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Current Status of Spontaneous Adverse Reactions Reporting System on Herbal Medicine in China, Japan, Korea and WHO  

Woo, Yeon-Ju (Korea Institute of Drug Safety and Risk Management)
Chung, Soo-Youn (Korea Institute of Drug Safety and Risk Management)
Park, Byung-Joo (Korea Institute of Drug Safety and Risk Management)
Publication Information
The Journal of Internal Korean Medicine / v.35, no.2, 2014 , pp. 111-118 More about this Journal
Abstract
Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.
Keywords
herbal medicine; adverse drug reactions; China; Japan; Korea; WHO;
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Times Cited By KSCI : 4  (Citation Analysis)
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1 CFDA, 2012. CFDA releases 2011 Annual Report on National Adverse Drug Reaction Monitoring. [accessed November 2013] Available from: http://www.ccpie.org/news/download
2 PMDA. 2013. Profile of Services 2012-2013. [accessed November 2013] Available from: http://www.pmda.go.jp/english/about/index.html
3 PMDA. The Pharmaceuticals and Medical Devices Agency Annual Report FY 2011. [accessed November 2013] Available from: http://www.pmda.go.jp/english/about/annual.html
4 PMDA. The Pharmaceuticals and Medical Devices Agency Annual Report FY 2005. [accessed November 2013] Available from: http://www.pmda.go.jp/english/about/annual.html
5 최돈웅, 최미섭, 고아라. 우리나라의 의약품 안전관리 현황. 대한의사협회지 2012;55:827-34.
6 한국식품안전정보원 [accessed November 2013] Available from: http://www.foodinfo.or.kr
7 대한한의사협회 [accessed November 2013] Available from: http://www.akom.org/report
8 한국의약품안전관리원. 의약품 안전성정보 보고동향 4호. 2013.
9 Sato A, Toyoshima M, Kondo A, Ohta K, Sato H, Ohsumi A. Pneumonitis induced by the herbal medicine Sho-saiko-to in Japan. Nihon Kyobu Shikkan Gakkai Zasshi 1997;35:391-5.
10 Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. NEJM 2000;343:1686-92.
11 이태호, 형례창, 양창섭, 외. 마황복용 후 사상 체질별 이상반응에 관한 임상연구: 무작위배정 이중맹검시험. 대한한방내과학회지 2009;30:144-52.
12 30. 황우석, 주창엽, 이재성, 외. 기관지천식 환자에 대한 소청룡탕의 부작용에 대한 평가. 대한한방내과학회 추계학술대회지 2002;49-55.
13 권영주, 조우근, 한창호. 1개 대학 한방병원에서 EMR을 통해 보고된 한약에 의한 약물유해반응의 현황. 대한한방내과학회지 2012;33:485-97.
14 Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ 2004; 329:15-9.   DOI   ScienceOn
15 Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prosepctive studies. JAMA 1998;279:1200-5.   DOI   ScienceOn
16 국가법령정보센터. 의약품등 안전성정보관리 규정 제2조. [accessed November 2013]. Available from: www.law.go.kr
17 Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991;84:341-4.   DOI
18 Institute Of Medicine. To Err is Human: Building a safer health system. Washington DC: National Academy Press; 1999, p. 27.
19 Bond CA, Raehl CL. Adverse drug reactions in United States hospitals. Pharmacotherapy 2006; 26:601-8.   DOI   ScienceOn
20 박실비아, 채수미. 외국의 의약품 부작용 피해구제제도 현황과 국내 실시 방안. 한국임상약학회지 2008;18:18-27.
21 Gawert L, Hierse F, Zink A, et al. The importance of patient perspective in drug survailance systems. Z Rheumatol 2010;69:795-802   DOI   ScienceOn
22 박병주. 의약품 부작용 모니터링. 병원약사회지 1999;16:99-107.
23 강휘중, 김효동, 박호재, 외. 일본동양의학회지에 수록된 '부작용'에 관한 논문 분석 - 한약 단독 투여시의 부작용. 한국한의학연구원논문집 2011; 17:47-56.
24 이선동. 한약.생약, 한약제제 및 생약제제 부작용에 관련 보고체계 마련 및 활성화연구. 식품의약품안전청 연구보고서 2007.
25 지제근. 알기쉬운 의학용어풀이집. 제3판. 서울: 고려의학; 2009.
26 국가법령정보센터. 약사법 제2조 4항. [accessed November 2013]. Available from: www.law.go.kr
27 Shaw D. Toxicological risks of Chinese herbs. Planta Med 2010;76:2012-8.   DOI   ScienceOn
28 CFDA, 2013. CFDA releases 2012 Annual Report on National Adverse Drug Reaction Monitoring. [accessed November 2013]. Available from: http://www.ccpie.org/news/download
29 WHO-UMC. About UMC. [accessed November 2013] Available from: http://www.who-umc.org/DynPage.aspx?id=96979&mn1=7347&mn2=7469
30 Classification and monitoring safety of Herbal medicines, [accessed November 2013] Available from:http://www.who-umc.org/graphics/24727.pdf
31 Zhang L, Yan J, Liu X, et al. Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: Current status and future perspective. J Ethnopharmacol 2012;140:519-25.   DOI   ScienceOn