Signal detection in pharmacovigilance: Methods, tools, and workflows from case identification to adverse drug...

Area of Science:

• Pharmacovigilance and Public Health
• Drug Safety and Epidemiology
• Global Health Policy

Background:

• Adverse drug reactions (ADRs) pose a significant, preventable global health burden, impacting morbidity, mortality, and healthcare costs.
• Vulnerability to ADRs is high in older adults, low-resource settings, and with specific drug classes like antibiotics and cardiovascular agents.
• Existing pharmacovigilance systems face challenges including underreporting, data quality issues, and methodological biases, particularly in low- and middle-income countries.

Purpose of the Study:

• To synthesize global evidence on the burden, surveillance systems, and prevention strategies for ADRs.
• To compare the strengths of various pharmacovigilance platforms and emerging analytical methods.
• To identify policy priorities for reducing severe medication-related harm globally.

Main Methods:

• Systematic review and synthesis of evidence from diverse global regions, healthcare settings, and drug classes.
• Comparative analysis of pharmacovigilance platforms (e.g., WHO's VigiBase, EudraVigilance) and statistical methods (e.g., machine learning).
• Evaluation of prescriber-level, system-level, and patient engagement prevention strategies.

Main Results:

• Significant variability in ADR incidence and mortality exists globally, with specific populations and medications at higher risk.
• Integrating spontaneous reporting with electronic health record analytics and employing advanced statistical methods like machine learning enhances ADR signal detection.
• Active surveillance and digital tools show promise over voluntary reporting, but implementation is hindered by infrastructure and policy gaps.

Conclusions:

• Achieving global goals for reducing medication-related harm requires integrating ADR surveillance into universal health coverage.
• Policy interventions, including interoperable safety systems and capacity building in resource-limited settings, are essential.
• Coordinated global action is needed to strengthen pharmacovigilance, enhance patient safety, and build sustainable health systems.