title: Development of an adverse events reporting form for Korean folk medicine.
abstract: OBJECTIVE
  We developed an adverse events (AEs) reporting form for Korean folk medicine.
  
  
  METHODS
  The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input.
  
  
  RESULTS
  We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added.
  
  
  CONCLUSIONS
  This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
authors: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors: Jeong Hwan
authors: JH
authors: Park
authors: Executive Director of R&D, Korea Institute of Oriental Medicine, Daejeon, Korea.|Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
authors: Sun-Mi
authors: SM
authors: Choi
authors: Mibyeong Research Center, Korea Institute of Oriental Medicine, Daejeon, Korea.
authors: Sujeong
authors: S
authors: Moon
authors: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.|Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
authors: Sungha
authors: S
authors: Kim
authors: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors: Boyoung
authors: B
authors: Kim
authors: Herbal Medicine Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, Korea.
authors: Min-Kyeoung
authors: MK
authors: Kim
authors: KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.|Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
authors: Sanghun
authors: S
authors: Lee
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects; D003695:Delivery of Health Care / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D055670:Medicine, Korean Traditional; D017891:Pharmacoepidemiology
chemical_list: D001688:Biological Products
keywords: Korea; adverse events; folk medicine; herbal medicine; pharmacoepidemiology; pharmacovigilance