Journal of Society of Preventive Korean Medicine (대한예방한의학회지)

Society of Preventive Korean Medicine (대한예방한의학회)
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Comparison about adverse drug reaction report forms among Asian's countries using herbal medicine

한약을 사용하는 아시아권 국가의 유해사례 보고 양식에 관한 비교 연구

  • Sun, Seung-Ho (Department of Korean Internal medicine, Colleg of Korean Medicine, Sang-ji University) ;
  • Lee, Eun-Kyoung (Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Jang, Bo-Hyoung (Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Park, Sunju (Department of Preventive Medicine, College of Korean Medicine, Daejeon University) ;
  • Go, Ho-Yeon (Department of Korean Internal Medicine, College of Korean Medicine, Semyung University) ;
  • Jeon, Chan-Yong (Department of Korean Internal Medicine, College of Korean Medicine, Gachon University) ;
  • Ko, Seong-Gyu (Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University)
  • 선승호 (상지대학교부속한방병원 한방내과) ;
  • 이은경 (경희대학교 예방의학교실) ;
  • 장보형 (경희대학교 예방의학교실) ;
  • 박선주 (대전대학교 한의과대학 예방의학교실) ;
  • 고호연 (세명대학교충주한방병원 한방내과) ;
  • 전찬용 (가천대학교 한의과대학 한방내과) ;
  • 고성규 (경희대학교 예방의학교실)
  • Received : 2015.11.19
  • Accepted : 2015.12.09
  • Published : 2015.12.31
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Abstract

Objective : The purpose of this study is to find out the possibility of application to herbal medicine's report form for adverse drug reaction (ADR) by reviewing and analyzing Asian countries's ADR report forms. Method : We investigated, compared, and analyzed ADR report forms (ADR-RF) of Asian countries's ADR institutions (ACAI), such as, Korea institute of drug safety & risk management and Dongguk university Ilsan oriental hospital (DUIOH) in Korea, national center for ADR monintoring (NCAM) in China, pharmaceuticals and medical devices agency (PMDA) in Japan, Ministry of Health and Welfare (MOHW) in Taiwan, and drug office, department of health, the government of the Hong Kong special administrative region (GHKSAR) in Hong Kong. Results : ADR-RF for ACAI included common contents, such as, patients information (name(initial), gender, age, weight), adverse event (AE)'s report information (Recognition and report for AE occurrence, first or follow up report, Severe AE), the detailed information of AE (the title of AE, onset & closing date of AE symptoms, the progress & results detailed test of AE), the information of AE's medicine (the types of medicine, product name, ingredient name, suspected or combination drug, single dose & frequency, dosage form, administration route, dealing for AE-suspected medicine), and AE reporter's information (reporter's information, institution's information). Taiwan had ADR-RF and the department exclusively for herbal medicine (HM), but others (except DUIOH) had not only no ADR report form but also contents for HM. Conclusion : ADR-RF for HM have to include the common contents of ACAI at least, as well as HM information related to ADR, such as the title, composition and types of HM, history related to HM's ADR, and the contents of drug-induced liver injury and so on. In addition, the main department of government for HM's ADR will be needed.

Keywords

References

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