• Korean Journal of Clinical Pharmacy
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• v.27 no.4
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• pp.221-227
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• 2017

Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.

• Journal of the Institute of Electronics and Information Engineers
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• v.52 no.1
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• pp.140-147
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• 2015

In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.5
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• pp.753-757
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• 2010

The objectives of this paper is to propose the pharmacoepidemiologic methodology to Research for Sasang Constitutional Pharmacology. We mainly searched "Journal of Pharmacoepidemiology and Risk Management". And we also searched "J Korean Oriental Med.", "J of Sasang Constitutional Med.", "J. Oriental Physiology & Pathology", "Korean J Orient Int Med." using these kew words - "adverse event" or "side effect" and "Sasang Contitution" or "Constitution" or "Constitutional medicine". Through the examination of the Pharmacoepidemiologic methodology and current research for sasang constitiutional pharmacology, we could establish the proposal to collect objective constitutional medical reaction. For the actualization of this proposal, the more advanced studies will have to be carried out continuously.

• 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.3
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• pp.204-214
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• 2022

Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

• Quality Improvement in Health Care
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• v.22 no.1
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• pp.41-57
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• 2016

Objectives: This study aimed to investigate how many healthcare professionals experienced near misses, what types of near misses occurred most often, and healthcare professionals' opinions about near misses at one university hospital in Korea. Methods: The authors developed a questionnaire including 26 core types of near misses and 4 questions about preventability and reporting barriers. The survey was conducted from Oct. 31st to Nov. 18th 2011, about 3 weeks, using a self-administrated questionnaire that was administered to 697 healthcare professionals (registered nurses, pharmacists, technicians, and nurses aides) who worked at a university hospital. Medical doctors and employees working in the department of administration were excluded. Results: About half of hospital workers experienced at least one or more near misses during the past one year. The drug dispensing process was the most common subcategory of near misses. Among the 26 items, patient falls was highest. Over 95% of respondents reported that the near miss they experienced was preventable. Also, more than half of respondents did not report the near miss and the main reason for omission was fear of blame. Conclusion: Regarding patient safety issues, a near miss is a very significant factor because it can be a potential adverse event. Therefore, we should grasp the size of the problem through tracking and analyzing near misses and should make an effort to reduce them. To do so, we should check whether our reporting system is well designed and functioning.

• Allergy, Asthma & Respiratory Disease
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• v.6 no.6
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• pp.315-321
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• 2018

Purpose: Radiocontrast media are widely used in medical imaging to improve diagnostic accuracy. However, studies on the adverse reactions of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods: We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data from children under the age of 19 from July 2011 to December 2017 and analyzed their characteristics. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results: During the period, a total of 88,050 radiocontrast media-enhanced imaging studies were performed and 184 cases of adverse reactions were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was $12.7{\pm}3.2$ years. The incidence of radiocontrast media-related adverse reactions was 0.09% and severe reactions were 0.002%. The most common clinical feature was skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusion: Adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reactions is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children scheduled for imaging studies using radiocontrast media.

• The Korea Journal of Herbology
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• v.36 no.5
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• pp.69-79
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• 2021

Objectives : In clinical practice, there are many cases of co-administration of herbal medicine and synthetic drugs. This study tried to identify whether the combined administration of herbal medicine and synthetic drugs including amoxicillin increases Helcicobacter pylori eradication rate compared to the single administration of synthetic drugs or the combined administration of synthetic drugs and placebo herbal medicine through systematic review. Methods : Relevant randomized controlled trials were searched in PubMED database. The risk of biases was assessed through the Cochrane Risk of Bias criteria. Three reviewers were extracted the characteristics and outcomes of each study. Meta-analysis of eradication rate and adverse event was conducted. Results : Four RCTs were selected. In meta-analysis, the combination of herbal medicine and synthetic drugs showed eradication effect, but it was not statistically significant (Odds Ratio [OR] 0.46; 95% confidence interval [CI] 0.17 to 1.24; p=0.13; I²=56%) than administration of synthetic medicine alone. Combination of herbal medicine and synthetic medicine did not increased the incidence of adverse event(OR 1.07; 95% CI 0.72 to 1.59; p=0.68, I²=0%) compared to single administration of synthetic medicine. Conclusion : Although no significant difference was observed between the two groups in the eradication rate and the incidence rate of adverse events, it was difficult to draw a clear conclusion due to the heterogeneity between studies and the low quality of reporting. A number of studies that have overcome these limitations in the future will lead to definite conclusions.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.165-181
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• 2024

Objectives: This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea. Methods: This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO's global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed. Results: Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death. Conclusions: This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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• pp.293-299
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• 2018

Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.