Effectiveness of National Reporting Systems in Capturing Adverse Drug Events Across Healthcare Cadres
Keywords:
Pharmacovigilance, Adverse Drug Event, Reporting Systems, Healthcare Professionals, Saudi Arabia, Medication SafetyAbstract
Background:
Adverse drug events (ADEs) are a leading cause of preventable patient harm worldwide. National pharmacovigilance systems play a critical role in detecting and mitigating ADEs; however, their effectiveness varies, especially in capturing reports from all healthcare professionals including nurses, physicians, and pharmacists.
Methods:
This systematic review followed PRISMA 2020 guidelines. A comprehensive search was conducted in PubMed for studies published from 2010 to 2024 using combinations of MeSH terms and keywords related to ADE reporting systems and healthcare personnel. Studies were included if they evaluated national ADE reporting mechanisms involving healthcare workers. Data extraction and risk of bias assessment were performed independently by two reviewers. Meta-analysis was not conducted due to heterogeneity.
Results:
Fifteen studies met the inclusion criteria, comprising both clinical trials and cohort studies. Interventions evaluated included educational programs, EHR-linked reporting tools, mobile apps, and pharmacist-led detection. Detection rates of ADEs improved significantly in studies using multifaceted interventions, with some reporting a fivefold increase post-intervention. However, passive strategies like email alerts showed minimal impact. Secondary outcomes included report quality, sustainability of reporting, and staff engagement. Pharmacists consistently contributed the most ADE reports, but underreporting persisted across all cadres. Limited local engagement was evident in Saudi Arabia, despite structured systems.
Conclusions:
Active, multidisciplinary interventions significantly enhance the effectiveness of national ADE reporting systems. Sustained improvements require ongoing education, system integration, and supportive institutional policies. There is a critical need to engage all healthcare professionals, particularly in low-reporting regions like Saudi Arabia.