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, combining qualitative and quantitative methods. Methods
Qualitative and quantitative research consisted of semi-structured
interviews and an online survey, respectively. Results Twelve key
informants from ten 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
pharmacovigilance development in LMIC: understanding the drivers of
pharmacovigilance development; adequately resolving core system
challenges; implementing an efficient organisational structure and good
governance; establishing procedures for pharmacovigilance 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 pharmacovigilance system.
Conclusions Findings from this research revealed progress in
pharmacovigilance systems in LMIC in the last decade, though significant
efforts are still needed to develop these systems to meet global
standards. Developing the different areas emerging from this research,
within the framework of a holistic, fit-for-purpose pharmacovigilance
system strengthening, would enable a comprehensive progression from basic
to functional and thus sustainable pharmacovigilance systems in LMIC.