP, UNICEF, PATH and others should also be involved in AEFI reporting. It is never appropriate to discontinue immunization while awaiting the completion of the AEFI Investigation. Pncenesnreen3.4 Steps to encourage reporting Staff should be encouraged to report AEF! without fear of penalty. Reporting can be enhanced by © Training. * Positive feedback. © Ensuring there are enough support available at all levels * Sharing results of the investigation and any corrective action taken. FreeseChapter AEFI InvestigationAEFI Investigation Chapter4 The ultimate goal of an AEFI investigation is to determine whether the reported event(s) was a result of the immunization process or the vaccine orto find another possible cause and correct if possible, and reassure the public. 4.1 Objectives of investigating AEFI cases » — Confirm the reported diagnosis of an AEFI and clarify the details and outcome * Record each incident that generates epidemiological data on safety of the antigen as well as injection safety practices © Determine the contribution of operational aspects of the programme tothe reported AEFI © Determine whether a reported event was an isolated event or part ofacluster © Determine whether unimmunized persons are experiencing the same medical event 4.2 Serious events that should trigger imme: investigation “The following trigger events should be investigated within 24 hours after Notification to the medical officer « AEFis thatare life threatening or those that resultin hospitalization (or prolong hospitalization), disability (or have the potential to result in disability) or death. * _ AEFis that may have been caused by programme error and occur in cluster (e.g. bacterial abscess, severe local reaction, high fever or sepsis, BCG lymphadenitis, toxic shock syndrome).* Serious events of unexplained cause occurring within 30 days after a vaccination + Events causing significant parental or community concem. * Events in which vaccine quality is suspected When an investigation is deemed necessary, It Is important to initiate it urgently so that the cause may be determined (where possible) and, in some cases, additional cases. prevented. ‘The reporting forms (FIR, PIR and DIA) will help and guide the periphery, district and stato health authorities in collating relevantinformation that will help in final (causality) assessment ofthe adverse event. Itis mandatory that the FIR, PIR and DIR (along with other relevant documents as described in section 3.3.3 Detailed Investigation Report) are fully completed for every notified serious AEFI case. 4.3 Steps in Investigating AEFIs The following are the steps in an AEFI Invastigation 1. Initial evaluation and First Information Reporting (FIR) by the health worker Confirming the FIR and First Investigation Decision on Preliminary Investigation by the District Preliminary Investigation Detailed Investigation, formulation of a probable hypothesis and action at local level Causality assessment by the State AEFI committee and conclusion of the investigation ‘Submission of investigation report Taking action PNBapwon 4.3.1 Initial evaluation and First Information Reporting (FIR) by the health worker ‘As soon as any serious trigger event as outlined above Is recognized, the health worker should first attempt to treat the serious condition before starting the documentation process. ‘The haalth workar should assure the parents or guardians that an invastigation is being intlated to determine the cause for the same. The basic information about the event as well as the demagraphic details should be completed by health worker in section A the FIR form (Annex 1) and sent to the Medical Officer of the Health Center by the fastest Penmeans possible. A private practitioner could report AEFI directly to the concemed medical officer of the nearest government institution or the district administration. 4.3.2 Confirming the FIR and First Investigation On receiving information of an AEFI from the area either through an FIR from the health worker or through print or electronic media, the MO should begin an investigation immediately. He should verify the information and categorize and assess the AEFI using the case definitions (Table 2.5). He should collect data about the patient, vaccine, immunization services, details pertaining to vaccine batch and lot numbers used (in the ‘session and in the center's stock) etc; complete the section Bin the FIR and determine if the AEFI was serious enough to warrant further investigation by the district or justity the reasons for not considering the AEFI forfurther investigation. This FIR should reach the DIO within 24 hours of case notification to the MO. 4.3.3 Decision on Preliminary Investigation by the District On receiving the FIR from the Medical officer, the DIO should rst assign an Epid Number that should be able to capture information on the state, district, year of occurrence of the AEFI and the serial number. The outline for the code is IND (AEFI) - ST - DIS- YR-NUM. (Gimilar to assigning epid numbers for AFP cases). © IND (AEFI) indicates country code (india) and the condition (AEFI), © ST indicates the state code (always two alphabets), + DiSindicates the district code (always three alphabets), © YRrepresents the year of event onset (e.g. 10 for 2010) and * NUMdenotes the serial number of the AEFI detected in the district in that year. Therefore, IND (AEFI)-TN-CBE-10-001 will be the code of the first AEFI case (001) investigated in a Tamil Nadu (TN) in Coimbatore district (CBE} in 2010. I the AEFI warrants further assessment, the DIO should complete section C of the FIR Notify the state and the national program managers (as indicated In section 3.3.1) and initiate appropriate actions such as informing the district AEFI committee and initiating action for preliminary investigation. Copy of FIR should be sentto the local drug Inspector, team conducting autopsy & other stakeholders and only If appropriate, the implicated vaccine, logistic samples, CSF, Serum (or other biological products) should be collected and dispatched to appropriate laboratories with LAF. Pener sIfthe case warrants no further investigation the details of the case should also be included in the monthly routine report and the FIR should be filed for records. 4.3.4 Preliminary Investigation ‘The DIO should spearhead the preliminary investigation. The DIO should collect background information such as the treatment taken by the case, the post-mortem details (if conducted) supported by the concemed MO. A disbict AEFI committee meeting (Including the reporting MO) should then be convened to finalise the process of AEF investigation. Using the PIR form as a guide, the DIO supported by the MO and AEFI committee members should collect data about the patient, vaccine, immunization services ete, It would be helpful to obtain the patient’s medical file (or clinical record), check details about the event from medical fle and document information, obtain any additional details missing in the FIR and the PIR forms and Identify any other cases that need to be included in the investigation. The completed PIA form should be sent to the State Immunization officer and the Asst Commissioner of Immunization Division Govt of India, immediately — not later than 7 days of submission of the FIR. Abrief summary of the details that should be collected for the PIR is outlined below * Patient + Demographic data about patient, including epid number, age, sex, place of residence , family history; + History of present ness — symptoms and their chronology, treatment, outcome and diagnosia - History of patient's past lines e.g, reactions to previous vaccine doses, drug allergies etc - Pre-existing disorders, current medications - Immunization history — vaccine, number of doses received, date and place of last immunization, mode and site of administration = Laboralory resulls aboul blood, stool or ollter samples if appropriale and available + Full autopsy report with toxicological screening and histopathological analysis - Common environmental exposures Pen* Event - History, clinical description, any relevant laboratory results about the AEFI and dlagnosis of the event - Treatmentand outcome * Vaccines and diluents administered to patient + Batch number(s) ~ Expiry dates(s) = — Manufacturers(s) + Vaccine storage - Points from where vaccine was distributed Whether other children were immunised with the same batch or same vial at same session and elsewhere + Laboratory test results about vaccine, if appropriate ¢ = Immunization services + Vaccine storage (including local vials), distribution and disposal + Diluent storage and distribution + lee Lined Refrigerator (ILR)- what else is stored (note if similar containers are ‘stored next to the vaccine vials which could be confused); which vacoines/ diluents: stored with other drugs, whether any vials have lost their label - _ Immunization procedures: use of syringes, reconstitution(Process and time kept), ‘Grawing up vaccine, injection technique, safety of needles and syringes, disposal of opened vials + Evidence of vial contamination + Number of immunizations greater than “usual” as in catch-up round or usual session load more than the standard norm: + Details of training in immunization practices for supervision and vaccinator(s) + Background data - Establish if cases have been reported from elsewhere and actively look for additional cases among other vaccinees and in the community Pener4.3.5 Detailed investigation, formulation of a probable hypothesis and action at local level Within 3 months of onset of the AEFI, the DIO should compile all the relevant documents including complete FIR and PIR, district reports, health centre reports, field reports, hospital records, laboratory results, post mortem reports and results of any tests conducted (only if Post mortem or laboratory tests were conducted). Adistrict AEF! committee meeting should be convened by the DIO where all the documents shouldbe reviewed and an attempt made to establish a probable hypothesis. The following conditions could possibly be considered for the probable hypothesis. * Vaccine Reaction = Known vaccine reaction * Vaccine manufacturer error © Programme related = Vasoine tranaportation or atorage error = Reconstitution error = Unrsterile practice = Incorrect administration technique * — Coincidental © Injection Reaction e® — Unknown ‘The DIO should send ALL the relevant documents pertaining to the AEFI case(s) (including the ‘conclusions of the District AEF! committee) to the state program manager / stats AEFI commitiog \within 90 days of submission of the FIR. Adverse events related to the vaccine Thia type of event is caused by some component of the vaccine - the active component of the vaccine itself, the preservative, the stabilizer or other. Minor events settle without treatment and have no long-term consequences. The serious events are rare. It is very important to investigate each case where the vaccine quality is suspected. PenIt the event is suspected to be related to vaccine, check for the following: * — Isthis a known reaction to the vaccine? * Are similar events known to occur with other diseases? © Isthere.a plausible (Ikely) mechanism for this event taking into account the biological properties of the vaccine? © Did the event occur within a plausible (likely) time frame from the vaccine administration? + Has the patient had simitar symptoms in the past? Did these occur after vaccination or independently of vaccination? © Was the patient on any concomitant or preceding drug therapy? © Did the patient have any concomitant or preceding medical condition, which could explain the event? » Were there any other factors that could explain the event e.g. programme errors: ¢ How frequentis the occurrence for this event (common/rare/not previously reported)? Did the event occur within the expected frequency range? Adverse event related to programme errors ‘Adverse event can be related to programme error when the events are caused by one or more of the errors outlined in table 4.1: (Page No. 40) If program errors are suspected, the following should be checked © Whether several cases occur and whether the same health worker administered the vaccines. © Whether the unimmunized population in the same age group and the same geographical area presents the same symptoms. + Whether the other people immunized with the same lot of vaccine in the same ‘geographical area present the same symptoms. * Whether the other people immunized with the same lot of vaccine in the same ‘eslablishments on the same day do nol present the same symploms. Hany of the above are found, local corrective measures should be initiated immediately through logistics supply, training, and supervision. PenTable 4.1 Adverse events related to programme errors Rolated to vaccine, diluents & administration Rolated to Neatlos & Syringos Incorrect dosage of vaccine andor dluent Inproper storage ofthe syringes and needles FReconstiution ofthe vaccine wih wrong duets Reuse of 5 mi reconattation (dliuent ) syringe Insp engl ve vil ting te Improper handling ofthe syringes and needles Incorrectmethod of administration ike injecting a wrong | Feilure overtly the condition ofthe packaging that sits orincorect route, ‘guarantoes the stoi of needles and syringes ‘Substiutton of vaccines or dlivents with drugs or other ‘Syringes & needles used after thelr expiry date substances Contamination of vaccines or diluents Injecting through clothes Inadequate aking o T-series vaccines Uss of reconstituted vaccine beyond stipulated hours Improper storage and use ofthe vaccines Ike freezing coterie vaccines, ‘Vaccines and divents used afte their expiration date \Vaooines not aliscardd atthe and ofimmurization session and used ata subsequent one ‘Ignoring cortradction to vaccination eg. child who had a severe reaction witha previous dose of DDPT vaccine immunized with the same vaccine again. Coincidental adverse events ‘Some clinical cases simply coincide with the vaccination; that is, the event would have. ‘occurred even if the person had not received the vaccine. This could be demonstrated if the same event also occurred in a population group that was not vaccinated. Even if the AEFI has not been linked to the vaccination, it may require adequate medical monitoring, and thus treatment /referral to higher center if needed should be done. (Adverse event where cause is inconclusive When causality cannot be determined by the state AEF! committee, the reasons forsame ‘should be indicated to the concemed levels. Pen4.3.6 Causality assessment by the state AEFI committee and conclusion of the Investigation Causality assessment is the systematic review of data about an AEFI case to determine the likelihood of a causal association between the event and the vaccine(s) received. Causality assessment is to be done at State or National level. The quality of the causalty assessment depends upon © the quality of the AEFI case investigation and report and the effectiveness of the reporting system, and © the quality of the causalty review process. ‘There are many challenges involved with deciding whether an adverse eventtis actually caused by the vaccine. Vaccines are offen administered to children at an age when many underlying diseases become evident. The fact that the vaccine was administered within & reasonable time period of that disease occurring does not automatically euggest that the vaccine caused or contributed to the disease. Causality assessment will not prove or disprove an association between an event and the immunization. It is meant to assist in determining the level of certainty of such an association. It Is not often that a definite causal association o lack of association Is established for an individual event Figure : 4.1 : Causality assessment of AEFI Clinical characteristics & Lab findings Concomitant or Preceding Conditions. Confident diagnosis of lesion Lab results favour causation RoR nine (time, ‘svodtion (ime, 9802) <— oo 1 Lo Biological Data pany Piauabity A Roprovecktty Prous toe a J Relisilty Reagion Likelihood/exclusion of other causes Specificity and strangth of Association ‘Treatment risk factors, susceptibility, program error PenPoor quality causality assessment can lead to erroneous conclusions, crises and loss of confidence in the national immunization programme. Whether an AEFI Is, or is not, attributable to the vaccine or the vaccination programme determines what, if any, steps. Need to be taken to address the event. Therefore the causality assessment of AEFI should be done only by the state AEFI committees (and NOT by the district AEFI committees) after very careful raview of the following findings of the investigation © Verify reason for reporting; diagnosis; whether serious or not * Evaluate and assess factors. + + + + + Is this event known to be related to the vaccine? (Consistency of findings, strength of association.) Whatis the frequency of occurrence of this adverse event? - Very common (>1/ 10); common (>1/100); uncommon (>:1/1000); rare (1/10 000); vary rare (<1/ 10.000), or not previously reported. Are similar events known to occur with other diseases? (Specificity of association.) Isthis event explainable by the biological properties of the vaccine? (Blological plausibility.) Is the vaccination-to-event interval compatible with the event? (Temporal relation.) Has the patient had similar symptoms in the past? Isthere a history of concomitant or preceding drug therapy? Is there a history of a concomitant or preceding condition? Are there other factors that could affect the occurrence of the event? * Determine causality category using WHO criteria (Fig 4.2). + + . . Is this an unknown event in relation to this vaccine? Is this a new event? Is there lack of sufficient data to reach a more definite conclusion? ‘Would the case benefit from a second review if more data became available? Based upon answers to the questions above, in which WHO category does the case fit best? PenFigure 4.2 : Categories of causality using WHO causality assessment criterla Vaccine reaction Injection Reaction “a Programmatic error == &S=- Insufficlent evidence to classify © Provide expert opinion on the case summary report sent by the district on the final causality assessment criteria. Take action on recommendation(s) from the review ¢ Consider the case for education purposes. ¢ Communicate findings to immunization programme staff, national, regulatory authority, and others (as appropriate). As causality assessment is a critical part of AEFI monitoring the, state AEFI committee should be exceptionally cautious when arriving at one of the conclusions below. © Very likely/ Certain: A clinical event with a plausible time relationship to vaccine administration and which cannot be explained by concurrent disease or other drugs orchemicals. * Probable: A clinical event with a reasonable time relationship to vaccine administration; is unlikely to be attributed to concurrent disease or other drugs or chemicals. ° Possible: A clinical event with a reasonable time relationship to vaccine administration, but which could also be explained by concurrent disease or other drugs or chamicals. © Unlikely: Aclinical event whose time relationship to vaccine administration makes a causal connection improbable, but which could be plausibly explained by underlying disease or other drugs or chemicals.* — Unrelated: A clinical event with an incompatible time relationship and which could be explained by underlying disease or other drugs or chemicals. © Unclassifiable: A clinical event with insufficient information to permit assessment and identification of the cause. 4.3.7 Submission of Investigation report ‘The completed investigation reports (FIR, PIR and DIR) and other relevant records need tobe submitted by the state to the Govt of India within 30 days of submission of the DIR by the district. Copies of all records must be accompanied with an AEFI case summary. Case summary report ‘The case summary in the DIR is critical to conclude the causality. This summary report should include the findings of the investigation conducted by the district AEFI committee. Case summaries related to deaths following AEFI must be completed on priority basis. Goneral Instructions to be followed when writing summary report * The case summary report is an event description report which provides historical record of AEF! and summarizes the findings and conclusions about a single serious AEFI or a cluster. It consists of a narrative describing and interpreting the event. * Adotailed write-up is necessary as the reports will be reviewed by expert panels at different levels (esp. at the State and National level) * Death cases following AEF! must be given a priority. Contents of the case summary report of the DIR: 1. General Information and detalls of Investigation: * Name of the case, the place where event occurred, name of the PHC/Ward, district and state. + When the first symptoms were observed, what they ware and who reported the event? * Who conducted the investigations and how long after the first symptoms were hese slarled? * Howwas the investigation conducted? (Was active search included; were relevant records checked and whether parents of children and other representatives of the community contacted? List should be attached) Pene* Hanyunimmunized child in the area had similar symptoms. 2. Clinical aspects for the affected child © Site of injection of each vaccine and time when given * — Detailed clinical picture = History of previous doses * Outcome ofillness * Diagnosis by treating physician and any relevant observation. 3. Operational Aspects * Batch no of involved vaccines © How is immunization sessions generally conducted in the area? Procedure followed on the day of the event (whether session was on the scheduled day) » When and from where the vaccines were received? How were the vaccines ‘stored and transported. Batch number of the vaccines © Howmany syringes and needles were available and procedure followed for the sterilization of equipment © Was the vaccinator trained «Hava similar reactions been observed in the past and were not reported 4. Laboratory investigation « Thesample of vaccines and diluents sent to the CDL Kasauli for testing. © sample of syringes and needles sent to CDL Kolkata + Hany other tests were done on the patient or samples sent for testing &. Autopsy © Htapost-mortem was conducted relevant findings may be included. 6. Follow up: © State briefly the follow-up measures taken 7. Suggestions and recommendations: * Probable underlying cause of adverse event © Whatwas the type of AEFI © Likely cause of adverse event Pener* Further steps that you would recommend to minimize the risks in the future: 4.3.8 Teking Action ‘The action following the investigation will depend on whether a cause for the adverse ‘event was identified or not and if so what was the cause of the adverse event. Table 4.2 ‘summarizes the actions that may be taken for different AEFis. ‘Table 4.2 Summary of actions that may be taken for AEFis: Vaocine reaetion ‘© Siato AEH committee along with Stato drug control authorities should immediately inform Govt of india the National Regulatory Authotty (OCG) and the Natfonal AEFI Comite, ‘+The Immunization Program dvision in consultation withthe OCG! wil then take a decision ‘to temporarily suspend the use of the product - the type or lot of vaccne/syringe that is suspected with the approval of MoHFW. The NRA will convey this offically to the manufacturer, Flo samples of the vaccines / syringes etc. shouldbe collected as per the established SOPs anc orwarte for tasting to the designated labortores warrant, the NRA may also r- evaluate the qual ofthe vaccine by conducting on-site GMP inspections etc) ++ Based onthe findings of vaccine testing, he folowing actions are recommended: It the vaccine Is implicated, the batci lot wl be witncrawn - the vaccine quays satisfactory, the orders for temporary suspension willbe withdrawn, Note: ts mandatory thatthe temporary suspended vaccine be property quarantined in adequat ‘cold chain as per established SOPS ofthe State / Central regulatory authorttes. Programme rar ‘Correcting the cause of the error. This may mean one or more ot the following: ‘© Caange n ogists for supplying vascine. ‘ Change in procedures atthe health tacit. «© Training of field workers. ‘Intensified supervision Note: Whatever action is taken, i is important to review at a later date to check that the pragramma errors have baen corrected. Coinoidentat ‘The main task is risk communication to ensure thatthe community is persuaded that the relation between the event and the vaccination isjust coincidental Atnough the AEF is nat irked tothe ‘vaccination itmay require medical management, thus a mechanism tor referral othe necessery health services should be established. Unknown Depending on the nature of the event, ts extent and whether Its ongoing, further technical ‘assistance from an expert may be needed to assist an investigation or causality ‘assessment However il mustbe accepted that in soma cases the relationship toimmunization snot clea. n action to reporting the findings ofthe Investigation tothe concemed, the reason that no conclusion wes drawn should be indicated, along with whatever progress was made. aIf the event(s) warrants urgent action Inguch a situation State AEF! committee along with State drug control authorities should immediately inform Govt of India -NRA / National AEF! committee. The Natlonal/State regulatory and AEFI committees should coordinate and immediately take the following steps. ‘+ Fleport the findings of the investigation to the State government & Govt of India. * The details of the implicated vaccine or product should be submitted to Government of India immediately so that a decision could be made on the temporary suspension of its use and await further instruction from Govt of India + NRA alongwith CDL and Immunization division will coordinate a re-evaluation of the quality of the vaccine and communicate to the manufacturer (by NRA), If necessary. 4.3.9 Challenges and pitfalls to causality assessment * Causality assessments not done, not systematic, or not done by trained personnel and/or not done in a timely fashion. * _ Information in AEFI reportis so limited that causality assessment cannot be done. © Lack ofexpertise and/or independence of the review committes responsible for formal causality assessment undermines credibility. * Non analysis of the AEFI in context after causality assessment may delay recognition of clusters and possible programme errors. + Lack of skilled communication of findinge, not addressing all target audiences, or lack of diplomacy and/or cultural sensitivity. All of these can damage the credibility of the immunization programme by reducing confidence in vaccine safety. 4.4 Investigating an AEFI Cluster Acluster of AEFIs is defined as two or more cases of the same adverse event related in time, place or vaccine administered. The exact nature of the relationship between the adverse events (e.g., duration of ‘time’, proximity of “place”) will differ by the nature of the ‘events and the circumstances within which they occur. A cluster may occurwithin the same district or geographical unit, or associated with the same vaccine, same batch number administered or same vaccinator. PenerIdentifying cause in an AEFI cluster (Fig 4.3) Even though the basic steps in investigation remain the same as described earlier, to identify the cause in an AEFI cluster, the following need to be checked A cluster of similar events is likely to arise out of program errors. If the event also ‘occurred in unimmunized people, it may be coincidental. Itis therefore important to identify if unimmunized people also developed similar symptoms around the same time. Identifying all persons in the area who have the illness that meets the case definition. ‘Obtaining immunization history (when, where and which vaccines were given) IFsimitar events are reported / seen in people from the same area in the same age ‘group who were not immunized then the adverse event was probably coincidental. Identifying any common exposure among the cases. Ifall cases received vaccines from the same health worker/facility and there are no other cases, programme erroris likely. Ifall cases recelved the same vaccine or lol/ batch number, and there are no similar cases in the community, a problem with the vaccine Is likely. Finally, Ifthe eventis a known vaccine reaction but occurring at an increased rate, a programme error or a vaccine problem are likely causes Figure 4.3 : Identifying cause In an AEFI cluster Peni case tn fom oniyons Ne Allcsses No Koen No ines Po eS — a ae a soacaon? diane’ get v 7 SRM? Prosremme ee, oS coincide uta Yes | “| ~| »| Pragenme oro Concise een pacers Siar tat Mentecors re wo iboah ERS no Programe aneror = Somers wm Seay a toate cats ana ™y “ CColnedental event Vaezine radon‘A cluster of similar events is lkely to erie out of program errors. Ifthe event also occurred in unimmunized ‘people, It may be colnckiental. Its therefore Important to identy i! unimmunized people also developed ‘similar symptoms around the same time. Case studies (examples) * — In2006 in a state A, four separate AEFI clusters of “collapse” occurred within five to 20 minutes following immunization with measles vaccine. All 14 cases presented with hypotonia; 11 became pale; seven cases had cyanosis, dyspnoea and increased saliva eecretion; three patients had depressed respiration and 8 patient died; others recovered in less than one hour. In two of the sessions, vials that contained muscle relaxants were found stored with vials containing diluent, and of the same size and ‘shape; labels on a number of vials recovered could nat be read. Investigations revealed use of a muscle relaxant. Cause: Use of muscle relaxant Instead of diluent. » — In 1999 in state B, 21 infants died out of 70 infants supposedly given DPT vaccine. Insulln was stored In similar looking vials In the same refrigerator as DPT vaccine. Cause: Use of ins * In 2008 in state C, three infants died after administration of measles vaccine. Symptoms that developed within one and a half hour following immunization were fever, rash, vorntting, and diarrhea, and described by the attending health worker as “toxic shock syndrome”. Reconstituted vaccine was routinely kept until it was used, and as AD syringes were not available the vaccinator used the glass syringes which were never sterlized, but washed with ordinary water and wiped with cotton wool. No testing couldbe done. Cause: Non-sterlle Injection (contaminated reconstituted vaccine). * In 2009 in State D, four children died and a fifth was hospitalized after receiving measles vaccine from the same vial. The infants died within minutes after receiving the vaccine. Before death the presenting signs and symptoms were high fever, frothing, vomiting, respiratory distress, cyanosis, rolling over of eyes and unconsciousness. The investigators found out the vaccinator had used some other drug instead of the diluent instead of DPT. PenCause: Program error (error in reconstitution of vaccine). + In 1997, country X used a new influenza virus vaccine for intranasal administration. To optimize both mucosal and systemic immune responses to the nasal vaccine, heat-labile Escherichia coli enterotoxin, was included in the formulation. However, after Bell's palsy was identified in some recipients of this intranasal vaccine, it was withdrawn from the market. Cause: Vaccine reaction. PenChapter Specimen collection and handling for AEFI Specimen collection and handling for AEFISpecimen Collection and Handling for AEFI e:5 Only the appropriate specimen in the correct quantity required for the investigation should be collected. Laboratory specimens should be accompanied by clear supporting documents (LAF,FIR, PIR and ather relevant document), reasons for specimen collection and any specific additional request for information by the investigators. Table 5.1 Activities and responsibilities for specimen collection following an AEFI Activity Responsibility 1. Decision to collect sample (samples ‘» District AEFI comnts thal includes local ‘shouldbe collected as soon as. ‘Drug inspector. required consul state possible and sent ony ithe district ‘AEF| commition AEF commites deciies) 2 Decision totemporarily suspendthe —® McHFW Govt of India. ‘uso limplcatedbatch ofthe vaccine” —_* Tholocal drug authorty representative dluentogistics aftr discussion wit the AEFI commitee. 3 Collection and sending of samples ‘© Drug Inspector and DIO 4. Decision on typeof samples thatneed © Basedon recommendations ofthe Distt tobecollected ‘AEF committee. ‘= TheDrug inspector may also collect ational samples ashe considers appropvite, 5 Packaging & Cold Chainof samples | Drug inspector and DIO 6 Sealing of specimen using “oficial lac ‘© Preferably by Drug Inspector; in case the ‘seal ‘drug Inepector seal not available, then by Using the CMO's seal 7 Transporation of samples to ‘+ Preferably DIO and! or Drug Inspector laboratories 8 Laboratory for sending specimen ‘+ Ienifed laboratories as described in his chapier ‘Specimen collection and handling for‘Activity esponelbiity 3 Funding ‘+ Tho expenses for activities relatadto AEFI surveillance, AEFIcase ‘management, transportation of vaccine and other AEF elated ‘ctv can be madi trom the availabe funds under Part (immunization) of NRHM PIP (under the provision for ‘Sate pectic ‘actives’ ter due approvalby competent authorty at blocks! statolevel ‘+ Allexpenses towards tating of vaccines in CDL Kasaui and Kolkata willbe tome by the respective laborers, ‘+ NIV Pune and NIV Goraktpur wil bear the expenses related {esting of samp for acveree events occurring following JE vacoinaton. 10 Reporting ot laboreoryresut/ reports |= The laboratory asa rule wil forward a copy of he report to CDSCO,, ‘AG Immunkatlon Dion, MoHFW, State Immunization ocr, ‘Stato Col chain offcar and State drug auhorty. ‘+ Laboratotes wil aiso send a copy o the laboraory resus oa ‘persons with contac deta (complete address with pln code, phone and fexrumbers and email address) mentioned inthe LRF. 11 Feedback of Laboratory resuts ‘© DiOto share with = Distt cold chan fee, = Drug inspector + Black Medical officer reportngthe case = Private heath facity reporting the case, Itis essential that testing Is conducted for biological samples from the patients and If indicated, testing of vaccines, diluents and logistics ara also performed. Laboratory testing of samples is not mandatory following AEFI, particularly if the cause is evident such as a coincidental event or a program error. However, laboratory testing is at times required to Confirm orrule out the suspected cause. The laboratories where tests are performed are outlined below.. For biological samples, * — Histopathology, body fluids etc at laboratories identified and approved by the district/ ‘state AEFI committees and * Autopsy specimens al approved and accredited state forensic laboratories Asper the Central Drug Standard Control Organization (CDSCO) the follawing laboratories have the legal mandate for testing we a Ce Ree eer* Vaccines and diluents for sterility and chemical composition at CDL Kasauli * Syringes and needles for sterility at CDL Kolkata 5.1 Testing of Blological specimens ‘The district AEF! committee should identity Govt and reliable private laboratories for testing of biological products like blood, CSF, urine etc. However in case of adverse events ‘occurring following JE vaccination, the CSF and blood samples should be sent to National Institute Virology in Pune or Gorakhpur after proper labeling and packing along with LAF and FIR. PIR and other relevant documents may be included if requested. NIV Pune- Contact detalls ‘The Director, National Institute of Virology, (JE Group) ‘Sus road Campus, Pashan,Pune 411021, Maharastra. mall nivicl@pn3.vani.netin, acm1750@reditimail.com ‘Tet: 020-25880982, 020-26127901, 020-26006290 ; Fax: 020-25883595, 020-26122689, 020-26128399 5.1.1 Biological specimens from AEFI cases Itis difficult to generalize what specimens will be required in a given situation as it will depend on the symptoms and signs of the patient and the clinical decisions made by the doctor in charge of the case. Table 5.4 gives a general outline of some of the specimens that could be collected. The list is not exhaustive. Table 5.4 Blologloal specimens to be collected for testing following AEFI Event ‘Specimen trom the patient Severe Local Reaction ‘Aces. ‘Swab , Blood Lymptadentis (CNS Attvorso events (ONS Symptoms, Noparaljes (Cerebrospinal fuid (CSF), blood (CNS Symptoms, vith paralysis Steal* Other Anapbyids Blood, Bld culture, Post mortem tissue specimen Toxic Shock Syndrome (es directed by physician) Death Urine Hf paralyt olowe acinetton of OP, sol specinens are Important, Ths ae tobe coleciod as per the gules for soo colton AFP case Ce Ree eer5.1.2 Autopsy specimens in an AEFI case resulting in death Itis recommended that an autopsy in a death suspected to be dus to an AEFI be performed as soon as possible (within 72 hours) to avold tissue damage, development of past mortem artifacts and lysis of the adrenal glands, which can alter diagnosis. ‘The DIO should ensure that a detailed patient's history is included.in the autopsy form that itis submitted to the team (autopsy surgeor/ pathologist/ forensic specialist) conducting autopsy. ‘The Additional specific information to the autopsy team will help them look for any underlying disease/patholagies in the deceased which may be cause of death or contributed in the cause of death. ‘Samples for both histo-pathological and toxicological examination should be sent to approved and accredited government reference laboratories through investigating police agencies, The samples should be collected and transported to forensic laboratories as early as possible to avoid loss of biological samples due to decomposition. All samples should be labeled with the name, Epid number, and autopsy report/ form along with documents requesting the examination and investigation, and theconclusions from the autopsy, which should list the cause of death, utilizing International Classification of Disease (ICD 10) and, if possible, the causative agents/drugs. The important aspects to be considered when conducting autopsies are outlined in Annex 10 5.2 Testing of vaccine/ diluents at CDL Kasauli (On the receipt of adequate samples with proper and complete documentation, CDL Kasauli tests vaccines and diluents for physical aspects, sterility, abnormal toxicity and biochemical Identity. Tests for potency are not applicable in AEFI cases (Itis related to efficacy rather than safety of vaccines). Laboratory tests are performed and results dispatched to the sender in approximately 30-45 days. I nhoratary tasting for implinntad vaecinea diluaniy! logistics should he mquasied anly an a clear suspicion and not as routine, and never before the working hypothesis has been formulated. Ce Ree eer}.2.1 Sample collection ‘The DIO and Drug Inspector should be involved in the collection of adequate quantity of implicated vaccine/ diluent samples from the site of occurrence of AEF and last vaccine storage point and shipping the same in cold chain to the CDL Kasauli as early as possible. First collect each vaccine / diluent as described in table 5.2. Prepare four sealed sets with equal quantity and - Send one set to CDL Kasauli laboratory. - Retain one set at the site of collection (PHO/GHC or district HQ). ~ Retain two sets with the drug inspector. ‘The desired quantity of vaccines or diluents must be collected from the next available vaccine storage point ifthe numbers outlined in table 5.2 are not avallable at the last vaccine storage point. Iti important that the quantity required by the CDL Kasauli must not be compromised. ‘Table 5.2 Quantity of implicated vaccine / diluents to be collected a ® © o DPT group of vaccines 10 dose X 40 vis NA 10 dose X 10 vals NA (Including Pentavalent) OR 01 dose X 120 vials NA OR 01 dose X 90 vias NA BCG Vaccine 10 dose X 180 vials 180 diuents 10 dose X 40 vals 49 diluents 20 dose X 160 vais 160 diluents 20 dose X 40 vals 49 dluonts Oral Polio Vaccines 20 dose X 40 via NA 20 dose X 10 vials NA MeaslesiMMR Group 01 dove X 80 vies 80 diluents Of dose X 20 vals 20 diluents (OR 05 dose X 60 vials 60 diluents OR 05 dose X 15 vias 15 dluents OR 10 099 x 40 vals | 40 clues OR 10.dos0 X 10 vids 1 alerts JE.& Hepatitis vaccines 01 dase X 120 vais 120 diluents 01 dose X 30 vals 30 divents ‘OR 05 dose X 60 vals | 60 dlluents OR 05 dose X 15 vias 15 diluents OR 10 dose X 40 vals | 40 diluents OR 10 dose X 10 vias 10 diluents for AEFI ca5.2.2 Packing of samples ‘Separate plastic zipper bags should be used for packing different vaccine and diluents. The name, age, date of collection, AEFI epid number and point of collaction of vaccines/ diluents should be mentioned only on the label of each plastic zipper bag. All the packed zipper bags (separate for vaccines and diluents) should then be put in a bigger zipper bag. ‘The big zipper bag should be placed in a card board box, tied with a string from all sides and an “official lac seal” affixed by the drug inspector (fig 5.1 and 5.2), The CMO's “official lac seat’ may be used if the “official” lac seal of the drug inspector is unavailable. Figure 5.1 Figure 5.2 5.2.3 Documentation and transportation of sample to laboratory ‘The completed LAF (Annex 4) also sealed with the same “official lac seal” should accompany the samples sent to the laboratory. The “official lac seal” ensures thatthe samples and details sent to laboratory are not tempered / changed during transportation. Ensure that the completed investigation forms (FIR, PIR) also accompany the samples tothe laboratory. Vaccines and diluents are tested eimultaneouely, therefore freeze dried vaccines (BCG, Measles, and JE) should be accompanied by their respective diluents. ‘The sample should be transported to the laboratory under cold chain (vaccine carrier with ice packs or thermocol boxes with Icepacks) preferably through a messenger. for AEFI* CDI laboratory Kasaull accepts samples received on all days of the week. The messenger carrying the samples to CDL Kasaull must insist on getting the ‘sample received receipt’ for official record. This receipt will also provide details on the condition of samples received in the laboratory. (issue of receipt will nat be possible in cases when the samples are received on weekends). * Samples may also be sent by courier thet has experience in handling biological products and can also guarantee delivery up to CDL Kasauli within the stipulated time under the stipulated conditions. ‘Address for shipment ot vaccines and diluents Head, Central Drugs Laboratory, Central Research Institute, Kasauli—173 204. Himachal Pradesh. Emall : nclkasaull@bsni.in ; Phone: 0179-2272046, 2272060 Fax: 0179-2272049, 2272016 Example of vaccine / diluent collection An AEFI occurred in district M following use of a 5 dose vial of Measles vaccine at a ‘session site. The District AEF! committee reviewed the case and decided to collect the implicated batch of measles vaccine and diluent for testing in CDL Kasauli. As per guidelines (Table 5.2) the team comprising DIO and Drug inspector planned to collect 60 vials of Measles vaccine and 60 ampoules of measles diluent. However, during the site visit, they were able to find only one partial and one unused vaccine vial of the same batch with the ANM, They therefore collected 59 unused measles vials from the PHC vaccine storage point. The total quantity required (i.0. 60 vials) was thus complete. The vaccine vials were then packed in different zipper bags and labeled mentioning the point from where they were collected, in this case il was session sile and PHC. The next step was to collect 60 measles diluents; they could only collect 45 diluents of the implicated batch from PHC and another 15 diluents from the district vaccine store. The total quantity required (i.¢. 60 diluents) was now complete. The sample was packed in zipper bag and labeled accordingly. ‘The zipped and labeled bunches of 15 vaccines and 15 diluants ware placad in cardboard cartons and sealed with the Drug Inspector's ‘official lac seal” and 4 sets were made ‘They sent one set containing15 vaccine vials (unused) and 15 diluents (unused) under cold chain for testing to CDL Kasauli (Table 5.2) along with a LAF, FIR and PIR. rece a‘The rest ofthe sets was packed and retained at different levels as per guidelines mentioned above. ‘Tests done on opened used / partially used vials at CDL Kasaull Used (opened) vials are technically not required by the GDL Kasaul for testing, the senders however ‘encouraged to send the used vial (i avallable) to engure that the same batch of the unused vials are being sent for testing. ‘The opened vials are usually not tested because of following reasons: © Quantity of vaccine is often inadequate for testing ‘* Once the vials are opened they become unstarle because of contamination from the surrounding ‘environment. ‘+ Heconsinutea wists cannot De tested beyona 4 nours. * Opened vials have weak legal sanctty. 5.2.4 Dos and Don'ts for collection of vacine/ diluent samples and transportation Dos 1. Collect unused samplas only from the implicated (suspected) batch. 2. Send the implicated samples of vaccine and diluent to the laboratory affixed with “official lac sear". 3, Ensure that the accompanying LF is also affixed with the “official lac seal”. 4. Packthe diluents carefully and separately in a sealed packet. 5. Mention the point from where the vaccines/ diluents were collected on the label of ‘each plastic zipper bag. 6. Ensure the name of the vaccine, batch number, manufacturing and expiry dates and ‘other details on the label as affixed by manufacturer are intact and clearly visible on allthe vials/ampoules of the samples. 7. The packing should be such that there is no breakage of vials. The small cartons in which the vaccines are supplied by the manufacturers may be used for this purpose. ‘The vaceines should be packed in a plastic zipper bag and sealed. The packis then put in the vaccine carrier or thermocol box with ice packs. (Dry ice may be used for ‘OPV samples and NEVER for freeze sensitive vaccines) 8 The address of the CDL Kasauli should clearly be written on the box. 9. The samples should be accompanied with the LAF and FIR. PIR and other relevant records if available may be sent, Ce Ree eerDon'ts. 1. Labels must NEVER be wrapped with adhesive tape or any other labels on the vaccine/ diluent vials as shown in fig 5.3. and 5.4 below 2. There should be no wetting of labels or mutilation. Appropriate labels may be affixed on the zipper bags with vaccine samples inside. 3. The vaccines should not have expired at the time of receipt of vaccine in the laboratory. Figure 5.3 Figure 5.4 5.3 Testing of syringes, needles and vitamin A samples at CDL Kolkata CDL Kolkata is the identified laboratory where implicated sample of AD Syringes! Reconstitution Syringes and Vitamin A etc are tested for standard sterility and physical parameters. The testing of the AD syringes! reconstitution syringes/ and vitamin A should be initiated following decision by the District / State AEFI committee and/or when there is dear hasis af suspicion and NOT as a routine procedure. Laboratory tests are performed and results dispatched to the sender approximately in 60 days of receipt of the samples 5.3.1 Sample collection ‘representative of the local Drug Authority (Drug Inspector) should be involved in the collection of Samples (Vaccine) as per Drugs and Cosmetics Rules and transfer of sealed samples to the CDL Kolkata. The sample of implicated AD Syringes, Reconstitution Syringes or Vitamin A that are sent should be of the same manufacture and batch number. The samples should be collected in 4 equal sets; one set has to be sent for testing; one set retained at the point of collection and two sets retained with the drug inspector! (table 5.3). The samples can be sent through reliable courier or postal services. Cold chain is. NOT required. Seu ear OyTable 5.3 Quantity of unused syringes! needles and VitA to be collected for testing Sample Unused quantity of implicated batch AD Syringes 4 Sets of 50 places each foal 200) ‘© SOpieces tobe sentto CDL Kolkata ‘50 pioces tobe retzined atthe source of coletion ‘+2 sts of 50 places each {total 100) tobe retain by Drug Inspectorfoeal Drug Authority) FRooonstutlon Syringes sets of places each (total 200) ‘+ 50pleces tobe sono CDL Kolkata, ‘+ So pieces tobe retained atthe source of coletion ‘¢2ssets of 50 pleces each {otal 100 tobe retaned by Drug Inspectorfocal Drug Autry) ‘4.8035 of two 100ml bottles (itl 8 bots) ‘© 2botes for COL Kola ‘2 bottles tobe retained atthe source of colection “bates tobe retained by drug inspector (oval Drug Authority) 5.3.2 Packing, documentation and shipment ‘+ Theused samples (AD syringes’ Reconstitution’ Disposable/ Vit A) it available should be sent along with the unused batch of the same manufacturer. Both items should be sealed in separate packets, labeled with the site of collection, placed in a card board box, tied with a string from all sides and an “official lac seal” affixed by the drug inspector/ . The CMO's “official lac seal” may be used if the “official” lac seal of the drug inspector is unavailable. ‘Address for shipment of syringes, needles and vitamin A ‘The Director, Central Drug Laboratory, Min. of Health & Family Weltare, Govt of india, 8, Kyd Strot, Kolkata 700016. Email: edlko1@ gmail.com Phone: 033- 22209541. Faxc 033-222 99380, 033-222 98936, © The samples should be sent with completed LRF form and FIR. PIR and other relevant may be sent if requested. * Incase Vitamin A is being sent for testing, the used bottle if available can also be sent along with the unused sealed bottles of Vitamin A with quality packing to avoid breakage or spillage during transportation. Important considerations ‘+ Heal authortiesneedo ordinate wth the pie /oher investigating departments and aoquant them with the National AEFI guidelines. ‘+ Alloriginl documents must be retained bythe medical oficern charge. Documents requested bythe pale! ‘ther investigating agencies shoud be shared as attested copies. Ce Ree eerChapterO Operational aspects of AEFI SurveillanceOperational aspects of AEFI Surveillance Chepter6 An effective immunization safety surveillance system must be able to detect and differentiate the types of AEFI in order to prevent their Occurrence and/ or reduce their impact. The surveillance of Adverse Events Following Immunization in India was first initiated in 1986. 6.1 The goals of AEFI surveillance * Minimize the negative impact of AEFI on public health © Monitor the quality of vaccine used for immunization © Ensure and monitor the quality of immunization services * Reduce morbidity and mortality dus to AEFIs The Central Drug Standard Control Organization (CDSCO) and the Universal Immunization Programme (UIP) coordinate the implementation of the AEFI surveillance system. The National, State and district AEFI committees, Central Drugs Laboratory (Kasauli and Kolkata), National and Sub-national drug authorities and State forensic laboratories play a pivotal role. 6.2 The objectives of AEF! surveillance * Detect , report, and respond to AEFIs timely and promptly © Identify unusual high rates of AEFI with any specific vaccine lots/ brands * Promptly address programmatic errors through Implementation of corrective measures: * Maintain confidence of the community and health workers in the immunization programme by properly and promptly responding to their concems* Estimate serious AEFI rates In the population as compared with local and global data. * Identify signals for unexpected Adverse Event and generate new hypotheses about these events that must be confirmed by planned studies and laboratory investigations. 6.3 Key elements of the AEFI surveillance system * Rapid notification and evaluation of AEF information followed by effective response * Adequate education and training of the key personnel, * Welldefined standard operating procedures to ensure clarity, uniformity and avoid duplication of efforts * AN AEFI database for comprehensive analysis at appropriate levels ‘+ Timaly investigation and complotanosa of roporiing ara the ortcal indioators of a tunetioning AEFI gystom in tho district corporation. ‘¢ Zero or no reporting of any non serious AEFI case In the district or a block or a ward Indicates poor senithty. 6.4 Roles and Responsibilities of Key Players: ‘The AEFI surveillance system involves a network of key players listed below 1. Subcentre level a. ANM, b. Anganwadi & ASHA. Health Supervisors 2. Private sector 3. PHC/CHC/Comoration/Ward/ Urban level: Medical Officer 4, District level: CMO/ DIO 6. State Level: Director FW/ State Immunization Officer 6. National Level: Assistant Commissioner of Immunization Division, MOHFW Their roles are outlined below. Frenennsienoenn6.4.1 Sub centre Level ANM ‘* Follow best injection practices including recording the particulars of the vaccine and diluents before beginning of the Rl session(e.g. manufacturer name, manufacturing and expiry date, batch number), * Provide a list of children vaccinated in session with the AWW/ASHA and request them to be alert, follow up and report AEF Is (if any) to the concemed MO. * Treat mild symptoms like fever, pain and refer other cases to MO (PHC) or to appropriate level of care * Provide immediate first aid and refer AEFI to MO (PHC) or to appropriate health facility for prompt treatment and report serious events/cluster of events immediately in section A of the FIR form to the MO (PHCYDIO. «Report AEFI details in the monthly progress report. A NIL report should be subrnited in case no AEF is observed. Detailed notes on reported AEF Is should be available with the ANM. * — Assistin investigation of AEF Is and take corrective action in response to the guidance fromthe MO{PHC). Anganwadl & ASHA * Post vaccination - follow up with beneficiaries to identify AEFIs. * Inform the adverse event immediately by telephone concemed ANM, MO etc © Assist in referral of cases * Assist the team investigating the event © Support in building community confidence Health Supervisors (HS) * To supervise and provide hands on training to the ANMs / vaccinators in the field. * Monitor the community for adverse events during their supervisory visits to immunization sites or sub centres. Also monitor and ensure follow-up of beneficiaries by health workers. © Encourage the Health Workers to report AEF ls. * Analyze the reported AEFis in the sub-centre monthly reports and keep track of Health Workers who have not reported any AEFI over a period of time. Prenenesienoenn© Assistthe investigation team in conducting the Investigation. 6.4.2 Block PHC/ CHC/Corporation/Ward/ Urban Health post Medical Officer In charge Detection of AEFis * Train staff in detecting, managing and reporting of AEFIs and differentiating between non serious and serious events. Encourage the staff to report AEF Is. * During investigation, enquire about any recent outbreak of disease /iliness or any death in the community which may or may not have been related to vaccination. Management of AEFls * Clinical case management of AEFI and referral to next level f required. «Ensure availability of emergency drugs and medical equipment to deal with an adverse event. Regularly check the emergency kits (functional status of equipment and expiry of drugs) Reporting of AEFis: «Ensure reporting of AEFis from sub-cenire to PHC to Districl/Corporation. Ascertain that NIL report from ANM gets submitted only after an effort o look for these events in the chikiren recently vaccinated. © Detailed nates ofall reported (non setious and serious) AEFis by Health Workers ‘should be recorded in an AEFI register. * Conduct timely investigations when cases are notified, completely fil up the section B of FIR and should justify if he disagrees with information in Section A and submit the same to the DIO. © Maintain quality (e.g. good clinical history, pre and post vaccination health status, community investigation etc) during investigation and documentation (when completing the FIR, PIR and DIR). * Ensure adequate supervision and monitoring in the field. * Communicate and share the results of investigation with health workers and the community wherever warranted. Paes sienoenn6.4.3 Role of the private sector The private sector in India plays an important role in providing of immunization services. © Inrural areas, sometimes they improve access to basic vaccines fill gaps in service delivery and are more flexible with timings and approachability. + Inurban and wealthy localities, the private seotor functions as a provider of new and underutilized vaccines, quickly adopt new vaccines and technologies before adoption by the public sector, ‘Thus AEF! detection management and reporting by the private sector is important to ensure timely and complete information about both conventional vaccines as well as new vaccines, and technologies. The private practitioner is encouraged to report AEFI to the nearest goverment health care facility or the district immunization officer. The FIR form could be used for notification of cases (Fig 3.2). 6.4.4 District Level cMO/DIO Pre event * — Establish a functional district/corporation (or local bodies) AEF! committee with defined Terms of Reference and responsibilities. * — Ensure adequate documentation of AEFI system is maintained and available at the District level. This should include contact list of AEFI committee officials at various levels, terms of reference of the AEFI committee, line listing of serious: AEFI cases, completed reporting formats (FIR/PIR/DIR) and their supporting documents, spot maps and other AEFI related communications such as letters, government orders(GOs), bulletins, State AEF! committee meeting minutes, feedback, vaccine sample results etc. © Establish sentinel surveillance for AEF Is, coordinate and lead activities related to AEFI detection, management and reporting in coordination with District AEFI committees. + Ensure that personal contact details are shared with appropriate staff in Government, autonomous bodies and private institutions undertaking vaccinations. * Ensure availability of adequate reporting forms (monthly reporting forms and FIR) and logistics to prevent AEF Is due to program errors Fae ssenoenn» Ensure AEF! guidelines are disseminated and staff trained and sensitized to detect and respond to adverse events on time. * If possible, identify nodal persons in institutions for reporting adverse events. ‘These can be the same persons who are presently supporting AFP and VPD surveillance. * Review data, analyze AEFis reported through HMIS/RIMS and other reporting channels in the district discuss AEFI surveillance as part of the monthly MO meeting and share feedback with State and block PHC / CHC in district. Event * Investigate all serious AEFIs immediately, Confirm the event reported by the MO, complete the FIR and recommend detailed investigation as indicated in chapter 3 “Reporting AEFI". Coordinate with the district AEFI committee and initiate the process of First Investigation and submit the details to the state and national levels within 24 hours of notification. + Ensure timely management of cases in district including coordination with local hospitals laboratories from govt. sector, medical colleges and other private hospitals to deal with any referral’ testing or other procedures following AEF. Post event * — Complete the preliminary and detailed investigation as per the stipulated timeline and coordinate with the district AEF! committee to complete the documentation and submission of the details to the state and national levels: * Coordinate with laboratories undertaking sample testing and share the conclusions and results of investigation with appropriate levels. «Within a district, a corporation should be considered as a separate entity for AEFI reporting and investigation. It should have its own independent AEFI committee. For AEF! surveillance the Corporation Medical Officer (In charge of immunization) should be considered 4s equivalent lo a DIO in a disticl Afler investigation, the Corporation MO should send the details of invastigation to the state forfinal causality assessment. Frenne sienoenne6.45 State Level Director FW / State Immunization Officer and drug authorities Pre event * — Coordinate and lead the AEFI activities in the state as the nodal person. © Establish a functional state AEFI committee (including state Drug Authority) with defined Terms of Reference and responsibilities. © Maintain AEFI related documentation at the State level. Avallable documentation ‘should include contact list of AEFI committees, the terms of reference of the AEFI commits, line listing of serious AEFI cases, completed reporting formats (FIF/PIF/DIR), case summaries and their supporting documents, spot maps and other AEFI related communications such as letters, Goverment Orders. (GOs) etc. * — Ensure the national AEFI guidelines and reporting formats are disseminated to the programme mangers and other staff at the district and sub district level and ensure that there is a plan to train the staff at periodic intervals. © Assist in responding to AEF and support the districts in investigation, when requested. © Strengthen AEFI surveillance in the state using the existing surveillance networks. Encourage AEFI reporting from government and private sector and encourage ‘submission of nil reports. Ensure effective AEF! monitoring and supportive ‘supervision. © Review, analyze AEFIs reported through HMIS/RIMS and other reporting channels in the state and share feedback with Government of India and the districts in stato. * Monitor reported AEFI data for potential signals of previously unrecognized ‘signals and vaccine related adverse events and make recommendations for further investigation. » Review AEFI during state and district review meetings and workshops. * Provide feedback of observations and recommendations of State AEFI committee, specimen testing results etc Event * Check if similar events have occurred in other districts by review of data, coordinate with the DIO{s) and provide technical assistance (e.g. specimen collection and shipment, handling the media etc) if requested for First Investigation. Pace csenoenn© Coordination with other state departments such as state drug authorities, hospitals /laboratories, medical colleges and other private hospitals to deal with any referral/ testing or other procedures following AEFI. « Ensure that the state communication plan is activated to handle any crisis Post event © Engage the State AEFI committee timely for final conclusion (causality assessment) of the reported serious AEFI, Ensure the completion of the preliminary and detailed investigation as per the stipulated timeline and coordinate with the district (and state) AEFI commitiees to complete the documentation and submission of the detalls to the national levels 6.4.6 National Level Assistant Commissioner of Immunization Division, MOHFW: © Review overall pattom of reports and investigations, revision of guidelines SOPs, maintenance of National database of serious AEFI cases and providing feedback to the states. * — Conducting periodic evaluation of the AEFI surveillance system of the country. Arranging and co-coordinating the meeting of the National Expert Committee on AEFI on regular basis. 6.5 National Regulatory Authority (NRA), State Regulatory Authority (SRA), & Central Drug Laboratory (CDL- Kasaull and Kolkata) AEF is a vital functional component of the NRA (National Regulatory authority) essential ‘ot only for assurance of vaccine quality in the country but also for praqualification of vaccines. Core functions of the NRA are * — Marketing authorization and licensing activities, * Post-marketing surveillance including surveillance for Adverse Events Following Immunization (AEFI) © — Coordination of Lot release process, © Laboratory support, * Regulatory inspections of Good Manufacturing Practices (GMP) * Authorization and approval of clinical rials of vaccine. Paes sienoennAdditional roles of NRA, SRA and CDL (Kasauli and Kolkata) * Technical point of contact for vaccine testing - receive vaccine samples or iniliate collection of samples (SRA/NRA) © Advise on vaccine quality and testing (NCL) * Control and release each batch of vaccine individually, including recalling ifnacessary (NRA) * Evaluate and monitor vaccine performance including safety. (NCLand NRA) 6.6 Performance of the AEFI surveillance syatem 6.6.1 Performance Indicators ‘The AEFI survelllance system needs to be regularly reviewed at all levels to ensure that the system is sensitive enough to identify and respond to AEFI rapidly. Some of the key indicators that help to monitor the system include * Timeliness , completeness and accuracy of AEFI reporting + Percentage of AEF! cases reported in Time * Percentage of serious AEF! cases investigated on time using standard formats with complete documentation. Number (%) AEF! cases being investigated and FIR completed and sent by the district within 24 hours of notification * Number (%) AEFI cases being investigated and PIR completed and sent by the district within 7 days of submission of FIR © Number (%) AEF cases being investigated and DIR completed and sent by the district within 90 days of submission of FIR: * Number (%) AEFI cases where final classification including causality assessment by State AEFI committee is completed within 30 days of receipt of DIR from districts * Number (%) AEFI cases reviewed by National AEFI committee following receipt of reported AEFI cases from State at National level * Number (2) causalty assessments done for the reported serious AEFI cases by the ‘State AEFI committees and forwarded to national AEFI committee * Response to AEFI by the program particularly those related to programme error Prenennsienoenn6.6.2 Analysis of AEFI reports Itis essential that both non serious and serious AEFI are reported. This is particularly importantin states and districts that are now rapidly improving thelr immunization coverage. In addition to basic time, place and parson analysis that should be done by the district and state program managers from the data received, key analysis that will help the district document efectiveness of the AEFI surveillance system include Number of AEFI reports received monthly (serious and non serious AEFIs including clusters) Classification of reported AEFI by types Classification of AEFI by antigen Classification of events by causality assessment Unusual AEFI 6.7 AEFI secretariat With the establishment of the state and the district AEFI committees, voluminous data Is being received at the national level. It is essential to collate, analyze, interpret and respond to the same to arrive at a logical conclusion. The National AEFI committee recommended that the AEFI secretariat should * Coordinate activities with Immunization Division, NRA, CDSCO, CBHI, E & | Division, and NCDG, IDSP, WHO/ NPSP or other partner agencies. * Liaise with State/ District AEFI committees, different Central Drug Laboratories. + Assist in surveillance, response and follow-up of serious AEFIs and monitoring of unknown AEFIs: * Coordinate with States on causality assessment exercises «Ensure /follow up on timeliness & completeness of data. + Ensure Data collation, compilation and analysis. * Design, develop and implement analysis tools. * Provide feedback (program relevant inferences). * Oversee documentation & publication. * Liaise with National & Intemational agencies. Frenne* Facilitate activities of National AEF! committee (including administration & logistic ‘support). + Facilitate National, State and District level workshops and trainings. 6.8 Liaison with the police and the district administration Police officers and the district administration workin partnership with the public. They are citizen-focused, responding to the needs of individuals and communities. Some of their important priorities include maintaining law and order, tacking antisocial behavior, reducing theft, robbery and crime, supporting victims and providing a reassuring presence in the community. ‘Therefore serious AEF! resulting in death will also be investigated in parallel by the police and the district administration to rule out any criminal intent for the event. They would also be participating in the process of investigation, conducting autopsies, collecting specimens and testing the same in specialized laboratories. It is important to remember that the goal of the district AEFI committee, the district administration and the police are identical i.e. io arrive ata conclusion on the cause of the adverse event that resulted in death. The AEFI committees are therefore encouraged to invite the police and district administration to participate in the AEF| investigation planning meetings, visit the sites together for investigation, and jointly collect specimens as far as possible, However, itis important to consider that the protocols for different agencies investigating the AEFI will be different and therefore the investigating officers need to handle the situation tactfully ensuring coordination between partners and stakeholders. They also need lo be updaled on the findings as the invesligalion proceeds logically to ils. conclusion. PresenceChapter / AEFI CommitteeAEFI Committees Chapter? AEFI committees are established at District, State and National level. ‘The objectives of AEFI committees are to strengthen AEFI reporting at alllevele, ensure maintenance of national policy and standards, and ensure prompt and thorough investigation of serious AEF. Periodical review of AEFI for trends of Non serious AEF Is reported through HMIS/ Routine immunization reporting/ RIMS etc. Experts in the committee will help in timely classification and assessment of causal association between the vaccine and the event. AEFI committees provide technical inputs to review the factors leading to the adverse avent and provide inputs ta improve the system to provide safe and effective immunization. They are NOT intended to blame any heatth facility’ individual. 7.1 Composition of the AEFI Committee The representative of the following specialists, programme officer, professional bodies should constitute members of the AEFI committee and the Immunization programme manager should be the member secretary. © Epidemiologist / Public Health Specialist © Representative from drug authority * Pediatrician, * — Microbiologist, + — Neurologist, © Pathologist, * Forensic expert, © Coldchain officer,* Member IDSP, * Representative from local bodies like corporation « Members from professional bodies like IAP, IMA * Representatives from partner agencies can be on panel as ex-officio members and should be invited, when required, Other members could be inducted as desired by National, state / region or district committee. If possible, the preference should be given for specialist working in medical collages a part of the AEFI committee. 7.2 Terms of reference for AEFI committee at various levels 7.2.1 District AEFI Committee Every District must constitute and establish a functioning AEF! committee with District Immunization Officer as member secretary. The members in the committee should include from the locally available resources persons representing the above mentioned field where ever possible, The concem Block Medical Officers (In charge) where AEFI has occurred could be the special invite to district AEFI committee. The committee to meet once every quarter or earller as per need as per the following terms of reference (TORS). © Analyze the FIR and plan for investigation of the AEFI as a team. © Provide appropriate information to the drug authority on the important aspects of temporary suspension of the implicated batch of vaccine/ logistics. » Prepare DIR based on the finding of the investigation of the AEFI. * Outline the further course of action on the current AEFI. * Analyze and review the quarterly AEFI data for any programmatic errors and remedial measure for the same. * Participate in the State/National AEFI committes meeting if required for casualty assessment. ‘* Monitor and analyze non serious AEF! data every quarter. * Tosupport the spokesperson for media communication © Where needed facilitate in propagating the massage of reporting AEF! from all sectors (including private sector).* Monitor the timely submission of completed investigation forms (FIR, PIR and DIR) along with supporting documents/medical record et * Communicate and share the conclusions and results of investigation with health ‘workers and the community where warranted. © Any other responsibility in context to vaccine safety that the committee would like to add. 7.2.2 State AEFI Committee ‘The Immunization Officer of the State willbe the member secretary in Siate AEFI committee. ‘The preference to be given for speciallst from medical colleges tobe inducted as members of the committee and the concer District Immunization Officers and other members of the district AEFI committee where AEFI has occurred could be the special invite. The committee to meet once every quarter or earlier as per need as per the following terms of reference (TORS). * Deskreview of the FIR, PIR and DIR for causality assessment. * — Inspection of the site visit and interview with the parents of the AEFI case and also Interview of the Districts AEF! committee members, If required. © Analysis of similar cases or clustering of cases in the State. * Periodic review of the data base of AEFI case. © Tosupport the spokesperson for media communication 7.23 Natlonal AEFICommittee The main role of the national AEF! committee is to + Toreview the State AEF! committees report on a periodic basis. © Assistin finalization of the AEF! bulletin. © Assist the state AEFI committee when requested Four sub committees would support the activities of the national AEFI committee, they include 1. Causality assessment sub committee 2. Operational group sub committee 9. Investigation sub committee 4, Media management sub committeeChapter Vaccine Risk communication and Handling of the Media Dec io ett LyVaccine risk Communication and Handling of the Media ChapterB ‘The media is an important gateway to inform the public and shapes their view and attitudes towards vaccines and immunization. Inthe long-term, building partnerships with the media ie key to keeping the public regularly informed aboutimmunization, the benefits, and to motivate families and communities to make use of immunization services. The mediais likely to publicize events where there are deaths or AEFI, where the national press has unearthed “ominous facts’, or where they have obtained information before the health professionals have done so. Health professionals may become the centre of a crisis ifthey are accused of not having done their job property or were found not to be truthful. It will be useful for the AEFI Committee/immunization program managers to be prepared with the most useful ways to communicate with media during an AEFI. ‘The media likes: a fast response, accuracy and simplicty, statistics with explanation, context (part of a wider picture), comments or explanation from the highest authority possible, and both or muttiple sides of the story. ‘The AEFI Committee/Immunization Programme Managers may follow the guidelines given below for effective management of media during. crisis. 8.1 Advance preparedness Effective communication with the media includes efficient coordination with the field staff, a plan, trained personnel, a budget, and practiced responses to potential issues around AEFI. It should be in place before an immunization campaign starts and as part of the on-going communication support to routine immunization programmes. A good media plan consists of the following: ‘Vaccine Risk Communication and Handling of the MedIA database of journalists: list of print and electronic media joumalists covering health (local, national, intemational) with contact information. Always use a database where updating can be done immediately in the master copy. Mention “updating date” somewhere on the page or the file name for easy recall. Update quarterly any changes in the media list. Information packages: Keep media informed through email or hardcopy by sending regular updates on any plans, programmes, decisions, etc, Sensitize media about health aspects like benefits of Immunization and its impact globally and nationally. Prepare monthly or quarterly updates. ‘Aninformation package may contain the following documents both in hard copy and stored on a CD: Frequently Asked Questions (FAQs) on immunization in general, for specific disease, and AEFI; Fact Sheet or a Technical Brief on a specific vaccine preventable disease; Recent updates — progress made in India and outside —and a few case studies; graphs and illustrations; photographs; contact addresses of spokespersons (experts) that media can talk to, Please rememberto check and permanently remove all old and outdated material from this information package. Draft media release: ‘The draft media release must specifically answer the 6 W’s for journalists: * Whois aflacted/is responsible? © What has happened? What is being done? © Where has it happened? © When did it happen? © Why did it happen? © Willithappen again? Mention the name and contact detalls of the AEFI Committee (on the top), and the name and contact details of the spokesperson (the AEF! Committes may also racommend another name such as a medical expert) for further details should journalists have more questions (at the end). Keep these ready. Mention a “for more information, contact AEFI Committee” (with the relevant persons name) at the end of your communication with media so that the media can refer to the relevant person in case of any queries. 2 [=|Information specific to media characteristics Local media: May have broken the story. Read and believed by more people in the community than national media. National media: Seen by goverment and national opinion leaders. Has a wide reach and influences national agendas. International media: Seen and read in headquarters of Intemational organizations. Has resources to produce investigative reporting. Can influence national agendas. A spokesperson system: |dentify in advance an appropriate spokesperson (or several spokespersons in the different agencies). Share contact details of spokesperson(s) before an immunization campaign starts with all concerned focal points at the district, state and national levels. This limits the possibilty of conflicting messages coming from different sources. Ensure spokesperson(s) has experience or some training in dealing with media. Orientation workshops and fleld visits for media: Regular orientation workshops and filed visits for joumalists will help them achieve a better understanding of immunization advantages as well as the complexities of an immunization programme. Orientation workshops and deliberations will also help to identify in advance the kind of questions or concems that joumalists specifically have. Always take note of all proceedings and discussions with journalists. This will help to be prepared with appropriate answers when required. 8.2 Media Management when an AEFI has occurred While every single AEFI must be investigated in detail, all AEFI cases may not be crisis situation. Acrisis often occurs from inaction rather than from taking appropriate action on AEFI. Monitor-media: When an AEFI occurs, substantive inaccuracies can get reported; for example, regarding the number of AEFI cases, gravity of the case, allegations of negligence, or simple rumors about vaccine procurement. The AEFI Committee should move very quickly to correct them, because the longer misinformation remains in the information environment, the more 2 [oe |difficult it becomes to correct. The AEF! Committee could take the following immediate actions: * Analyze rumor, Its level, and potential to cause damage. * Anticipate how situations might evolve following response; prepare before responding. * Deal with a simple mistake with a simple solution. Ift is an Isolated error, make a polite call to the reporter and offer to help the reporter with correct data and facts then and in the future. * Ifthe rumoris confined to a small audience, correct it within that group only. Ifthe error is widely reported, you may call a media conference to present the correct facts before it leads to further damage or proves detrimental to the programme goals. Plan howto prevent future rumors. Prepare messages: ‘The best messages get to the heart of the problem without lengthy explanations. Listeners. and viewers remember that one key message if they remember nothing else. Try to repeat the message at least once during an interview with the madia. Far instance, here are two effective messages on immunization in general: © Immunization is the most cost-effective health intervention. © Immunization is the right of every child. Some more examples of messaging specific to the situation * Benefit of immunization in preventing disease is well proven. © itis vary risky not to immunize (risk of disease and complications). * Before the introduction of vaccines, vaccine-preventable diseases caused thousand ‘of death and/or disabilty. That situation would retum without continued use of vaccines, * Vaccines do cause some reactions, but these are rarely serious and hardly ever cause long-term problems (have data ready and available to substantiate this fact). * Wehavea well-established immunization safety surveillance in place. Immunization safety Is of paramount importance, and even the slightest suspicion of a problem is investigated. © TheAEFis currently being investigated, but Is likely to be coincldental/due to a local problem (depending on type of event), and the immunization programme must continue to keep the population safe from disease. 2 [osPrepare a media release: Anetlective media release should include: * Acomplete account of the event, framed in its context (e.g. an isolated event or a luster of AEFI, or coincidental event). The media release must specifically answer the'6 Ws’ * Keep media release free from technical jargon. © Anoutline of actions taken or planned (such as the AEF! investigation). * — Adescription of the cause of the event (but only when this is known with certainty). * Anassurance that corrective action has been taken or will be taken. © Reference to any relevant publication, video material or web site. * Sender's name and spokasparson's details. «Limited to one page of matter (400-500 words max). © Short sentences (not exceeding two lines). = Quotes from key officials may be used after seeking their permission. The quotes. must be positive and cany the key messages. © Key message(s) are repeated. Call a media conference: Media conferences need to be used judiciously, as there are also dangers, especially if preparation fortis weak and the journalists are assertive (see Box 1 below). Especially when different stakeholders will be present, everything must be planned well in advance. Media conferences may need to be conducted if AEF is being reported extensively and widely and there is a need to provide accurate facts and de-sensationalize the story. A media conference enables all journalists to have the same information, thus there is then less likely of event being ‘sensationalized’. Consider the following steps when preparing for the media conference: * AEFI Committee takes the lead but identifies who facilitates the press conference. * _ Ifthere are several members on the panel, agree beforehand on the key message(s) in response to the AEFI. © Agree on roles of each panel member beforehand, including the type of questions (media, political etc. each panel member may best handle); 2 [|* Panel members must avoid contradicting each other in the press conference unless itis critical to clarify something incorrect that has been said. Have a media kit ready and share it with journalists. The media kit may consist of a media release) with all the essential information, supplementary background Information (e.g. on the benefits of immunization) and a set of frequently asked questions (FAQs) about immunization. 8.3 Post-AEFI actions Keeping promises to the media: Iithas been promised that media will be kept updated about the Investigation findings, make sure the media is updated by the promised date. Ifthe findings have been delayed, ensure the media Is Informed because they would be expecting answers. Providing answers to unanswered questions: During media conferences, If a question could not be answered for any reason — for example due to absence of data, orf you were unprepared to answer the questions — get back to the media with the answers as soon as possible. Keeping media intormed about eubsequent developments: If any decision or action is taken at the highest levels following AEFI investigations or during the investigations, and the public must know about it, Keep the media informed though a press release or hard copy document. ‘Some delicate questions that the spokesperson needs to be prepared with answers (questions documented from the field over the last few years) ‘Why does the government provide vacalnes which cause bad reaotons/death? ‘Why don’t health authorities train vaccinators so that these accidents are avoided? ‘Why are injections for vaccines and other medical procedures stil dangerous in our state/country? ‘Why are vaccines still given whlch damage our children with serlous side effects? ‘Why parents are not tod the truth about vaccines? Is there something that is being hidden? Questions on specific vaccines Has there been episode where children dled after getting reconsttuted measles vaccine? ‘Doss OPV {oral poliomyelitis vaccine) cause paralysis? ‘Why should our children get OPV and risk paralysis when there are hardly any pollomyelitis cases in the country any more? 4._Are vaccines contaminated during the manulacturing process? 5. Could this vaccine have catalyzed a reaction if not caused, that led to death of child? eyo 2 [|AnnexuresTE FIR : Page 1/2 FIRST INFORMATION REPORT (FIR) iam raporsing the AEFI ene anne tz MO - Immmacttntnty) ing Iomnasition Death / Hospitalized / Guster” Disabiity Distt _ ~ Dacian,” Tine ai orapanng ime hone —=~SSCARET PRE | ne sete Ba weft ete) ay | [as civeccnsins 7 Tine tava Py | om sce eres taeotite semiea | > [TT ia Dect Sil Hasta +7 7 EEE TT irate {Aguiar al armaton Sate Hiv Bb ERE HA Seouon B FIRST INVESTIGATION RFPORT (FIR) (To be comptntes by MO ve HOw atin 24 ours of AEFI (Only for Serious Adverse Events Foftowir ization) “AEFI Case 1D {ia be assigned! by O10); mam {aE} Seta 1 SRS wee | Reporing Mesa Dicer or i.e ~ "eof ing BY i | Paseo a Desigeion Mallet Foxthh, i [itd Line (with STB Cosi) = ‘fae faformad By | Ne Taurean 1 SEeLO8 A, [hae ofa Sie of oresion Dato Yassin (Fao onsetPIR: Page 2/7 (nein no tvoaef ETT |" [orien i (Var ad Aas hw ° | Tine eee) Cath Sted Rovmoen 8 chad a Faia Walia Ree baa) mites EP Di fgeatian PPE LT “Testrotan doe? eure Yao Pango a Teale 1 each apo (fava th FR ‘elas of eoecig, MRIS & Vlei gv the gti ‘(te es wtrwisteed entre ume Te ose act Wy Doren Ike 1.2%. 2, Snowe a ay oT Yeccinetvi-A/Divem | *Dose Name ofManufacturer | Batch No. | Manufactuing | Expiry Admiistored | Gn BLOCK ators) Date ace _ i cH DRE T “ones ‘Pac fascia Hea Foch Pea Pa AE Pay Ot Session: 6 Aoume/ DINE ‘ata msnvr ol bsmpicartes imam 2 gst hig, ean eee rose Muvber et eter bene rice who recived vaccine fo tho SAKE ta _Siaratre al Meporing Mada etsor [thet Nodal Perso (Ocerterwending hs repo) i | Nit25 ese ac smnann BHP ees nienenee Desrter | [hoo eeseamsene w we LANEME HBSTE CO san att ' ! fesse ct v Gorrplete Dice ado HA 79 GMB) ssn sect an ! be strain’ |PIR: Page V7 ae PRELIMINARY INVESTIGATION REPORT (PIR) (Te {Only for Serious Adverse Events Following Immunization - Death / Hospitalized / Cluster / Disability) DIOIRCHO/DIstrct Nodal Ofcer to compete al detlsin BLOGK teers only [a - Case 1D MD Mery] SESE 7 RR TI 7a Bloch Ward Wilage/ Uroan rea Place of Vactnation encircle) = Govt Heal Fas! Private Heath Fecity/ Otber Speciy | vaccination in (ence): 514 Routine Typo site ence) Oureack/ S0/ PHD / CHC / PHC/Dist Hospi Ste Hosoi Media Gotuoe Otte spe, —_ si ~ orcad vo State & Gol wienin J gaye of eusmisting FIR) at Pastet at | Mobile Now: Fox No. { "ser i AC a (Dae ofr I [Fathers Name | | Motters Name Lt Lit it | i | cl { = dat — | an ity 7 feyetopayer-f or] i ci aos mitt 6 alta tal ne fou Hr cect we nus ot as VaccineAI-AMDiMent | * Dose Name of Manufacturer | Batch No.| Manufacturing | Expiry ‘Administered | Gn BLOCK Letters) Dae Date t I fr Tandatks (Stat nae, fuse eum, go, | I L ‘Bok TG, Fin eth { | aS T Measles Divert (nthe doves adrsted eau wie the dose ieonved by beefy he 1” 2 3 bostr and ay ther Dataof Frat niomation| [||| {” ate of nary = | ties [F TTI] te often ea “Time of eet symotam | | (a [_] ire Hospi Datoof fist seem Dateottnspisasion | “| Guicame icice)———Deatn/ SiPIR: Page 2/7 Hama Case kd Mucmber IND (AEFI, SCOR SS Past iat event Reaction aller previo race He ale Preventing ness disorder “ro hospitalization in ast 30 days with cause Recent Ho trauma wih date, ie, site and mode For eciet women + Currently Preacart?™ Yes fo _Sumerly Seaartecsing yes Mo “Fart stey of wy disease or aeay Yes/No : + Nats nstory = Ful term pre mahi post dated + Sateosy + Normal /Ceasean Assisted bith ny com ptcirion ee ie a ‘Was the pation! ov any concuertrmedicaton for ‘Yeo / 8a Unkoroum any ines [ites : name the crus, indication & Doses) “Instructions ~ Aétach eopies of ALL available docameals and thes complete additional laformalion WOT AVAWABLE Inevisng documems (case sheet, lscharge summary, cese notes, past mortem reacts a)... | Baier! as cakcr meckcat erie» Atach copies of ef avaeble documents (inlusing Case sheet dischanye sunmmayy, laboratny reports and post mortem reports - I evaliable) 20 Compete ony aceMlona, unayavdl formal Delow +H patent nas at ten snedical care ~ Gompt is form ly 1m any at me document(s} mentioned above, the same may + sige investigate nas disagreement with dhe facia 4e expressed hore with usieation Suge ol rdormetzn Grae enw any): Examination bythe investipatar/ Documents Verbal avegsy/ ter on Nesne of the porcor who frst exarama Uw chi {Yo vert aot lease meni the suite asomn : ‘ther sources ispeisd Signs and Symptoms bs Chrenalagicat order, The einical details below ane filled xp by, Designation Dats and find of eased ot 181 epmnploms Bate and time o) axainaon ing 2g er fv santo thot eve HOT sere Inthe avalale documents ar ifthe mestigesor cisagrees ‘win te ingcemngtn dycumented slease second details (wh justification? here Consciousness Alerts drowsy Unconscious ober (sues Deseide . ra Fuse Tempest Respuatary rate ep skla Rash ! ovanosis / elechiae J ator / icundiee 7 cers (eoeclfe____ Describe: Eves: Vision: Narra? kepatrod Pupil Nowmet Constrcted / Dilated ¢ Reactmg to lit Hazing Speen omisi/ Impeirao (Dasone) ¢ Abnosmal (Bascnbe}PIR: Page 3/7 Case Wd Number fick Neck Silos: Prosent / Assan Chest Auscultzion Noumal reps / Rrenchi Hear sounds ‘Normal Murmur (Beceribe Raspiratory Noni / Cough { Shortuess ol teat! ethers (spac) Describe: a Pain abdesnen / Voiting jcigamea aysertery/oters (specty) Deserve < apcamer Normal / Distendes Tender Liver: ot palpi} Papal paable specity sie) Shieen; Not pagal’ Palzabie (I paiablespwcly size {Bese Lins Tone + Unger Limbs Normal increased Decreased + Loner Limbs Narmal/ increased / Decreased Fatlexes + ess omel /tncoaned J eoreased # Aboot + Wicaps Norra ineease /Decreased/ ADsont + Supmator ——tnvmsl Irereased / Decreased / Abseat Plantar - Esarnsoi / Flexor ‘Any elnor aonaranal signs, Teaiment arovided. Provitiona diagnosis, Aad additonal rages if eedPIR: Page 4/7 — ase Wi Number Ho (asry/ OT mace + e/a Niribar af beretetaes eee | 3 irimunized session at, Bai {DPT | DET brea pera torrad ory: lopez sxact reo saa ot | 5s am-OT PTT | Wo | | ! 42) Number of beefs Inrmunized fom the imxieates vaccine vavampeule 1b) Whe as Ue pati reno? = _Witen the fast vaccinations ofthe session With the last wacenatios el the Rl session / Unerwe ‘Win the first few cosas oft vial aavirietred 7 Whine doses ofthe vial adinesterad Uninc “¢)_ umber ot CTHER aenet 1} Nurnbar of OTHER tanalicirins imrvurizel wih tha implicated vaccing awicg the same buh umber in he PHC CHC /distret hospital otter nealinn specify vas 8] ISitds case apart of aster? 7 Yes/No + tyes, (law many che cases have been dectac inh chister? + Did ail to casos revolve acc from the same vil? + HENo, hurrbor of vials Inplicatod Temp soot ser 6) + une! ices abi, i agi lave? vee | he gabe on er hn acts a nth Wea vest No st, FosOMsH ho WA? 7 Yes No ation ape no wo VEE inggT CA WOES Ws = Unusable sues lesaied, amytachire not msieyet, seth, Tindiags addons? on er ions and corMnente: = Tyas of vaneine carer used = Warcine carr sent o Tho su on the sere day ol vaccination?PIR: Page 5/7 pan oe li i in a eee Ee ernges ITE Raconsttution: (camaete only F apaicable, write NA Hoot appliaey + Reconstuton procedure (ence) ‘Sane recension syringe use: to mailed of same vreine? Save ounsuion syringe use for reconsbting decent vaccines? ‘Separate raconaituion syringe fr each vaccinia __ Separate constitution sync tr each vee? ns te same manlaener? [Space key findings/acdtional observations ard corners. Ingcton technius:(Geserve another sessicn in the samme fsalty - same or erst pace] + Gorrectdoscand vite? _ No ‘Siti of x sain t pate ie frock) ‘Status of cold chain at presiramar fea) “ifit complies with ALL criteria in section E “Last varcine storage poinl" ‘Additiona observations anc comments: Any Sima events reported recentiy inthe focalty? Yes /No Yee, Deseribe trae, How any vents sno Of thowe olfactad, How many ate + Vascinatad: + No. Vaccinaled + Uae,PIR : Page 6/7 Gase ld Number IND{AER)) “Or Siew vem Beate a). Distict AEF commitee review relat 1F¥es then date of eve by dist AEF cornice 1) Any inpilicatel simples sent Jor testing Totawing District AEM committee eeaew? ‘Dati of Vaccine? Dluentsampies sot to ODL Kasaull ead Bath no, Lot , cpt | ye SAREE nansot| yualEny| nL | ome en Name | Quennty’ | eaiey Dota o Syringa/ Moa samples sent ty COL Kolkata : Bach no, Lot Tweol Bach ap, Lot a0, Syinges | Wnty | “hu, caté of Date Sant | Typaaf tances | Pati spp” | Date Sent )_ Any beuical product (C8F, Blood, Won, ete) sent tor testing? Wives, Spocify dct uf the ab, attach copy ef raport dl available Yes No tenet 228 eo si 2 ary eee eel aru OS, Sar Drees Was Goes lechry aukltional samples? Probable underhing causa ofthe adverse event “gpa af Adverse Frent species aon ager an rogers Esor a Reaction cesimanary tinings {encircle} ‘Speerte masons for suspecting the above: Corrective sctivisrecorimendations: Wm otis tga mela te veel ues mst sori rood nial DAY och tio coe the ‘ormabon mba Mate WEEE SE We Seapets BE BMG yee! Heres Yau AE WAN UW espePIR : Page7/7 Imoqaerys Tower Saree Name Case I Number Attucned aoaies of reports /ceeurmonts te wi this FIRE Name one # ‘anature ame on Destonanc Dare of eulynisswn fa Slate? narnal level Mabie Wo A arsting Qty STD 668) ae eee Fox No Ema ia 1 Pemeletn Ofea aarass (it pi eat). Signature non lease ensure tka this PIR Toin (AP 7 pages) sete: Soite Imupization Oiicar & Assistat comm songs (HIP), Immunization dvsion of Gout of India, MOHEW, Nirman Bhgsan, Nese Dail T0708, Faro, - O14 B9G62720 o¢ Emails satan een lrnportant Leboratery Adresses: ‘Gard Vaconss and Dnusist) Seid vances and Divas Jevd Vanerea a DEMS Bi Kapaa TOL koran iy snake nv Fie rector. — irectar Siren Direios ~ Cera: Drugs Lanoclory — Celta Diugs Lanoratory Che In-Crange atinadInstte of Velagy GenvalRessaren neve Hdrsty of Heath a Farmly fae al astute af Virlagy 202 A fe Ambedkar Pad, asoul~ 173208. Wolaie Govt cf ia Gorathgur Unt Pea! Boxo, TE irochal hariash ASE Shee BRD Minded Colege Camous Fue 111904 _ Kolkata 700018 Garairnut 272013. Mabarasnws Emaincikasaiteansalin Criss oubol@girelaoih Fri) cilol@gma.con Emil nbisiBend vol. net ‘Fiune: ui ezerzuan rare: u33-2226902 | ier 085 |-7508986 Pluss, 820-20127901 ha9-22 (2080 0%3.228708 13, zo-2e0ceza0 fay) O17-22/a0G9 Fae 38-20200380 ax: CSO1.2808098 Fak: UeD.2OTEBNR Osga-22 72086 Uae-222 69511 20-28 128898 facSie aml se aly Fite “han nr fez bene i vac)! ure, tn enna eos CUE 2A Suis clrdcton Oi ta calaese rloneaie eale-a he Ashe syed sucoecto ba ‘hive tasovid mate, Tho See Way ga so Sede a ef rks ey pO br Shee mstongr Oneer and Taree oer er webEOUSeE DIR : Page 15 FO fo Fi page 1 to ¢ ans SERIO tot page 46» to complete a detain BLOCK teters only Distt Case wn (ergy RSS | lock wara _ _ ‘vilaga/ urban Area Place of Vaccinatian (enctcit! : Govt. Wealth Facility’ Private Healy Faculty ’ Omar Saeaity Yaccination im (encscle) SIA {Routine [ype of ste enone) Outcach 86, THC CHG/ BPC, Cit Hezpta State Hosp Medical Galiage Cie: spect | | | Kare af Reporting Officer —_ 7 Dale of ang DI - - Designation: . Posted at: Land Ling nah STD Gra): tobie No. [eatetnmeer TT ET Td TEE =e nna om ec treo | (ETT) mmr 1] [Fates ham TT ia LI ‘Mothers Name tif I | Covrgiot Residenil Aidress ol he at, ROU a oy Dh, Ha, Hi-+H hi ate tel 1 i welll t i | Tweoflannat’ |=] T™ ‘noo ns a Lett Againsl Medical AGvice .AWA| | Hot Hooptelizod hate Dea CEE Prime ote owe tremtaonen [=p [te | |” | | * [TaneorPost mea [* Ve aes [eck Documents allached with this DIR: (Please retain the original andl enclose ONLY COPIES) - 1. No Documents, Tate of Attachad with | Remarks (if ay} ane | subrrissiuy | this docurnent? | i case response is 5 | compledon | eeckck) "No" then give L ae eee red eon iil Rabemninest tr =e Preliminary knvestigation Repost (FIR) | wes/No | ul us 2 BSN [a reso Post Morin Repert cone? casa of death) | Tinaiih nf anny PaainayAfieratitoos (Slood. | | CS Sua Uiiney ew care | Doctors presoviption/treaiment record for this AEFL | Report of Laboraioey ae oF vara Wert (Eten for resting) Coctor’spressiptiontrealmen reseed or otherness I Vo vesisn | | [Patient Marre Case Number Wn gry SAO «Shem Pee 3. | feporco Labora esutiotsrinaesotar dus Ws / fio 3 | Report of Lanny tes of vanoane dient Yes itty | Hy6s, Specify & | ef sem for weg) | alla seport, “Ficer‘e FiR & PIR (or wating the folowing case summery, Remember te molune the Tuscwing points, ad additional ‘shoe? as necessary : Doeated msm of agn2 ens syria ard irs m ote noiagal oer Adatona relevat incre parte imemanzali: ‘Sas ufiavranizaion onthe cay o! AE repaid {Cormpleted doses befure te eve: ‘Yaesu aémaniterd on the day of the event Exanenaton fxs on tet sarinsten ot aenaus AEF ease ATH fer ANNO SNS (any GOGETAE GUeTG ma BANE AN ALU ae ee Frograss ofthe yates condition, neazrentprovices anc apnosis Detas of Garment snvestvaloa f corded CASE SUNWARY Please add adutional sheets to complete. Please add addtional sheets to complet,DIR : Pages Patient Name Gase id Number ko (aR) Se" Probable underving cause ofthe adverse event: _ Vaccine | Conedental ! Iejecton | Union | ‘Type of Adverse Evont Susyccted | Programme based on preliminary nenys. enor | Reazton™ » eect | (encrcie} ‘Speuilc reasons for suspecting the adova “Corradi aelienatasommnendations: ‘arevevnt tanpeeod Bic ome to ese lew), han wats wots shoved by (10 Dt Go chan Oar fo ca Swivel 2 -rurber ef osts eased wrt Be woe @ BEER Std RDN ot nar acca wah re sispscad aia wd "Saat umber of teks sapien | Vol ariber 0 hearfriatesvaccirated Tare Gachof suspered | ‘esnien —iaeaneier | witsepete westaienn | ath syenes acs ts Sabet i pee ileor __| Advis Prea women se ee Brig. ole of subrnission to sale’ national eve arise Calls ST gota fae Ne. ‘Compete Oflioe adress ith BN COLE)... orese onDIR : Page 4/5 cose Ww mumier wo mer) ORE 7 SON Fee eo [Das ot orien ae PUTT AT Note: Stale wtcine safety (AEFI cmmits to complete causa ssc axerise ard ines the raged tu Gut wha 2 days of fag FIR Proparation for causality assessreent chuck {st far state I officer Bi 1 Lista diame coples sort ta We God ol nota | Avaiafiy fancilen | Remarks (rary) / Gino why) Fast nica Report vim) ‘Frerirary wostigaton Repo! (PAD ee Ww “he case sua compo he DR? Vers No | apo af Post Maraa Fr ‘ivtase oTdeut [Yes 78D - opt any Pathology crbiaayy (vot. CSF uray ! Tes cone tees Ne ‘inies & Duclos oreswrinonreamgnt vert yes No ogy ot abortoryReques Fa LE) Yes 5 my _ ‘ony ofkavoeloreresucoryeoonectsaTicttwstnm | Yes ¢ Na ony of ably ea oF rage ose , : tugs cena eg ves fe 40. Any other docurvent “vari to case Yos No ItNes, spaty & tart epcry Probable urdeshing cause ofthe adverse event Adverse Fvem Suspacied — Prograrime | Vavcine “Y Geincidertal | lajeetion | Unincwen ‘vases on pretinary findings Ener | Rezetiont | Reaction | (enciclay L Leal **Cauaally: Vary WBely/Gerlay Probeble-Pusstloy Unike!y¢Unretuled/Unclassiiable [P** Retr to he relevant gocionon-Re Operon! Guieines ACF Suveiance «016 MGW - Govererent of sk) “petite reasons for suspecting the above: _ emresilve acdionsy‘econenendations:Date of eview ot 7 * iba.cas rept Gah ‘aie of submieion oF | Fay evo seucpcewato a vasiotoy doer Hen eae Parks sald ba ral by DCist Cad ca Oo wcahae {oe emios estes rer oks sie ute suspic and Nueces acted il He suse ad the eonsldeizd cata ne b perind wt for bs Told murer of bane carssweccinad Wareot |” Bitenct saspeeret Tata numner at biscas supple! VacckeDtart | veccineivint ——witrsusecto vaccine’uectin | th suspected batch ne soit ie dstie! hikren ‘Ault Pag- nan ee of submission to state’ national love Landing (ty STD 2038) «sess sons FENG, sss Complete Otice adress fwith pi ence}. a. Pease arsur tat this DIR fon reaches: Assislant Commissioner Immunization Division, mmunvzaton abision of Gow. of da. MOHPU, Niravan Bhewan, New Delhi - 110106, Fax No, - 017 25062726 or Email: alindieeDgma'l com [ Date af ssp of OR for Disk Dale oF ucaipt of BR from State (voy sae utLRF : Page 1/2 AEFI - LABORATORY RE QUESTION FORM (LRF) (Te v0 comptacea by tha Drug Inzpsotor/DIO. LRF snowta Caso W wo (Aer Designation: | Lend Line (For Seraas adverse Events Fellawing immanicatn) clagory rele) Death / Hospitalized Cluster /Disaty Case tame aisatsolacimat [7 i= |= = soenime 1. Praise dosetion ofsampies: 2) Forvocrayundsspecines: i be ansperted reverse sot can) Mention Quantity Name of Manufacturer Batch No. vaccine/dilent | Sent ‘in BLOCK Lets} Manufacturing Date Expiry Date 1] For logistics specimens: (AD, Reoonsttuion, Oisposable syringes Menton Quanity | Name of Manufacturer Batch No. vaccine/diuent | Sent fu 100K ees Manufacturing Date Expity DatePage 2/2 = "The an EE Nama orAgFiCase; Case 1D 16D (AEFI 7 2 Test sequesteg™ "3, Preliminary clinica dagnasis fwortng hypaheses) of strict ALN corms: 4. Nama & completo acrass of officals to whom laboratory @sults should he sent Son tn enmplote address PhonoiFaw State Drug Contraler Slate Geld Chan Oiticer Slate EPI Oftcor District immnization Onticer «D4 mers spect) To be completed lab officials after receiving ihe speciment poy | Date of recagt of seecinen alabratary ei ec a() aTabo toy ica lab (ences vistogit or beceiohet [kb ary - Signature a Landing No Fax No. "Piso ea era Sp atc. AEA edaPage 1/2 ANNEX ; ‘State AEFI Line List of Serious Cases: State: Year : 2010 Date at | Pobabe | Vaccination outcome Cause | by Death | Tact | outs AEFI Case ID Bock! | Case | Age in Date ot | Date of iniae.s1.1.| PES | Corporaion | Name |Months| S®% | Novficaton finvestigation|Page 2/2 ‘State AEF! Line List of Serious Cases: State: Year: 2010 Probabe | Vaccination AEFI | AEFI Case ID Bock! Case | Age in Date of Date of Date of | Date of Date of - catey Dat HL) cormatn | rane [sents S| teat fivesinaton]Yaranamn | onset [OUCEM® Ges | MSE | 6 OYOO a Role and responsibilities in response to AEFis ‘Ths following tablo surimarizes the role and responsibiltiss In rasponse to @ AEFI casa, (for detals refer fo page 6 and for treatment guidelines refer Annexure 62). Situation ‘Action Peeson Timatine Village Mild symptoms ike | + Adkiso cold sponging & ‘ASHAIAWW | Same day fove, pain afar Inform ANBZHW(H) vaccination Injection Site ‘+ Adviee cold fomentation Immediately ‘Abscesses, excessive | for abscesses & Inform Crying ete ANMHW) Serious AEFL = Tato ANID Tnmediately Sub-cerre Wild symptoms like |» Appropriate Wweatment at ANM HWY | Same day fever, pain ear local level uv vaccination Injection Ste ~ Give fret -aid and refer ‘A the earlesvSame Apscesses, excessive | to PHC/CHG cay Grying ete ‘Serious AEFT ~ Give fread and immediatly TmimediotaHall nour ‘afer to nearest heath facity «Infor MO-MG of PHC PHCIGHE Injection Sie “Appropriate treabnent Wedical Officer] inate ireatment same ‘Abscesses, excessive Mowe cay Crying ete Serious AEFL “Appropriate management with Trimediate emergency drugs. «If he patent requires further specialized treatment, stabilize the patlont and refer to nearoet fcity (District Hosptel Medical College) for futher management « Inform Dietit Immuntzaon Officer District Hospital Serious AEFL ‘= Appropriate management of patent | Paedlaticlan/ | Immediate Medical Omtcer «+ Rush a team tothe sub-contey At the ears! vilago where session was conducted to find about any other similar AEFI caseBa Beetle el elmer way A ‘Treatment Vaccine ‘Vaccine associated ‘No pectic treatment available; supportive care, ow Daralyicpaliomyelis (presanting as AFP) ‘Anaphyactod reaction | Sett-Imbing, Ant-histamines maybe useful al (coutehypersensivty reaction) ‘Anaphytexts ‘Adrenalin Infection (Bee Append 6.4), CPR, al Hydrocortisone, Onygent IV Fluids if fact exist Disseminated BOE ‘Should be treated wth ant-tuberculosis regimens 0G infections inclucing isoniazid and cams Encephalopathy ‘No specific treatment avalabl; supportive care. Measles, Pertussis Fever ‘Symptomatic; pracetamol al Give extra ora ud. ‘Topid sponge or bath, In ceses of high and extreme fever, other signs and sympinea shold he cng a reported/managed as appropriate. ypotoie, typo ‘The episode is translent and eet-mitng, and does not ‘Mainty DP, rarely responsive episode require specific treatment tis nata contraindication to bers (HHE or shock-collanse) | further dosss of the vaccine, Injection steabscess | Incte and drincAntibotis bacterial All injectable vaccines Lymphadenits Heals spontaneously over months and best noo treat. eG (Mnoludes suppurative | lesion s stoking to ak or already drafnin, surgical lymphadenitis) drainage and local instilaion of ant-uberculoas drug, Systemic treatment with at-tubercucals drugs is nefectiva Ostet Osteomyettis | Should treated wth ant-tuberculass regimens Incudng | BC ‘eonlazid and rifampicin, ParastantIncorsolabia | Satie within a dy o 0; analgesics may help. PT, Pertussis ‘sereaming Seizures Soft-liiking; supportive cars; paracetamol and cooling it | Al, especially feb; rarely anticomvusants. Pertussis, Measles Sepsis Cilcal to recognize and treat early, Urgent hosaialization | Al injectable vaccines forintravenous antblatis and thids Severe oa! reaction | Selle spontaneous within afew days toa week. ‘A injectable vaccines Symptomatic Teatment with analgesics. Antibiotics are inapproprate, Tecshocksyorome | Gil econo ard eat ea pet eetiiaton | Aiea vsces i) for intravenous antibiotics, steroids mainly measiesRecognition and Treatment of Anaphylaxis Anaphylaxis i a vary rare (etimated as once avery milion dases of vaccine given) but savers and patel fatal allergic reaction. When anaphyiaxs does occur the patient must be eagnosed propery treated and managed urgent by tained stat and traneferrd toa hospital sting. ‘Theres a high risk that health workers who lack training will misdlagnose faints (vasovagal syncope) and dizziness folowing Immunization ter the onset of anaphylaxis. Vaccinators, paramedics and physlclans shouldbe adequately tained a that they fare ale to dlstingulah anapnytax from farting (¥asovagal syncope), anxlety and breath-hoiding spells, whlcn are common, benign reactions, During fainting, the ndvigual suddenly beeomes pele, lanes nselousness and collapses nthe ground. Fainting ls sometimes. ‘accompanied by bret clonic seizure activity (.., rhythmic jerking of the iis), but this requires no specific treakment or Investigation. Fainting is relatvely common after immunization of adult and adolescents, but ery rare in young children. tt |smanaged by simply placing the patent ina recumbent postion, Recovery of consciousness oocurs within a minute artwo, but pationts may take some more time to racavor fully. An ariety spell can len to pale fearful appearance ard symptoms of hypervertlation (Ight-heaied, dlzziness, tnglng Inthe hhandsand around the mouth). Breath holding occurs in young chitiren and will lead to facil flushing and cyanosis Itcan end In unconsciousness, during which breathing resumes. Recognition of anaphylaxis Anaphvaxis s a sovere reaction of rapid onset (usually 5-30 minutes ater the injaction) characterized by circulatory collapse, ‘The eary Signs of anapnyians are generalized eryiiemaand urtceria with upper andor lower respratory rect onstruction. In more severe cases, limoness, pallor, loss of consciousness and hypotension become evident in addition, Vaccinators ‘should be able to recognize the signs and symptoms of anaphiylnls In the box below. Clinieal Progression ‘Signs and symptoms of anaphylaxis Mild, Earty Waning Signs Itching of the skn, rash and swelling eround injection site. Diziness, ‘general feeling of warmth Palnless swellings In part of the body 6.9, face or mouth, Flushed, ttchng skin, ‘nasal congestion, sneezing, tears. Hoarseness, nausea, voting ‘Swelling inthe throat, iffult breathing, abdominal pain ‘Wheezing noisy, dificult breathing, collapse, low blood pressure, irregular Late, Lite-threatoning Symptoms} wook puloo In genera, he more severe the reaction, the more rapd is the onset. Most ife-hreatening reactions begin within 10 minutes of Immunization. Thats why t's advised thet the beneficlary be kept uncer observation for atleast 30 minutes after the injection. custo ary Ure ees mpi = ny Ucn alse ere cae A oy centrel pulse (¢:0. carte) is maintained during afeint, but notin anaphylaxis. Anaphylaxis usually involves multiple body ‘ystems, However, symptoms imitd 10 only one body system (ag, skin itching) can occur, leading to delay in cagnosis. Occasional reports have described reactions where symptoms recur & to 12 hours after onset of the original attack and prolonged attacks lasting up to 48 hours.Distinguish anaphylaxis from Faint (Vasovagal reaction) Fait ‘Anaphlanie Onset Usually ath time or son afr the Iection ‘Usually some delay batween 5-30 ‘minutes efter Infection System skin Pale, sweaty, cold and clammy ed, rlsed and hy rash; swollen yes face, generalized rash Respiratory Normal to deep breaths ‘Noisy breathing from airways bstruction (wheeze or stsor) Gardiovasoular | Brecycarca, Transient Hypotension ‘Tachycardia, Hypotension Gastrointestinal | Nausea, Vomting ‘Abdominal cramps Neurological | Transient oss of consciousness, ood loss of consciousness, tie response once prone eponse once prone ‘Treatment of anaphylaxis: Once the diagnosis is made, consider the patient as belng in a patentially fatal condition, regardless of the severity of ‘the current symptoms. Bogin treatment immediatly and, atthe same tme, make plans to transtr the patient Immediately ‘tw the hospital (not already in ahospital setting). Role of Adrenaline: ‘Adrenaline (epinephrine) stimulates te heart and reverses the spasm inthe lung passapes, and reduces edema and urticaria, ‘thus countering the anaphylaxis. But this vey potent agent can cause ireguiar hearthat, heart failure, savers nypertansion, ‘nd tissue necrosis it usod in Inappropriate doses. Every heath facility should have health sta! trained in treatment of anaphytaxis and should have rapid access loan emergency ‘itwith adranaling, and be familiar with its cosage and administration. The expiry date ofthe adrenaline should be written on ‘the outside ofthe emergency Kttand the whole Kit should be checked three or four times a year. Adrenaline thats a brown ‘tinge must de discarded. The adrenaline has a short expiry Ie, 80 monitor the expiry date on regular basis. ‘Steps In ital management, ‘+ foiready unconecioue, place the patient in the racovery position and eneurs that airway ie dr. ‘© Assess heart rate and respiratory rate (tthe patent has a strong carcid pulse, ba/she is probably not sufering fram arapylants) «+ fappropriate, begin cardiopulmonary resuscitation (CPR). * Give adrenaline 1:1000 (See below for correct dose for age or weight) by deep intramuscular injection into the opposite |Imb to that In which the vaccine was given, (Subcutaneous administration Is acceptable In mild cases) and give an additional half dose around the Injection site (to delay antigen absorption). + the patient is conscious after the adrenaline is given, place his/her head lower than the feet and keep the patient warm, © Give axyganby face mask, if available. ‘= Call for professional assistance but never leave the patient alone. Gall an ambulance (or arrange other means of transport, aftertha fn injortion of ening seen hero ara sufentanil tn lp ya. © if there is no improvement in the patient's condition within 10-20 minutes, of the first injection, repeat the dose of adrenaline up to a maximum ct three doses In total. Recovery trom anapylactic shock Is usually rapid after ‘adrenaline.‘© Whore facility exists, Rapid WV infusion of physiologic saline solution, Ringer lactate solution to maintain blood pressure. ‘© Corticosteroids must be used in all cases of anaphylaxis except that are mild and have responded promptly to inal therapy. Record, ar get someone to record, vial signs (pulse rate, respirator rate ard blood pressure), as wellas time and exact dose af any medication given. Make sure the datais accompany the patient when se is transferred. Mark the immunization card clearly so the individual never gels a repeat dose of he offending vaccine. Ata suitable moment, explain to parents or relatives the importance of avoiding the vaccine in the future, Report the occurrence of anaphylaxis ta the appropriate officer by phone followed by the reporting form. ‘Adrenaline dosage: 1:1000 adrenaline (opinestrine) at a doao of 0.01 kg up toamanimum of 0.5 ml injected intramuscularly (orsuextaneousty n very mild cases the weight ofthe patent is uninown, an approximate guide is: 0.0625 mi (roam) 0.125 mi (178° of ami) 025ml (174 ot am) 05mi (eotam)‘Toensure safety during mass Imuntzation campaigns with injectable vaccines Mass Immunization campaigns pose speciic safety challenges, due to thelr objective of Immuntzing large Populations over a short period of time and often being Conducted outside the normal healthcare setting, Two of tha ‘moat notable challenges are Injection setety and adverse vents following immunization (AEF), Fly, wit respect to injection safety, the large number of injections to be administered andthe targe volume of wast the probability ‘hatbreaches nsatety may occu Secondly, wit respect to AEA, there might be the perception of Increased rate of AEF. Reasons for this includa the large number of doses beng ven over a hort per of tmeand te adminstrton cf wacine to wider, usualy oder, age grou. not prevented ‘oF managed propery, these safety issues cant result in transmission of Infections, Impalred public and donor confidence in the campaign, and ultimately, reduced caverage ae public health impact. However, one can avoid such problems by considering safety sues from the stat of ‘the-campalgn. Components to ensure safety Include: 1. Assessing the exstng Injection safety station 2 Preparing a detailed campaign plan which addresses ‘ey seus idonttiodby the assessment Implementing the pian. 4. Monitoring the rests. Managers aso neato ensue that they have a simple and ‘ely monitoring system for adverse evens for campalgns. Such yetem not ony supports the ongoing campaign, but ‘also provides opportunities to erty key immunization and Injection safety lsaues. These lsues shouldthen be addressed in routine immmunizaon actives and included ina longer ‘rm immunization eafsty plan, ‘The maln elements in ensurtng Immunization say curing a ‘mass campaign are: ‘+ Anassuredcourca tsa vaccines safe inaction suppiios ‘nd other materia. ‘© Measures to eneure safety of vaccine administration. (+ Measures to ensure safe sharps wasts management. ‘© Asystem for AEFI monitoring and management WORLD HEALTH ORGANIZATION SAFETY OF MASS IMMUNIZATION CAMPAINGS ‘* Anadvocacy and sfety awareness strategy forthe publ ‘and health staf, ‘+ A budget to ensure funding of al planned components. [erect Detaled campaign plana mast * Wont at ey payers and partners 4 Plan, budget fr and order edlequte supplles ofall receesary toms ‘+ Assos the currrtinjecton safety station Include a detaled budget with costs ofall safety components ‘+ Planforstet traning and media messages “+ Includ aafoy in tho eampaign from the ott ‘¢ Monitor, document and disseminate results ‘© Evaluate and ident lessons leamied Safe vaccine administration ‘© Use WHO/UNICEF pre-qualified or netionaly approved. vaccine and injection material Bundled distribution of vaccine and diluent with reconstitution syringes, auto-dlsable (AD) ayingas and ‘Sharps bowes to theimmunization sites Emphasize need for sterlle technique, correct ‘econsttvton and safe administration Train healthcare workers in proper techniques. Ensure traceability of vaccine by manufacturer and lot umber ‘Sharps waste management ‘+ Assans local raguatons and possiblities for sharps troetment and dlsosel + dentity practical, simple solutions for waste collection and disposal ‘+ Enaure erably of aherps waste diposo!faciics, adequate sxity bos. ‘¢ Plan transportation, storage and disposal procedures. before the campaign beghns Provide clear instructions and guidelines for health staff ‘on disposal‘© Monitor disposal on a daily basis ‘AEFI Management and monitoring ‘© Assos or sat up AEF monitoring system ‘Develop rapid reporting channels * Decide which AEFI are to be reported and which ‘contraindications to observe ‘© Tran health care workers to Investigate and manage ‘AEFI and respond to rumours Explain to key people involved in the campaign why the ‘campaign may resutn the perception of ncrsased rates Ot AEA. Plenand tranarit media messages onthe campaign which adkiessiocaly percelvad safety concoms. Form an AEFI review commiting ‘+ Koop alert for“iesuse" and rumours ‘Words of advice ‘© Campaign policies and stratagies should be identified wall In advance of te campaign. ‘Practical, country-soetifie solutions for sharps waste ‘management shouid be identified and planned well in advance, ‘© Allsupplies and materials shouldbe ordered atleast six ‘months before the campaign. ** Roles and responsiblies for the campaign shauld be ‘leafy statod from the start and should include deadlines {for completing all ack. ‘+ Al players and partners (including nongoverumental ‘organizations, medical andrursing associations, lgous ‘groups, etc.) should be contacted to help disseminate ‘Safety wareness messages. '* Regular monitoring throughout the campaign, followed byafinel evaluation shoud be concucted so aso identity ‘successes, problems and lessons leamed. The findings sould then be disseminated tal partners. Key elements Planning for mass campalgns, 1. A detailed budget with identified | © Dacide.onapratocal for treatment ‘Including sefety components ‘funding sources; ‘of anaphylaxis, and provide the ‘raining, drugs and Identify the different key players | 2 A micro-plan for distributing necessary ‘and clearly assign activities, ries ‘vaccines, dluents, injection and eaupment, ‘and regrets to each player. reconstution materials, and | + Review contraindications to tet sale boy, vaccination (e.g. AIDS) and * Enoure that campaign advocacy implications forthe campaign; messogeecidecaty cuss | a ee nis ‘tanta according. © Conductan assessment of curent ompreh isposa | * Plan to monitor activities, injectonsieypracteastassss | RoTmeterave wae d success and poble tyough ‘he station andiderttytheneets routine reporting byalvaceination ‘and challengestorthe forthcoming | 5 The Information flow on AEF; sites. campaign. Thestandars WHO tol | 6, A crisis management plan with | © Plan trom the start to undertake a {for the assessment of injection communication strategies ta final evaluation and use thie 10 safety practices might be | preventrumourstom endangering a ong-erm plan of acon ono becarean ‘paste tepals arto ‘© Include the following safety | © Prepare “Questions and Answers" that have been Identified. ‘components In immunization mass ‘or the media on the background Disseminate lessons learned $0 ‘campaigns: ‘forthe campaign and the potential ‘that others can leam from the Yor AER,Vaccine Administration Sharps Waste Management ‘EFI Monitoring ‘= Procure vaccines, AD syringes and | » The safe disposal of used injection | » nstuteasimple suvellance system safety boxes (and reconstitution | aquipment is one of the most | for advorse events, if one does not syringss Hf necessary), from pre- | importantissuesinassurnginjaction | exist already, with casa definitions, 2 ‘qualled WHO/UNICEF or national | safely. Theresa single unhersalty | reporting form and instructions on regulatory authority-approved | accepted method, but a locally | howand where oropor. sources. acceptable solution needs to be | © Monitor the distribution and use of ‘© Ensure that quant ofellsupples | Wend nd agreed upon wth al! | all vasine tots. ‘match and that all distibution is | parinersbetore the campaign. Enaure routine reporting and ‘buncied, Pian logistics caretuly to | * Assess locel possibilities of sharps | managing of AEFI at vaccination ‘ensure avilbity of ll supplies at | treatmentand disposal (e.g. identfy | sitas/clncs through raining staff at ‘al vacclnation posts. funcloning Incinerators, stes for | all points where AEFI might occu, + Place ordora cil advance (atleast | burning, re-cycing aafe burl cla). | points for acu AEF and points for ‘ix months) befor the stat of the | * Construct incinerators where | delayed AEFL ‘campaign. needed, orf temporary restment | ¢ Maintain monitoring frat least four ‘Raise heath care worker awareness | ses weeks after the campaign and ‘onthe need for safety troughoutthe | © Pan for transportation, storage and | inteduce as a permanent system campzign troatment of sharps waste. Safety | wharavar possible. “+ Needles should never be recapped | boxes should be numbered soas to | + Estimate the expected! rates ot AEFI bbutmustbe placed into an approved | vary theirretum tothe destruction | forthe vacino(s fo beused, andthe safety box or puncture-resistant | point differences in background rates of ‘container immediately. end deposed | * Icontty practioal, simple solutors | diseases in target ago groups of safely as soon as possible after | thalcanbeimplemented during the | involved ine campaign. Use these se, ‘campaign Use the waste disposal | baseline figures to compare with © Thetrahingot staf at each level ust | planandsystemdevelopedtorrauine | actual rates occurring in the inclide reconstitution of freeze-dried | sharps waste management in the | campaign. vacone (usecniytnediventsuppied | future. (Possibiities Include | « identity & focal potnt and form a withthe vaccine, use whole amount | incineration, bumring, recycing, safe | committee to receive and review fiver te use of AD swringes and | burial) reports of AEFi during the campaign, ‘ofthe need for proper disposal ina | * Prepare clear instructions and | * Ensure rapid response to AEF with ‘safely box {uidelines for heath sta on sharps | the necessary investigation and tispasa and waste management. | correction o potential programmatic ‘© Instruct personnal on practices | rors. recommended forthe campaign and | * Be sensive to rumours that might ‘monitor the compliance «rig about AEF and follow them up actively (Ordering code: WHO/V&B/02.10 ‘Thle document Is avaliable on the Internet at: httpyjwww.who. Intivaccines-documents: Additional information on immunization safety can be obtained on the Internet at Immunization Safety Priority Project httpufwew.whoJntvaccines Department of Vaccines and Biologicals World Health Organtzation 20 Avenue Appla, GH-1211 Genova 27, Switzerland Fax: +41 22 791 4210; Email: epidata@who.int ‘World Health Organization, 20 Avenue Appla, CH-1211 Geneva 27, Switzerland @ ‘wew-who.intivaccines:Purpose: This aide-mémoire serves as a guide to a ‘systematic, standardized causally assessment procass far ‘serious adverse events folowing Immuniztion (nluding ‘clusters, tis intended tobe used by sat atthe national (or ‘rst sub-national) lave, AEF causally assessment overview ‘Al reported AEFs require verification ofthe diagnosis, cading review, cotton and storage fan AEFI is serious, requires triage for aystematic, standardized causalty sgesement. Mary AEFs, including serious ones, may be coincidental while others are well known to be vaccin related (@.., orl polo vaccine-associated paralytic pola (arn. Causality assessment is the roview of data about an AEF case ta determine te Ikellhood of 2 causal association between the event and the vaccine(s) received. Causalty assessments a critical part of AEFI monttring ‘and enhances confidence in national immunization programmes. Whether an AEFIs, or isnot, atifovtable to the ‘vaccine or the vaccination progremnme determines wht, ‘any, stops need to be taken to address the event. Causallty assessment Is important for: dentition of urgent probes fr invstgaiowacton; Identieaton of programmatic anc batch problems, ‘detection of signals for potential follow up andresearch; basis fr estimation of ates of serious AEFs; ‘comparison of AEFs between vaccine products; \elidation of pre-osnsure AEF data, CCausaltty assessment outcomes help raise awareness of ‘vaccine associated risks among healt-care workers; this, combined with knowiedge of benefits of immunization forme ‘the bosisofvaezne Information for parents and/or vaccinees.. ‘The quality of tha causality assexement depends upon ({)tte qualty of the AEF case report and te effectiveness of ‘he reporting system, and (2) the qualty of the causally review process, Poor quality causality assesament can lead ‘tm erroneous conclusions, crises and loss of confidence in ‘he national immunization programme, 9 a 3 4 9 9 WORLD HEALTH ORGANIZATION Bs tay FOLLOWING IMMUNIZATION sero ing pts Causalty assessment of adverse avents with vaccines versus drugs ‘Many satety monitoring systems deal wth vaccines and drug ‘roduc together yet there ar important etterences betwoan, them that elect causality assessment. ‘+ Vacelnes ae given to healthy populations and mstiy (tarts ta vunerabie age; they are elect, have a complex compo-slton (biologics! products), immunological considerations in addition to Damacologial, may cause thelness they are meant ‘tO preventt(¢.9., VAPP), have a short duration of exposure, ‘a “long” time for response, and “minor" adverse events ar important as they may indicate programm error. ‘© Drugs are given to popuitons and most aut, they are rarely elective, chalenge/dechallenge! Fechallenge, chemical products, pharmacological canlderatione main, anger exposure, may averse events reported, many classes of drugs, and minor ‘adverse events rarely important, Expertise needed fr causalty assessment vache averse evens i cfereat rom that needed fr causality assessment ‘of drug adverse events. Routine AEF review and tage ‘AIL AEFis need to be screened and tiaged by trained ‘Immunization programme staff to determine the subsequent ‘pps neon (ouoW Up, acnon, accmen Tp ceranase,anaryss, reference for systematic causally assessment etc). ‘AEFI mustbe reviewed to very the dlagnasis and the timing with reapect to immunization, and to classify them on the basis of standardized national case definitions. 11 Standardizac case defiations for some AEFisare avaliable from, the Brighton, Ooleboraton, at (_hpi/ Ironcuraged, espoiy fr eovoun casas where ‘yetomatic etanvardized causality assosamentis required. Syetomatio oauoallty sovosamont Al serious AEFis and signals, defined botow, require systematic causality assessment (s2e Checklist, Section C, page 2).1) WHO standard detnton for drug and vaccine acversa event is “any untoward mecical occurence that esti in death, hospitalization or prolongation of hospializtion, Doraitent or signitcant dlsabity/incapacity, or Ise ‘threatening’. 2. Additional AEFis that need systematic causality assessment are: ‘© AEFis that may be caused by a programme error, ‘0g., 2 clustorof bacterial abscesses; ‘© ‘serous unexplained AEFI occurring within 30 days _aftervaccination and not listed in product label; “© events causing significant parental or community ‘concem. ‘Signat Reported information on possible causal relationship between AEFI and vaccine; relationshia Previously unknown or Incompletaly documented. ‘WHO categories for causality" Use step-by-stap gulde {see Checklist, Section C, page 2) to eterminocategory. ‘Vory Ilkaly/Certalr:A clinical event witha plausibe timo ‘elationship to vaccine administration and which cannot ba explained by concurrent clsease or other drugs or chemicals. Probable: A clinical event with a reasonable time relationship to vaccine administration; is unlikely to be atributed to concurrent sense or ater drugs or chemicals. Possible: A clinical event with a reasonable time ‘elationship ta vaccine administration, but which coud alsa be explalned by concurent disease or other drugs or chemicals. Unilkaty: Acinical evertwhose time relatonship to vaccina administration makes a causal connection Improbable, but ‘Which coud be plausibly explained by underlying disease or ther drugs or chemicals. Unrelated: A cllnical event with an Incompatible te relationship and which could be explained by underiying tisease or other drugs or chemicals. Unciesainiabie: A cnicaleventwithinsuficentnformation ‘tw permit assessment and identification of the cause, T“Sevaie" ent synonymous wh “serous. 2 A'chusttwo or more AEFa lated in tie, plae ard or by vaccine Adapted tor vaccines tom ofginal WHO catagories favalabie at htp/Aewxtoume.orgindex2 im! 4 Gan be certain rare Instances where there Is a ‘domonsialed riatonahip eg, VAPP or mumps vaccing- Telstod asople meningla wih lelaton of the vaccine stain 1 chectast Be prepared Develop centralized system to very ciagnsis, review, code, collate, store reports and analyse AEF data, Estabilen a national (schnical) advisory commitise, Enaure independence, breadth and depth of technical ‘expertise needed for qualty causally review. Provide ‘administrative supporto this commits, ‘Adopt standard cese definitions for AEFI Grighton Collaboration definitions i avallable or national case ‘efnitions), Deine signal fr programme purposes, Detinea routine process and acopt iterator referral Of AEFI cases fora systematic causality assessment by ‘he committee, Define frequoncy of meetings for systemic causally assessment and triggers for exceptonal (.., urgent) reviews. Develop a process for action on recommendations arsing from causaltyassessrent. Recelve and process reports at reglonal/nationsl lew Preliminary review of AEF: vanty agnosis, timing of ‘vent In relation to Immuntzaton, If event meets Clefiton, ii tts crea tor reteral for systematic standardized causality assessment (ese under Systemat causal assessment, page 1). Code, cola, store reports and analyse data, Fer cases refered for systematic standardized causalty assessment very case Information and gathor more data na timely manner. Prepere case file for review, 24g make information inthe le anonymous, Conduct systematic standardized causallty ‘assessment using the step-by-step guide below 1. Vasity reason for reporting: ciannosis: whether serous. 2 Evelunte and assess factors. 2.1 this overt known to be roltod tothe vaccine? (Consistency of findings, strength of ‘association 22 Whats the frequency of occurence ofthis acre ‘event? Vary common (>1/10};comman (>1/1005, ‘uneammon(=1/10005 rare (>1/10 000); very rae (<1/10 000), or not previously reported. 23. Are similar events known to occur with other seases? (Spocttity of association ) 24 Is this event explainable by the biological ‘Properties ofthe vaccine? (Biological plausiblty) 25 is the vacolnationto-cvent Interval compete with the event? (Temporal elation.) ee26 Hes the patlnt had sirilr symptoms in the past? 2:7 tethers ahietry of concomitantorpracedng drug therapy? 28s ther a history ofa concomitant or preceding condition? 29 Are there other factors that could affect the ‘ocurranca ofthe event? Determine causailty category using WHO ‘eriterta (see page 1). 1 bthisanuninowm overtin relation to this vaccine? Isthisa now event? Is there lack of sufficient data to reach a more definite conclusion? ‘Would the case benef from a second revow i ‘more data became available? ‘Based upon answars to the questions above (r this Seotian, in which WHO catagory does tha case fitbest? NB. nota numeical score. Propare a briefcase surmary, ‘Tako action on recommendations) fram the review. Consider the ease for education purposes. 7. Communicate tindings to Immunization ‘programme sta, nsonal regulatory suthority, ‘and others (as appropriate). D, Systematic causality assessment process for AEFI cluster ‘© Define case definition for cluster, verity i'cases meet. ‘© Conduct systematic causalty sssessment as per polis 1-7 of section C above, including taking action. Pp & € BRE *& n ‘© Determine if equency of eventis expected, increased, decreased, previously unrecognized or W itis new event (Challenges and pitfalls to causality essecsment 11. Causa assessment é not done, not systematic, nat hone by trained personnel and/or not cone in timely ‘ashion. 2. Information in AEF reports ao limited thet causality assessment cannat be done. 3, Lack of expertise and/or independence ofthe reviow ‘committe responsible for formal causalty assessment undermines credibility. 4. Non analysis of the AEFI in context after causality ‘asgesement may delay recognition of clusters and possible programme errors. 5, Lack of skilled communication of findings, not addressing all target audiences, or lack of elplomacy ‘and/or cutural sensitivity. ‘Allo thase can damage the credibility of tha immunization ‘rogramme by reducing confidence In vaccine safety. 1. Ensure timely review of cases based on the best caso Informetion available: alilt addtional information on, ‘cases soon after receipt when memory s “fresh”. 2. Eneure timely ttage and referral of sertous AEFI for expert systematic causalty assessment. 3. Programme expertise is needed for credible quality ‘evisw, assessment and analysis, 4. Act an recommendations following causality assessment io ensure programme safety and credibly. 5, Feedhack and effective communication about the Process andthe outcomes to stakeholders and the mesa | vital to avoid misinterprtation. ‘Aasietanco for cauealty asseasmant le avallabo trom tho World Health Organization through the Degartment of [immunization Vaccines &Bioiogicas. Additional information (on AEFI survaliiance, Investigation, management and ‘causality assessment, andon vaccine safety communication ccan be found on the Web at http://www.who.int? ‘immunizaton_safetyfon Department of immunization, ‘Vaccines and Blologloals ‘World Health Organization 20 Avenue Appia, CH-1211 Geneva27, Switzerland Faxc+41 22791 4210Anatverse event following immunization (AEF) isa medical Incidert that takes place after an immunization, causes concern and i belleved tobe caused by the Immunization, Programmes providing immunization sorices shoul incude _eyeiem for AEF detection and raring, invesgation nd management, data analyes,corrective action, relevant communication and evaluation ofthe system. ‘The uitmatn goal of an investigation sto detarmine whother ‘thevaccine oF immunization process is responsible forthe reported events) ort fd another and corectt i pasibie, ‘and reassure the public. ‘There are 4 possible causes of AEF: ‘Vaccine reaction: event caused by some component othe ‘accne ~ the active component ofthe vaccine ita, tho rocaratve, the cabilizer or other. The majority of raccina reactions ae “common” and expected, mid, sett witout ‘treatment and have no long-torm consequences. More wrote ase eee (abet exramaty lo roquoncy; Pregacane era: ev cuted by oer In cine broparaton, handing or administation Brent ‘where something happens ater the Immunization buts nat caused by he vaccine othe programme; and Infection reaction: event arising from anvety about the Injecton needle) ‘The purposes of investigating AEFI cases are: 1) toconfim a reported dlagnoeis of AFT and cary tha etal and outcome; 2. tw determine whether unimmunized persons are experiencing the same medical aventis; 3) to vestigate the link between the vaccine glven and ‘the AEFI; 4) to determine the contribution of operational aspects of ‘the programme tothe reported AEF; a ‘p determine whether 2 reported event was oii or part ofa cluster, © todetermine the cause ofthe AEFI 90 as to provide the bot intarventiowmedical care and take any furthar action deemed necessary. WORLD HEALTH ORGANIZATION S| tte Ee) ‘nmostases, a preliminary Investigation ofan AEFI can be ‘mage by the heath worker wha detected the case, €.9.& heath centre staff member or a nurse or physican In & hospital, ‘Sertous AEF canes or AEF clustors should bo investigated immediately withinvolvoment from contallvele incling epidemiological andr cinical expertise. A cluster of AERIS. can be defined as two or more cases ofthe same adverse event related intime, place or vaccine administered. ‘Inadequate planning of response may lead toacrsis with ‘oss of confidence Inthe vaccination service. tls essential that programme managers: “1, _antitpate the crisis and be prepared to deal with ft ‘when occurs; 2) verify the facts of ary event before making any public. stxsment, 3) srefamillar witha plan tor reacngtn any isis should [thappen. tno plan exists programme managers should ‘develop one; 4) be well Informed so that appropriate national and ‘regional managers can be reply briefed to take charge ‘and deal wth potical and media enquiries. M ‘Checklist ‘© Rng the resource documents en reporting, management and investigation of AEF “+ _Davelop standards: case defntons fr reportale AEF, Use ofreporting forms and investigation procedures, ‘© Designate and rin sao conduct an AEF ivostigation using tha investigation form. ‘© Tran staff on how focllect specimens. ‘+ Establish procedure, criteria and designated parson for ‘natfylng WHO and UNICEF (F UN- supped vaccine} or other relevant party depending on procurement mechanism ‘© Esfablsha National Technical Adsory Commitee wth "representation frommajor medical organizations ‘*Idantity a spokesperson fr public communications.x Receiving a report Ensue immediate reporting of ost serious events and ‘apleatention to reports received Verity the information in the report and classify and asanss the AEF using estabibed case detntons, Dec whether needs futher investigating. + investigation wararted, rave tote locaton ofthe ‘AEF or logo responsi anchor ireined person Investigate and collect data + Askaboutthe patent ‘© pak about the vaccine and other drugs potently recelved e ‘Ask about other vaccines ‘Ask about immunization sorvices Observe the service inaction ‘Ask about cases in unvaccinated persons Establish a more specific case definition Hf needed Formulate a hypothesis a to what caused the AEFL Collect spocimone tf appropriate: ‘© fromthe patient ‘© the vaccine (and dient if applicable) ‘2 thesyringos and noodles 4. Dispatch specimens. to appropriate testing facity (laboratory, regulatory authority, etc.) Analyze the data Review epldemiological,clinicsl, and aborstory ‘ndings ‘Summarize and report findings. Take action. (Communicate with health staff Communicate findings and action to the parents and obi: Correct problem (beved on the cause) by imoreving ‘training, supervision, and/or distribution of vaccines! Injection equipment © Replace vaccines if indicated Kay data to be collected 1) Data oneach patient demographic data about patent, including a unique casa numba, age, 20, pla of residence fami history, ‘+ hisoryotpetent's present ness gymptomsand when cach appeared ard ls duron, Veatment, oucome, [i ‘history of patients past lnesees e.., reactions to previous vaccine doses, drug allergies; pre-existing disorders, curent medications; ‘© immunization history - vaccina, number of doses recelved, date, and placa of last Immunization or Immuntzations, mode end ste of administrtion, ‘+ laboratory results about blood, stool, or other samples, if appropriate and avaiable ‘¢tllautopsy report wth tovccoglcal screening and histo pathological analysis ‘© [ook for common environmental exposures between, patients. Data about the vaccino(s) and dient applicable) administered tothe patient Lot number(s) Expry date(s) Manufacturers) ‘Vaccine storage Identy where the veccine(s was dlsttuted Whether other children were immunized wth same ft (same vial at same session and elsewhere Results of procedures to control vaccine quay Laboratory tet rests ebout vacing,ifappropriate. Prograrmme-rotated data, Common practices in storing and handing vaccines, ‘sndvacine ane the then nich Immunization or her homay rept ped etn ed instead of vaccine or dent 4) Background data ‘¢ _Estatlish tt cases have been reported trom elsewhere ‘and actively ook for addtional cases among other ‘vaccinees and atarge in the community Role ofthe districtireglonal manager 1) Training Staff should be trained in diagnosing, treating and raporeng of ACs, and dHerarating terwoon rl non-significant reactions and more serious events, 2 Supervision Non-serlous AEFIs (e.g. abscesses) raported by Peripheral health workers should be reviewed with ‘raining during site visits, 3) Investigation and collection of data Following a reportof serous AEF, the manager should be esponsiba for investigation, collection and reporting of data. This may be under the overall supertsion of natonalfeam, 4 Communication ‘The manager or designated person should setup the ‘eons for continuous communication Between heath ‘workers andthe commun, directly and through the ‘medi. The pubic shouldbe informed frequerty about egee\whatisboing done dung an vestigation and reassured ‘where necessary. 5) Correction ote problem tan AER was caused by programme err the actions ‘be taken wil probably include one or more of tha tollowing: = Lonietics Improving fogistics wil be the appropriate response it programme errors can be traced to the lack of appropriate supplies o equipment ort afalure inthe cold chain. © Training Setvng operational problems trough raining wil deal wt ark ofl and knowledge and wth poor atu, © Superson Regular supervision and intensified when needede.g., probioms detacte in reporting or programmatic errs dented. Did the vaccine or its delivery cause the reactions? Ik will be necessary to determine if there is 2 causal ‘ssocation between the vacchne and the adverse event. n ach cage the following shouldbe considered: onslstancy of findings —arealleported ACs tho same? ‘Temporal sequence — conflm thatthe symploms of AFL curred only after, not before, the vaccine was given and it ‘he vaccine-ovent Imerval is compatible wih a vaccina reaction Biological plausibility - does the medical event seem ‘plausibly due to an effect ofthe vaccine or other concomitant oF preceding conditions? Previously known reaction —check this type of reaction is known to be related tothe vaccine and with which ‘requency ‘Specificity and strength of association ~estabish the ‘same everts are being reported in unvaccinated persons and it 30, how ofts.and ifthe custrisimited toon health center or not Concomitant or precoding conditions ‘AEF evaluation requires a 2 by 2 table of exposures and ‘tcomes and data shouldbe callectd in orer ta mare fully complete the fable and calculate ask of even fomreceit of the vaccine Le, (a'a+-\ofb+<), Cell a represents case ‘reports only Possibie To Adteorse Event | Advorsa Event ‘Vaccinated a e Unvaccinated b el pee ketal o eon “y ~ | + he Sa Sar ~ ‘Words of atvics: © The Investigation should start within 24 hours of notification ‘© There je seldom need to test the vaccine unless clearly Indicated by the epidemioioglc Investigation, but cold chain should be maintained ‘* _Aational committee can be very helpful inraviowing ‘the outcome ofthe vestigation and communication of findings: © Aecess medical fles ‘© Pule out aliemative aetiologies than the vaccination, ‘The actthata particular vaccine does no always mean ‘thatthe case undar investigation i also related tothe veccine ‘¢ Have direct discussions withthe patients or parents if Possible ‘Additional information on the definitions, monitoring, ‘management and investigation of AEF can be found onthe ‘World-Wide Wob at wovw.aho.ntvimmunization_safotyfon \acelne Assesement and Montioring Department of Immunization, Vaccines, and Biologicals Wore Health Organization ‘20 avenue Appia, 1211 Geneva 27, Switzertand “Tel: +41 22791 4468 Fax: 441 22791 4710 mal: mmunzationsafety@vhointTo ensure the efficiency and safety of mass Immunization campaigns with injectable vaccines ‘Mass Immunization campaigns pose specific challenges ver routine immunization that national managers and decision-makers must be aware of so as to maximize the bereft and any potential rea or percaived negate Impact. of the campalgn. Campalgns represent a substantial ‘nancial investment that could be wasted ifthe necessary coverage is not reached. Campaigns are also a focus of igh vstalty and scrutiny by the general publlc and the media, Adverse events that occur during campaigns and ‘the impact ofthese events must be managed quickly and etfecivly to encourage good practice and promote pute confidence In the programme. ‘There are substantial challenges in reaching large populttons over short pero of me. n order for campalns to be successful high coverage must be achieved In the ‘tal target population, including hard to reach populations, ‘Al partners and payers at al levels need to be mobilized. ‘There adefinte need to explain and justly the impact of ‘he campaign toalinvolved parties wit eapectto optimal ‘lssase-specific control and inthe wider context of disease Prevention and heath car. ‘The alm of mase immunization campaigns is to immunize large populations over a short parod of time, which may be beyond the capacty ofthe exsting heath Infrastructure, Campalgns may be conducted outside the normal health care seting. This necessitates proper and pect planning and very careful supervision. Gaod planning is assertial ta campalgn success. ‘Withrespecto injection safty, te large numberof injections ‘tobe administered andthe large volume of wasta generated ose added strains onthe syste, increasing the probably ‘hat breaches in safety may occur With respectto adverse ‘events following immunization (AEF), an apparetncrease Inthe numberof adverse events may occur Reasons fortis Include the large number of doses belng given overashort period of time and the administration of vaccine oa wider, ually older, age group. not prevented or managed propery, these safety Issues can result inthe ransmission of infection, impaired public and dna contin inte cari, and ultima, reduced coverage and a negative public hea However, by considering safely issues from ‘pe eat of WORLD HEALTH ORGANIZATION Ae Tere eg Biologicals Aide Mémoire ‘campaign planning, EP managerscan avoid such problems. ‘Components to encure safety Include: (1) assessing the exiting Inection safety situation, (2) preparing a cetalled ccampalgn plan which addresses key Issues identtied by the assessment, (3} implementing the plan, and (4) ‘monitoring the resuts. Managers also need to irroduce & ssmpe and timely for adverse events for ‘campaigns if this not already in place. Such a system, in ‘ation to supporting the campaign, provides opportunities, {or the Kentficaton of kay immunization ard nection safety ‘soues tht should be adressed in routine Immunization sehiesanielietinaorgs-tzm rez sty a Checklist ‘Campaign planning |s there sufficient evidence of the need fora campaign and tthe pertinence ofthe ting an targeted populations? ‘© Epidemiological investigation carried ou, including & review of immunization data, ‘+ Need fora campalgn, timing and targeted populations (ane, se, location) propased. ‘+ Conclusions endorsed by the rational committee, ‘+ Conclusions and plan of operations approved by the national etticel review board as needed. Have all key players and partners been identified and reapectiv roles and reaponobltie cert assigned?” © Partners sted, ‘© Roles and responsibil asigned. ‘+ Roles and responsibilities approved by partners. Hes the interagency coordinating committe reviewed the plan and budget? + Plan reviewed. ‘© Plan to berevised, * Plan agreed. 's there evidence that adequate supplies ofall necassary ams have been planned fer and wil be dallvrod on time? ‘© Supple liste and quantities estimated. ‘+ Costestimated. ‘+ Sources of procurement identified, supplesevallabie and estimated date of delivery specified. ‘+ Cold storage and other storage space secured.© Custom formelties ascertanedend exernpion obtained, necessary. ts there a detailed micro-plan from al local levels targeted Including strategies for hard to reach population? ‘© Geographic area and population defined. ‘© Mlero-plans incluiing delivery strategy avalible. Hes a plan for socal mobilization been developed? ‘Communication plan formulated and resourced. ‘© Communication materials developed (including pre-teatng) in consuation with ke local and national stakeholders (including community and raigious representatives) + Mocheaniams for sissrnination of matorals in place (brit, radio and 7). ‘© Advooacy meetings with Key local religious and community epreseniaives scheduled. Istherea olan for ragular monitoring othe mplemetation of the campalgn Including corractve action if necessary? ‘© Monitoring olan developed with tools forms) avaliable ‘for monitoring. ‘© Supersor Kenttiod and tained. Supervisory checklists availabe. ‘© Plan for ragular review of progress and problems cneaunteredavalate, Hos a plan been developed andresourced forthe evaluation ofthe campaign? ‘* Monitoring plan developed with tools (forms) available ‘ormontaing. Supervisors ienttod and tained, ‘© Supervisory checklists availabe, ‘+ Plan for regular review of progress and probleme encountered availabe, Has a plan baen developed and resourced forthe evaluation ote campaign? ‘© Ustof process and outoome indicators tobe measured at each level avaiabl, ‘¢Plantor dlaseminating results to al kay players exists. ls there a sufficient number of Qualified vaccinaiors and support staff (including voluntaers) to mast the ‘campalgn objectives? Number of tf valable Is adequate to met campalan objectives. © Adequate numbers of Qualified with workers and support staf (neluding volunteers) are avaiable, © Sufficient umber of supervisors availabe to provide supportive supervision of al teams stfctvaly. Has the avalablity of tranaport for supervision, sociel ‘mobilization activi, vaccine and injection material been verted? ‘+ Sufficient number of vehicles available for transport ‘or planned actvtes i area of superision and socal mobilzstion and for vaccine end Injection material distrbuton, ‘+ Sufficent funds avaliable for transport costs, Have superasory ts boon mad to all povinces/stovel administrative subdivisions to review plans and Preparedness? ‘© Vit reports avalabia from each provnceft level ‘administrative subdivision indicating that campaign reparations are satisfactory, or including recommendations fr revisions to pans, Sate and efficlent vaccine administration \Willonly WHO/UNCEF pre-qualified vaccine or vaccine and Injection material approved by rational regulatory ahortes be used? ‘¢ List of vaccines and injection materials with procurement source iented. ‘© All vaccines listed pre-qualified or approved by national regulatory authortes, ‘vaccine bundld wth recansttuton syringes, autp-deaio synges and shanps boxes as per the terms of the jot \WHO/UNICEF/UNFPA statement on injection safety? ‘+ Uistot quantties of vaccine, reconstitution syringes, ‘auto-dlseble syringes and sharps boxes. Have responsible staf been clearly informed of the importance of sanding corect and matching quanitis of lluents vith reaze-trted vaccines? ‘© lear information gen toresponsibe sta wit respect tp the sanding of correct and matching quanttes of tiluents wit freez:dried vaccines, Have al heath care workorsbeon rained in proper vaccine adminisation techniques wth an emphasis onthe need for storllo tochniquo, cerract reconstitution and sat Immunization injection practices, and onthe need to comply with proper cold chain procedures? ‘+ Traning currcuum wentited with writen traning material prepered. ‘+ Training completed. ‘+ Number of neath workers wo completed the course andnumberofabsontees. Have staff been clearly instructed not to recap syringes? ‘© Clear instructions given to staf nat to recap syringes. Have staff beon clearly instructed to dlocard all reconstituted veceines within sixhours or atte end of ‘he immunization session, whichever comes rt? ‘© Glearinstuctons given o sata discard recontiuted vaccines within six hours or at the end of the Immunizaton seseon, whichever comes fst.|e vaccine distibution appropriately tracked by lot? © Vaccine distribution forms include lot number and ‘mount of vacoine and dents dsbuton talievels, Have the logistics been carefully planned to ensure avalailty ofall supplies at att vaccination posts? ‘© Ustot supplies (including quantties) to be delivered to each post avaleble, ‘© Distribution plan for supplies availabe Have vaccine and Injection matertal storage sites been Identified? List of storage sites and capacity ofeach site, ‘© Required storage capecty Identified, Has the capac in reezesufcientice packs been ensured? + Ustof sits for freezing and capacity of exch sta, ‘+ _Surloient freezing capaoty Is avaliable, Istherea sufficient numberof vaccine- caries forall teams? © Number of vaccine carriers available known. Has the need for vacotnatons cards been assessed? Hr vaccination cards necessary. ‘© Number of vaccination cards needed and avalabla number to enable tracking. ‘© Tralning provided on accurate use of vactnaton cards, ‘Sharps wasle management Have local regulations ane possibiltes for sharps treatment and disposal ban assessed? Local regulations éetified. ‘© Possbitis for sharps treatment and csposal assessed (functioning Incinerators, tes forburring, et). ‘© Most appropriate option for treatment and disposal ented, Have practical, simple solutions for waste collection and ‘sposal been ier? ‘© Waste disposal system used for routine immunization programme identified. ‘© Plan for waste collection and olsposal developed, Have equigment, places and facilities been identified for ‘sherpa wasts disposal? ‘+ Ustot equipment, paces and faites for sharps waste tisposal ented. asthe avallablty of adaquate safety bovee,sharpe waste disposal faites, etc, been ensured? © Quanttiss of required suppies determined ‘¢ Sufficient quantties of al supple curently avalable. ‘+ Sufficient supplies have been ordered and thee is an appropriate entmated delivery date, Have clear Instructions and guidelines for health stat on safe west isposal(assembiy, use, colection and dsposel of eefety boxes) been provided? ‘© Trahing and has been provided fr heat sat, ‘© Wren gudelines for safe waste dlsposel avaliable. ‘Wil disposal bs monftored ona daly basis? ‘+ Rsponsble person dente to monitor waste cleposal on adally bass, AEF management and monitoring {ethora an AEFI monitaring systems in place? ‘© Responsibie focal pont for AEF montloring dente. ‘© Clear guidelines exst on what to report, how to report and what to investgats. ‘Are rapid reparting channels for AEFI and vaccine safety {soues in place? ‘¢ Reporting channels clearly stated ‘© Method of reporting known, Has a decision been make on which AEFI shouldbe reported ‘and which contrainicationa should be observed? ‘+ Ustof AEF to be reported avallabe. ‘© stot contraindication tobe observed avallable. Has an AEF review committe been formed and the strucare ‘ang capactty to rapidly respond to and investigate serious ‘AEFI been planned? ‘+ Membership of review committee documented, ‘+ Training incorporates information on pote adverse events, Have heath care workers been trained on how fo Investigate and mange AEF and respond to rumours? ‘© How to Investigate and manage AEF included in ‘raining. ‘+ Focal points identified to deal with rumours. Ordering code: WHOWSBIO2.10 This documont Is available on tha Internet at: httpufwwe.who.Intvaccinoe-

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