A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring

Abstract

Adverse drug reactions (ADRs) are a major concern for patients, clinicians, and regulatory agencies. The discovery of serious ADRs leading to substantial morbidity and mortality has resulted in mandatory phase IV clinical trials, black box warnings, and withdrawal of drugs from the market. Real-world data, data collected during routine clinical care, is being adopted by innovators, regulators, payors, and providers to inform decision making throughout the product life cycle. We outline several different approaches to modern pharmacovigilance, including spontaneous reporting databases, electronic health record monitoring and research frameworks, social media surveillance, and the use of digital devices. Some of these platforms are well-established while others are still emerging or experimental. We highlight both the potential opportunity, as well as the existing challenges within these pharmacovigilance systems that have already begun to impact the drug development process, as well as the landscape of postmarket drug safety monitoring. Further research and investment into different and complementary pharmacovigilance systems is needed to ensure the continued safety of pharmacotherapy.

Figure 1

Overview of pharmacovigilance methods at varying stages of development. Established (green, left), emerging (yellow, middle), and experimental (red, right) pharmacovigilance data sources and systems are presented. Examples of methodological areas that are currently used and under active development for the analysis of these different data types are included in the bottom box. FAERS, FDA Adverse Event Reporting System.

Figure 2

General pharmacovigilance workflows for emerging and experimental systems. EHR based pharmacovigilance workflow is shown in the purple top row. A mobile device‐based pharmacovigilance workflow is shown in the orange middle row. The social media‐based pharmacovigilance workflow is shown in the blue bottom row. These data can then be used separately or in combination to perform pharmacovigilance research and analysis. API, application programming interface; EHR, electronic health record.