대한한방내과학회지 (The Journal of Internal Korean Medicine)

대한한방내과학회 (The Society of Internal Korean Medicine)
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VigiAccess를 통한 WHO의 약물 이상사례 보고 현황 검색과 그 활용 가능성 탐색 : 비만 치료제를 중심으로

Investigating the Status of WHO VigiAccess Adverse Drug Event Reporting and Exploring its Potential for Application Using Anti-Obesity Agents as Examples

  • 김미경 (동국대학교 일산한방병원 한방내과)
  • Mikyung Kim (Dept. of Internal Medicine, Dongguk University Ilsan Oriental Medicine Hospital)
  • 투고 : 2024.02.29
  • 심사 : 2024.03.21
  • 발행 : 2024.03.30
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초록

Objectives: This study reviewed the status of adverse event (AE) reporting in VigiAccess using anti-obesity agents as examples and explored the possibility of its use and future challenges. Methods: AE reports related to some representative drugs among herbal medicines (HMs), complex HM prescriptions, ingredients of supplements, and over-the-counter and prescription medicines were investigated using VigiAccess on February 1, 2024. Results: AE reports on prescription drugs were overwhelmingly higher than those on HMs or supplements. Although most reports were submitted from North America, reports on Ephedra sinica and green tea extract (GTE) were more from Asia and Europe, respectively. The female population reported more, and the difference in the sex ratio was the smallest for Ephedra spp. The age group was concentrated on young adults, but many older patients reported GLP-1 receptor agonist-related AEs. Symptoms related to the gastrointestinal and nervous systems were most commonly reported, but mental and cardiac disorders were common in Ephedra-type HMs. Hepatobiliary disorders are also commonly found in GTE-related reports. Conclusions: VigiAccess was useful for easily checking the global status of AE reporting for prescription drugs. However, several limitations were observed in using VigiAccess for HMs because of the few reports. Thus, it is necessary to increase the number of reports by education and to promote AE reporting among HM prescribers and users. The full range of HMs should be included in the pharmacovigilance system, and the coding and classification of HMs should be revised.

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