Development of an adverse events reporting form for Korean folk medicine

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.