A new paradigm in adverse drug reaction reporting: consolidating the evidence for an intervention to improve reporting.

Introduction: Adverse drug reaction (ADR) under-reporting is highly prevalent internationally and interventions created to address this problem have only been temporarily successful. This review aims to investigate how to leverage digital applications and automation across the healthcare industry to improve the quantity and quality of ADR reporting.

Areas Covered: This review investigated the significance of ADR under-reporting, the barriers of reporting ADRs, and the magnitude of success of various interventions to improve ADR reporting by searching the EMBASE and MEDLINE databases to include studies published between January 2000 and February 2022. This data was integrated with a view to describe a future ADR reporting framework.

Expert Opinion: Digital transformation has presented a significant opportunity with vast quantities of patient health data becoming available in electronic formats. The application of artificial intelligence to detect ADRs and then using automation to report these directly to regulatory agencies without human input would significantly enhance the quantity and quality of ADR reporting. Emphasis should be placed on ADRs identified for newly approved or black triangle medicines. Future studies are needed to measure the success of this ADR reporting framework in reducing the time taken to identify new safety issues and improving patient outcomes.