• 대한한방내과학회지
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• 제45권1호
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• pp.55-74
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• 2024

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.

• Journal of Cerebrovascular and Endovascular Neurosurgery
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• 제25권3호
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• pp.275-287
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• 2023

Objective: Flow diverting stents (FDS) are a validated device in the treatment of intracranial aneurysms, allowing for minimally invasive intervention. However, after its approval for use in the United States in 2011, post-market surveillance of adverse events is limited. This study aims to address this critical knowledge gap by analyzing the FDA Manufacturer and User Facility Device Experience (MAUDE) database for patient and device related (PR and DR) reports of adverse events and malfunctions. Methods: Using post-market surveillance data from the MAUDE database, PR and DR reports from January 2012-December 2021 were extracted, compiled, and analyzed with R-Studio version 2021.09.2. PR and DR reports with insufficient information were excluded. Raw information was organized, and further author generated classifications were created for both PR and DR reports. Results: A total of 2203 PR and 4017 DR events were recorded. The most frequently reported PR adverse event categories were cerebrovascular (60%), death (11%), and neurological (8%). The most frequent PR adverse event reports were death (11%), thrombosis/thrombus (9%) cerebral infarction (8%), decreased therapeutic response (7%), stroke/cerebrovascular accident (6%), intracranial hemorrhage (5%), aneurysm (4%), occlusion (4%), headache (4%), neurological deficit/dysfunction (3%). The most frequent DR reports were activation/positioning/separation problems (52%), break (9%), device operates differently than expected (4%), difficult to open or close (4%), material deformation (3%), migration or expulsion of device (3%), detachment of device or device component (2%). Conclusions: Post-market surveillance is important to guide patient counselling and identify adverse events and device problems that were not identified in initial trials. We present frequent reports of several types of cerebrovascular and neurological adverse events as well as the most common device shortcomings that should be explored by manufacturers and future studies. Although inherent limitations to the MAUDE database are present, our results highlight important PR and DR complications that can help optimize patient counseling and device development.

• BMB Reports
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• 제50권4호
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• pp.157-157
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• 2017

• BMB Reports
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• 제51권3호
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• pp.105-105
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• 2018

• BMB Reports
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• 제52권1호
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• pp.1-2
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• 2019

• BMB Reports
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• 제56권1호
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• pp.1-1
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• 2023

• BMB Reports
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• 제53권1호
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• pp.1-2
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• 2020

• BMB Reports
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• 제54권1호
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• pp.1-1
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• 2021

• BMB Reports
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• 제55권1호
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• pp.1-2
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• 2022

• 기록학연구
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• 제48호
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• pp.45-92
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• 2016

기업은 자신들의 경제 환경 사회적 영향 및 성과에 대해 설명책임의 수단으로 '지속가능성보고서'를 발간하고 있다. 법적 규제인 재무 공시와는 달리 '지속가능성' 보고는 비재무적 요소에 대한 기업들의 성과를 보고하는 것이기에 이에 대한 신뢰성은 기업에 의존할 수밖에 없다. 그러나 현재 발간되는 지속가능성보고서는 지표 데이터에 대한 증거나 출처를 포함할 수 없는 유형으로, 기업의 홍보 수단으로 여겨지는 경향이 있으며 신뢰성에 대한 의혹이 여러 차례 제기되고 있다. 이에 따라 본 연구에서는 업무에 대한 내용과 맥락이 담긴 기록으로 기업의 설명책임을 입증할 수 있도록 증거기반 설명책임에 대한 개념을 적용해 보았다. 증거기반 설명책임이란 행위에 대한 증거 기록을 생산 및 축적하고 이용가능한 정보로 관리하여 설명책임으로 활용하는 것이다. 국내 기업에서 발간한 지속가능성보고서의 지표데이터 유형과 영국 보다폰의 웹 기반 보고서 사례를 살펴보고, 업무 기록을 지표 데이터의 증거로 연결할 방안에 대해 연구해보았다. 이를 위해 필요한 기록을 증거로 확보할 수 있도록 기록의 생산체계를 재설계하였다. 업무 중 생산된 기록을 SR(Social Responsibility)설명책임정보로 취합 및 관리하고 이해관계자에게 제공할 수 있는 SR시스템(Social Responsibility System)과 기록관리시스템(RMS)의 연계 구축을 제안하였다. 또한 조직체계 및 규정을 통해 기업의 전문적인 기록관리 체계를 단계적으로 구축하고 관련 업무 담당자와의 협업을 통해 기업의 신뢰성 있는 설명책임을 지원할 수 있는 인프라 구축을 이야기했다.