Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Claimed Adverse Events of Korean Medicine in South Korea: Analysis of Cases in the Korea Medical Dispute Mediation and Arbitration Agency Databases

한의 의료와 연관된 조정 요청 이상반응: 한국의료분쟁조정중재원 접수사례 분석

  • Hwang, Hye-Won (Pusan National University School of Korean Medicine) ;
  • Lee, Ji-Sun (Pusan National University School of Korean Medicine) ;
  • Kim, Kun Hyung (Pusan National University School of Korean Medicine)
  • 황혜원 (부산대학교 한의학전문대학원) ;
  • 이지선 (부산대학교 한의학전문대학원) ;
  • 김건형 (부산대학교 한의학전문대학원)
  • Received : 2017.08.01
  • Accepted : 2017.09.11
  • Published : 2017.09.27
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Abstract

Objectives : The purpose of this study was to describe the type of claimed adverse events related to Korean Medicine practices in South Korea. Methods : Claims with regard to the Korean Medicine practice submitted to the Korea Medical Dispute Mediation and Arbitration Agency from April 2012 to December 2016 were collected. We analyzed claims that explicitly reported the type of Korean medicine intervention and were deemed as being adverse events as defined by the Korea Good Clinical Practice. Claims that did not mention the Korean medicine practice explicitly or those related to the patient's dissatisfaction to the service rather than adverse health outcomes were excluded. Types, related interventions and the suspected severity of claimed adverse events were summarized. Results : Of 197 claims obtained, 140 claim cases were eligible and 144 claimed events were deemed as possible adverse events of the Korean medicine practice. Pain(16%), local infection/inflammation(12%) and neurological symptoms(11%) were the most frequently reported types of claimed adverse events. Thirty-nine claimed serious adverse events(SAE) were identified, including pneumothorax(28.2%) and death(17.9%). Conclusions : A wide range of claimed adverse events were identified. Routine monitoring of claims data may provide undetected safety information with regard to the Korean medicine practice. High risk of misclassification of the intervention and claimed adverse events due to insufficient information is the main caveat of this study.

Keywords

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