• 한국임상약학회지
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• 제31권4호
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• pp.324-331
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• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

• 한국임상약학회지
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• 제23권3호
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• pp.256-268
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• 2013

Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.

• 식품과학과 산업
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• 제48권4호
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• pp.16-20
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• 2015

• 시스템엔지니어링워크숍
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• 통권4호
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• pp.81-85
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• 2004

시스템 엔지니어링은 시스템의 일생 주기동안 수행되며 고장정보체계(Failure Reporting and Corrective Action System)는 제작단계부터 수행되는 RAMS(Reliability, Availability,Manitani bility,safety)과업 중의 하나이다. 고장정보체계는 설계와 제작단계에서 생성된 고장원인을 제거하고 수정작업을 구현하기 위한 방법을 제공한다. 본 논문에서는 한국형 고속열차를 대상으로 고장정보 분석 및 관리, 신뢰도 평가를 위해 구축한 고장정보체계와 그 활용사례를 제시한다.

• 항공우주시스템공학회지
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• 제17권4호
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• pp.34-42
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• 2023

본 연구는 공군에서 운영되고 있는 "항공관제통합관리"체계 내 최근 추가된 항공안전관리시스템(SMS) 안전자율보고를 통해 접수된 안전보고 사례를 분석하여, 위해요인을 식별하고, 해당 지역(기지)별 개선사항을 제시하여, 향후 데이터 기반의 안전관리를 수행할 수 있는 기초를 마련하기 위함이다. 위해요인 식별을 위해 자율보고체계 내 16개로 분류된 데이터를 기반으로 1차적으로 기지별 분류를 하였고, 기종 및 기술된 내용을 기반으로 세부적으로 2차 분류하였다. 가장 많은 보고가 이루어진 관제협조(306건) 항목에 대하여 RCIAA(Reporting, Category, Identification, Analysis, and Action, 이하 RCIAA)과정(연구자 작성)을 거쳐 위해요인을 분석하였으며, 분석한 결과를 토대로 위해요인을 크게 정보 공유, 규정, 절차 교육·훈련 및 장비 항목으로 나누어 개선사항을 도출하였다. 위해요인 및 특정 개선사항이 기지별(12개) 로 상이함을 확인할 수 있었으며, 통계적 분석을 바탕으로 기지(지역)별 운항관제분야 안전관리의 방향을 제시할 수 있는 근거로 활용할 수 있다. 또한, 민(民)·군(軍)을 통틀어 특정 기지(지역)별 데이터 기반의 위해요인 분석 연구가 부족한 점에 비추어 볼 때 데이터를 기반으로 한 안전관리의 중요성을 재확인 할 수 있는 결과로 제시할 수 있을 것으로 사료된다.

• 대한간호학회지
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• 제52권4호
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• pp.378-390
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• 2022

Purpose: This study developed an in-service training program for patient safety and aimed to evaluate the impact of the program on nurses in the operating room (OR). Methods: A pretest-posttest self-controlled survey was conducted on OR nurses from May 6 to June 14, 2020. An in-service training program for patient safety was developed on the basis of the knowledge-attitude-practice (KAP) theory through various teaching methods. The levels of safety attitude, cognition, and attitudes toward the adverse event reporting of nurses were compared to evaluate the effect of the program. Nurses who attended the training were surveyed one week before the training (pretest) and two weeks after the training (posttest). Results: A total of 84 nurses participated in the study. After the training, the scores of safety attitude, cognition, and attitudes toward adverse event reporting of nurses showed a significant increase relative to the scores before the training (p < .001). The effects of safety training on the total score and the dimensions of safety attitude, cognition, and attitudes toward nurses' adverse event reporting were above the moderate level. Conclusion: The proposed patient safety training program based on KAP theory improves the safety attitude of OR nurses. Further studies are required to develop an interprofessional patient safety training program. In addition to strength training, hospital managers need to focus on the aspects of workflow, management system, department culture, and other means to promote safety culture.

• 대한안전경영과학회지
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• 제13권2호
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• pp.1-8
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• 2011

The Chicago Convention in 1944 made important contributions to aviation safety improvement, building an aviation safety monitoring system for its signatory countries. As ICAO is now on the verge of changing its supervision system from self-reporting to preventive Continuous Monitoring Approach(CMA) in 2013, we also expect our own safety system to make a progress accordingly. The government is pushing ahead with plans to build an integrated safety management system at government level that satisfies international standards and reflects domestic features. To this end, this report proposes the most effective system-building model, by analyzing the current status of the system that is in use and meets the requirements of international aviation agencies.

• 대한안전경영과학회지
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• 제6권2호
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• pp.49-65
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• 2004

Ministry of Environment developed ‘Emergency Response Information System (ERIS)’ in 2001, which is in operation. As a next step, currently National Emergency Response Information System (NERIS) is being developed. The main difference among ERIS and NERIS is to enhance the system in the national level, including transportation of hazardous materials. This paper introduces concepts and methods applied to NERIS, especially HAZMAT, and the information system, operating strategies. Based on GIS and transportation-network data, the best route can be offered using Risk Analysis. Strategies for reporting and first-response information systems are also designed for emergencies in the paper.

• 해양환경안전학회지
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• 제21권3호
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• pp.259-265
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• 2015

It is clearly understood that e-navigation is beneficial to prevent collision and grounding of ships. The purpose of this study is to define and present a future ship operation system under the e-navigation environment in order to provide clear direction for the design of Korean e-navigation system. The future ship operation system consists of shipboard navigational system, shore supporting system and maritime communication system. To achieve the objectives of this study, the ship operation system was discussed separately into SOLAS ships and non-SOLAS ships in this study. In SOLAS ships, mariners become a system manager, choosing system presets, interpreting system output, and monitoring vessel response. In small ships and fishing vessels, mariners may enjoy their navigation by using the automatic tracking of ship's position on the portable electronic chart display. The improved bridge design, integrated and harmonized navigational system and single window reporting will reduce significantly the administrative and physical workload of mariners. Mariners can concentrate their attention more on navigational duty under the e-navigation environment. To build an effective Korean e-navigation system, the essential navigational functions and e-navigation services for small ships and fishing vessels must be identified and developed taking into account user needs.

• 대한안전경영과학회지
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• 제1권1호
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• pp.69-77
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• 1999

One of the objectives of any task design is to provide a safe and helpful workplace for the employees. The safety and health module may include means for confronting the design with safety and health regulations and standards as well as tools for obstacles and collisions detection (such as error models and simulators), Virtual Reality is a leading edge technology which has only very recently become available on platforms and at prices accessible to the majority of simulation engineers. The design of an automated manufacturing system is a complicated, multidisciplinary task that requires involvement of several specialists. In this paper, a design procedure that facilitates the safety and ergonomic considerations of an automated manufacturing system are described. The procedure consists of the following major steps. Data collection and analysis of the data, creation of a three-dimensional simulation model of the work environment, simulation for safety analysis and risk assessment, development of safety solutions, selection of the preferred solutions, implementation of the selected solutions, reporting, and training. When improving the safety of an existing system the three-dimensional simulation model helps the designer to perceive the work from operators point of view objectively and safely without the exposure to hazards of the actual system.