• Title/Summary/Keyword: Adverse Drug Event

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Intravenous levetiracetam versus phenobarbital in children with status epilepticus or acute repetitive seizures

  • Lee, Yun-Jeong;Yum, Mi-Sun;Kim, Eun-Hee;Ko, Tae-Sung
    • Clinical and Experimental Pediatrics
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    • v.59 no.1
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    • pp.35-39
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    • 2016
  • Purpose: This study compared the efficacy and tolerability of intravenous (i.v.) phenobarbital (PHB) and i.v. levetiracetam (LEV) in children with status epilepticus (SE) or acute repetitive seizure (ARS). Methods: The medical records of children (age range, 1 month to 15 years) treated with i.v. PHB or LEV for SE or ARS at our single tertiary center were retrospectively reviewed. Seizure termination was defined as seizure cessation within 30 minutes of infusion completion and no recurrence within 24 hours. Information on the demographic variables, electroencephalography and magnetic resonance imaging findings, previous antiepileptic medications, and adverse events after drug infusion was obtained. Results: The records of 88 patients with SE or ARS (median age, 18 months; 50 treated with PHB and 38 with LEV) were reviewed. The median initial dose of i.v. PHB was 20 mg/kg (range, 10-20 mg/kg) and that of i.v. LEV was 30 mg/kg (range, 20-30 mg/kg). Seizure termination occurred in 57.9% of patients treated with i.v. LEV (22 of 38) and 74.0% treated with i.v. PHB (37 of 50) (P=0.111). The factor associated with seizure termination was the type of event (SE vs. ARS) in each group. Adverse effects were reported in 13.2% of patients treated with i.v. LEV (5 of 38; n=4, aggressive behavior and n=1, vomiting), and 28.0% of patients treated with i.v. PHB (14 of 50). Conclusion: Intravenous LEV was efficacious and safe in children with ARS or SE. Further evaluation is needed to determine the most effective and best-tolerated loading dose of i.v. LEV.

Design for a Medical Devices Safety Information Reporting System for the Hospitals (의료기기 안전성 정보 원내 보고 시스템 설계)

  • Jang, Hye Jung;Choi, Young Deuk;Kim, Nam Hyun
    • 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.

Near Misses Experienced at a University Hospital in Korea

  • Park, Mi-Hyang;Kim, Hyun-Joo;Lee, Bo-Woo;Bae, Seok-Hwan;Lee, Jin-Yong
    • 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.

The Lived Experience of Patients with Heart Transplantation: A Phenomenological Study (심장이식환자의 체험: 현상학적 연구)

  • Hwang, Younghui;Yi, Myungsun
    • Journal of Korean Academy of Nursing
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    • v.47 no.1
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    • pp.110-120
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    • 2017
  • Purpose: The purpose of this study was to describe the lived experience of patients with heart transplantation in Korea. Methods: Individual indepth interviews and a focus group interview were used to collect the data from nine patients who had heart transplantations in 2015. All interviews were audio-taped and verbatim transcripts were made for the analysis. Data were analyzed using Colaizzi's phenomenological method. Results: Among the nine participants, eight were men. Mean age was 57.30 years. Six theme clusters emerged from the analysis. 'Joy of rebirth obtained by good luck' describes the pleasure and expectation of new life after narrow survival. 'Suffering from adverse drug effects' illustrates various psychosocial difficulties, such as low self-esteem, helplessness, alienation, and burnout, arising from the side effects of medications. 'Body and mind of being bewildered' illustrates disintegrated health and haunting fear of death. 'Alienation disconnected with society' describes isolated feeling of existence due to misunderstandings from society. 'Suffering overcome with gratitude and responsibility' includes overcoming experience through various social supports and suitable jobs. Finally, 'acceptance of suffering accompanied with new heart' illustrate changed perspective of life itself. Conclusion: The findings in this study provide deep understanding and insights of the lived experience of heart related illness for these patients and should help in the development of tailored-interventions for patients with heart transplantation.

A Case Report of Esophageal Ulceration after Taking Doxycycline (독시사이클린 복용 후 발생한 식도궤양형성 사례)

  • Kim, Ga Yeon;Lee, Chan Hee;Lee, Jeong Woo;Lee, Jung-Min;Lee, Mo-Se;Ji, Eunhee
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.3
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    • pp.209-214
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    • 2019
  • Doxycycline is frequently prescribed to treat urogenital infections or acne vulgaris. A 39-year-old man was prescribed doxycycline as a treatment for his skin infection. He took each tablet on an empty stomach in the morning, and just before going to bed with insufficient water. After taking the prescribed medication for approximately 3 weeks, he was diagnosed with esophageal ulcer. He had not experienced these symptoms before, and the drug label says that doxycycline rarely causes esophageal ulcer. After discontinuing the medication, the symptoms disappeared. Using the World Health Organization-Uppsala Monitoring Center criteria, the causality for doxycycline-induced esophageal ulcer was evaluated as "possible." Additionally, using the Naranjo scale and Korean causality assessment algorithm (Ver. 2), the causality was evaluated as "probable." Previous reports have stated that most patients who took doxycycline with insufficient water just before going to bed or in the supine position developed esophageal ulcer. Therefore, all patients taking doxycycline must be provided with detailed instructions about the appropriate administration methods.

Transient Non-Regenerative Anemia in a Dog with Granulomatous Meningoencephalitis Following Leflunomide Treatment

  • Ga-Hyun Lim;Ju-Hyun An;Su-Min Park;Jeong-Hwa Lee;Ye-In Oh;Kyoung-Won Seo;Hwa-Young Youn
    • Journal of Veterinary Clinics
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    • v.41 no.3
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    • pp.165-169
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    • 2024
  • A 10-year-old, spayed female Maltese dog was tentatively diagnosed with granulomatous meningoencephalitis (GME) on magnetic resonance imaging. The meningoencephalitis was classified as aseptic GME because cerebral fluid analysis did not reveal an infectious aetiology. Two months after leflunomide treatment (Arava; Sanofi; 4 mg/kg/day), the patient developed non-regenerative, macrocytic, and normochromic anemia. As the patient's anaemia began after the administration of leflunomide, and other differentials for anaemia had been ruled out, the leflunomide was determined to be the cause and this treatment ended. After 15 days, the anaemia resolved spontaneously. This is the first report of reversible aplastic anaemia following treatment with leflunomide in a canine patient with GME.

Patient safety practices in Korean hospitals (우리나라 병원의 환자안전 향상을 위한 활동 현황)

  • Hwang, Soo-Hee;Kim, Myung-Hwa;Park, Choon-Seon
    • 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.

A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system (시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로)

  • Kim, Byung Gwan;Choi, Young Sook;Kim, Mi Sun;Yang, Seok-Jo
    • 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.

Complete Versus Culprit-Only Revascularization for ST-Segment Elevation Myocardial Infarction and Multivessel Disease in the 2nd Generation Drug-Eluting Stent Era: Data from the INTERSTELLAR Registry

  • Kwon, Sung Woo;Park, Sang-Don;Moon, Jeonggeun;Oh, Pyung Chun;Jang, Ho-Jun;Park, Hyun Woo;Kim, Tae-Hoon;Lee, Kyounghoon;Suh, Jon;Kang, WoongChol
    • Korean Circulation Journal
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    • v.48 no.11
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    • pp.989-999
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    • 2018
  • Background and Objectives: We aimed to compare outcomes of complete revascularization (CR) versus culprit-only revascularization for ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) in the $2^{nd}$ generation drug-eluting stent (DES) era. Methods: From 2009 to 2014, patients with STEMI and MVD, who underwent primary percutaneous coronary intervention (PCI) using a $2^{nd}$ generation DES for culprit lesions were enrolled. CR was defined as PCI for a non-infarct-related artery during the index admission. Major adverse cardiovascular event (MACE) was defined as cardiovascular (CV) death, non-fatal myocardial infarction, target lesion revascularization, or heart failure during the follow-up year. Results: In total, 705 MVD patients were suitable for the analysis, of whom 286 (41%) underwent culprit-only PCI and 419 (59%) underwent CR during the index admission. The incidence of MACE was 11.5% in the CR group versus 18.5% in the culprit-only group (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.37-0.86; p<0.01; adjusted HR, 0.64; 95% CI, 0.40-0.99; p=0.04). The CR group revealed a significantly lower incidence of CV death (7.2% vs. 12.9%; HR, 0.51; 95% CI, 0.31-0.86; p=0.01 and adjusted HR, 0.57; 95% CI; 0.32-0.97; p=0.03, respectively). Conclusions: CR was associated with better outcomes including reductions in MACE and CV death at 1 year of follow-up compared with culprit-only PCI in the $2^{nd}$ generation DES era.

Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial

  • Yong-Joon Lee;Yongsung Suh;Jung-Sun Kim;Yun-Hyeong Cho;Kyeong Ho Yun;Yong Hoon Kim;Jae Young Cho;Ae-Young Her;Sungsoo Cho;Dong Woon Jeon;Sang-Yong Yoo;Deok-Kyu Cho;Bum-Kee Hong;Hyuckmoon Kwon;Sung-Jin Hong;Chul-Min Ahn;Dong-Ho Shin;Chung-Mo Nam;Byeong-Keuk Kim;Young-Guk Ko;Donghoon Choi;Myeong-Ki Hong;Yangsoo Jang;TICO investigators
    • Korean Circulation Journal
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    • v.52 no.4
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    • pp.324-337
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    • 2022
  • Background and Objectives: Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs). Methods: In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISE-DAPT) score ≥25. The primary outcome was a 3-12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events). Results: Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76-4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92-4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178). Conclusions: In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.