在埃塞俄比亚和巴基斯坦利用 COVID-19 疫苗安全性监测加强全系统安全性监测。

IF 2.5 3区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Aida Arefayne Hagos, Zelalem Sahile, Waqas Ahmed, Souly Phanouvong
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引用次数: 0

摘要

COVID-19 疫苗的快速开发、引进和全球使用要求各国建立强大的药物警戒系统,以监测和处理免疫接种后的不良事件 (AEFI)。这些系统可提供有关疫苗安全性的及时数据,从而支持有关疫苗不良事件的潜在风险与疾病预防益处的决策。在埃塞俄比亚,由于缺乏通过被动监测系统提交的数据、调查严重不良事件和进行因果关系评估的延迟以及缺乏向世界卫生组织 (WHO) 全球数据库 VigiBase 的报告,监测系统受到了限制。在巴基斯坦,药物警戒系统缺乏报告要求和指导文件,监管政策不足,工作人员缺乏评估 AEFI 报告的能力。这两个国家都采取了一些干预措施,以改善药物警戒系统和流程,这是收集、分析和向国家层面报告来自医疗机构的 AEFI 所必需的,并促进全球和国家电子报告工具的使用。此外,巴基斯坦改善了监管政策环境,并首次让疫苗生产商和私营部门医疗机构参与 AEFI 报告。成果包括报告的 COVID-19 疫苗相关 AEFI 和完成的因果关系评估数量增加,这意味着对潜在安全问题的分析更加迅速、全面和准确。巴基斯坦监管机构向 VigiBase 提交的 AEFI 报告数量从 2021 年的每季度约 5,000 份增加到 2022 年的每季度 28,555 份,增加了五倍多。在埃塞俄比亚,截至 2022 年 10 月,已收到 44,000 份 AEFI 报告,并完成了 40 次因果关系评估。在这两个国家,及时的 AEFI 数据审查和分析促成了迅速的建议和监管行动,凸显了加强国家级药物警戒系统的深远影响。这些经过强化的系统现已用于所有疫苗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Leveraging COVID-19 Vaccine Safety Monitoring in Ethiopia and Pakistan to Enhance System-Wide Safety Surveillance.

The rapid development, introduction, and global uptake of COVID-19 vaccines required countries to have strong pharmacovigilance systems in place to monitor and address adverse events following immunization (AEFIs). These systems provide timely data on vaccine safety that support decisions about the potential risks of vaccine adverse events relative to the benefit of disease prevention. In Ethiopia, the monitoring system was limited by the lack of data being submitted through its passive surveillance system, delays in investigating serious adverse events and conducting causality assessments, and the lack of reporting to the World Health Organization (WHO) global database, VigiBase. In Pakistan, the pharmacovigilance system lacked reporting requirements and guidance documentation, regulatory policies were insufficient, and staff lacked the capacity to evaluate AEFI reports. Several interventions were implemented in both countries to improve pharmacovigilance systems and processes necessary to collect, analyze, and report AEFIs from health care facilities to the national level and facilitate the use of global and national electronic reporting tools. In addition, Pakistan improved the regulatory policy environment and engaged vaccine manufacturers and private sector health facilities in AEFI reporting for the first time in the country. Outcomes include an increased number of COVID-19 vaccine-related AEFIs reported and causality assessments completed, which means that potential safety issues were being analyzed more quickly, comprehensively, and accurately. The number of AEFI reports submitted to VigiBase by Pakistan's regulatory authority more than quintupled from approximately 5,000/quarter in 2021 to 28,555/quarter in 2022. In Ethiopia, by October 2022, 44,000 AEFI reports had been received, and 40 causality assessments completed. In both countries, timely AEFI data review and analysis led to prompt recommendations and regulatory actions, highlighting the far-reaching implications of strengthening the country-level pharmacovigilance systems. These strengthened systems are now in place for use with all vaccines.

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来源期刊
Global Health: Science and Practice
Global Health: Science and Practice Medicine-Health Policy
CiteScore
3.50
自引率
7.50%
发文量
178
审稿时长
22 weeks
期刊介绍: Global Health: Science and Practice (GHSP) is a no-fee, open-access, peer-reviewed, online journal aimed to improve health practice, especially in low- and middle-income countries. Our goal is to reach those who design, implement, manage, evaluate, and otherwise support health programs. We are especially interested in advancing knowledge on practical program implementation issues, with information on what programs entail and how they are implemented. GHSP is currently indexed in PubMed, PubMed Central, POPLINE, EBSCO, SCOPUS,. the Web of Science Emerging Sources Citation Index, and the USAID Development Experience Clearinghouse (DEC). TOPICS: Issued four times a year, GHSP will include articles on all global health topics, covering diverse programming models and a wide range of cross-cutting issues that impact and support health systems. Examples include but are not limited to: Health: Addiction and harm reduction, Child Health, Communicable and Emerging Diseases, Disaster Preparedness and Response, Environmental Health, Family Planning/Reproductive Health, HIV/AIDS, Malaria, Maternal Health, Neglected Tropical Diseases, Non-Communicable Diseases/Injuries, Nutrition, Tuberculosis, Water and Sanitation. Cross-Cutting Issues: Epidemiology, Gender, Health Communication/Healthy Behavior, Health Policy and Advocacy, Health Systems, Human Resources/Training, Knowledge Management, Logistics and Supply Chain Management, Management and Governance, mHealth/eHealth/digital health, Monitoring and Evaluation, Scale Up, Youth.
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