• Journal of Society of Preventive Korean Medicine
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• v.15 no.2
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• pp.131-143
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• 2011

Objective : The aims of this study are to investigate the trend of internet journalism about the toxicity and safety of the herbal medicine, and to suggest the regulatory solution of the issue. Method : In this study, we had searched the internet news article published from 2001 to 2011 in the five major portal sites-NAVER, DAUM, Nate, Google Korean, and Yahoo Korean. The search terms were 'herbal medicine', 'adverse event', 'toxicity'. If the articles described the same event in the same form and tone, the articles were considered overlapping. The overlapped articles were excluded. The articles were categorized by the form and tone. The form categories were straight news, interpretative story, editorial, interview, and the tone categories are the positive, the negative, and the neutral. The regulations were searched about the negative issue. Result : Total 56 articles were reviewed. There were 19 positive articles, 29 negative articles, 8 neutral articles. Most negative issues have the proper regulations, but insufficient measures for the adverse event reporting system. Conclusion : The herbal medicine specified adverse event reporting system is essential.

• Quality Improvement in Health Care
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• v.22 no.2
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• pp.43-73
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• 2016

Purpose: The aims of this study were to assess the presence of core patient safety practices in Korean hospitals and assess the differences in reporting and learning systems of patient safety, infrastructure, and safe practices by hospital characteristics. Methods: The authors developed a questionnaire including 39 items of patient safety staffing, health information system, reporting system, and event-specific prevention practices. The survey was conducted online or e-mail with 407 tertiary, general and specialty hospitals. Results: About 90% of hospitals answered the self-reporting system of patient safety related events is established. More than 90% of hospitals applied incidence monitoring or root cause analysis on healthcare-associated infection, in-facility pressure ulcers and falls, but only 60% did on surgery/procedure related events. More than 50% of the hospitals did not adopted present on admission (POA) indicators. One hundred (80.0%) hospitals had a department of patient safety and/or quality and only 52.8% of hospitals had a patient safety officer (PSO). While 82.4% of hospitals used electronic medical records (EMRs), only 53% of these hospitals adopted clinical decision support function. Infrastructure for patient safety except EMRs was well established in training, high-level and large hospitals. Most hospitals implemented prevention practices of adverse drug events, in-facility pressure ulcers and falls (94.4-100.0%). But prevention practices of surgery/procedure related events had relatively low adoption rate (59.2-92.8%). Majority of prevention practices for patient safety events were also implemented with a relatively modest increase in resources allocated. Conclusion: The hospital-based reporting and learning system, EMRs, and core evidence-based prevention practices were implemented well in high-level and large hospitals. But POA indicator and PSO were not adopted in more than half of surveyed hospitals and implementation of prevention practices for specific event had low. To support and monitor progress in hospital's patient safety effort, national-level safety practices set is needed.

• Korean Journal of Clinical Pharmacy
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• v.32 no.4
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• pp.352-361
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• 2022

Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

• Korean Journal of Clinical Pharmacy
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• v.34 no.2
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• pp.100-107
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• 2024

Background: The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database. Methods: This study was conducted using AEs reported from January 2009 to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPP-IV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected. Results: Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of reported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, pharyngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15). Conclusions: Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.

• Journal of the Korean Society of Radiology
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• v.84 no.1
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• pp.3-14
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• 2023

Breast Imaging Reporting and Data System (BI-RADS) is a communication and data tracking system that standardizes and controls the quality of reporting by presenting lexicon descriptors, assessment categories, and recommendations for managing breast lesions. Using standardized terminology recommended by BI-RADS, radiologists can concisely and reproducibly communicate breast imaging results to clinicians. They can also provide the estimated malignant probability of the lesions found and guide management for them by determining the final assessment category. The limitations of BI-RADS 5th edition currently in use are that there are some areas for which standardized terminologies still need to be established, and that the diagnostic criteria of MRI assessment categories 3 and 4 are ambiguous compared to those for mammography or ultrasound. The next revision of BI-RADS is expected to include solutions for overcoming current limitations.

• Korean Journal of Clinical Pharmacy
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• v.13 no.2
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• pp.72-81
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• 2003

Adverse drug reaction (ADR) may increase hospital admission, morbidity and mortality and adding extra cost to healthcare expenditures. AIMS: This study was performed to identify the types of ADR being reported in a tertiary hospital, and to find out the ways to improve current ADR monitoring system. To investigate the attitudes of hospital pharmacists towards, and their understanding of ADR reporting. METHODS: Of 117 reports submitted to the pharmacy department during 3 months survey period, A questionnaire survey of 75 randomly selected hospital pharmacists was conducted. RESULT: Of the report was from patients aged between 60 and 70. The medical department with the high frequency in ADR reporting was Internal Medicines $(60\%)$. The most common ADR manifestations were gastrointestinal complaints $(47.8\%)\;and\;80\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $38.4\%.\;55.5\%$ of respondent were aware of the need to education and information about ADR monitoring. The important reasons for unreporting ADR were unknown of how to report ADRs $(94.6\%)$. CONCLUSIONS: An ADR reporting system based on reporting by staff pharmacists has been effective increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs. Pharmacists have the knowledge and responsibility to contribute to ADR reporting program. A great opportunity exists for pharmacists to contribute in this area of patient care.

• Journal of Korean Academy of Nursing
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• v.37 no.2
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• pp.185-191
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• 2007

Purpose. The purpose of this study was to develop and evaluate an error reporting promoting program(ERPP) to systematically reduce the incidence rate of nursing errors in operating room. Methods. A non-equivalent control group non-synchronized design was used. Twenty-six operating room nurses who were in one university hospital in Busan participated in this study. They were stratified into four groups according to their operating room experience and were allocated to the experimental and control groups using a matching method. Mann-Whitney U Test was used to analyze the differences pre and post incidence rates of nursing errors between the two groups. Results. The incidence rate of nursing errors decreased significantly in the experimental group compared to the pre-test score from 28.4% to 15.7%. The incidence rate by domains, it decreased significantly in the 3 domains-"compliance of aseptic technique", "management of document", "environmental management" in the experimental group while it decreased in the control group which was applied ordinary error-reporting method. Conclusion. Error-reporting system can make possible to hold the errors in common and to learn from them. ERPP was effective to reduce the errors of recognition-related nursing activities. For the wake of more effective error-prevention, we will be better to apply effort of risk management along the whole health care system with this program.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.42 no.4
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• pp.848-854
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• 2017

Recently, false reports to governmental offices such as police stations have not been decreased. As a result, if a violent crime or a fire occurs that needs to be promptly responded to and reacted to these accidents in real time, it may lead to serious results such as loss of life. Also, the waste of police enforcement and administration due to false reporting can cause serious problems. In this paper, we try to clarify the difference between the actual and false reports based on the actual sound sources which were reported to the police stations. In addition, we will intend to develop a false report discrimination system that can identifies false reports and actual reports based on this.

• Journal of the Korean Applied Science and Technology
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• v.38 no.4
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• pp.1129-1142
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• 2021

This study was conducted to identify the impact factors of SBAR reporting education applied during clinical practice of nursing students on communication clarity, communication satisfaction, reporting confidence, and communication competency. Data collection period was from December 1st, 2019 to December 20th, 2019 and two nursing universities extracted conveniently for third graders who completed clinical practice for more than six weeks. The number of eligible applicants is 103 who received SBAR reporting and training and 113 who did not receive training. Data were analyzed by t-tests, one-way ANOVA, Pearson's correlation coefficient analysis using the SPSS 21.0 program. Positive correlation were between communication clarity and communication competency(r=.52, p<.001), and between reporting confidence and communication satisfaction(r=.53, p<.001), communication competency and reporting confidence(r=.46, p<.001). communication competency was a significant influence factor with communication clarity(𝛽=.28, p<.001), communication satisfaction(𝛽=.43, p<.001), and reporting confidence(𝛽=.15, p=.009) 49.0% explanatory power. In conclusion, it is necessary for nursing students to develop educational systems and teaching methods to strengthen the reporting system by identifying practical skills during clinical practice.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.111-118
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• 2014

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.