Abstract
BackgroundNational 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.ResultsWe 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.ConclusionsThe 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.
Highlights
IntroductionNational pharmacovigilance centres (national centres) are gradually gaining visibility as part of the healthcare delivery system in Africa
National pharmacovigilance centres are gradually gaining visibility as part of the healthcare delivery system in Africa
The realization that the tragedy could have been prevented if countries collected and shared data on medicine safety led the World Health Organization (WHO) decision-making body i.e. the World Health Assembly to issue a resolution inviting “Member States to arrange for a systematic collection of information on serious adverse drug reactions (ADR) observed during the development of a drug and, in particular, after its release for general use” ([4], pp 14)
Summary
National pharmacovigilance centres (national centres) are gradually gaining visibility as part of the healthcare delivery system in Africa. The realization that the tragedy could have been prevented if countries collected and shared data on medicine safety led the World Health Organization (WHO) decision-making body i.e. the World Health Assembly to issue a resolution inviting “Member States to arrange for a systematic collection of information on serious adverse drug reactions (ADR) observed during the development of a drug and, in particular, after its release for general use” ([4], pp 14). In response to this call, national governments around the world established national pharmacovigilance centres to coordinate medicine safety surveillance efforts. In high income countries, national centres function as central nodes for national PV efforts and they contribute to building national PV systems by collaborating with other stakeholders be they local, national or international [2, 5, 6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
