Root cause analysis from the perspectives of patients in primary care units: cases study of typical adverse drug events

Abstract Objective To identify the root causes of typical adverse drug events through the lens of patient experiences proposing novel strategies to mitigate preventable harm. Methods A qualitative case study leveraging in-depth interviews with patients and families, anchored by Interactive Patient Participation Theory, to analyze 4 high-severity adverse drug events (ADE) cases.Cases were purposively sampled from 8 communities in China’s National Adverse Event Monitor Center (2018–2023). Semi-structured interviews explored patient perspectives, with data analyzed via thematic coding and triangulation against clinical records. Results Five interconnected themes emerged: (1) erosion of trust, (2) communication breakdowns, (3) information asymmetry, (4) environmental inadequacies, and (5) technological alienation. Notably, 75% of participants had ≤high school education, and 50% used ≥7 medications daily, compounding ADE risks. Conclusions We considered elements mentioned by theory, exploring trust, communication, information, and support as the root causes. In addition, we added “adaptability to new technology” as an important and necessary component. It is important and necessary to analyze typical adverse drug events from the perspectives of patients.