• Korean Journal of Clinical Pharmacy
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• v.24 no.1
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• pp.39-44
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• 2014

Purpose: To investigate adverse drug reactions (ADR) and causative drugs in the elderly 65 years of age or older, using Korean spontaneous reporting adverse events reporting database from June 2009 to December 2010. Methods: We estimated the association between ADRs and implicated medications by calculating a proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We reexamined the most frequently implicated medications and ADRs, and the seriousness of ADRs. Then, we assessed reports and concordant rate of ADRs due to medications designated as "high-risk" in elderly by 2012 healthcare effectiveness data and information set (HEDIS) or "potentially inappropriate" by 2012 American Geriatrics Society updated Beers criteria for potentially inappropriate medications (PIMs). Results: Among 15,484 elderly reports, data-mining analysis by PRR, ROR and IC showed that 421 drug-ADR pairs were detected as signals (3,189). The most frequently reported ADR and causative drug were urticaria (470) and contrast media agents (647), respectively. One hundred eighty nine ADR cases were graded as serious. Twenty-two kinds of high-risk medications were shown to be implicated in only 0.9% of ADRs. Only thirty-nine cases were consistent with 2012 Beers criteria or HEDIS. Conclusion: These results suggest that management of the other medications including contrast media agents as well as close monitoring of PIMs are necessary for reducing ADRs in the elderly.

• Korean Journal of Clinical Pharmacy
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• v.27 no.3
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• pp.143-149
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• 2017

Background: L-asparaginase (L-ASP) is a critical agent for the treatment of acute lymphoblastic leukemia and lymphoma, which is associated with serious toxicities including hypersensitivity, pancreatitis and thrombosis. Methods: To evaluate the toxicity of L-ASP in real clinical settings, we included the patients with L-ASP adverse drug reactions (ADRs) reported in a regional pharmacovigilance center of Seoul St. Mary's hospital from January 2014 to December 2015. Results: A total of 83 cases of L-ASP related ADRs were reported in 54 patients. Of these 83 cases, 65 cases (78.3%, 65/83) were spontaneously reported and 18 cases (21.7%, 18/83) were detected by further medical records review. Of the patients with ADRs, pediatric patients accounted for 83.3% of the cases (45/54) and median age was 9 years. The most common clinical manifestations of ADRs were hematology manifestations (31.3%, 26/83), followed by hepatobiliary manifestations (18.1%, 15/83). Thirty-four serious ADRs were reported in 19 patients. The sserious ADR group showed significantly longer hospitalization and higher rate of discontinuation of L-ASP than the non-serious ADR group (p = 0.005, 0.03). The most common clinical manifestations of serious ADRs were hepatobiliary manifestations (41.2%, 14/34). In total, 8 cases (9.6%, 8/83) of unlabeled ADRs were identified. They were serious ADRs. Conclusion: We identified unlabeled serious ADRs of L-ASP. Also, correlations were observed between serious ADRs and length of hospitalization, discontinuation rate respectively. Further investigations and developed spontaneous ADR reporting systems are needed to evaluate these correlations.

• 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.

• The Korean Journal of Emergency Medical Services
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• v.8 no.1
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• pp.149-160
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• 2004

Background : To save out-of-hospital cardiac arrest cases is a major concern for Korea. Cardiac arrest is a very common problem, with > 18,000 cases dying each year in Korea. Overall, survival to hospital discharge remains poor. Resuscitation has become an important multidisciplinary branch of medicine, demanding a spectrum of skills and attracting a plethora of specialities and organizations. Since the "Utstein Style" was advocated in 1991, many reports about out-of-hospital cardiac arrest have been published based on this guideline. These differences prevent valid inter-hospital and international comparisons. However, we do not know the true effectiveness of resuscitation. There are no guideline for reviewing, reporting, conducting research on resuscitation in Korea. This study evaluated the out-of-hospital factor associated with survival discharge of out-of-hospital cardiac arrest, was especially to provide basic data for the unified reporting guideline of resuscitation in Korea. Methods : From January 1990 to July 2004, we collected data about out-of-hospital cardiac arrest at Wonju Christian Hospital(WCH-CAD), Ewha Women University Mokdong Hospital(Ewha-CAD), I used same record form based on the "Utstein Style". The "Utstein Style" is internationally recommended guidelines for reporting outcome data from resuscitation events. Results : Resuscitation was performed in 1443 out-of-hospital cardiac arrest patients at 2 hospitals. Five hundred eighty(40.25%) patients recovered the spontaneous circulation at least once and One hundred sixty eight(11.66%) patients discharged alive. Initial EKG showed Ventricular Tachycardia/Ventricular Fibrillation in One hundred thirty five(9.33%) patients, asystole in one thousand nine(69.73%) patients and other rhythms in one hundred thirty nine(20.94%) patients. Among one hundred two cardiogenic cardiac arrest patients, two(2.0%) patients was discharged alive. Conclusion : Overall survival rate of out-of-hospital cardiac arrest patients was 11.66% which was poorer than that of the western country. The proportion of the cardiogenic cause was 33.38% which was only half of the western country. VT/VF is relatively not common ac a initial EKG rhythm. These differences might be to due difference in the prevalence pattern of out-of-hospital cardiac arrest as well as prematurity of the EMSS. It is needed that the best survival can be achieved if all following links have been optimized : rapid access, early CPR, early defibrillation, early ACLS.

• YAKHAK HOEJI
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• v.50 no.3
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• Journal of Preventive Medicine and Public Health
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• v.23 no.2 s.30
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• pp.216-223
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• 1990

To identify the factors influencing the charges per case of acute appendicitis and normal spontaneous vaginal delivery (NSVD), the personal data-base files and hospital-characteristics-reporting data files of Korea Medical Insurance Corporation were analyzed. One hundred and twenty-nine institutions were selected. The results of this study were as follows 1. The differences of charges per case with respect to hospital ownership, location, and equipment levels were statistically significant. 2. The results of multiple regression analysis revealed that bed capacity was the most significant variable in both diseases. 3. Ownership was significant variable in acute appendicitis. In NSVD, ownership and hospital equipment level were statistically significant. In conclusion, bed capacity was statistically the most significant variable in the analysis of charages per case. And we thought that the results of this study would influence the policy of the hospital bed supply.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.172-180
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• 2016

Background: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. Methods: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). Results: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. Conclusion: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.

• 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.

• Archives of Plastic Surgery
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• v.49 no.5
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• pp.617-632
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• 2022

Tracheoesophageal puncture (TEP) and voice prosthesis insertion following laryngectomy may fail to form an adequate seal. When spontaneous closure of the fistula tract does not occur after conservative measures, surgical closure is required. The purpose of this study was to summarize the available evidence on surgical methods for TEP site closure. A comprehensive search across PubMed, Web of Science, SCOPUS, and Cochrane was performed to identify studies describing surgical techniques, outcomes, and complications for TEP closure. We evaluated the rate of unsuccessful TEP closure after surgical management. A meta-analysis with a random-effect method was performed. Thirty-four studies reporting on 144 patients satisfied inclusion criteria. The overall incidence of an unsuccessful TEP surgical closure was 6% (95% confidence interval [CI] 1-13%). Subgroup analysis showed an unsuccessful TEP closure rate for silicone button of 8% (95% CI < 1-43%), 7% (95% CI < 1-34%) for dermal graft interposition, < 1% (95% CI < 1-37%) for radial forearm free flap, < 1% (95% CI < 1-52%) for ligation of the fistula, 17% (95% CI < 1-64%) for interposition of a deltopectoral flap, 9% (95% CI < 1-28%) for primary closure, and 2% (95% CI < 1-20%) for interposition of a sternocleidomastoid muscle flap. Critical assessment of the reconstructive modality should take into consideration previous history of surgery or radiotherapy. Nonirradiated fields and small defects may benefit from fistula excision and tracheal and esophageal multilayer closure. In cases of previous radiotherapy, local flaps or free tissue transfer yield high successful TEP closure rates. Depending on the defect size, sternocleidomastoid muscle flap or fasciocutaneous free flaps are optimal alternatives.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.33 no.1
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• pp.60-69
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• 2023

Objectives: Business operators handling hazardous chemicals regulated under the Chemical Substances Control Act (CSCA) must receive permits to operate their business from the Ministry of Environment. This study analyzed the status of recent legal violation in chemical handling workplaces in Ulsan where a large volume of chemicals is handled for industrial use. Methods: A total of 557 corporations have been granted legal status as business operators in Ulsan. For all business operators, legal violations in regard to the CSCA that were discovered by the environmental office in the last five years (2018~2022) were thoroughly analyzed. Results: A total of 225 violations of the CSCA have been discovered at 165 corporations, with the violation rate accounting for approximately 27% of all business operators. In particular, 22% of the 165 violators (36 corporations) were discovered to have violated twice or more, and some business operators (6%) even violated in consecutive years. Non-compliance of facility inspection was the most frequent violation (45 cases, 20.1%), followed by non-reporting of important changes in the permitted matters (23 cases, 10.3%), non-completion of legal safety education (19 cases, 8.5%), failure to secure permission for modification in the permitted matters (18 cases, 8.0%), and failure to submit chemical transport plans (16 cases, 7.1%). Conclusions: Most of the violations could have been prevented if the field personnel had paid sufficient attention. Thus, it is fundamentally necessary to create an environment for spontaneous safety management for themselves and to strengthen individual capabilities.