IMPROVING AND SCALING PHARMACOVIGILANCE WITH MODERN TECHNOLOGIES By Jennifer Markey
Pharmacovigilance organisations are struggling to meet greater demand with increasing adverse events from multiple sources and greater patient and regulatory scrutiny. New approaches to safety combined with modern technologies can scale pharmacovigilance processes to handle larger volumes of adverse events, make compliance easier, and improve decision-making. Innovation in artificial intelligence, cloud technologies, and unified safety solutions are making a big impact on pharmacovigilance by driving greater efficiencies and better leveraging of safety data. Between 2009 and 2019, the number of adverse events (AEs) recorded by the FDA Adverse Event Reporting System (FAERS) increased more than 300%, from 409,040 to 1.66 million cases.[1] Given the growth in case volume, the expanding number of sources for potential adverse events, and the complexity of new therapies – there is a significant opportunity to use innovative technology to improve efficiency in pharmacovigilance. Untapped Potential of Artificial Intelligence and Automation In a recent survey, 90% of life sciences’ executives recognised that artificial intelligence (AI) is important in driving innovation and achieving new levels of efficiency. [2] Safety surveillance needs to go beyond data mining of spontaneous reporting systems (SRSs) and medical literature. Internal data sources can be supplemented with real world data from electronic health records (EHRs), insurance claims, social media, and online communities. However, with traditional pharmacovigilance approaches, it is challenging – if not impossible – to incorporate, review, and analyse all these data in a timely manner.
AI can have a huge impact on pharmacovigilance and ultimately provide valuable information to protect patients by improving data quality, providing real time data insights during processing, and enabling faster and more proactive signal detection. As drug safety shifts focus from operational tasks to more proactive risk management and greater data transparency among pharma, patient, and providers – AI will become more essential.
Automating many manual and repetitive processes, AI can enable greater consistency as well as provide valuable insights for data scientists, medical reviewers, and physicians. They can understand their data in a much more comprehensive and extensive way that has not been possible before.
Simpler and More Efficient Unified Safety Solution Many pharmacovigilance systems are fragmented with multiple tools and technologies from different vendors that often do not work well together. Significant resources 26
