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.  ...