World Health Organization Headquarters, Geneva, Switzerland.
Scientific Centre of Drug and Medical Technology Expertise of MoH, Yerevan, Armenia.
Drug Saf. 2021 Oct;44(10):1085-1098. doi: 10.1007/s40264-021-01100-z. Epub 2021 Jul 31.
The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and building national competence for those activities that cannot be delegated.
The 3S principles were applied to Armenia, Brazil, Ethiopia, India, Peru and Thailand using three priority products: bedaquiline, rotavirus vaccine and tafenoquine. A baseline assessment of pharmacovigilance preparedness was used to identify gaps and establish a work plan. The impact was measured by comparing pre and post 3S-intervention outcomes, which included the number and quality of reports (completeness scores) in the WHO global database of Individual Case Safety Reports, VigiBase, and number of structural indicators met. The implementation period was 9-18 months, ranging from March 2018 (earliest started) until May 2020 (latest).
An increase in adverse drug reaction (ADR) reporting was demonstrated in Armenia (bedaquiline), Brazil (TB and malaria medicines), India (rotavirus vaccine) and Ethiopia (TB medicines). Completeness scores were above 0.5 at baseline in all countries, and reports improved in quality for Brazil (TB), Peru (malaria), Thailand (malaria) and India (immunization). The number of structural indicators met increased by more than double for Ethiopia. Ethiopia and India demonstrated an increased capacity for signal detection and signal evaluation. Armenia, Brazil, Peru and Thailand showed increased capacity to assess risk management plans following the implementation of 3S principles.
The 3S concept has demonstrated success in different ways across the six countries. Activities focused on three products for a proof of concept of the 3S principles, with the expectation that the project impact will be sustained through strengthened systems, to guide pharmacovigilance activities of other products in the future. It is important to continue monitoring the countries to understand if the gains and successes of the current 3S project are sustainable.
智能安全监测（3S）概念基于以下理解：当面临相互竞争的药物警戒优先事项时，各国将不得不明智地进行投资，专注于新的优先产品，在可能的情况下与其他国家共享工作和资源，并为那些无法委托的活动建立国家能力。
使用三种优先产品（贝达喹啉、轮状病毒疫苗和他非诺喹），将 3S 原则应用于亚美尼亚、巴西、埃塞俄比亚、印度、秘鲁和泰国。使用基线评估药物警戒准备情况来确定差距并制定工作计划。通过比较 3S 干预前后的结果来衡量影响，这些结果包括世界卫生组织个体病例安全报告全球数据库（VigiBase）中报告的数量和质量（完整性评分），以及满足的结构指标数量。实施期为 9-18 个月，从 2018 年 3 月（最早开始）到 2020 年 5 月（最晚）。
在亚美尼亚（贝达喹啉）、巴西（结核病和疟疾药物）、印度（轮状病毒疫苗）和埃塞俄比亚（结核病药物），药物不良反应报告有所增加。所有国家的基线完整性评分均高于 0.5，巴西（结核病）、秘鲁（疟疾）、泰国（疟疾）和印度（免疫接种）的报告质量有所提高。埃塞俄比亚满足的结构指标数量增加了一倍以上。埃塞俄比亚和印度在信号检测和信号评估方面的能力有所提高。亚美尼亚、巴西、秘鲁和泰国在实施 3S 原则后，对风险管理计划的评估能力有所提高。
3S 概念在六个国家以不同的方式取得了成功。该项目集中开展了三项产品活动，以验证 3S 原则的概念，预计该项目的影响将通过加强系统得到维持，以指导未来其他产品的药物警戒活动。重要的是，要继续监测这些国家，以了解当前 3S 项目的成果是否可持续。
