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

Background
Detecting, assessing and preventing adverse events and other medicine-related issues necessitate a functional pharmacovigilance system. In many low- and middle-income countries (LMIC), key elements of functional pharmacovigilance, such as effective organisation and procedures for vigilance activities are missing. With increased access to essential and novel medicines in LMIC, and taking into consideration other factors that can influence medicine use and the safety profile of medicines such as the healthcare system, socio-political and genetic factors, LMIC must establish and maintain functional pharmacovigilance systems to ensure adequate safety surveillance of authorised medicines.
Objectives
This research aims to analyse the development of pharmacovigilance systems across high-, middle- and low-income countries and to carve out essential elements for functionality and sustainability of pharmacovigilance systems in LMIC.
Design
A convergent parallel mixed methods design, co..., Study design
The study had a convergent parallel mixed methods design, consisting of qualitative and quantitative methods. Qualitative research contained 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.
Sampling, setting and study population
To ensure adequate representation of national and global PV stakeholders, study participants included representatives from the NRA, National Immunisation Programmes (NIP), and global technical and donor agencies (hereafter referred to as Technical and Financial Partners [TFP]).
For the interviews, countries were selected based on the publicly available information corresponding to their PV maturity levels, such that all PV maturity levels were adequately represented. Potential participants were contacted via email addresses provided by their organisations, or via regional PV mailing lists. In addition, authors of a..., , # 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 - presented as Supplemental File 1 (.docx)

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...

# 构建功能完备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

## 背景
检测、评估并预防不良事件及其他与药品相关的问题，有赖于功能完备的药物警戒（pharmacovigilance, 以下简称PV）系统。在许多低收入和中等收入国家（low- and middle-income countries, 以下简称LMIC）中，功能完备的药物警戒体系的核心要素仍存在缺失，例如缺乏高效的药物警戒活动组织架构与操作流程。随着中低收入国家可获取的基本药物与创新药物数量不断增加，再结合医疗体系、社会政治及遗传因素等可影响药品使用与药品安全特征的其他因素，中低收入国家必须建立并维持功能完备的药物警戒系统，以确保对获批药品开展充分的安全监测。

## 研究目标
本研究旨在分析全球高收入、中等收入及低收入国家的药物警戒系统发展现状，并厘清中低收入国家药物警戒系统实现功能完备与可持续性所需的核心要素。

## 研究设计
本研究采用汇聚式并行混合研究设计，包含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覆盖范围，同步开展与半结构化访谈主题一致的定量问卷调查。（原文此处存在省略内容）

## 抽样、研究场景与研究人群
为确保充分覆盖国内及全球药物警戒利益相关方，本研究的参与者涵盖国家监管机构（National Regulatory Authority, 以下简称NRA）、国家免疫规划（National Immunisation Programmes, 以下简称NIP）以及全球技术与捐助机构（以下简称技术与金融合作伙伴（Technical and Financial Partners, 以下简称TFP））的代表。
访谈阶段的国家选取基于公开可得的药物警戒成熟度相关信息，确保所有药物警戒成熟度层级均得到充分覆盖。潜在参与者通过其所在机构提供的电子邮箱，或区域药物警戒邮件列表进行联系。（原文此处存在省略内容）

## 数据与文件结构
1. 访谈指南——作为补充文件1（.docx）
定性数据围绕"构建功能完备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情况分析"这一主题，通过半结构化访谈采集。访谈指南（补充文件1）基于本研究目标及此前开展的范围综述(1)制定，共分为5个章节，包含30个问题：
1. 关键信息提供者在国家药物警戒系统中的角色
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. ...（原文此处省略后续内容）