PMID- 27501410
OWN - NLM
STAT- MEDLINE
DCOM- 20171030
LR  - 20210109
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 26
IP  - 5
DP  - 2017 May
TI  - Development of an adverse events reporting form for Korean folk medicine.
PG  - 498-508
LID - 10.1002/pds.4077 [doi]
AB  - PURPOSE: 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. (c) 2016 The Authors. Pharmacoepidemiology and Drug Safety 
      Published by John Wiley & Sons Ltd.
CI  - (c) 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley 
      & Sons Ltd.
FAU - Park, Jeong Hwan
AU  - Park JH
AD  - KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, 
      Republic of Korea.
FAU - Choi, Sun-Mi
AU  - Choi SM
AD  - Executive Director of R&D, Korea Institute of Oriental Medicine, Daejeon, Korea.
AD  - Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
FAU - Moon, Sujeong
AU  - Moon S
AD  - Mibyeong Research Center, Korea Institute of Oriental Medicine, Daejeon, Korea.
FAU - Kim, Sungha
AU  - Kim S
AD  - KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, 
      Republic of Korea.
AD  - Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
FAU - Kim, Boyoung
AU  - Kim B
AD  - KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, 
      Republic of Korea.
FAU - Kim, Min-Kyeoung
AU  - Kim MK
AD  - Herbal Medicine Research Division, National Institute of Food and Drug Safety 
      Evaluation, Ministry of Food and Drug Safety, Cheongju-si, Korea.
FAU - Lee, Sanghun
AU  - Lee S
AD  - KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, 
      Republic of Korea.
AD  - Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
LA  - eng
PT  - Journal Article
DEP - 20160808
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Biological Products)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Biological Products/administration & dosage/adverse effects
MH  - Delivery of Health Care/organization & administration
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - *Medicine, Korean Traditional
MH  - Pharmacoepidemiology
PMC - PMC5434846
OTO - NOTNLM
OT  - Korea
OT  - adverse events
OT  - folk medicine
OT  - herbal medicine
OT  - pharmacoepidemiology
OT  - pharmacovigilance
EDAT- 2016/08/09 06:00
MHDA- 2017/10/31 06:00
PMCR- 2017/05/17
CRDT- 2016/08/09 06:00
PHST- 2015/12/08 00:00 [received]
PHST- 2016/06/24 00:00 [revised]
PHST- 2016/07/15 00:00 [accepted]
PHST- 2016/08/09 06:00 [pubmed]
PHST- 2017/10/31 06:00 [medline]
PHST- 2016/08/09 06:00 [entrez]
PHST- 2017/05/17 00:00 [pmc-release]
AID - PDS4077 [pii]
AID - 10.1002/pds.4077 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2017 May;26(5):498-508. doi: 10.1002/pds.4077. Epub 
      2016 Aug 8.