Mitigating Challenges in Pharmacovigilance

Abstract

Although pharmacovigilance is a concept well acknowledged, the practice of reporting falls short. A qualitative analysis of the challenges in pharmacovigilance revealed diverse factors contributing to the lack in reporting. Health care professionals (HCP) need to contend with their own myths and fallacies to surmount the paucity of ADR reporting. Clinical trials have standard protocols for identifying adverse events (AEs) and regulatory guidelines mandate timely reporting of ADRs, AEs, and serious adverse events (SAEs). But, in clinical practice it is trickier to obtain ADR data. Trials have active monitoring, while clinical practice relies on passive reporting from healthcare providers and patients who lack knowledge in connecting symptoms to treatment. This inadvertently leads to under-reporting of AEs and hinders the motto of patient safety. Effective pharmacovigilance hinges on skilled personnel, advanced analytical tools, data management systems, and technology. Extracting meaningful safety signals requires sophisticated data mining techniques and artificial intelligence. The vast amount of electronic health data is equally an opportunity as well as a challenge. Inconsistent reporting formats across countries could potentially lead to inaccurate or misleading interpretations. Embracing new technologies for data analysis and addressing various challenges can help in upholding patient safety in an ever-evolving healthcare landscape.