Abstract: Objective To explore the application of the patient-reported outcome in adverse drug reaction report. Methods Through the method of literature review, the background, drivers, current regulatory framework of patient-reported outcome adoption in foreign drugs safety studies are comprehensively reviewed. Results Limitations with current data collection, discordance between patients and prescribers, better patient context drive the adoption of patient-report outcome effectively, as well as the regulatory measures formulated by many countries such as America and Britain. Conclusion Patient-reported outcome with patient-centered, which provides a rich and valuable information for comprehensive analysis of the effectiveness, risks and outcomes of drug use, can be used as a supplement to the current pharmacovigilance and post-marketing studies, and provides an important reference for our country to adopt patient-reported outcome in drug safety studies.

Key words: patient-reported outcome, adverse drug reactions, literature review