• Title/Summary/Keyword: Event Reporting

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Patterns of Spontaneous Adverse Events Reporting on Human Papillomavirus Vaccines according to the Applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017 (국내 사람유두종바이러스백신 접종 후 자발적 이상반응 보고사례의 Brighton Collaboration 기준 활용 가능성 연구)

  • Kim, Myo-Song;You, Seung-Hun;Park, Hye Min;Lee, Min-Taek;Kang, Ye-Jin;Koo, Hyunji;Jung, Sun-Young
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.19-30
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    • 2020
  • Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

Event Reporting Overview in MPEC-21 (MPEG-21 이벤트 리포팅 개요 및 동향)

  • 지경희;문남미;송영주;홍진우
    • Proceedings of the IEEK Conference
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    • 2003.07d
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    • pp.1447-1450
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    • 2003
  • 이벤트 리포팅 기술요소는 MPEG-21 내에서 발생하는 모든 이벤트 및 상호작용에 대한 표준적인 측정방법 및 인터페이스를 제공한다는 점에서 그 중요성을 가진다. 본 논문에서는 MPEG-21 의 7 가지 주요 요소 중의 하나인 이벤트 리포팅에 대한 정의 및 필요성에 대해 알아보고, 이벤트 리포트 요구 및 이벤트 리포트로 나뉘는 이벤트 리포팅의 체계를 분석한다. 또한 MPEG-21의 이벤트 리포팅에 대한 표준화 동향을 분석하고, 이벤트 리포팅에 대한 향후 표준화 활동 방향을 제시한다.

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Window-Based Computer Code Package CONPAS for an Integrated Level 2 PSA

  • Ahn, Kwang-Il;Kim, See-Darl;Song, Yong-Mann;Jin, Young-Ho
    • Proceedings of the Korean Nuclear Society Conference
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    • 1996.05b
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    • pp.493-498
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    • 1996
  • A PC window-based computer code, CONPAS(CONtainment Performance Analysis System), has been developed to integrate the numerical, graphical and results-operation aspects of Level 2 probabilistic safety assessments (PSA) for nuclear power plants automatically. As a main logic for accident progression analysis, it employs a concept of the small containment phenomenological event tree(CPET) helpful to trace out visually individual accident progressions and of the large supporting event tree(LSET) for its detailed quantification. Compared with other existing computer codes for Level 2 PSA, the CONPAS code provides several advanced features: computational aspects including systematic uncertainty analysis, importance analysis, and sensitivity analysis, reporting aspects including tabling and graphic, and user-friend interface.

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Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records (EMR의 자발적 약물부작용보고 시스템을 이용한 한약약물유해반응 분석)

  • Kim, Mikyung;Han, Chang-Ho
    • The Journal of Korean Medicine
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    • v.36 no.1
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    • pp.45-60
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    • 2015
  • Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

An Autonomous Command Recommend and Execution System for the Satellite Operation (위성 운영을 위한 이벤트 시퀀스 기반의 자동 명령 추천 및 수행 시스템)

  • Yang, Seung-Eun;Jung, Jae-Yeop;Cheon, Yee-Jin
    • Aerospace Engineering and Technology
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    • v.13 no.2
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    • pp.29-37
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    • 2014
  • Telemetry, satellite event and error information are used to check the satellite status in ground station. Different from telemetry which only informs the parameter value, event and error gives explicit information of a certain operation or status. Event also contains ground action information because every command execution is logged as event. Currently, those information is gathered and applied only for monitoring of the satellite. However, the load of the operation is getting grown because of the excessively increased information of the satellite with the number of satellite increasement. Also, the process of reporting problem to developer (or an expert) induce time delay for satellites fault management. In this paper, we propose a satellite operation assistant system which collects event sequence and stores in different group by its feature, and then recommends or executes an appropriate action for the identified abnormal state. This system is applicable to on board system for resolving LEO-satellite autonomous fault situation since is has limited contact time.

The Comparative Study on Post-Marketing Surveillance System for Pharmaceuticals (의약품의 시판후 조사제도 비교연구)

  • Kim, In-Beom;Kim, Hong-Jin;Sohn, Uy-Dong
    • YAKHAK HOEJI
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    • v.50 no.3
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    • pp.145-153
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    • 2006
  • The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

A Study on the Status and the Perception of Near Miss Reporting Activities in Domestic Manufacturing Industry (국내 제조업의 아차사고 발굴활동 현황 및 인식에 관한 연구)

  • Lee, Seok Ki;Park, Jungchul
    • Journal of the Korea Convergence Society
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    • v.12 no.12
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    • pp.287-294
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    • 2021
  • A near miss is an unplanned event that did not result in injury/illness, or property damage, but had potentials to do so. The importance of the near miss has been emphasized by many researchers and organizations. However, only a few studies have quantitatively approached the near miss from the viewpoint of safety culture. The purpose of this study is to investigate the current status of near miss reporting activities in manufacturing workplaces in Korea. It also aims to understand how the activities related with the safety culture and the occurrence of industrial accidents. To this end, a survey was conducted on manufacturing workplaces and the results were analyzed. As a result, there was a marked difference in the perception on near miss according to whether or not the near miss reporting activity was conducted. However, it was found that only 56% of the workplaces were carrying out the reporting activities. It was found that the number of near misses reported varied depending on the reward. Although no correlation could be found between whether or not the near miss reporting activities were carried out and the history of industrial accidents occurred, it was found that safety culture level was hier at the workplaces conducting the activities.

A Study on Fault Detection Scheme on TMRed Circuits (삼중화된 회로에서의 결함 감지를 위한 방법에 관한 연구)

  • Kang, Dong-Soo;Lee, Jong-Kil;Jhang, Kyoung-Son
    • Proceedings of the Korean Information Science Society Conference
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    • 2011.06b
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    • pp.313-316
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    • 2011
  • SRAM-based FPGAs are very sensitive to single event upset(SEU) induced by space irradiation. To mitigate SEU effects, space applications employ some mitigation schemes. The triple modular redundancy(TMR) is a well-known mitigation scheme. It uses one or three voters as well as three identical blocks performing the same work. The voters can mask out one error in the outputs from the three replicated blocks. One SEU error in TMRed circuits can be masked but it needs to be detected for some reasons such as to analyze the SEU effects in the satellite or to recover the circuits from the error before additional error occur. In this paper, we developed a fault detection circuit and reporting system to detect a fault on the TMRed circuits. To verify our error detection circuit and reporting circuit, we performed an irradiation test at MC-50 Cyclotron. Experimental results showed that error detection circuit can detect a fault on the TMRed test circuit in radiation environment.

Violence experiences, coping, and response of paramedics in the emergency room (응급실 내 1급 응급구조사의 폭력경험과 대처 및 반응)

  • Han, Seung-Eun;Lee, Kyoung-Youl
    • The Korean Journal of Emergency Medical Services
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    • v.22 no.2
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    • pp.51-65
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    • 2018
  • Purpose: The purpose of this study was to investigate experiences of violence with patients or family members by paramedics working at emergency rooms. Methods: A questionnaire was administered from June 1 to 31, 2017 to 225 paramedics working at 27 emergency medical centers. The collected data were analyzed with SPSS statistics ver 24.0 program. Results: Within the past year, 208(92.9%) of 224 participants experienced violence among whom 202(90.2%) experienced verbal abuse, 193(86.2%) experienced physical threat, 89(39.7%) experienced physical violence, and 52(23.2%) experienced sexual violence. The level of violence response depending on the overlapping experience of violence type showed significant difference from emotional response (p= .001), social response (p= .001), physical response (p= .004), and overall violence response (p= .001). Conclusion: In conclusion, paramedics are frequently exposed to violence in the emergency rooms, of which they mostly experience verbal abuse. In addition, because the reporting system in the event of violence and the coping process are not well-informed, paramedics are unable to sufficiently utilize the reporting system and programs established within the institution. Therefore, the support of the legal system is needed to create a safe working environment for the medical staff who work in the emergency medical centers.

Convergence with International Financial Reporting Standard and Its Effect on Stock Return: Evidence from Malaysia

  • ZAKARIA, Zukarnain;SORAYA, Evi Oktoviana;ISMAIL, Mohd Roslan
    • The Journal of Asian Finance, Economics and Business
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    • v.8 no.12
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    • pp.153-158
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    • 2021
  • Convergence is the process of gradual adoption of a certain accounting standard issued by different regulatory bodies. The aim is to achieve uniformity and standardization across borders to open opportunities for international investment and collaboration. The implementation of IFRS, in theory, encourages more transactions by presenting financial statements in a simple and understandable manner for all investors and other businesses interested in the company. Using event study methodology, this study investigates whether Malaysian companies' adoption of IFRS is recognized by the investment community. A total of 89 public listed companies in Bursa Malaysia are involved in this study. The results show that about 62.8 percent of the companies that adopted IFRS-based financial statements experienced an increase in their average abnormal return after the announcement. However, the paired sample test results show that only 5.6 percent out of 89 companies studied experience a significant difference in abnormal return before and after the announcement. The inexistence of the average abnormal return difference between before and after the announcement may indicate that IFRS-based financial statements do not have any new market informational content. This study found little evidence to show that convergence with IFRS affects the company's stock price in Malaysia.