Abstract
Background and Objectives: The spontaneous reporting (SR) of adverse drug events (ADEs) is a cornerstone of pharmacovigilance and a critical mechanism for safeguarding patient safety. However, underreporting remains a persistent global challenge. In Korea, despite the widespread use of herbal medicines (HMs), adverse event reports from traditional Korean medicine doctors (KMDs) are remarkably scarce. This study aimed to assess the knowledge, attitudes, and experiences of KMDs regarding SR, identify key barriers, and suggest strategies to strengthen the safety culture within traditional Korean medicine. Materials and Methods: A cross-sectional, anonymous online survey was distributed to licensed KMDs registered with the Association of Korean Medicine. The questionnaire collected information on respondents' sociodemographic characteristics and assessed their knowledge, attitudes, and experiences related to ADE reporting. Descriptive statistics and multivariate logistic regression were used to analyze the associations between the variables. Results: Of the 1021 KMDs who completed the survey, the vast majority acknowledged the importance of SR and recognized their role in pharmacovigilance. Nevertheless, only 5% had ever submitted an ADE report. A widespread lack of awareness about the national spontaneous reporting system (SRS), particularly its inclusion of licensed HMs, was evident. Although many respondents expressed support for expanding the scope of SR to cover all HMs, significant gaps in pharmacovigilance knowledge and limited access to relevant training were major barriers. KMDs affiliated with academic institutions or specialist groups showed higher levels of awareness, education, and reporting behavior. Conclusions: While KMDs exhibit positive attitudes toward patient safety and understand the importance of SR, their participation in it remains low due to knowledge deficits and insufficient training. Addressing these gaps through targeted education and expanding the national SRS to comprehensively include herbal medicines are essential steps toward enhancing pharmacovigilance and cultivating a proactive safety culture in Korean medicine.