• Korean Medical Education Review
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• v.22 no.1
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• pp.32-45
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• 2020

This narrative review introduces global trends in pharmacovigilance (PV) education for healthcare professionals and the status of PV education in Korea. Proactive participation of healthcare professionals, including physicians, pharmacists, and nurses in reporting suspected adverse events is the main driving force for effective operation of the spontaneous adverse event reporting system database, which in turn facilitates early safety signal detection of otherwise unknown suspected adverse events. The World Health Organization recognizes PV education curriculum as a key aspect in promoting awareness of PV and adverse event reporting among healthcare professionals, and multiple studies have demonstrated that PV educational interventions for healthcare professionals have increased overall adverse event reporting. Considering the global trends in PV education, the curriculum in Korean universities still has room for improvement in promoting PV obligation among future healthcare professionals. Further research is needed to develop PV education curriculum. We suggest a three-step project for innovating PV education in Korea to meet the global PV educational standards: a survey to gauge current PV competencies among healthcare professionals, reform of current PV academic curriculum, and evaluation and fine-tuning of the reformed curriculum.

• Journal of Korean Medicine Rehabilitation
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• v.24 no.4
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• pp.97-109
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• 2014

Objectives Bee venom acupuncture (BVA) is emerging as a potential therapeutic option for several conditions. However, evidence regarding accurate estimates of its adverse events are not available. Therefore, by combining occurrence rates of adverse events in relevant randomized controlled trials (RCTs), we have aimed to give an overall estimated rate of each adverse event following BVA intervention. Methods A systematic search for adverse events of BVA in Pubmed, Cochrane Central Register of Controlled Trials, Embase, NDSL, KoreaMed, KISS, RISS, KISTI, and KMbase was performed. For the quality assessment of the trials, we applied the CONSORT harms reporting recommendations. The overall occurrence rate of each adverse event was assessed as the primary outcome. The overall drop-out rate due to adverse events was assessed as the secondary outcome. Results Ten RCTs reported adverse events following BVA. Two RCTs were eligible of further synthesis. Adverse events of pruritus, localized edema, and erythema occurred significantly more frequently in the BVA group compared to the control group. Data of drop-outs were available in seven RCTs. However, no comparisons showed a significant difference. Conclusions Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. Still, limited evidence shows a tendency that adverse events occur more frequently after the appliance of BVA compared to the control. Thus, we await well designed future studies of BVA with more proper and strict harms reporting methods.

• Quality Improvement in Health Care
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• v.21 no.1
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• pp.66-76
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• 2015

Objectives: The purpose of this study is to develop a case review form for detecting adverse events through a medical records review in hospitalized patients in South Korea. Methods: To develop the case review form, several literatures were reviewed, first. Through the clinical expert meeting, screening criteria were selected and case review form was developed. Result: The Korean version of case review form consisted of the review form-1 for adverse event screening and form-2 for adverse event identification. The applied methodology for the case review form is determined according to the previous studies. For example, the method used in the first stage review is nurse review. Furthermore, the National Coordinating Council for Medication Errors Reporting and Prevention index is used to categorize disability, and a scale of 1 to 6 was used in the causation scores and preventability scores, respectively. Through the clinical expert meeting, a total of 41 screening criteria were selected. Conclusion: The Korean specific case review form was developed for detecting adverse events in hospitalized patients. The results from this study can be used in a large-scale study regarding the nationwide incidence of adverse events.

• 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.

• Journal of the Korea Society of Computer and Information
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• v.14 no.3
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• pp.183-192
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• 2009

ADESS(Adverse drug event surveillance system) is the system which distinguishes adverse drug events using adverse drug signals. This system shows superior effectiveness in adverse drug surveillance than current methods such as volunteer reporting or char review. In this study, we built clinical data mart(CDM) for the development of ADESS. This CDM could obtain data reliability by applying data quality management and the most suitable clustering number(n=4) was gained through the reproducibility assessment in unsupervised learning techniques of knowledge discovery. As the result of analysis, by applying the clustering number(N=4) K-means, Kohonen, and two-step clustering models were produced and we confirmed that the K-means algorithm makes the most closest clustering to the result of adverse drug events.

• 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 korean journal of orthodontics
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• v.51 no.3
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• pp.199-216
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• 2021

Objective: The aim of this systematic review was to evaluate the complications and side effects associated with the clinical use of orthodontic miniscrews by systematically reviewing the best available evidence. Methods: A survey of articles published up to March 2020 investigating the complications associated with miniscrew insertion, in both the maxilla and mandible, was performed using 7 electronic databases. Clinical studies, case reports, and case series reporting complications associated with the use of orthodontic miniscrew implants were included. Two authors independently performed study selection, data extraction, and risk-of-bias assessment. Results: The database survey yielded 24 articles. The risk-of-bias assessment revealed low methodological quality for the included studies. The most frequent adverse event reported was root injury with an associated periradicular lesion, vitality loss, pink discoloration of the tooth, and transitory loss of pulp sensitivity. Chronic inflammation of the soft tissue surrounding the miniscrew with mucosal overgrowth was also reported. The other adverse events reported were lesion of the buccal mucosa at the insertion site, soft-tissue necrosis, and perforation of the floor of the nasal cavity and maxillary sinus. Adverse events were also reported after miniscrew removal and included secondary bleeding, miniscrew fracture, scars, and exostosis. Conclusions: These findings highlight the need for clinicians to preliminarily assess generic and specific insertion site complications and side effects.

• 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.21 no.4
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• pp.383-389
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• 2011

CSS for identifying ADEs are sufficiently developed for broad use and they are much more accurate than spontaneous reporting and more time- and cost-effective than manual chart review. Also computer alert systems can be used to identify opportunities to prevent or reduce patient injury associated with a broad range of ADEs. This CSS can be used to identify opportunities to prevent or reduce patient injury associated with preventable ADEs and increase patient safety, increase quality of drug therapy and decrease the extra-cost of the treatment for ADEs. In the future, increasing utilization of this concurrent CSS should have an enormous beneficial impact on the quality of medical care.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.35-41
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• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.