Background: Korea has a dualized health care system of conventional medicine and traditional Korean Medicine[KM], and both were being used to treat various diseases. It has established pharmacovigilance[PV] system well in conventional medicine, but KM has not equipped Pharmacovigilance system yet, so KM has few information on adverse events[AEs].
Objectives: This study was performed to estimate AEs scale relating KM, such as acupuncture, moxibustion, cupping, pharmacopuncture, herbal medicine, and manual therapy using Korean Medicine Utilization and Herbal Medicine Consumption Survey 2017[KMUHMCS], one of the Korean National statistics.
Methods: Using KMUHMCS, the number of inpatients and outpatients who experienced AEs was calculated. The proportion of patients who experienced AEs during the last 1 year was calculated and then, the number of AEs relating KM was estimated by complex sampling analysis.
Results: A total of 1,010 outpatients and 904 inpatients were included in KMUHMCS. The number of patients who had experienced AEs in the past 1 year was 28 (16 for outpatients, 12 for inpatients). One patient could experience multiple types of AEs, total case of AEs is 31 cases – 9 cases in skin and appendages disorders (eg. bruise, rash, pain, pruritus, heat sensation), 7 cases in kidney system disorders (eg. edema), 6 cases in gastro-intestinal system disorders (eg. dyspepsia, diarrhea), 4 cases in cardiovascullar system disorders (eg. palpation), 2 cases in nervous system disorders (eg. insomnia, hemiplegia), 2 cases in respiratory system disorders (eg. dyspnea), and 1 case in unspecified AE. There is no case in liver & billary system disorders (eg. jaundice). By consideration for the complex sample survey, the rate of outpatients who had experienced AEs in the past 1 year was estimated at 0.706% and 1.386% in inpatients. When applied to the entire population of Korea, estimating the annual number of AEs relating KM was 96,367 (35,891-165,842) patients in Korea, 94,202 (35.426 – 152,978) in outpatients, and 2,165 (465 – 3,864) in inpatients.
Conclusions: From the results of this study, it was possible to estimate the scale of AEs relating KM, and suggesting that it is necessary to establish its management system.
