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首页> 外文期刊>Therapeutic advances in drug safety. >Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo
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Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo

机译：资源有限国家的药物检药制度的发展：刚果民主共和国的经验

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Implementation of pharmacovigilance (PV) systems in resource-limited countries is a real endeavor. Despite country- and continent-specific challenges, the Democratic Republic of the Congo (DRC) has been able to develop one of the most active PV systems in the sub-Saharan Africa. The World Health Organization (WHO) regional Office identified the DRC experience to set up a PV system for antimalarial drugs safety monitoring as a ‘best practice’ that needed to be documented in order to help DRC improve its PV system and to be scaled up in other African countries. In response to the WHO request, a best practices and bottlenecks analysis was conducted in 2015. This analysis was updated in 2018 in the light of the minimum requirements of the WHO to set up a PV system taking into account other guidance for PV systems. The following themes were retained for analysis: (1) creation of the national PV center; (2) implementation of PV in the health system; (3) data collection and analysis; (4) collaboration with public health programs; (5) collaboration with the National Regulatory Authority. Lessons learnt from the DRC experience show that it is possible to implement PV systems in order to promote patients’ safety in resource limited sub-Saharan African countries with no guaranteed funding. The ability of national PV centers to collaborate with Public health stakeholders, including public health authorities at all levels as well as public health programs, and to use existing health information systems are considered the main key to success and may substantially reduce the cost of PV activities.
机译：资源有限公司的药物检测系统（PV）系统是一个真正的努力。尽管是国家和大陆特定的挑战，但刚果民主共和国（DRC）能够在撒哈拉以南非洲发展最活跃的光伏系统之一。世界卫生组织（世卫组织）区域办事处确定了DRC经验，为抗疟药的PV系统进行了抗疟药，作为“最佳实践”，以便有助于记录，以帮助DRC改善其光伏系统并进行扩大其他非洲国家。为了回应世卫组织请求，2015年进行了最佳实践和瓶颈分析。该分析是在2018年更新了2018年，鉴于旨在考虑到PV系统的其他指导的世界卫队的最低要求，在2018年的最低要求。保留以下主题进行分析：（1）国家光伏中心的创建; （2）在卫生系统中实施PV; （3）数据收集和分析; （4）与公共卫生计划的合作; （5）与国家监管机构合作。从DRC体验中汲取的经验教训表明，可以实施光伏系统，以促进患者在资源有限公司撒哈拉以南非洲国家的安全，没有保证资金。国家PV中心与公共卫生利益攸关方合作的能力，包括各级公共卫生当局以及公共卫生方案，以及使用现有的健康信息系统被认为是成功的主要关键，并可能大大降低光伏活动的成本。

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