GSK, Avenue Fleming 20, 1300, Wavre, Belgium.
PATH, Geneva, Switzerland.
BMC Public Health. 2022 Aug 17;22(1):1568. doi: 10.1186/s12889-022-13867-6.
Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveillance and reporting procedures. The GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aimed to strengthen passive safety surveillance through a training and mentoring program of HCPs in healthcare facilities in three SSA countries: Malawi, Côte d'Ivoire, and Democratic Republic of Congo (DRC). Project implementation was country-driven, led by the Ministry of Health via the national PV center or department, and was adapted to each country's needs. The implementation phase for each country was scheduled to last 18 months. At project start, low AE reporting rates reflected that awareness of PV practices was very low among HCPs in all three countries, even if a national PV center already existed. Malawi did not have a functional PV system nor a national PV center prior to the start of the initiative. After 18 months of PV training and mentoring of HCPs, passive safety surveillance was enhanced significantly as shown by the increased number of AE reports: from 22 during 2000-2016 to 228 in 18 months to 511 in 30 months in Malawi, and ~ 80% of AE reports from trained healthcare facilities in Côte d'Ivoire. In DRC, project implementation ended after 7 months because of the SARS-CoV-2 pandemic. Main challenges encountered were delayed AE report transmission (1-2 months, due mainly to remoteness of healthcare facilities and complex procedures for transmitting reports to the national PV center), delayed or no causality assessment due to lack of expertise and/or funding, negative perceptions among HCPs toward AE reporting, and difficulties in engaging public health programs with the centralized AE reporting processes. This pilot project has enabled the countries to train more HCPs, increased reporting of AEs and identified KPIs that could be flexibly replicated in each country. Country ownership and empowerment is essential to sustain these improvements and build a stronger AE reporting culture.
在撒哈拉以南非洲（SSA）的许多国家，药物警戒（PV）系统尚未完全运作。SSA 的自发不良事件（AE）报告率低于世界任何其他地区，并且 SSA 国家的医疗保健专业人员（HCP）对 AE 监测和报告程序的认识有限。葛兰素史克（GSK）PV 增强试点倡议与 PATH 和国家 PV 利益相关者合作，旨在通过培训和指导医疗保健设施中的 HCP，加强被动安全监测，该倡议在 SSA 的三个国家开展：马拉维、科特迪瓦和刚果民主共和国（DRC）。项目实施由国家主导，通过国家 PV 中心或部门由卫生部领导，并根据每个国家的需求进行调整。每个国家的实施阶段预计持续 18 个月。在项目启动时，AE 报告率低反映出所有三个国家的 HCP 对 PV 实践的认识非常低，即使已经存在国家 PV 中心。在该倡议启动之前，马拉维既没有功能齐全的 PV 系统，也没有国家 PV 中心。在对 HCP 进行了 18 个月的 PV 培训和指导之后，被动安全监测得到了显著增强，AE 报告数量增加：从 2000 年至 2016 年的 22 份增加到 18 个月的 228 份，再到 30 个月的 511 份；科特迪瓦约 80%的 AE 报告来自经过培训的医疗保健设施。在 DRC，由于 SARS-CoV-2 大流行，项目实施在 7 个月后结束。遇到的主要挑战是 AE 报告的传输延迟（1-2 个月，主要是由于医疗保健设施偏远和向国家 PV 中心报告的程序复杂），由于缺乏专业知识和/或资金，因果关系评估延迟或不存在，HCP 对 AE 报告的负面看法，以及在将公共卫生计划纳入集中 AE 报告流程方面的困难。该试点项目使这些国家能够培训更多的 HCP，增加 AE 的报告，并确定了可以在每个国家灵活复制的关键绩效指标。国家自主权和赋权对于维持这些改进和建立更强的 AE 报告文化至关重要。
