• Title/Summary/Keyword: safety reporting system

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Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System (의약품부작용보고시스템을 이용한 바레니클린의 이상사례 실마리정보 도출)

  • Jang, Min-Gyo;Gu, Hyun-Jin;Kim, Junwoo;Shin, Kwang-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.1
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    • pp.1-7
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    • 2022
  • Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

Meta-Analysis of Factors Related to Patient Safety Nursing in Nursing University Students (간호대학생의 환자안전간호 관련요인에 대한 메타분석)

  • Seo, Youngseon;Seo, Eunju;Hong, Eunhee
    • Journal of Industrial Convergence
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    • v.18 no.2
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    • pp.9-18
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    • 2020
  • Purpose is to systematically examine the factors related to patient safety nursing of nursing university students in a convergent and complex aspect and to identify the effect size through meta-analysis. The research method used PRISMA(Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Medline, Embases, CINAHL, DBpia, Research Information Service System (Riss), and Korean Studies Information Service (Kiss) were used, while overseas databases were searched using MeSH terms and Emtrees. The search term was [(patient safety or patient harm or safety management) and (students, nursing)] or [(patient safety or patient harm or safety management) and (education, nursing, graduate)].The research found that nursing performance, knowledge, attitude, self-confidence, recognition, and cognition were found to be relevant factors in the order of confidence, attitude, recognition, and knowledge.

A Study on the Improvement of Safety Management System for ATO - Base on the Aviation Safety Voluntary Reporting System -

  • Kim, Jin-Tae;Lee, Gun Young;Choi, Jin-Kook
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.28 no.4
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    • pp.182-186
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    • 2020
  • As all flight training institutions in Korea were approved by the Ministry of Land, Infrastructure and Transport (MOLIT) as aviation training organizations (ATO), safety management based on the Aviation Safety Management System (SMS) became mandatory. However, even though safety management using SMS has become mandatory, the performance of aviation safety voluntary report, which is the core of the system, remains low compared to other countries. The current address of SMS, a ATO, is like a watermill without water. The present study is to find out why voluntary aviation safety reports, which is equivalent to water from waterwheel, is underperforming and to suggest ways to revitalize it.

A Study on the Establishment of an Integrated Management System for Forest Fire Prevention and Suppression Measures (산불예방 및 진압대책의 통합관리체계 구축 방안 연구)

  • Lee, Jeong-Il
    • Journal of the Korea Safety Management & Science
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    • v.24 no.2
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    • pp.163-169
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    • 2022
  • Recently, in Korea, if a very large forest fire occurs due to the people's carelessness, it is of great interest because it spreads into a large forest fire. If a wildfire spreads and becomes large, it will inflict great damage (appointment and property), and the damage is irreversible. The best way to extinguish a wildfire is to prevent it before it occurs. If a forest fire occurs due to a failure in prevention, the early firefighting activities to prevent the progress of the forest fire by promptly dispatching it by reporting it and approaching the site as soon as possible should now be managed with a systematic integrated management system. To do so, it is necessary to prepare a preventive system, such as issuing warnings for each weather condition by the Korea Forest Service, consisting of cooperation (support) activities for forest fire prevention by related organizations, etc. In order to minimize the loss of precious lives and forests, measures have been taken to establish a system, to establish a prompt and accurate situation reporting system, and to establish an integrated command system (ICS) for on-site commanders.

Suggestion for the Application of the ADR system under the Patient Safety Act (환자안전법상 ADR제도 적용을 위한 제언)

  • Mingyu, Choi
    • Journal of Arbitration Studies
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    • v.32 no.4
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    • pp.3-31
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    • 2022
  • In the past, there has not been a law with the main purpose of preventing or preventing a risk in advance in order to protect the safety of patients in relation to medical services. It is evaluated that the enactment of the Patient Safety Act has a very important meaning in protecting patient safety as the top priority and further improving the quality of medical care. However, looking at the status of patient safety accidents reported to the Patient Safety Reporting System after the Patient Safety Act was enacted and implemented, various types of risk factors for patient safety still exist in the medical field. Meanwhile, Korea Consumer Agency and Korea Medical Dispute Mediation and Arbitration Agency, the existing domestic ADR specialized agencies, have been operating reasonable damage relief procedures such as recommendation of settlement, mediation, and arbitration according to the purpose of their establishment. Therefore, with the aimof broadening the choice of compensation system for patients, we propose the establishment and revision of ADR-related laws to apply the damage relief procedures of both institutions.

Frame Analysis on Risk Reporting: Food Safety Reports from 1989 to 2005 (위험보도의 위기구축 기제 프레임 분석: 식품안전 보도를 중심으로)

  • Park, Sung-Hee
    • Korean journal of communication and information
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    • v.35
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    • pp.181-210
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    • 2006
  • This frame analysis attempts to shed light on the process by which the Korean press constructs crisis as social reality through a series of risk reporting on food safety. Based on the FSSI(Food Safety Sentiment Index) developed by KIHASA(Korea Institute for Health and Social Affairs), 11 cases of food safety reports from 1989 to 2005 were collected from the Korean Integrated News Database System(KINDS) and analyzed to yield the following salient features: risk diffusion frame; attribution of responsibility frame; conflict frame. It was observed that the press exhibited a tendency to approach the food safety incidents from a bi-polarized perspective, amplifying dichotomy between the victim and the perpetrator rather than treating them as scientific, or environmental hazards that require precise and synthesized information for resolution. This occupational habit of attributing status to agents of news was also found to contribute towards construction of crisis as social reality.

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Adverse Drug Reaction Surveillance System in Korea (우리나라 약물유해반응 감시체계)

  • Choi, Nam-Kyong;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.40 no.4
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    • pp.278-284
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    • 2007
  • Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

Analyzing Health Information Technology and Electronic Medical Record System-Related Patient Safety Incidents Using Data from the Korea Patient Safety Reporting and Learning System (환자안전보고학습시스템 자료를 활용한 의료정보기술 및 전자의무기록시스템 관련 환자안전사건 분석)

  • Cho, Dan Bi;Lee, Yu-Ra;Lee, Won;Lee, Eu Sun;Lee, Jae-Ho
    • Quality Improvement in Health Care
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    • v.27 no.2
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    • pp.57-72
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    • 2021
  • Purpose: At present, there are a variety of serious patient safety incidents related to problems in health information technology (HIT), specifically involving electronic medical records (EMRs). This emphasizes the need for an enhanced electronic medical record system (EMRS). As such, this study analyzed both the nature of and potential to prevent incidents associated with HIT/EMRS based on data from the Korea Patient Safety Reporting and Learning System (KOPS). Methods: This study analyzed patient safety incidents submitted to KOPS between August 2016 and December 2019. HIT keywords were used to extract HIT/EMRS incidents. Each case was reviewed to confirm whether the contributing factors were related to HIT/EMRS (HIT/EMRS-related incidents) and if the incident could have been prevented (HIT/EMRS-preventable incidents). The selected reports were summarized for general clarity (e.g., incident type, and degree of harm). Results: Of the 25,515 obtained reports, 2,664 incidents (10.4%) were HIT-related, while 2,525 (9.9%) were EMRS-related. HIT/EMRS-related incidents were the third largest type of incident followed by 'fall' and 'medication incidents.' More than 80% of HIT/EMRS-related incidents were medication-related, accounting for approximately one-third of the total number of medication incidents. Approximately 10% of HIT/EMRS-related incidents resulted in patient harm, with more than 94% of these deemed as preventable; further, sentinel events were wholly preventable. Conclusion: This study provides basic data for improving EMR use/safety standards based on real-world patient safety incidents. Such improvements entail the establishment of long-term plans, research, and incident analysis, thus ensuring a safe healthcare environment for patients and healthcare providers.