한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석

초록

Background : This study aimed to monitor the Adverse Drug Reaction (ADR) reporting system in terms of pharmacovigilance in the field of Korean medicine. In addition, we investigated more efficient ways to monitor ADRs and systematic information about the safety of Korean medicine. This study provides a means by which Korean medicine restores reliability as well as an opportunity for the development of pharmacovigilance. Methods : The cases on Korean medicine ADR were collected from March 2014 to December 2014 in Kyung Hee University Korean medicine Hospital. Drug adverse events were monitored using a causality assessment by WHO-UMC Causality Assessment, Naranjo, KA indicators. The cases of ADRs were analyzed based on WHO-Adverse Reaction Terminology and System Organ Class (SOC) code. Results : Based on the report, of the 227 cases of ADR, a total of 141 cases from 135 patients were confirmed. Regarding the frequency of ADRs, diarrhea was the most common adverse reactions in 37 cases (16.3%), followed by abdominal pain in 19 cases (8.4%), dyspepsia in 19 cases (8.4%), and headache in 15 cases (6.6%). Separating frequency of ADRs by the SOC, the most frequent were gastrointestinal disorders, 117 cases (51.5%); followed by systemic disease, 35 cases (15.4%), central and peripheral nervous system disorders, 24 cases (10.6 %), and skin and appendages disorders, 20 cases(8.8%). Forty-four cases (19.4%) showed simultaneous intake of Korean medicines and Western medicines. Conclusion : Spontaneous ADR reporting in healthcare should be actively conducted in Korean medicine medical institutions. There is a need for ongoing public education and outreach by oriental doctors, nurses, and oriental pharmacists. Pharmacovigilance is needed in the training of experts, to ensure progress.

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