• Journal of Acupuncture Research
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• v.31 no.4
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• pp.71-79
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• 2014

Objectives : The aim of this study is to evaluate the safety of acupuncture therapy when applied to patients who are undergoing anticoagulants / antiplatelet medication therapy combined with herbal medicine using a retrospective, case-control study. Methods : 428 charts of patients were reviewed in this study. Odds ratio between case of bleeding-related adverse event and control was calculated as main analysis. Exposures were anticoagulants / antiplatelet medication, Hwalhyeolgeoeo herbal medicine and combination of both drugs. Additionally, odds ratios were calculated according to the severity of bleeding-related adverse events. Results : The results were as following: 1. Analysis of all bleeding-related adverse events showed there was no increased risk of combined therapy compared with other exposures and control group. 2. Analysis of only clinically significant adverse events showed there was no increased risk of combined therapy compared with other exposure and control group. 3. Hwalhyeolgeoeo herbal medicine group showed a tendency of increased risk of bleeding-related adverse events in all analysis but was not statistically significant. Conclusions : The results suggest that Hwalhyeolgeoeo herbal medicine-anticoagulant / antiplatelet medication combined therapy may not increase risk of bleeding-related adverse events in acupuncture therapy. By executing various modules of analysis, it was possible to acquire useful data for possible future studies. Further research is needed to confirm such results.

• Korean Journal of Clinical Pharmacy
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• v.27 no.4
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• pp.250-257
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• 2017

Objective: The prevalence rate of osteoarthritis in Koreans aged 50 years or older is 14.3%, and the total amount of medical costs is more than KRW 1 trillion. Recently, the reimbursement guidelines for osteoarthritis treatment have changed. Methods: In this study, we sought to describe prescription patterns of nonsteroidal anti-inflammatory drugs (NSAIDs) and gastro-protective agent (GPA) and analyze the clinical and economic impacts of the new policy using the national health insurance claims data. The incidence of upper gastrointestinal adverse event by policy change was identified through the odds ratio, and changes in medicine and medical costs related to osteoarthritis through mean and median. Results: There were 204,552 patients before the reimbursement guidelines relaxation and 239,710 after it, a 17.2% rise. The prescription ratio was 3.3% for the patients prescribed with COX-2 selective NSAIDs alone and 1.3% for those with both COX-2 selective NSAIDs and GPA combination before the reimbursement guidelines relaxation. The reimbursement guidelines relaxation significantly increased their ratios to 6.9% and 2.8%, respectively. Gastrointestinal adverse events significantly reduced by 1.21%p after reimbursement guidelines relaxation. The average medicine cost per person increased significantly to KRW 140,291 from KRW 137,323 after the reimbursement guidelines relaxation, while the average medical cost per person slightly decreased from KRW 311,605 to KRW 310,755 after the relaxation, showing no meaningful difference. Conclusion: The reimbursement guidelines relaxation may influence on decreasing the upper gastrointestinal adverse event, increasing the medicine costs and maintaining the medical costs for osteoarthritis.

• Korean Journal of Clinical Pharmacy
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• v.25 no.1
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• pp.50-55
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• 2015

Background: Phosphodiesterase Type 5 Inhibitors (PDE5Is), which are prescription drug in South Korea, have been concerned about misuse, overuse and illegal provision of the drugs. This study was performed to investigate utilization and safety of illegal Phosphodiesterase Type 5 Inhibitors (PDE5Is), and related factors among South Korean men. Methods: A questionnaire survey was conducted from May to July in 2013 among 1,500 nationally representative general males using computer-assisted telephone interview (CATI). The questionnaire included the characteristics of population, the characteristics of PDE5Is use, the experience with the use of illegally obtained PDE5Is, and adverse events after PDE5Is use. Results: Among study population, the 1,015 (67.7%) men answered that they have used the illegally obtained PDE5Is. Younger age, single, lower frequency of PDE5Is use in a lifetime was associated with an increased use of illegally obtained PDE5Is. The men experienced adverse events after PDE5Is use is 528 (35.2%). The most common adverse event was mild to moderate hot flashes. Conclusion: We need to enhance awareness about the risk of illegally obtained PDE5Is use, especially in younger men and single. Proactive educations and public relations on safe use of PDE5Is for proper patients are needed.

• 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.

• The Journal of Internal Korean Medicine
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• v.45 no.1
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• pp.55-74
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• 2024

Objectives: This study reviewed the status of adverse event (AE) reporting in VigiAccess using anti-obesity agents as examples and explored the possibility of its use and future challenges. Methods: AE reports related to some representative drugs among herbal medicines (HMs), complex HM prescriptions, ingredients of supplements, and over-the-counter and prescription medicines were investigated using VigiAccess on February 1, 2024. Results: AE reports on prescription drugs were overwhelmingly higher than those on HMs or supplements. Although most reports were submitted from North America, reports on Ephedra sinica and green tea extract (GTE) were more from Asia and Europe, respectively. The female population reported more, and the difference in the sex ratio was the smallest for Ephedra spp. The age group was concentrated on young adults, but many older patients reported GLP-1 receptor agonist-related AEs. Symptoms related to the gastrointestinal and nervous systems were most commonly reported, but mental and cardiac disorders were common in Ephedra-type HMs. Hepatobiliary disorders are also commonly found in GTE-related reports. Conclusions: VigiAccess was useful for easily checking the global status of AE reporting for prescription drugs. However, several limitations were observed in using VigiAccess for HMs because of the few reports. Thus, it is necessary to increase the number of reports by education and to promote AE reporting among HM prescribers and users. The full range of HMs should be included in the pharmacovigilance system, and the coding and classification of HMs should be revised.

• Journal of The Korean Society of Clinical Toxicology
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• v.13 no.1
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• pp.1-10
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• 2015

Purpose: The purpose of this study was to evaluate the usefulness of intravenous lipid emulsion as well as adverse events in acute poisoning patients. Methods: Literature was accessed through PubMed, EMBASE, Cochrane library, Web of science, and KoreaMed. All forms of literatures relevant to human use of intravenous lipid emulsion for acute poisoning were included. Cases reports or letters without description of clinical outcomes for each case were excluded. The literature search was conducted by two investigators in March, 2015, with publication language restricted to English and Korean. The effect, onset time, and adverse event of lipid emulsion and final outcome of each case were analyzed. Results: Eighty-one published articles were included, excluding articles whose title and abstract were not relevant to this study. No articles were classified as high level of evidence. Sixty-eight case reports were identified, consisting of 25 local anesthetics and 43 other drugs, such as tricyclic antidepressants and calcium channel blockers. Although most cases described significant clinical improvements, some of them showed no beneficial effect or worsening of clinical course. Several adverse events including hyperamylasemia and laboratory interference were reported. Conclusion: Although there were many case reports illustrating successful use of lipid for various drug poisonings, the effect cannot be estimated due to significant possibility of publication bias. Therefore, lipids might be considered in severe hemodynamic instability resulting from lipophilic drug poisoning, however further studies should follow to establish the use of lipid as the standard of care.

• Journal of Korean Institute of Industrial Engineers
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• v.39 no.1
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• pp.20-29
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• 2013

Medical errors such as adverse drug event, improper transfusion, wrong-site surgery, mistaken patient identity and so on commonly occur at health care practice. Information technology, like Drug Utilization Review(DUR) system which reviews, analyzes, and interprets medication data when prescribing, can play a key role in reducing such medical errors and improving patient safety. Korean Government has guided all hospitals to implement concurrent DUR(cDUR) system, which is the first case worldwide in that all healthcare providers have to use cDUR system when prescribing. This paper introduced a case study that a tertiary hospital has integrated the cDUR system into its comprehensive Hospital Information System(HIS) and analyzed the whole prescription data during a week right after adoption of cDUR system. Considering technical strength and weakness, the cDUR system was integrated into the HIS, using Broker Servers for minimizing doctors' anxiety. As the quantitative analysis of the whole prescription data, DUR conflict events, which mainly included duplicate medications and contra-indicated drug interactions for outpatients, were 2.77%. Although only 0.7% is for the contra-indicated drug interactions, it will be greatly devoted to achieve the purpose of DUR such as improving patient safety.

• Clinical and Experimental Pediatrics
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• v.54 no.10
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• pp.422-424
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• 2011

Acute disseminated encephalomyelitis (ADEM) is an inflammatory demyelinating disease of the central nervous system that typically follows an infection or vaccination and has a favorable long-term prognosis. We describe the first reported case of ADEM after vaccination against novel influenza A (H1N1). A previously healthy 34-month-old boy who developed ADEM presented with a seizure and left-sided weakness 5 days after vaccination against novel influenza A (H1N1). Cerebrospinal fluid examination revealed elevated cell counts. T2-weighted images and fluid-attenuated inversion recovery images revealed multiple patchy hyperintense lesions in the frontal and parietal subcortical white matter and the left thalamus. After the administration of intravenous corticosteroid, the patient's clinical symptoms improved and he recovered completely without neurologic sequelae.

• Proceedings of the Korea Information Processing Society Conference
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• 2022.05a
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• pp.549-552
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• 2022

최근 소셜미디어 리뷰 데이터를 활용한 약물 이상 반응 탐지 연구가 활발히 진행되고 있지만, 약물을 복용하기 전 증상과 약물 이상 반응을 구분하지 못한다는 한계가 있다. 본 논문에서는 약물 이상 반응 탐지에서 약물 복용 전의 증상을 구분할 수 있는 Filtering Clinical BERT(FC-BERT) 모델을 제안하였다. FC-BERT 는 약물 복용 전 증상과 다른 약물에 대한 부작용 표현을 제거하기 위해 약물명이 나오기 전 모든 문장을 제거하는 필터링과 약물-부작용 쌍을 추출하는 모델을 사용했다. 성능 평가 실험을 위해 문장에 대한 ADE(Adverse Drug Event) 여부가 들어있는 ADE Corpus V2 데이터를 활용하였고 SPARK NLP 라이브러리에서 제공하는 ADE Pipeline 모델과 비교하여 성능 평가를 실시하였다. 실험 결과 필터링을 활용한 FC-BERT 모델이 기존 모델보다 정확도, 평균 정밀도, 평균 재현율, 평균 F1-score 가 모두 높은 결과를 보여주었다. 본 논문에서 제시한 모델은 기존 연구의 한계점을 보완하여 보다 정확한 약물 부작용 시그널을 탐지하는데 기여할 수 있을 것이다.

• Korean Journal of Clinical Pharmacy
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• v.25 no.3
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• pp.171-177
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• 2015

Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.