The African Collaborating Centre for Pharmacovigilance, 1 Vigilance Place, Mango Tree Avenue, Asylum Down, Accra, Ghana.
WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, 3508 TB, Utrecht, the Netherlands.
Global Health. 2018 Nov 16;14(1):109. doi: 10.1186/s12992-018-0431-0.
National pharmacovigilance centres (national centres) are gradually gaining visibility as part of the healthcare delivery system in Africa. As does happen in high-income countries, it is assumed that national centres can play a central coordinating role in their national pharmacovigilance (PV) systems. However, there are no studies that have investigated whether national centres in Africa have sufficient organizational capacity to deliver on this mandate and previous studies have reported challenges such as lack of funding, political will and adequate human resources. We conducted interviews with strategic leaders in national centres in 18 African countries, to examine how they link the capacity of their organization to the outcomes of activities coordinated by their centres. Strategic leaders were asked to describe three situations in which activities conducted by their centre were deemed successful and unsuccessful. We analyzed these experiences for common themes and examined whether strategic leaders attributed particular types of resources and relationships with stakeholders to successful or unsuccessful activities.
We found that strategic leaders most often attributed successful experiences to the acquisition of political (e.g. legal mandate) or technical (e.g. active surveillance database) resources, while unsuccessful experiences were often attributed to the lack of financial and human resources. Stakeholders that were most often mentioned in association with successful experiences were national government and development partners, whereas national government and public health programmes (PHPs) were often mentioned in unsuccessful experiences. All 18 centres, regardless of maturity of their PV systems had similar challenges.
The study concludes that national centres in Africa are faced with 3 core challenges: (1) over-reliance on development partners, (2) seeming indifference of national governments to provide support after national centres have gained membership of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) and (3) engaging public health programmes in a sustainable way.
国家药物警戒中心（national centre）作为非洲医疗保健体系的一部分，逐渐受到关注。与高收入国家一样，人们认为国家中心可以在国家药物警戒（PV）系统中发挥核心协调作用。然而，目前尚无研究调查非洲国家中心是否具有足够的组织能力来履行这一职责，而且先前的研究报告称，这些中心面临着资金、政治意愿和充足人力资源等方面的挑战。我们对 18 个非洲国家的国家中心战略领导者进行了访谈，以研究他们如何将组织能力与中心协调的活动结果联系起来。战略领导者被要求描述三个中心活动被认为成功和不成功的情况。我们对这些经验进行了主题分析，并研究了战略领导者是否将特定类型的资源和与利益相关者的关系归因于成功或不成功的活动。
我们发现，战略领导者最常将成功经验归因于获得政治（例如法律授权）或技术（例如主动监测数据库）资源，而不成功经验往往归因于缺乏财务和人力资源。在成功经验中经常提到的利益相关者是国家政府和发展伙伴，而在不成功经验中，国家政府和公共卫生计划（PHPs）经常被提及。所有 18 个中心，无论其 PV 系统的成熟度如何，都面临着类似的挑战。
研究得出结论，非洲国家中心面临着 3 个核心挑战：（1）过度依赖发展伙伴，（2）国家政府在国家中心获得世界卫生组织（WHO）国际药物监测规划（PIDM）成员资格后，似乎不愿意提供支持，（3）以可持续的方式使公共卫生计划参与进来。
