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加拿大的八要素疫苗安全系统:医护人员入门指南。

Canada's eight-component vaccine safety system: A primer for health care workers.

作者信息

MacDonald Noni E, Law Barbara J

机构信息

Canadian Paediatric Society, Infectious Diseases and Immunization Committee, Ottawa, Ontario.

出版信息

Paediatr Child Health. 2017 Jul;22(4):236. doi: 10.1093/pch/pxx102. Epub 2017 Jun 15.

Abstract

Concerns about vaccine safety make some parents hesitant about immunization. Health care providers are pivotal in helping parents understand that Canada is a leader in vaccine safety. The present practice point provides an update on the eight components of Canada's vaccine safety system: (1) an evidence-based pre-license review and approval process; (2) strong regulations for manufacturers; (3) independent evidence-based vaccine use recommendations; (4) immunization competency training and standards for health care providers; (5) pharmacovigilance programs to detect and (6) determine causality of adverse events following immunization (AEFIs); (7) a program for vaccine safety and efficacy signal detection; and (8) the Canadian Immunization Research Network's special immunization clinics for children who have experienced serious AEFIs.

摘要

对疫苗安全性的担忧使一些家长对免疫接种犹豫不决。医疗保健提供者在帮助家长了解加拿大在疫苗安全方面处于领先地位方面起着关键作用。本实践要点提供了加拿大疫苗安全系统八个组成部分的最新情况:(1) 基于证据的上市前审查和批准程序;(2) 对制造商的严格监管;(3) 基于独立证据的疫苗使用建议;(4) 医疗保健提供者的免疫接种能力培训和标准;(5) 药物警戒计划以检测和 (6) 确定免疫接种后不良事件 (AEFI) 的因果关系;(7) 疫苗安全性和有效性信号检测计划;以及 (8) 加拿大免疫研究网络为经历过严重 AEFI 的儿童设立的特殊免疫诊所。

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