Assessing the effectiveness and challenges of adverse drug reaction reporting systems: a systematic review

Abstract

Adverse Drug Reaction (ADR) reporting is a process that includes recording adverse events that are suspected to have a relationship with the utilization of medicinal products, medical devices and cosmetics. However, persistent underreporting remains a major global concern that limits the early detection of drug safety issues and may ultimately compromise patient well-being. Strengthening ADR reporting systems is therefore crucial for improving drug safety surveillance and protecting public health. This study aimed to investigate causes contributing to inefficiencies in ADR reporting. To achieve the study aim, a review of literature drawn from regulatory documents, peer-reviewed publications, and case studies was carried out. A thematic analysis was performed on qualitative data extracted from the identified literature was carried out to identify recurring themes, on both the challenges and opportunities for improvement of the ADR reporting process. A review of 65 studies conducted in 28 countries indicated that ADR reporting continues to be a vital yet multifaceted element of pharmacovigilance (PV). A significant contrast in the nature of challenges and proposed solutions between High‑Income Countries (HICs) and Low‑ and Middle‑Income Countries (LMICs) was identified, with behavioural and systemic barriers predominant in HIC, while, conversely, fundamental issues regarding awareness, training, and infrastructure were the predominant barriers in LMICs and LICs. The most commonly proposed interventions were often aligned with the reporting stakeholder, with HCPs leaning towards training and digital integration, while patients emphasised simplification and improved communication. This study indicates that there is no one-size-fits-all solution to address the issue of underreporting. Instead, pharmacovigilance systems should be adapted to align with each country's healthcare structure, regulatory development, and workplace capacity.