"Emergency Plan for Emergency Safety Event in Linyi City"

"Emergency Plan for Emergency Safety Event in Linyi City"

To maximize the dangers of vaccine safety incidents and ensure public health and life safety

In order to establish and improve the emergency response mechanism of vaccine safety incidents in our city, effectively prevent and actively respond to vaccine safety incidents, efficiently organize emergency response work, maximize the hazards of vaccine safety incidents, ensure public health and life safety, and maintain normal socio -economic order. Recently, , "Emergency Plan for the Safety Incident in Linyi City".

The "Emergency Plan for the Emergency Safety Event of Linyi City" is applicable to the response work of vaccine safety incidents in the administrative area of ​​Linyi City. Follow the principles of unified leadership, hierarchical responsibility, prevention, rapid response, synergy response, regulation in accordance with the law, and scientific disposal.

The vaccine safety incident referred to in the plan refers to the suspected vaccination response of vaccine and adverse groups, confirming or suspecting the quality of the vaccine after the organizational investigation, or the vaccine safety information found in daily supervision and inspection and risk monitoring, and other other Vaccination safety incidents that seriously affect public health.

The city's vaccine safety incident emergency command system consists of the emergency headquarters and their working groups at all levels of the city, county (district), and in accordance with the principles of hierarchical responsibility, responsible for organizing, coordinating, and guiding the corresponding event level of vaccine quality and safety emergency response work. The municipal emergency headquarters is responsible for responding to the general and above vaccine safety incidents in the administrative region; the county and district emergency headquarters are responsible for responding to the safety incident of vaccine in the administrative region.

Under the leadership of the municipal government, the emergency headquarters (hereinafter referred to as the city headquarters) was established to establish the city's vaccine safety incident, which is responsible for organizing, coordinating and guiding the city's vaccine safety incident response. The city headquarters has a comprehensive coordination group, medical treatment group, hazardous control group, public opinion guidance group, event investigation team, social stability group, expert group and other working groups. The counties and districts set up the corresponding vaccine safety incident emergency headquarters and working group with reference to the "Emergency Plan for the Emergency Safety Event in Linyi City", which is responsible for organizing, coordinating and guiding the response to vaccine safety incidents in the region. Under the unified leadership of the city headquarters, the county and districts where vaccine safety incidents should do a good job of emergency response work in accordance with the principles of territorial management.

The "Emergency Plan for the Emergency Safety Event of Linyi City" clarifies the monitoring system and information transfer system, including monitoring, early warning, reporting, and event assessment. Among them, in the preliminary report, after the suspected vaccine safety incident, the market supervision and health departments of each county (district) should grasp the situation as soon as possible and report the initial information of the incident in time. Scope and degree (the number of patients, the number of diagnosis and treatment, and the number of critical weights), the main symptoms and signs; the vaccine manufacturer and the product name and batch number; the preliminary disposal situation, the approach of the report, the development trend, and the other content that should be reported. Especially major (level I) and major (level II) vaccine safety events should be reported in writing within 30 minutes after learning about the relevant information; a large (level III) vaccine safety event should be reported. Report in writing within 6 hours; general (level IV) vaccine safety incident should be reported in writing within 24 hours after learning about the relevant information.

Relevant departments such as market supervision and health and health at all levels shall carry out emergency knowledge propaganda, education and training on vaccine supervision, disease control institutions, and vaccination units to enhance the awareness of emergency responsibility and improve their awareness of risk and prevention.

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Hierarchical standards and response levels of vaccine safety events

Vaccine safety events are divided into 4 levels of major, significant, larger, and general, and correspond to the response of I, Ⅱ, III, and IV in turn.

Especially major vaccine safety incidents, in line with one of the following situations: the same batch of vaccines caused more than 5 patients to die, suspected of quality -related events; in a relatively concentrated time and area, the comparison of the same vaccine in the batch number caused similar clinical manifestations to similar clinical manifestations And rare or non -expected adverse events of more than 20 people; or cause particularly serious adverse events (may cause permanent disability to the human body, cause permanent injury or life -threatening to organ function), suspected and quality Related events; other vaccine safety incidents that are particularly serious and cause social impact.

Major vaccine safety incidents are in line with one of the following situations: the same batch of vaccines caused more than 2 cases (excluding 2 cases), and less than 5 patients died, suspected of quality -related events; The concentration of the same vaccine causes similar clinical manifestations, and the number of rare or non -expected adverse events exceeds 10 people, not more than 20; There are more than 3 people permanent injury or life), not more than 5 people, suspected of quality -related events; confirmation of quality problems, involving 2 provinces; other vaccine safety incidents that have serious harm and social impact.

Large vaccine safety incidents, in line with one of the following situations: the same batch of vaccines caused 2 patients to die, suspected of quality -related events; in a relatively concentrated time and area, the same vaccine with the batch number caused similar clinical manifestations. And the number of rare or non -expected adverse events exceeds 5 people, not more than 10 people; or cause particularly serious adverse incidents (may cause permanent disability to the human body, cause permanent damage to organ function or life -threatening) more than 2 people) Suspected of events related to quality; confirmation of quality problems involved in one province; other harms and social impact are limited to vaccine safety incidents in a certain province.一般疫苗安全事件，符合下列情形之一的：同一批号疫苗引起1例患者死亡，疑似与质量相关的事件；在相对集中的时间和区域内，批号相对集中的同一疫苗引起临床表现相似的，且There are more than 3 people who are rare or non -expected adverse events, not more than 5; Suspected of incidents related to quality; other general vaccine safety incidents.

Lin Newspaper Rong Media Reporter 雪 Hengxue Intern Wang Yu

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