Integrating Digital Technologies to Strengthen Adverse Drug Reaction Reporting in Indonesia’s Pharmacovigilance System
Keywords:
Digital pharmacovigilance, adverse drug reaction, artificial intelligence, e-MESO, health information system, IndonesiaAbstract
The optimization of pharmacovigilance through digital transformation has become a global priority to improve patient safety and drug regulation. Indonesia’s pharmacovigilance system, which has traditionally relied on manual and fragmented reporting, faces persistent challenges such as underreporting, limited awareness, and slow data processing. This study aims to analyze the integration of digital technologies to strengthen Adverse Drug Reaction (ADR) reporting within Indonesia’s pharmacovigilance framework. Using a literature review method, ten national and international studies published between 2023 and 2025 were analyzed, focusing on mobile health applications, electronic medical records (EMR), artificial intelligence (AI), and the e-MESO platform. The results show that digital technologies significantly enhance ADR reporting accuracy, speed, and completeness, while improving coordination between healthcare professionals and regulatory authorities. AI and Big Data analytics further enable early signal detection and predictive risk assessment, reducing human error and facilitating evidence-based decision-making. However, challenges remain in data standardization, system interoperability, digital literacy, and cybersecurity. The study concludes that digital integration within pharmacovigilance is not only a technical innovation but also a strategic effort to foster transparency, accountability, and a safety-oriented culture. Strengthening infrastructure, policy alignment, and cross-sector collaboration is crucial to achieving a sustainable and intelligent pharmacovigilance ecosystem in Indonesia.
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