On April 3, the National Commission on health and family planning official website released a total of ten "suspected preventive vaccination (AEFI) monitoring of knowledge", which read as follows:
A, what is the suspected preventive vaccination (AEFI)? How to understand its meaning?
AEFI is after vaccination of suspected reactions or events associated with the vaccination. It main including three a aspects of meaning: ① must of time associated: reaction must is in prevention vaccination Hou must of time range within occurred; but has time associated sex, not is equal to has causal associated sex; II must of damage consequences: reaction must exists must of clinical damage consequences, as organization organ or function aspects of damage; ③ suspicious of causal associated: reaction and prevention vaccination of vaccine may exists causal associated, or temporarily cannot excluded both Zhijian of causal associated; has causal associated sex, must exists time associated sex.
Second, what is the abnormal reaction? What features does it have?
Abnormal reaction is practice for qualified vaccine inoculation process or implementation specification after inoculation caused by damage to body tissues and organs, function, adverse drug reactions of the relevant parties without fault. Unusual reaction characteristics: ① by the inherent properties of the vaccine caused ② low c clinical severe symptoms, usually requiring disposal about reaction can resume, few may have permanent damage; II vaccinations were qualified; ⑥ vaccination practice.
Three, what is abnormal clinical damage? How high is the incidence?
Exception reaction caused of clinical damage including allergy reaction, and nervous system reaction and other clinical damage three big class; which, allergy reaction main has allergy sex rash, and allergy sex shock, and throat edema, and vascular sex edema, and platelet reduced sex Purpura, and local allergy necrosis reaction,; nervous system reaction main has hot sex convulsions, and vaccine related paralysis type polio,; other clinical damage main has no bacteria sex abscess, and BCG caused of local abscess, and lymph nodes inflammatory or lymphatic inflammatory, and bone inflammatory, and spread sex BCG infection,.
Serious abnormal allergic reactions, including anaphylactic shock, laryngeal edema, allergic Purpura, thrombocytopenic purpura, necrosis, local allergic reactions, febrile seizures, brachial plexus neuritis, vaccine-associated paralytic polio, BCG Osteitis, disseminated BCG infection. Investigations a drugstore in Shanghai was selling
Different varieties of abnormal reaction rate is different. Who on part vaccine of exception reaction research displayed, BCG caused of lymph nodes inflammatory, and bone inflammatory, and spread sex infection occurred rate respectively for 1-10/million agent times, and 1-700/1 million agent times, and 0.19-1.56/100 million agent times; hepatitis b vaccine caused of allergy sex shock for 1.1/1 million agent times; Ridge gray reduction HIV live vaccine caused of vaccine related paralysis type polio first agent times for 1/750,000 agent times, follow-up agent times 1/5.1 million agent times; measles/leprosy/ Gill wind of anaphylactic shock caused by vaccines is 1/1 million doses.
Four abnormal reaction, which does not belong to?
The following circumstances don't belong to abnormal reaction:
General reaction: after the vaccination, inherent characteristics caused by the vaccine itself, the body will only lead to a dysfunction of physiological reactions, including fever and redness, and may be accompanied by a general malaise, fatigue, loss of appetite, weakness, the syndrome.
Vaccine quality accidents due to substandard vaccine after inoculation caused by damage to body tissues and organs, function.
Inoculation accident due to violation of vaccination in the vaccination process specifications, guiding principles for immunization programs, vaccine, vaccination programmes, caused by damage to body tissues and organs, function.
Coupling: the who at the time of vaccination in some disease incubation period or prodromal period, incidence of coincidence after vaccination. That vaccination or not, the couple will definitely happen, unrelated to the vaccine and vaccination.
Psychogenic reactions: in the implementation of vaccination after vaccination due to psychological factors or occurrence of individual or group responses.
Five, which AEFI reporting provisions?
AEFI report range according to occurred time is divided into following case: ① 24 hours within: as allergy sex shock, and not with shock of allergy reaction (urticaria, and spot papules, and throat edema,), and poisoning sex shock integrated levy, and syncope, and hysteria syndrome,; II 5 days within: as fever (axillary temperature ≥ 38.6 ℃), and vascular sex edema, and body fester sex infection (HIV blood syndrome, and sepsis, and pus HIV blood syndrome), and vaccination parts occurred of redness (diameter >2.5cm), and induration (diameter >2.5cm), and Local fester sex infection (local abscess, and lymphatic inflammatory and lymph nodes inflammatory, and cellular organization inflammatory),; ③ 15 days within: as measles sample or scarlet fever sample rash, and allergy sex Purpura, and local allergy necrosis reaction, and hot sex convulsions, and epilepsy, and multiple neural inflammatory, and brain disease, and encephalitis and meningitis,; II 6 week within: as platelet reduced sex Purpura, and Guillain-Barre integrated levy, and vaccine related paralysis type polio,; ⑤ 3 months within: as arm bundle neural inflammatory, and vaccination parts occurred of no bacteria sex abscess, ; F 1-12 months after BCG vaccination: lymphadenitis and Lymphangitis, Osteitis, disseminated BCG infection; sadly, other suspected other serious AEFI associated with vaccination.
Liu, who reported AEFI? When the AEFI report? AEFI reported to the who?
Medical institutions, vaccinations, disease prevention and control agencies, ADR monitoring institutions, vaccine manufacturers wholesale, vaccine companies and persons carrying out the functions the responsibility of AEFI reporting units and speakers. Species or their guardian may report to the responsibility of reporting units and speakers.
Responsibility report units and report people found belongs to report range of AEFI (including received by species who or its guardian of report), should timely to by species who location of county health family planning administrative sector, and drug supervision management sector report; found suspected and prevention vaccination about of death, and serious disability, and group AEFI, and on social has major effect of AEFI Shi, should in 2 hours within by species who location of county health family planning administrative sector, and drug supervision management sector report, county health family planning administrative sector, and Step by step up the drug regulatory agency health family planning administrative departments, reported the drug regulatory agency. AEFI reports by national AEFI information management system for direct reporting network.
Seven, what AEFI investigation? Who investigate AEFI? When the investigation?
In addition to definitive diagnosis of the general reaction (such as fever, redness, induration of the vaccination site alone), other AEFI reports require investigation. County-level disease prevention and control agencies need to investigate AEFI, organizations to carry out investigations within 48 hours after receipt of the report. Suspected deaths associated with vaccination, severe disability, group AEFI of AEFI, society has a significant impact, the municipal level or immediately after receiving the report, the provincial disease prevention and control institutions organized experts to investigate.
Eight AEFI investigation, who diagnosed? When the investigation concludes? Judging based on what?
Need for investigation and diagnosis of AEFI, investigated by the disease prevention and control institutions at the county level the Organization of expert diagnosis. Death, major disability, group AEFI, society has a major impact on AEFI, by municipal or provincial organizations for the prevention of disease prevention and control institutions for vaccination diagnosis expert group to investigate diagnostic investigations. Group of experts made up of epidemiological, clinical, pharmaceutical, and other experts.
AEFI investigation diagnosis within 30 days after the end of the investigation as soon as possible. Investigation diagnosis expert group in accordance with the law and administrative regulations, departmental rules and technical specifications, based on clinical symptoms, medical examination results and vaccine quality test results, analyze and conduct the investigation concludes.
When the species, inoculation, vaccine manufacturers to investigate the preventive vaccination diagnosis when there is a dispute, in accordance with the preventive vaccination and identification procedures of the relevant provisions.
Nine, which damage caused by abnormal reaction needs to be compensated? Compensation for costs borne by the who?
Preventive vaccination who caused death, severe disability or organ or tissue damage, per kind of one-time financial compensation should be given. Compensation for abnormal reaction immunized against first class by provinces, autonomous regions and municipalities in vaccination funding arrangements in the financial sector; a second kind of vaccine adverse reaction compensation for costs borne by the relevant vaccine production company.
Ten, the release of national vaccination monitoring information
National vaccination surveillance information by the State Health Commission and the food and drug administration of China diseases prevention and control center and the National Center for adverse drug reaction monitoring joint press release. Information released each year for the previous year's total national vaccination report and the reported incidence of major adverse reaction reports, to monitor actual statistical data time shall prevail.
No comments:
Post a Comment