Adverse Events Following Immunization, AEFI

AEFI WHAT IS AN AEFI? AEFI IS A MEDICAL INCIDENT AFTER AN IMMUNIZATION AND IS BELIEVED TO BE CAUSED BY THE IMMUNIZATION BASICALLY TWO TYPES AVOIDABLE AND UNAVOIDABLE

AEFI MODERN VACCINES ARE GENERALLY SAFE NOT ENTIRELY WITHOUT RISK BENEFITS FAR OUTWEIGH RISKS

AEFI WHY MONITORING OF AEFI ARE IMPORTANT ? UPSETS PEOPLE REFUSAL FOR FURTHER IMMUNIZATION

AEFI CLASSIFICATION OF AEFI VACCINE EFFECT PROGRAMME ERROR COINCIDENTAL INJECTION REACTION UNKNOWN

AEFI THE USEFULLNESS OF MONITORING AEFI TO IDENTIFY PROGRAMME ERRORS IDENTIFY VACCINE DEFECTS TAKE CORRECTIVE MEASURES INCREASE IMMUNIZATION ACCEPTANCE IMPROVE THE QUALITY OF SERVICES

AEFI AEFI ARE DUE TO: VACCINE EVENT CAUSED OR PRECIPITATED BY THE VACCINE WHEN GIVEN CORRECTLY, CAUSED BY THE INHERENT PROPERTIES OF THE VACCINE

AEFI PROGRAMME ERROR EVENT CAUSED BY AN ERROR IN VACCINE: PREPARATION HANDLING ADMINISTRATION

AEFI COINCIDENTAL EVENT THAT HAPPENS AFTER IMMUNIZATION BUT NOT CAUSED BY THE VACCINE – A CHANCE ASSOCIATION

AEFI INJECTION REACTION EVENT FROM ANXIETY ABOUT, OR PAIN FROM THE INJECTION ITSELF RATHER THAN THE VACCINE UNKNOWN THE CAUSE OF THE EVENT CANNOT BE DETERMINED

AEFI SURVEILLANCE DETECTION AND REPORTING INVESTIGATION DATA ANALYSIS CORRECTIVE ACTION EVALUATION

HOW CAN AEFI’S BE DETECTED? WHAT MECHANISMS ARE AVAILABLE?

AEFI LIST OF AEFI LOCAL ADVERSE EVENTS CNS ADVERSE EVENTS OTHER ADVERSE EVENTS

AEFI LOCAL ADVERSE EVENTS 1.INJECTION SITE ABSCESS STERILE BACTERIAL

AEFI FORMATION OF A STERILE ABSCESS WRONG ROUTE (SC INSTEAD OF DEEP IM) NOT SHAKING THE VACCINE BOTTLE BEFORE DRAWING IN TO THE SYRINGE WRONG DOSE (LARGER DOSE)

AEFI 2. LYMPHADENITIS AT LEAST ONE LYMPH NODE 1.5 CM IN SIZE OR DRAINING SINUS OVER LYMPH NODE 2 – 6 MONTHS AFTER BCG ON THE SAME SIDE AS INOCULATION

AEFI 3. SEVERE LOCAL REACTION REDNESS AND/OR SWELLING AT THE SITE WITH ONE OR MORE OF THE FOLOWWING 1. SWELLING BEYOND JOINT 2. LASTING MORE THAN 3 DAYS OR 3. REQUIRES HOSPITALIZATION

AEFI CNS ADVERSE EVENTS ACUTE PARALYTIC POLIOMYELITIS WITHIN 4-75 DAYS RESIDUAL PARALYSIS AFTER 60 DAYS OR DEATH

AEFI 2. GBS 3. ENCEPHALOPATHY OCCURING WITHIN 30 DAYS CASES OCCURING WITHIN 72 HOURS AFTER VACCINATION

AEFI 4. ENCEPHALITIS 5. MENINGITIS CASES OCCURING WITHIN 72 HOURS WITHIN 1- 6 WEEKS SEIZURES – AFEBRILE - FEBRILE

AEFI OTHER ADVERSE EVENTS 1.ALLERGIC REACTION 2.ANAPHYLACTIC SHOCK 3.ARTHRALGIA 4.DISSEMINATED BCG-IT IS 5.HIGH FEVER

AEFI OTHER ADVERSE EVENTS(CONT) 6. HYPOTENSIVE EPISODE (SHOCK/COLLAPSE) 7. OSTEITIS/OSTEOMYELITIS 8. PERSISTENT SCREAMING 9. SEPSIS (SEVERE GENERALIZED ILLNESS CONFIRMED BY BLOOD CULTURE)

AEFI OTHER ADVERSE EVENTS(CONT) 10.TOXIC SHOCK SYNDROME FEVER, VOMITTING AND WATERY DIARRHOEA- FEW HOURS AFTER IMMUNIZATION – OFTEN LEADING TO DEATH

Examples of types & frequency of AEFIs (in some common vaccines)

AEFI Avoiding Programme Errors Use sterile needle & syringe for every injection Reconstitute only with specific diluent Discard reconstituted vaccines after six hours Do not store drugs & other medicines in the same fridge as the vaccines and diluents Train & supervise health workers to ensure safe injection practices Monitor, Investigate and Act when AEFIs occur Programme Error and their Consequences

AEFI Why monitor AEFI? No vaccines are 100% safe and without any risks It is important to know the risks and how to handle such an event when it occurs Informing people correctly on AEFI helps keep public’s confidence in the immunization programmes Monitoring AEFI also helps improve the quality of service

AEFI Steps in AEFI surveillance Detection and reporting Investigation Data analysis Corrective and other actions Evaluation This slide outlines the basic steps to be taken when an AEFI is reported and you are called upon to investigate. An investigation of an AEFI follows the same principles of investigation, containment, and public health education just like for any other disease outbreak. It is better to have a team formed, with clear cut job responsibilities during the investigation. For example, who is the team coordinator, who is the media focal person, who will do the data quality control, who will be responsible for the data analysis, and who will coordinate the public education activities. Once a team is formed, the team must have a clear idea as to what resources would be needed. But MOVE QUICKLY as investigation and response must be rapid and effective However, while the team is being formed and resources gathered, the health worker at the local site, to the best of his abilities, must initiate investigation, provide treatment and support, and allay public fear and anger

AEFI Detection and reporting Every individual that administers an immunization injection should know about AEFI There should be a national system for detecting and reporting of AEFI At least the following should be included in the national AEFI monitoring system- “trigger events” All injection site abscesses All cases of BCG lymphadenitis All deaths suspected to be related to immunization All hospitalisation suspected to be related to immunization For those who are not aware, the WHO publication, “Surveillance of adverse events following immunization, Field guide for managers of immunization programmes,” (WHO/EPI/TRAM/93.02/REV.1) is an excellent resource book, as a guide for both the development of a national AEFI monitoring and reporting system as well as investigating an AEFI. If copies are required, contact WHO, EPI Programme, either in the respective WHO Regional Offices, or WHO/HQ, Geneva. The four “trigger events” listed above, and some add a fifth one -’Other severe or unusual medical incidents that may be thought to related to immunization,” are important indicators. The basic idea is have these “trigger” events built into a routine reporting system so that they act as triggers to fire a response when something is reported. Most routine EPI do not conduct systematic AEFI investigations on a regular basis unless there is an adverse (real or false) reported.

AEFI Detection and reporting The above basic categories act as “trigger” mechanisms for further course of action The national monitoring system should define the flow of information and mechanisms for taking actions While minor events may be recorded and reported as a routine activity to be analysed only at periodic times, sudden, unexplained deaths or large scale hospitalisation or a cluster of events reported following immunisation warrants immediate investigation It is necessary for National Immunization Programmes to define their trigger events, the manner of reporting those events, and the process of responding when a trigger event actually is reported. It is essential to establish clear responsibilities among health workers at the local level, and at higher level, amongst public health experts and NIP programme functionaries. Health workers must be trained and must be given clear guidelines as to what is to be reported normally, what is to be considered abnormal and, in the event of an abnormal event occurring, what actions to take place, who to contact and to whom to pass on the information.

AEFI Investigation AEFI investigation will attempt to confirm or propose alternative diagnosis of the reported event identify the specifications of the vaccine incriminated examine the operational aspects of the programme identify whether it was an isolated event or a cluster of events and, if a cluster, where the immunization was given and what vaccines were used Preliminary investigation may be carried out by the local health worker, but serious AEFIs or clusters of AEFIs should be investigated by special teams from district or central level An AEFI investigation follows the same principles of investigation as any disease outbreak investigation. Of course, the actions will differ slightly at different stages.

AEFI Investigation Data on the patient(s); vaccine (lot number, expiry, manufacturer, lab results if any), storage, reconstitution practice, diluent used, general disease information in the area, similar disease episodes in unimnunized persons in the same locality, etc. should be collected Collect samples of vaccines and diluents used (make sure vaccine sample collected are kept in the cold chain) The slide is self-explanatory

AEFI: An example of an AEFI investigation Background It is reported that following a measles campaign in a primary school in District X, several children had convulsions. It was widely rumoured that the measles injection was responsible for it Hypothesis that the reported health event (convulsion) was an AEFI following measles vaccination Define the case You define your ‘case’ as any child in that primary school who received measles injection on that particular day and had convulsions. As an example, the following slides will demonstrate the approach and process to an AEFI investigation.

AEFI: example contd.. Case investigation Line list all children, with age & sex, who had received measles injection on that day Find those that reported to have had convulsions Find out all the details regarding the convulsions- onset time after immunization, manner of convulsion, recovery following the convulsion, concomitant medications, fever, any other health problems. Determine the quality of the vaccine (expiry, storage), reconstitution, diluent, injection process, etc. Take samples of the vaccine vials used for lab testing Scrutinise the stock entries, stock balance, etc. Example of investigation, continued….

AEFI: example contd.. One child had an attack of fit half an hour after the immunization. Following this three other children had fainting spells in the same class. All recovered spontaneously although the child who had the first convulsion took longer to recover. Also, the first child sustained a minor cut on the forehead from the fall Next day, five more children called in sick on grounds that they had also attacks of fits after the school Example of investigation continued….

AEFI Data analysis Once the data is collected, it should be analysed as quickly as possible to determine whether the AEFI is Programme related (incorrect dose of vaccine, wrong site, wrong diluent, improper storage & handling, use of other medicines as diluent, etc.) Vaccine induced AEFI Coincidental AEFIs (caused by something other than vaccine or programme errors) Unknown Laboratory support If patient hospitalised, tests may confirm diagnosis Testing vaccines often yield doubtful answers Send case investigation report with vaccine for test The slide is self explanatory

AEFI: example contd.. Data Analysis You find that the vaccine used has not expired, was well maintained in the cold chain, correct diluent was used, There was no evidence of contamination, the health workers always discarded reconstituted vaccine at the end of the session. The medical history showed that the fits which the other children had were mere fainting spells, lasting only for a few moment, with spontaneous recovery. No subsequent attacks occurred The index child had a true convulsion. No fever or other illnesses at that time. This slide continues on the example of an AEFI investigation….

AEFI: example contd.. However, going over the medical history of the child, the health worker recalled that last year the same child had an episode of convulsion for which he had provided treatment. He had advised that the parents should consult a medical or a neurological expert for further management. On questioning, it was found that the parents did not have the time or the money to do that and it was felt that it would resolve naturally Example of AEFI investigation..cotd..

AEFI Corrective and other actions Action must not wait for investigation to be completed Treat the patient(s) as the first response Communicate, inform the public, parents, media people on the event, actions being taken & next steps Once the investigation is completed, publicise the results Take corrective actions, where necessary Training of health workers & supervision to prevent avoidable AEFIs in future

AEFI: example contd.. Conclusion From the available information, and based on the data analysis, you conclude that event was not an AEFI, but Coincidental. Following this, you will take time to explain to the parents, teachers and the community about the event, your investigation and your final conclusions. Example, contd… The point to be highlighted here is that investigation without corrective actions is not good enough. Investigation must lead to improvement in the manner in which future activities would be carried out. It is also an opportunity to provide field workers the chance to learn to conduct such investigation and also provide them hands-on training. The second point to be highlighted is that actions must NOT wait till investigation is complete. Patients are priority: treat them and make sure that all available support is given to them. Next is the general public or the parents. Give them enough information, show that you care about this as much as they do and that your interest in the welfare of their children is genuine and professional.

AEFI Evaluation Like any other surveillance systems, AEFI surveillance must also be evaluated periodically to examine its usefulness and to modify it if necessary Issues to consider when evaluating a surveillance system are timeliness, completeness, accuracy of the system swiftness with which response was effected when a trigger event was reported appropriateness of actions taken potential for strengthening of immunization system Finally, a surveillance system should be as flexible to make it more appropriate to changing needs. Evaluation of a surveillance system may not be necessary as an annual exercise, but periodically a group of experts must sit together to review the relevance and usefulness of the surveillance system and make changes, where appropriate or necessary.

AEFI An ounce of prevention is always better than a pound of cure. Good training & close supervision of health workers, coupled with a functioning surveillance system for monitoring & reporting are the best guarantee against the likelihood of an event occurring at all That is simple enough to need no further explanation. Thank You