• The Journal of the Korea Contents Association
• /
• v.16 no.9
• /
• pp.473-481
• /
• 2016

Adverse drug reactions(ADRs) were caused by dexran 40 in patient with ischemic stroke and related 22 patients reported to formal ADRs at Jesus Hospital in Jeonju. This study was aimed to search ADRs related factors, type and the degree associated with dextran 40. Adverse Effects of Dextran 40 is including marked hypotension, nausea, dyspnea, generalized urticaria, fever and pulmonary edema. The average hospitalization period was 20 days and it was extended 26.8%. ADRs of Dextran 40 to incidence is 12.4%, and 9 persons(28.1%), itching, rash was 7 people (21.9%). Dextran induced ADRs reaction may be reported on early injection period and first time shot, but adverse drug reactions occurred after 4 days in 4 patients(18.2%). US FDA has recommanded that Dextran 1 significantly reduces the incidence of severe ADRs in USA. Because low molecular weighted dextran 1 prevented dextran molecules from combined Ig G completely. In Korea. Generally not yet introduced dextran 1, active use dextran 1 is able to be a good way in order to reduce ADRs of dextran 40.

• Journal of the Korea Safety Management & Science
• /
• v.16 no.4
• /
• pp.427-431
• /
• 2014

The purpose of this study is to monitor the current adverse reactions in administering CT contrast agents at general hospitals and also to suggest the practical guidelines to minimize the risk and to show the successful patient management. At four Dajeon city general hospitals, the contrast agents were administered in 646,828 cases and the overall prevalence of adverse reactions was 4,110 cases from January 2010 to December 2013. However, we excluded the two hospitals' 3,658 cases because the patients' data was inadequate. Consequently, the case surveys on the rest of 452 cases have been studied and submitted. After comparing the patients with a control group, we evaluated that the key factors of the adverse reactions were the gender and age difference of the patients, the examination period, the examination method, the quantity and administrating speed of the contrast agents. Even though the four general hospitals have their own management systems on adverse reactions, but their systems were not satisfying. To improve the quality of the management systems and to investigate further cases, some hospital administration procedures on the subject should be systemized and general hospitals should follow the recommended procedures. Moreover, the existing three-year-term evaluation should not only judge the adverse reaction management but also conclude some details on the sub criteria of the evaluation. The details on the sub criteria include the contrast agent characters, the quantity and administrating speed of the drug, the incidents' occurred time, an anamnesis; a case history, the medical history of the patients and the reaction occurring body parts, and the examination title. The details of the medical examiners are also added to the sub criteria.

• Korean Journal of Radiology
• /
• v.20 no.1
• /
• pp.148-157
• /
• 2019

Objective: To evaluate the current status of managing adverse reactions to iodinated contrast media (ICM) for computed tomography in referral hospitals in South Korea compared with hospitals in other countries. Materials and Methods: This survey investigation involved 59 Korean and 15 overseas hospitals using guideline-based questionnaires consisting of 24 items in 7 main categories related to managing adverse reactions to ICM. Results: Informed written consent with risk factor evaluation was appropriately performed in most of the Korean hospitals. There was considerable variability in assessing renal function across the hospitals; serum creatinine level was used as a reference in 76.4% of Korean hospitals. The Korean hospitals preferred a more stringent approach to determining normal renal function (p = 0.01), withholding metformin (p = 0.01), and fasting before ICM exposure (p < 0.001) compared with overseas hospitals. All the Korean hospitals had an emergency protocol and in-hospital system for adverse reactions to ICM. The Korean (87.7%) and overseas hospitals (100%) were similarly equipped with epinephrine (p = 0.332), but only 38.6% of Korean hospitals were equipped with a bronchodilator (p = 0.004). For patients with a previous hypersensitivity reaction to ICM, 62.3% of Korean hospitals pre-medicated with anti-histamine and corticosteroid according to the severity of the previous reaction, and changed the culprit ICM in 52.8%, while skin test was performed in 17%. Conclusion: In general, Korean referral hospitals were well-prepared regarding informed consent, protocol, and an in-hospital system for managing adverse reactions to ICM. Nevertheless, there was considerable variability in details and management, thus requiring standardization by reflecting current guidelines.

• The Korean Journal of Emergency Medical Services
• /
• v.25 no.3
• /
• pp.93-109
• /
• 2021

Purpose: This study aims to investigate the knowledge and attitudes regarding adverse drug reactions (ADR) of emergency medical services (EMS) students, so that suggestions for further education on ADR can be made. Methods: A survey on knowledge and attitude was created and modified according to Lee's and Kim's test tool. In total, 149 students' data were collected and compared with previous studies. Results: Knowledge of ADR was relatively low (54%) but attitude was relatively high (75%). Clinical experience was important in knowledge and attitude. Knowledge and attitude showed a positive correlation. Conclusion: Increased knowledge of ADR leads to a more active attitude towards it. Hence, modification of the education system to provide a more personalized education is required.

• The Journal of Pediatrics of Korean Medicine
• /
• v.28 no.3
• /
• pp.1-16
• /
• 2014

Objectives The purpose of this study is to investigate the incidence and clinical features of adverse events associated with herbal medicine, and to analyze their causality and severity. Methods This study was carried out from 159 children and adolescents who took herbal medicine in the Department of Pediatrics, ${\bigcirc}{\bigcirc}$ Korean Medical Hospital from december, 2013 to april, 2014. The data was collected by survey in person or telephone. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to analyze causality for each adverse events. Results 1. 207 cases were surveyed from 159 children and adolescents who took one or more kinds of herbal medicine. 2. A total of 12 general adverse events (5.8%) were reported from the study. Among these adverse events, 8 cases (3.9%) were associated with herbal medicine. 3. Gastro-intestinal system disorders were most frequently reported (70%) as adverse events, which is followed by psychiatric disorders (15%), skin and appendages disorders (10%), urinary system disorders (5%). 4. The most common clinical symptom was abdominal pain (20%), followed by diarrhea (15%), loose stools (10%), vomiting (10%) and borborygmus (10%). 5. The severity of adverse drug reactions was mostly mild (87.5%), and moderate (12.5%). There was no severe case. Conclusions The adverse events from herbal medicine on children and adolescents were mostly minor, most of them could continue herbal medicines.

• Korean Journal of Clinical Pharmacy
• /
• v.22 no.1
• /
• pp.41-46
• /
• 2012

Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.

• Clinical and Experimental Pediatrics
• /
• v.54 no.7
• /
• pp.304-309
• /
• 2011

Purpose: There are very few reports of adverse drug reactions (ADR) and almost no study of drug provocation test (DPT) in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods: We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009). With various suspected drugs, 71 DPTs were done in 16 patients using our own protocol, and skin tests to antibiotics were combined in ADRs to antibiotics in medical history. Results: There were 17 (23.9%) positive DPTs results out of 71 individual DPTs, and 11 patients (68.8%) from 16 patients were positive to at least one drug. Drugs causing positive reactions were acetaminophen in 5 (31%), Non-steroidal anti-inflammatory drugs in 4 (25%), penicillin in 3 (19%), cephalosporin in 2 (13%), and cotrimoxazole, macrolide and lactose in 1 each. Conclusion: DPT seems a safe and useful procedure to confirm causative drug and identify safely administering alternative drugs in children with ADR.

• Korean Journal of Clinical Pharmacy
• /
• v.17 no.1
• /
• pp.46-51
• /
• 2007

This study was aimed to provide the controlled terminology for adverse drug reactions by selecting an appropriate internationally standardized classifications (WHO-ART or MedDRA). We collected the relevant information on ADR terminology systems including WHO-ART and MedDRA by online searching and visiting pharmaceutical companies and WHO UMC (Uppsala Monitoring Centre, Uppsala, Sweden). For MedDRA, project leader directly communicated with the officer of MSSO (Maintenance and Support Services Organization). Collecting all the pertinent information, two possible terminology classifications or systems (WHO-ART and MedDRA) were compared in the views of acceptability, cost-effectiveness and international feasibility and reviewed by the consultation committee and finally WHO-ART was selected.

• Korean Journal of Clinical Pharmacy
• /
• v.28 no.2
• /
• pp.154-157
• /
• 2018

Levosulpiride is one of the most frequently prescribed medicines in Korea. An adverse drug reaction (ADR) after taking levosulpiride was reported at a community pharmacy in Korea. A 31-year-old woman reported the symptoms of lactation and amenorrhea after taking levosulpiride; an evaluation of whether these symptoms were caused by the medication was therefore necessary. Several tools can be used to determine if the ADR resulted from the administered drug or other factors, including the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, the Naranjo scale, and the Korean causality assessment algorithm (Ver. 2). The causality was evaluated as "possible" by the WHO-UMC and Naranjo scales, but as "probable" by the Korean causality assessment algorithm (Ver. 2). In conclusion, the information provided did not indicate definite causality and there were slight differences in the results obtained from each assessment method.

• Journal of Preventive Medicine and Public Health
• /
• v.40 no.4
• /
• pp.278-284
• /
• 2007

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.