Artificial intelligence in pharmacovigilance - Opportunities and challenges.

Pharmacovigilance (PV) is a data-driven process to identify medicine safety issues at the earliest by processing suspected adverse event (AE) reports and extraction of health data. The PV case processing cycle starts with data collection, data entry, initial checking completeness and validity, coding, medical assessment for causality, expectedness, severity, and seriousness, subsequently submitting report, quality checking followed by data storage and maintenance. This requires a workforce and technical expertise and therefore, is expensive and time-consuming. There has been exponential growth in the number of suspected AE reports in the PV database due to smart collection and reporting of individual case safety reports, widening the base by increased awareness and participation by health-care professionals and patients. Processing of the enormous volume and variety of data, making its sensible use and separating " needles from haystack ," is a challenge for key stakeholders such as pharmaceutical firms, regulatory authorities, medical and PV experts, and National Pharmacovigilance Program managers. Artificial intelligence (AI) in health care has been very impressive in specialties that rely heavily on the interpretation of medical images. Similarly, there has been a growing interest to adopt AI tools to complement and automate the PV process. The advanced technology can certainly complement the routine, repetitive, manual task of case processing, and boost efficiency; however, its implementation across the PV lifecycle and practical impact raises several questions and challenges. Full automation of PV system is a double-edged sword and needs to consider two aspects - people and processes. The focus should be a collaborative approach of technical expertise (people) combined with intelligent technology (processes) to augment human talent that meets the objective of the PV system and benefit all stakeholders. AI technology should enhance human intelligence rather than substitute human experts. What is important is to emphasize and ensure that AI brings more benefits to PV rather than challenges. This review describes the benefits and the outstanding scientific, technological, and policy issues, and the maturity of AI tools for full automation in the context to the Indian health-care system.