APPLICATIONS OF PHARMACOEPIDEMIOLOGY IN DRUG SAFETY SURVEILLANCE AND PUBLIC HEALTH DECISION-MAKING: A NARRATIVE REVIEW

Abstract

Pharmacoepidemiology, the scientific discipline that integrates principles of pharmacology and epidemiology, plays a critical role in evaluating the use, effectiveness, safety, and outcomes of medications in real-world populations. While pre-marketing clinical trials provide essential evidence regarding drug efficacy and short-term safety, they often involve selected populations, limited sample sizes, and restricted follow-up periods, which may not adequately identify rare, delayed, or population-specific adverse events. Consequently, pharmacoepidemiological studies have become indispensable for post-marketing drug safety surveillance and evidence-based public health decision-making. This narrative review examines the applications of pharmacoepidemiology in pharmacovigilance, adverse drug reaction detection, risk assessment, comparative effectiveness research, drug utilization evaluation, and healthcare policy development. Various study designs used in pharmacoepidemiology, including cohort studies, case-control studies, cross-sectional studies, self-controlled methods, and analyses based on electronic healthcare databases, are discussed. The review highlights the role of real-world evidence, large healthcare datasets, artificial intelligence, and data-linkage systems in enhancing drug safety surveillance. Furthermore, the contributions of pharmacoepidemiological evidence to regulatory decision-making, health technology assessment, and public health interventions are explored through contemporary examples.

Despite significant advances, challenges such as data quality issues, confounding, privacy concerns, underreporting of adverse drug reactions, and methodological limitations persist. Strengthening international collaboration, improving data interoperability, and integrating advanced analytical approaches will further enhance the value of pharmacoepidemiology in optimizing medication safety and supporting informed public health policies.