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Pharmacoepidemiol Drug Saf. 2017 May;26(5):498-508. doi: 10.1002/pds.4077. Epub 2016 Aug 8.

Development of an adverse events reporting form for Korean folk medicine.

Author information

1
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
2
Executive Director of R&D, Korea Institute of Oriental Medicine, Daejeon, Korea.
3
Korea Medicine Life Science, University of Science & Technology, Daejeon, Korea.
4
Mibyeong Research Center, Korea Institute of Oriental Medicine, Daejeon, Korea.
5
Herbal Medicine Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, Korea.

Abstract

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. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

KEYWORDS:

Korea; adverse events; folk medicine; herbal medicine; pharmacoepidemiology; pharmacovigilance

PMID:
27501410
PMCID:
PMC5434846
DOI:
10.1002/pds.4077
[Indexed for MEDLINE]
Free PMC Article

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