Transcript (AEFI)?
World Health Organization Global Training Network Programme 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 World Health Organization Global Training Network Programme AEFI Modern vaccines Are generally safe Not entirely without risk Benefits far outweigh risks World Health Organization Global Training Network Programme AEFI Why monitoring of AEFI are important ? Upsets people Refusal for further immunization World Health Organization Global Training Network Programme HOW DOES AEFI REPORTING INTERACT WITH ADR REPORTING? Adverse drug reaction form World Health Organization AEFI reporting form Global Training Network Programme BARRIERS TO REPORTING Not considering the event as related to immunization Not knowing about reporting system and process Lethargy, lack of interest or time, inability to find report form Fear that the report will lead to personal consequences Guilt about having caused harm and being responsible for the event Uncertainty about reporting an event when not confident about the diagnosis World Health Organization Global Training Network Programme MOH goal for establishing AEFI surveillance AEFI surveillance has been started to improve the quality of immunization services World Health Organization Global Training Network Programme objective Estimation of AEFI rates. Detection, correction, and prevention of program errors . Early detection of AEFI associated with a specific vaccine lots or brands and early response. Maintaining the community confidence on immunization services after an AEFI . World Health Organization Global Training Network Programme Political commitment A circular was distributed in 2003 by MOH for health facilities to report every AEFI to medical universities and CDC. World Health Organization Global Training Network Programme Establishment of National immunization safety committee - 2001 The members include: National EPI manager ,as the head of committee Pediatric neurologists Neurologist Infectious disease specialist Virologist Epidemiologist Immunologist NRA representative The committee has regular meeting sessions monthly or in necessary intervals World Health Organization Global Training Network Programme central immunization safety committee activities Providing a guideline on accurate AEFI definition Designing a reporting system based on WHO recommendation Designing and disseminating of AEFI reporting forms. Providing materials for training of health- care workers, managers and supervisors. World Health Organization Global Training Network Programme Reportable AEFI It is mandatory to report the following: All deaths suspected to be related to immunization All cases requiring hospitalization due to vaccination All injection sites abscesses All cases of BCG lymphadenitis Anaphylactic reactions Any seizure during one month after vaccination Hypotonic reactions Encephalitis Other severe or unusual medical events DEFINITION OF EACH OF THE ABOVE IS INCLUDED IN THE COUNTRY GUIDELINE. THESE ARE BASED ON WHO GUIDELINES. World Health Organization Global Training Network Programme How AEFI should be reported All serious AEFI such as hospitalization, death and abscess should be reported immediately by phone to district, province and CDC. All mild reactions included in the national AEFI list should be reported to the focal points in the province and then to CDC, monthly. Zero reporting for measles and polio is mandatory and the AEFI zero reporting is collected with the same form monthly. World Health Organization Global Training Network Programme How AEFI should be reported (cont‘d ) All health-care workers have to report any AEFI which occurs during or soon after vaccination to the AEFI focal point, immediately. All health workers have to report any event suspected to be related to immunization in the monthly report. THE REPORTING SYSTEM IS PASSIVE World Health Organization Global Training Network Programme WHAT IS AN ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI)? A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization Vaccine reaction - caused by vaccine’s inherent properties Programme error - caused by error in vaccine preparation, handling, or administration Coincidental - happens after immunization but not caused by it (a chance association) Injection reaction - anxiety or pain of injection not vaccine Unknown - cause cannot be determined World Health Organization Global Training Network Programme VACCINE REACTIONS Common, minor reactions vaccine stimulates immune system settle on their own warn parents and advise how to manage Rare, more serious reactions anaphylaxis (serious allergic reaction) vaccine specific reactions World Health Organization Global Training Network Programme COMMON, MINOR REACTIONS Vaccine Local reaction BCG Hib (pain, swelling, redness) 90-95% 5-15% Irritability, malaise & systemic symptoms Fever >38oC - - 2-10% 1-6% HepB Adults: 15%; Children: 5% Measles/ ~10% 5-15% MMR Polio <1% 5% rash <1%** (OPV) Tetanus DTP (pertussis) ~10%* Up to 50% ~10% ~25% Up to 50% Up to 55% * Rate of local reactions likely to increase with booster doses, up to 50-85% ** Symptoms include diarrhoea, headache, and/or muscle pains World Health Organization Global Training Network Programme MANAGEMENT OF COMMON, MINOR REACTIONS Local reaction cold cloth at injection site paracetamol Fever >38°C give extra fluids tepid sponging paracetamol Irritability malaise and systemic symptoms give extra fluids paracetamol World Health Organization Global Training Network Programme RARE, MORE SERIOUS REACTIONS Vaccine Reaction Onset interval Rate per million doses BCG Suppurative lymphadenitis BCG osteitis Disseminated BCG 2-6 months 1-12 months 1-12 months 100-1000 1-700 2 Hib Nil known Hep B Anaphylaxis Guillain Barré syndrome 0-1 hour 1-6 weeks 1-2 5 Measles /MMR Febrile seizures Thrombocytopaenia Anaphylaxis 5-12 days 15-35 days 0-1 hour 333 33 1-50 OPV Vaccine-associated paralytic poliomyelitis (VAPP) 4-30 days 0.76-1.3 (1st dose) 0.17 (subsequent doses) 0.15 (contacts) Risk is higher for first dose, adults, and immunocompromised World Health Organization Global Training Network Programme RARE, MORE SERIOUS REACTIONS (2) Vaccine Reaction Onset interval Rate per million doses Tetanus Brachial neuritis Anaphylaxis Sterile abscess Nil extra to tetanus reactions 2-28 days 0-1 hour 1-6 weeks 5-10 1-6 6-10 Persistent (>3 hrs) inconsolable screaming Seizures Hypotonic, hyporesponsive episode (HHE) Anaphylaxis/shock Encephalopathy 0-24 hours 1000-60 000 0-3 days 0-24 hours 570 570 0-1 hour 0-3 days 20 0-1 Tetanus-diphtheria DTP World Health Organization Global Training Network Programme ADVERSE EVENTS ASSOCIATED WITH SPECIFIC VACCINES WHO case definitions are used here Lack of standardized case definitions in the literature e.g. fever The Brighton collaboration developing case definitions for AEFI promoting global implementation of these definitions [email protected] http://brightoncollaboration.org World Health Organization Global Training Network Programme ANAPHYLAXIS Type 1 hypersensitivity reaction Circulatory failure Bronchospasm +/- laryngospasm/laryngeal oedema respiratory distress May include pruritis, flushing, angioedema, seizures, vomiting, abdominal cramps & incontinence Occurs in previously sensitized individuals World Health Organization Global Training Network Programme ANAPHYLAXIS Reported less from developing countries Less sensitization? Less reporting? Anaphylaxis is rare (1/1 000 000 vaccinations) Fainting is common Untrained staff may misdiagnose fainting/dizziness for anaphylaxis or vice versa Administration of adrenaline in a faint may be dangerous PROMPT MANAGEMENT IS VITAL! World Health Organization Global Training Network Programme SEIZURES Particularly associated with measles and DTP vaccination (pertussis component) febrile seizures Temp >38 afebrile seizures Temp normal Febrile seizures more common with pertussis An association with non-febrile seizures has not been proven World Health Organization Global Training Network Programme ADVERSE REACTIONS TO BCG Disseminated BCG widespread infection, 1-12 months after BCG usually in immunocompromised individual confirm by isolation of Mycobacterium bovis BCG strain treat with antituberculous regimen including Rifampicin and Isoniazid Osteitis/osteomyelitis infection of the bone with M bovis BCG strain management as above World Health Organization Global Training Network Programme ADVERSE REACTIONS TO BCG Suppurative lymphadenitis occurs within 2-6 months of BCG vaccination case definition 1 lymph node> 1.5 cm in size/draining sinus over a lymph node usually occurs in the axilla, on the same side as innoculation Management heals spontaneously over months only treat if sticking to skin or draining surgical drainage and local installation of antituberculous drug systemic Rx is ineffective World Health Organization Global Training Network Programme World Health Organization Global Training Network Programme World Health Organization Global Training Network Programme TETANUS VACCINE Brachial neuritis Presents with pain in shoulder and upper arm Followed by weakness +/- wasting of arm and shoulder muscles Sensory loss not prominent Occurs 2-28 days after vaccination Possibly a manifestation of immune complex disease Management is symptomatic World Health Organization Global Training Network Programme ENCEPHALOPATHY AND ENCEPHALITIS Possibly associated with measles & pertussis vaccine Case definition of encephalopathy 2 out of 3 of seizures alteration of consciousness lasting for one day or more distinct change in behavior for one day or more Temporal relationship within 48 hrs with DTP within 7-12 days after measles or MMR World Health Organization Global Training Network Programme HYPOTONIC HYPOTENSIVE EPISODE (HHE OR SHOCK-COLLAPSE) Mainly associated with DTP Case definition Event of sudden onset occurring within 48 (usually less than 12) hours of vaccination and lasting from one minute to several hours In a child < 10 years of age ALL of the following must be present limpness (hypotonic) reduced responsiveness pallor or cyanosis - or failure to observe/recall Transient, self-limiting, NOT a contraindication to further vaccination World Health Organization Global Training Network Programme POLIO VACCINE - ACUTE FLACCID PARALYSIS Vaccine associated paralytic poliomyelitis Occurs within 4-30 days of receipt of OPV or 4-75 days after contact with vaccine recipient Case Following a national immunization day in 1996, cases of paralysis were reported after receiving OPV. On laboratory analysis, the wild virus was found, showing that the children had been infected with wild poliovirus before immunization. The cases of poliovirus were coincidental, and not caused by the vaccine. World Health Organization Global Training Network Programme TOXIC SHOCK SYNDROME Case definition: Abrupt onset of fever, vomiting and watery diarrhoea Occurs within a few hours of immunization Often leads to death within 24-48 hours needs to be reported as possible indicator of programme error World Health Organization Global Training Network Programme UNPROVEN ASSOCIATIONS AND PUBLIC CONCERNS Influenza vaccine and Guillaine Barré Syndrome MMR and autism, Crohn’s disease Polio and HIV Hepatitis B and multiple sclerosis DTP and permanent brain damage DTP and increased risk of mortality Aluminium and macrophagic myofasciitis Bovine spongiform encephalopathy (BSE) Thiomerosal Multiple vaccines given simultaneously World Health Organization Global Training Network Programme PROGRAMME ERRORS Non-sterile injection infection Incorrect preparation abscess (inadequate shaking) drug effect (use of drug instead of vaccine/diluent) Injection in wrong site local reaction/abscess (wrong tissue level) nerve damage Vaccine frozen local reaction Contraindication ignored avoidable severe reaction World Health Organization Global Training Network Programme World Health Organization Global Training Network Programme World Health Organization Global Training Network Programme World Health Organization Global Training Network Programme Turkey Programmatic error India Algeria Yemen 1997 Insulin given to 70 infants instead of DTP vaccine with 21 deaths TT DTP Insulin vial Vaccine vials World Health Organization Global Training Network Programme CLUSTER >=2 cases of the same adverse event following immunizations related in time, geography or in the vaccine administered Why is it important to monitor for clustering? World Health Organization Global Training Network Programme WHICH EVENTS TO REPORT? Death, hospitalization, or other severe/unusual events Toxic shock syndrome Severe local reaction Sepsis Injection site abscess (bacterial/sterile) BCG lymphadenitis AEFIs causing concern or suspicion of vaccine involvement World Health Organization Global Training Network Programme World Health Organization Global Training Network Programme ____________ ____________ ____________ ____________ ____________ World Health Organization Global Training Network Programme SERIOUS EVENTS Anaphylactoid reaction (acute hypersensitivity reaction) Anaphylaxis Persistent (more than 3 hours) inconsolable screaming Hypotonic hyporesponsive episode Seizures, including febrile seizures (6-12 days for measles/MMR; 0-2 days for DTP) Encephalopathy (6-12 days for measles/MMR; 0-2 days for DTP) World Health Organization Global Training Network Programme SERIOUS EVENTS (CONTINUED) Acute flaccid paralysis (4-30 days for OPV recipient; 4-75 days for contact) Brachial neuritis (2-28 days after tetanus containing vaccine) Thrombocytopaenia (15-35 days after measles/MMR) Disseminated BCG infection Osteitis/osteomyelitis World Health Organization Global Training Network Programme