Challenges and Solutions in Quality Assurance for Pharmacovigilance in Low-Resource Settings: Strengthening Medicine Safety Surveillance Systems through Practical and Contextual Strategies

Abstract

Pharmacovigilance plays a pivotal role in ensuring the safety of medicines, especially in low-resource settings where the burden of disease is high, and access to healthcare is limited. However, the implementation of robust quality assurance (QA) systems for pharmacovigilance activities in these settings faces several challenges, including inadequate infrastructure, lack of trained personnel, limited regulatory oversight, and insufficient data collection mechanisms. This paper explores the key challenges hindering effective quality assurance in pharmacovigilance systems in low-resource countries and provides practical, context-specific solutions to address these gaps. Emphasis is placed on the integration of digital technologies, capacity building, policy reform, and stakeholder collaboration to enhance pharmacovigilance practices. By aligning global standards with local realities, low-resource settings can achieve meaningful improvements in drug safety monitoring and public health outcomes.

Keywords:Pharmacovigilance, Quality Assurance, Low-Resource Settings, Drug Safety, Health Systems Strengthening