Menang Olga, van Eeuwijk Peter, Maigetter Karen, de Soyres-Kuemmerle Andrea, Agbenu Edinam, Burri Christian
Department of Medicine, Swiss Tropical and Public Health Institute, Kreuzstrasse 2, Allschwil 4123, Switzerland.
University of Basel, Basel, Switzerland.
Ther Adv Drug Saf. 2025 Jun 10;16:20420986251342941. doi: 10.1177/20420986251342941. eCollection 2025.
There has been notable progress in pharmacovigilance (PV) in low- and middle-income countries (LMIC) in the last decade. However, only a few of these PV systems are fully functional, unlike in high-income countries where stringent legislation, regulations and operational guidelines have enabled the establishment of effective PV systems. The key challenges faced in LMIC include organisational inefficiencies; weak infrastructure; inconsistent and poorly enforced regulations; and inadequate financing and shortage of trained personnel. Furthermore, low adverse event volume and poor data quality hinder the capacity for safety data generation and utilisation. With the increasing availability of essential and innovative medicines in LMIC, establishing robust PV systems is crucial for effective safety surveillance.
This research aims to analyse the development of PV systems across high-, middle- and low-income countries and to carve out essential elements for functionality and sustainability of PV systems in LMIC.
A convergent parallel mixed-methods design, combining qualitative and quantitative methods.
Qualitative and quantitative research consisted of semi-structured interviews and an online survey, respectively.
Twelve key informants from 10 countries were interviewed and 52 respondents from 36 countries completed the online survey. From the qualitative and quantitative data, we identified nine essential elements for sustainable PV development in LMIC: understanding the drivers of PV development; adequately resolving core system challenges; implementing an efficient organisational structure and good governance; establishing procedures for PV activities; ensuring availability of qualified and trained staff; identifying alternate sources of financing; having a strategic development plan; adequately leveraging the health system; and effectively integrating the pharmaceutical sector in the national PV system.
Findings from this research indicate that significant efforts are still needed to upgrade PV systems in LMIC to meet global standards despite the progress achieved in recent years. Developing the different areas emerging from this research, within the framework of a holistic, fit-for-purpose PV system strengthening, would enable a comprehensive progression from basic to functional and thus sustainable PV systems in LMIC.
在过去十年中，低收入和中等收入国家（LMIC）的药物警戒（PV）取得了显著进展。然而，与高收入国家不同，这些PV系统中只有少数是完全功能齐全的，在高收入国家，严格的立法、法规和操作指南促成了有效的PV系统的建立。LMIC面临的主要挑战包括组织效率低下；基础设施薄弱；法规不一致且执行不力；资金不足以及训练有素的人员短缺。此外，不良事件数量少和数据质量差阻碍了安全数据生成和利用的能力。随着LMIC基本药物和创新药物的可及性不断提高，建立强大的PV系统对于有效的安全监测至关重要。
本研究旨在分析高、中、低收入国家PV系统的发展情况，并梳理出LMIC中PV系统功能和可持续性的基本要素。
采用定性和定量方法相结合的收敛平行混合方法设计。
定性研究和定量研究分别包括半结构化访谈和在线调查。
来自10个国家的12名关键信息提供者接受了访谈，来自36个国家的52名受访者完成了在线调查。从定性和定量数据中，我们确定了LMIC中PV可持续发展的九个基本要素：了解PV发展的驱动因素；充分解决核心系统挑战；实施高效的组织结构和良好的治理；建立PV活动程序；确保有合格和训练有素的工作人员；确定替代融资来源；制定战略发展计划；充分利用卫生系统；以及有效地将制药部门纳入国家PV系统。
本研究结果表明，尽管近年来取得了进展，但LMIC仍需做出重大努力来升级PV系统以达到全球标准。在全面、适用的PV系统强化框架内发展本研究中出现的不同领域，将使LMIC从基本的PV系统全面发展到功能齐全并因此可持续的PV系统。
