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

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.