Building functional and sustainable pharmacovigilance systems - an analysis of pharmacovigilance development across high-, middle- and low-income countries

Background Pharmacovigilance (PV) is an essential component of health systems. Functional PV systems protect and promote public health by supporting the safe and effective use of medicinal products through the prevention and mitigation of harm. With increased simultaneous introduction of innovative products in high-, middle- and low-income countries, e.g., COVID-19 vaccines, or solely in low- and middle-income countries (LMIC), e.g., malaria vaccines, PV systems in LMIC must be able to detect safety signals and ensure adequate 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 implementing functional and sustainable PV systems in LMIC. Methods A convergent parallel mixed-methods design, consisting of qualitative and quantitative methods was used. Qualitative research consisted of semi-structured interviews. To expand the breadth and range of the study, a quantitative surv..., Study design This research aims to analyse stakeholders’ perspectives on the development of PV systems across high-, middle- and low-income countries and to carve out essential mechanisms necessary to establish and ensure functionality and sustainability of PV systems in LMIC. To achieve this, a convergent parallel mixed-methods design, consisting of qualitative and quantitative methods was used (see Figure 1). Qualitative research consisted of semi-structured interviews. To expand the breadth and range of the study, a quantitative survey was conducted, focusing on the same thematic questions as the semi-structured interviews. Setting and study population Sampling of key informants was purposive. Recruitment criteria were based on informants’ knowledge and expertise in PV, active participation in national or global PV, and/ or decision-making position within national and global PV organisations. To allow a global perspective on building robust PV systems, PV stakeholders from high-, mid..., , # Building functional and sustainable pharmacovigilance systems - an analysis of pharmacovigilance development across high-, middle- and low-income countries [https://doi.org/10.5061/dryad.2547d7wzs](https://doi.org/10.5061/dryad.2547d7wzs) ## Description of the data and file structure ## 1.    Interview guide (.docx) - presented as additional file 1 Qualitative data were collected through semi-structured interviews built around the theme ‘Strategies to build functional and sustainable pharmacovigilance systems – an analysis of pharmacovigilance implementation in high-, middle- and low-income countries’. An interview guide (Additional file 1) was developed based on the study’s objective and on the previously performed scoping review(1). The interview guide was divided into five sections with a total of 30 questions: 1.    Key informant’s role in the national pharmacovigilance (PV) system 2.    Organization of the national PV system 3.    PV and health system development 4.  ...背景 药物警戒（Pharmacovigilance, PV）是卫生系统的核心组成部分。功能完善的药物警戒系统通过预防和减轻药品相关危害，保障药品安全有效使用，从而保护并增进公众健康。随着高收入、中等收入和低收入国家同步推出创新产品（如新冠疫苗），或仅在低收入和中等收入国家（Low- and Middle-Income Countries, LMIC）推出创新产品（如疟疾疫苗），低收入和中等收入国家的药物警戒系统必须能够检测安全信号并确保充分的安全监测。本研究旨在分析全球高、中、低收入国家的药物警戒系统发展情况，并明确在低收入和中等收入国家构建功能完善且可持续的药物警戒系统所需的核心要素。 方法 本研究采用收敛平行混合研究设计，结合定性与定量研究方法。定性研究采用半结构化访谈。为拓展研究的广度与范围，本研究开展了定量调研（原文此处为"a quantitative surv..."，内容截断）。 研究设计 本研究旨在分析利益相关方对全球高、中、低收入国家药物警戒系统发展的看法，并明确在低收入和中等收入国家建立并保障药物警戒系统功能与可持续性所需的核心机制。为此，本研究采用收敛平行混合研究设计，结合定性与定量研究方法（见图1）。定性研究采用半结构化访谈。为拓展研究的广度与范围，本研究开展了定量调查，其核心主题问题与半结构化访谈保持一致。 研究场景与研究人群 本研究采用目的性抽样选取关键知情人。招募标准基于知情人在药物警戒领域的知识与专业背景、积极参与国家或全球药物警戒工作，以及/或在国家及全球药物警戒组织中拥有决策职位。为获取构建稳健药物警戒系统的全球视角，研究纳入来自高、中…… # 构建功能完善且可持续的药物警戒系统——全球高、中、低收入国家药物警戒发展分析 [https://doi.org/10.5061/dryad.2547d7wzs](https://doi.org/10.5061/dryad.2547d7wzs) ## 数据与文件结构说明 1. 访谈指南（.docx）—— 作为附加文件1呈现 定性数据围绕"构建功能完善且可持续的药物警戒系统——全球高、中、低收入国家药物警戒实施分析"这一主题，通过半结构化访谈收集。本研究基于研究目标及此前开展的范围综述(1)，制定了访谈指南（附加文件1）。访谈指南共分为5个章节，包含总计30个问题： 1. 关键知情人在国家药物警戒（Pharmacovigilance, PV）系统中的职责 2. 国家药物警戒系统的组织架构 3. 药物警戒与卫生系统发展 4. ……