Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities

Abstract

There are significant challenges and opportunities in deploying and utilizing advanced information technology (IT) within pharmacovigilance (PV) systems and across the pharmaceutical industry. Various aspects of PV will benefit from automation (e.g., by improving standardization or increasing data quality). Several themes are developed, highlighting the challenges faced, exploring solutions, and assessing the potential for further research. Automation of the workflow for processing of individual case safety reports (ICSRs) is adopted as a use case. This involves a logical progression through a series of steps that when linked together comprise the complete work process required for the effective management of ICSRs. We recognize that the rapid development of new technologies will invariably outpace the regulations applicable to PV systems. Nevertheless, we believe that such systems may be improved by intelligent automation. It is incumbent on the owners of these systems to explore opportunities presented by new technologies with regulators in order to evaluate the applicability, design, deployment, performance, validation and maintenance of advanced technologies to ensure that the PV system continues to be fit for purpose. Proposed approaches to the validation of automated PV systems are presented. A series of definitions and a critical appraisal of important considerations are provided in the form of use cases. We summarize progress made and opportunities for the development of automation of future systems. The overall goal of automation is to provide high quality safety data in the correct format, in context, more quickly, and with less manual effort. This will improve the evidence available for scientific assessment and helps to inform and expedite decisions about the minimization of risks associated with medicines.

Automation Opportunities in Pharmacovigilance: An Industry Survey

“…Further analysis is needed to evaluate which technologies are best suited for which ICSR process steps and how such solutions can be validated and sustained over the long term. Similar research needs to be performed for signal detection, aggregate safety reporting, risk management, and other pharmacovigilance processes to extend the benefit of intelligent automation beyond the ICSR process [18].…”

Strategies for automating pharmacovigilance adverse event case processing

“…Processing of an AE is an expensive resource-intensive process, which includes a high risk of errors and operational inefficiencies (Ghosh et al, 2020). A detailed review of the literature concluded that innovative technology such as data mining, machine learning, AI, and robotics could result in new operating models for PV (Beninger & Ibara, 2016;Lai, 2017), improve efficiencies and reduce PV operations costs (Karimi et al, 2015;Lu, www.jpadr.com m 2009;Schmider et al, 2018), better allocation of resources, and improve patient outcomes (Lewis & McCallum, 2019). In this doctoral study, we explored the strategies that PV systems managers in the pharmaceutical industry use to implement innovative technology solutions to automate AEs case processing (see System's model in Fig 2) The single case that we selected to study was the implementation of an innovative technology solution to automate AE processing.…”

Aspects of Utilization and Limitations of Artificial Intelligence in Drug Safety

“…This will save the time, cost, and manpower required for these activities. Introducing AI in PV also improves the quality and accuracy of drug safety results [12,13].…”