한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석

@article{ART002226065},
author={ 이상학 and 송보완 and 최혁재 and 김은영 },
title={한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석},
journal={병원약사회지},
issn={1226-640X},
year={2017},
volume={34},
number={2},
pages={183-199},
doi={10.32429/jkshp.2017.34.2.005},
url={http://dx.doi.org/10.32429/jkshp.2017.34.2.005}

TY - JOUR
AU - 이상학
AU - 송보완
AU - 최혁재
AU - 김은영
TI - 한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석
T2 - 병원약사회지
PY - 2017
VL - 34
IS - 2
PB - 한국병원약사회
SP - 183-199
SN - 1226-640X
AB - 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.
KW - ADR, Adverse Drug Reaction, Herbal-drug-associated ADR, Korean Medicine
DO - 10.32429/jkshp.2017.34.2.005
UR - http://dx.doi.org/10.32429/jkshp.2017.34.2.005
ER -

이상학 , 송보완 , 최혁재 and 김은영 (2017). 한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석. 병원약사회지, 34( 2), 183- 199.

이상학 , 송보완 , 최혁재 and 김은영 . 2017, “한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석”, 병원약사회지, vol. 34, no. 2, pp. 183-199. Available from: doi:10.32429/jkshp.2017.34.2.005

이상학 송보완 et al. 최혁재 김은영 “한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석” 병원약사회지 34.2 pp. 183-199 (2017): 183.

이상학 , 송보완 , 최혁재 , 김은영 . 한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석 병원약사회지 [Internet]. 2017; 34( 2), : 183-199. Available from: doi:10.32429/jkshp.2017.34.2.005

이상학 , 송보완 , 최혁재 and 김은영 . “한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석” 병원약사회지 34, no.2 (2017): 183-199. doi: 10.32429/jkshp.2017.34.2.005

홈 권호 목록 논문 목록 논문 상세

한방의료기관에서 자발적 보고된 한약의 약물이상사례 분석

병원약사회지

약어 : JKSHP

2017, vol.34, no.2, pp.183 - 199

DOI : 10.32429/jkshp.2017.34.2.005

발행기관 : 한국병원약사회

연구분야 : 약학

이상학¹ , 송보완² , 최혁재³ , 김은영⁴

¹경희의료원 약제본부

²경희의료원

³경희의료원

⁴중앙대학교

인용한 논문 수 : 2 서지 간략 보기

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.

키워드

ADR, Adverse Drug Reaction, Herbal-drug-associated ADR, Korean Medicine

참고문헌(20)

[단행본] B.J. Park / 2012 / Pharmacoepidemiology / Seoul University Press : 2 ~ 11
[학술지] 유기연 / 2011 / 식품의약품안전청 약물유해반응 보고자료 분석 / 한국임상약학회지 21 (2) : 138 ~ 144
[인터넷자료] B.K. KOO / Korea institude of Drug Safety &Risk management : KIDS dsi(1) stat 2015 Q2Resource Page
[학술지] 우연주 / 2014 / 중국, 일본, 한국, WHO의 한약 자발적부작용보고체계 현황 / 대한한방내과학회지 35 (2) : 111 ~ 118
[학술지] 강휘중 / 2011 / 일본동양의학회지에 수록된 ‘부작용’에 관한 논문 분석 -한약 단독 투여시의 부작용- / 한국한의학연구원논문집 17 (2) : 47 ~ 56
[학술지] K.T. Suk / 2012 / A Prospective Nationwide Study of Drug-Induced Liver Injury in Korea / The America Journal Of Gastroenterol 107 (9) : 1380 ~ 1387
[학술지] 김미경 / 2015 / EMR의 자발적 약물부작용보고 시스템을 이용한 한약약물유해반응 분석 / 대한한의학회지 36 (1) : 45 ~ 60
[기타] / 1994 / World Health Organization-Adverse reactions terminology (WHO-ART) / World Health Organization
[학술지] 신현택 / 2007 / 의약품 부작용에 관한 국제 분류체계인 WHO-ART와 MedDRA의 비교분석 / 한국임상약학회지 17 (1) : 46 ~ 52
[학술지] 송명균 / 2008 / 약물유해반응의 인과관계 판정을 위한 Naranjo와 WHO-UMC 지표의 비교 / 대한내과학회지 74 (2) : 181 ~ 187
[학술지] S. Choi / 2001 / Estimation of Adverse Drug Reactions and Methods to Encourage the Adverse Drug Monitoring in Tertiary Hospital / Journal of Korean Society Health-System Pharmacists 18 (1) : 64 ~ 77
[학술지] C. Bond / 2006 / Adverse drug reactions in united states hospitals / Pharmacotherapy : The Journal of Human Pharmacology and Drug Therapy 26 (5) : 601 ~ 608
[기타] S.D. LEE / 2013 / Korean Medicine Toxicology / Korean Studies Information
[학술지] 권영주 / 2012 / 1개 대학 한방병원에서 EMR을 통해 보고된 한약에 의한 약물유해반응의 현황 / 대한한방내과학회지 33 (4) : 485 ~ 497
[학술지] M.N. Belhekar / 2014 / A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions / Indian journal of pharmacology 46 (1) : 117
[학술지] L.R. Dunk / 2006 / Rechallenge with clozapine following leucopenia or neutropenia during previous therapy / British Journal of Psychiatry 188 : 255 ~ 263
[학술지] 경은정 / 2013 / 약물감시사업과 약물유해반응에 대한 인식도 조사 / 한국임상약학회지 23 (3) : 256 ~ 268
[학술지] C.K. Desai / 2011 / An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital / Perspectives in Clinical Research 2 (4) : 129 ~ 136
[학술지] 안소현 / 2014 / 일반인에서의 의약품 부작용보고제도 인식도 / 보건행정학회지 24 (2) : 164 ~ 171
[학술지] 박영철 / 2011 / 한약의 약물상호작용 기전과 연구방향- 독성학적인 측면을 중심으로 - / 대한예방한의학회지 15 (1) : 1 ~ 16