Division of Pharmacoepidemiology & Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.
Paul Ehrlich Institut, Langen, Germany.
BMC Health Serv Res. 2021 Nov 20;21(1):1258. doi: 10.1186/s12913-021-07235-0.
Haemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries.
We piloted the integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) to assess the haemovigilance function of national regulatory authorities (NRAs) in Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. Data obtained from documents and face to face interviews were used to determine the status of implementation and performance of the following six indicators; legal provisions regulations and guidelines, organisation and governance, human resources, regulatory processes, transparency and accountability and finally, monitoring progress and assessing impact, by estimating median scores across 20 sub-indicators. In addition, a cluster analysis was performed.
The countries showed inter-organisation variability in implementation and performance of the haemovigilance function. The overall median score (all sub-indicators) was 44 % (range: 7.5 % - 70 %). The lowest average performance scores were for the arrangement for effective organisation and coordination (35 %) and human resources (35 %) indicators. The highest average scores were observed for the mechanism to promote transparency and mechanism to monitor regulatory performance indicators (50 % and 60 %, respectively). We identified clusters of best-implemented sub-indicators from the procedures for haemovigilance and poorly implemented sub-indicators from the legal provisions, regulations and guidelines for haemovigilance and human resources.
Implementation of sub-indicators and performance of haemovigilance systems varied greatly for all countries with a few countries performing reasonably well in the implementation of some sub-indicators under procedures for haemovigilance. Most countries were poorly implementing sub-indicators in the legal provisions, arrangement for effective organisation and human resources indicators. The legislative provisions in most countries were at a nascent stage. There is a need to set up targeted and customised technical support coupled with prioritised interventions to strengthen the capacities of NRAs.
血液监测是血液管理的重要组成部分。它包括收集和评估因使用血液和血液成分而导致的不良事件信息，旨在提高供者和患者的安全性。我们描述了在撒哈拉以南非洲的 10 个国家试点综合世卫组织全球基准工具加血液（GBT+Blood）以评估国家监管机构（NRA）血液监测功能的结果。
我们试点了综合世卫组织全球基准工具加血液（GBT+Blood），以评估埃塞俄比亚、肯尼亚、马拉维、尼日利亚、利比里亚、卢旺达、南非、坦桑尼亚、乌干达和津巴布韦 10 个国家的国家监管机构（NRA）的血液监测功能。通过文件和面对面访谈收集的数据用于确定以下六个指标的实施和绩效状况；法律规定、规章制度和指南、组织和治理、人力资源、监管程序、透明度和问责制，最后通过估计 20 个分指标的中位数分数来监测进展和评估影响。此外，还进行了聚类分析。
各国在血液监测功能的实施和绩效方面存在组织间差异。总体中位数分数（所有分指标）为 44%（范围：7.5%至 70%）。人力资源和有效组织协调安排两个指标的平均绩效得分最低（分别为 35%和 35%）。促进透明度的机制和监测监管绩效指标的机制的平均得分最高（分别为 50%和 60%）。我们从血液监测程序中确定了最佳实施的分指标聚类，从血液监测的法律规定、规章制度和人力资源中确定了较差实施的分指标聚类。
所有国家的分指标实施和血液监测系统的绩效差异很大，少数国家在血液监测程序的一些分指标实施方面表现相当不错。大多数国家在血液监测的法律规定、有效组织安排和人力资源指标方面分指标实施较差。大多数国家的立法规定处于起步阶段。有必要建立有针对性和定制化的技术支持，并结合优先干预措施，加强国家监管机构的能力。
