How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?

Abstract Real‐world evidence (RWE) is an emerging scientific discipline which is being increasingly utilized for decision making on prescription‐only medicines. However, there has been little focus to date on the application of RWE within the nonprescription sector. This paper reviews the existing and potential applications of RWE for nonprescription medicines, using the nonprescription medicine life cycle as a framework for discussion. Relevant sources of real‐world data (RWD) are reviewed and compared with those available for prescribed medicines. Existing life‐cycle data gaps are identified where RWE is required or where use of RWE can complement data from randomized controlled trials. Published RWE examples relating to nonprescription medicines are summarized, and potential relevant future sources of RWD discussed. Challenges and limitations to the use of RWE on nonprescription medicines are discussed, and recommendations made to promote optimal and appropriate use of RWE in this sector. Overall, RWE currently plays a key role in specific phases of the nonprescription medicine life cycle, including reclassification and postmarketing safety surveillance. The increasing availability of patient‐generated health data is likely to further increase the utilization of RWE to aid decision making on nonprescription medicines.