Adverse Drug Reactions in Traditional Korean Medicine

Strategic Insights -

A significant gap in pharmacovigilance has been identified in traditional Korean medicine, where only 5% of traditional Korean medicine doctors (KMDs) have ever submitted an adverse drug event (ADE) report. Despite acknowledging the importance of spontaneous reporting (SR), many KMDs lack awareness about the national spontaneous reporting system (SRS) and its inclusion of licensed herbal medicines. 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.

Key Takeaways:

  • Only 5% of traditional Korean medicine doctors (KMDs) have ever submitted an adverse drug event (ADE) report, highlighting a widespread underreporting of ADEs in traditional Korean medicine.
  • The majority of KMDs (95%) acknowledged the importance of SR and recognized their role in pharmacovigilance, but lacked awareness about the national spontaneous reporting system (SRS).
  • KMDs affiliated with academic institutions or specialist groups showed higher levels of awareness, education, and reporting behavior, indicating a positive association between academic affiliation and SR behavior.
  • Significant gaps in pharmacovigilance knowledge and limited access to relevant training were major barriers to KMDs' participation in SR, highlighting the need for targeted education and training.
  • Expanding the national SRS to comprehensively include herbal medicines is an essential step toward enhancing pharmacovigilance and cultivating a proactive safety culture in Korean medicine.

Statistics:

  • 1021 KMDs participated in the cross-sectional, anonymous online survey.
  • 95% of KMDs acknowledged the importance of SR, but only 5% had ever submitted an ADE report.
  • 71.4% of KMDs affiliated with academic institutions or specialist groups showed higher levels of awareness, education, and reporting behavior.
  • 63.2% of KMDs exhibited positive attitudes toward patient safety, but lacked awareness about the national SRS.
  • 56.8% of KMDs reported limited access to relevant training, highlighting the need for targeted education.

Sources:

  • The Knowledge, Attitudes, and Experiences of Traditional Korean Medicine Doctors in the Spontaneous Reporting of Adverse Drug Events: A Cross-Sectional Survey. Healthcare, 2025;13(13):1620.