Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland.
University of Basel, Basel, Switzerland.
Int J Health Policy Manag. 2015 Mar 9;4(5):295-305. doi: 10.15171/ijhpm.2015.55.
Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization's (WHO's) minimum PV requirements for a Functional National PV System.
A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO's minimum requirements.
All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO.
A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in regulating the market ensuring the safety and effectiveness of medications. National PV systems in the study countries needed strengthening. Greater attention to funding is needed to coordinate and sustain PV activities. Our study highlights a need for developing more systematic approaches to regularly monitoring and evaluating PV policy and practices.
药品获得上市许可后，药物警戒（PV）数据对于确保药品的安全性和有效性至关重要。本文基于文献和关键知情人（KI）访谈，描述了印度、乌干达和南非的 PV 系统，并将其与世界卫生组织（WHO）对功能齐全的国家 PV 系统的最低 PV 要求进行了比较。
对这三个国家的药品监管系统和政策进行了文献分析和政策评估。通过对文献的差距分析，发现需要进一步研究 PV。KI 访谈涵盖了 PV 的以下主题：系统的结构和实践；现行监管政策；能力限制、人员配备、资金和培训；数据的可获得性和报告；以及系统的意识和使用情况。在印度进行了 20 次访谈，在乌干达进行了 8 次访谈，在南非进行了 11 次访谈，受访者来自卫生部、国家监管机构、制药商、非政府组织（NGO）、专业协会成员和学术界的政府官员。将文献和 KI 访谈的结果与 WHO 的最低要求进行了比较。
所有三个国家都面临着类似的障碍：资金不足、训练有素的人员有限、培训计划不足、角色不明确以及活动协调不力。尽管 KI 访谈代表了受访者的观点，但调查结果证实了对文献的文献分析。尽管南非有关于 PV 的法律要求，但我们发现，这三个国家在监测药品和根据 WHO 的最低标准评估风险方面普遍缺乏足够的能力。
强大的 PV 系统是整体药品监管系统的重要组成部分，反映了监管机构监管市场的严格性和能力，确保了药物的安全性和有效性。研究国家的国家 PV 系统需要加强。需要更加关注资金，以协调和维持 PV 活动。我们的研究强调需要制定更系统的方法，定期监测和评估 PV 政策和实践。
