• Korean Journal of Veterinary Research
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• v.38 no.3
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• pp.544-552
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• 1998

A random study of 574 dairy farms in Gyeongnam area was designed to determine 1) management factors that may be associated with the occurrence of drug residues; 2) the dairy farmer's attitudes and knowledge about residues; 3) how these variables influence the occurrence of residues in dairy cattle. Management factors perceived as having the greatest influence on drug residues in milk were insufficient knowledge about withdrawal periods, errors due to hired help, insufficient identification and record of animals treated for mastitis, dry cow treatment for mastitis, and metritis treatment. Seventy-one percent of farms with residues problem used mixed own feeds compared with twenty-nine percent of farms with premedicated feeds. Factors significantly associated with the occurrence of residues were herd size, increased number of hired persons, increased frequency of use of mixed-own feeds, category of medicated feed, and producer's attitude toward the public health significance of residues. Our findings suggest that residue occurrence was mainly associated with errors due to hired help, insufficient knowledge about withdrawal periods, poor animal identification and records of treatment animals and use of medicated feeds. Any residue avodiance educational program needs to stress how to deal with these factors. This educational program should be directed to dairy farmers and employees, especially temporary employees. In addition, Dairy farmer's attitudes and knowledge about drug residues need to be improved. More evidence on the public healths significance of residues should be available to them. Because belife in importance of public healths concerns was related to successful residue avidance and because 81.3% of the dairy farmers with residue problem thought public healths concerns were less important than economic ones, it would be helpful to provide educational programs specifically directed to this issue. it may be useful to provide programs not only for the dairy farmers but also change of their concerns about on the public healths.

• YAKHAK HOEJI
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• v.54 no.6
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• pp.455-460
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• 2010

We evaluated the inappropriateness of metformin use in patients with type 2 diabetes and chronic medical conditions to identify the frequency of the prescription metformin in violation of the food and drug administration (FDA) black box warning. We reviewed medical records of 307 outpatients who received metformin at endocrinology department in a hospital setting between January 1, 2005 and August 30, 2009. Of the 307 outpatients, 25 discontinued treatment of metformin due to elevated serum creatinine level (Scr${\geq}$1.5 mg/dl in male, Scr${\geq}$1.4 mg/dl in female), cancers, and/or liver disease. 5 were lost to follow-up. 89 (29.0%) of the patients had cardiovascular disease, 54.1% for hypertension, 9.8% for liver disease, and 60 (20.8%) for chronic kidney disease. 12 patients (3.9%) with chronic kidney disease and/or elevated serum creatinine level, and 1 patient (0.3%) with lactic acidosis were contraindicated to metformin use. Metformin should be avoided in 7 outpatients (2.3%) with active hepatitis and 1 patient (2.6%) with liver cirrhosis. Of the 307 outpatients, 13 (4.2%) patients who received metformin at the first visit and 16 (8.7%) patients who received metformin at the last visit violated to black box warning. 8 (2.6%) of the patients were in precautionary conditions to metformin use. Adjusted mean difference of serum creatinine was -0.16 mg/dl [95% CI: -0.22 to -0.11 (p<0.05)] and adjusted mean difference of alanine aminotransferase was 4.46 IU/l [95% CI: 2.47 to 6.44 (p<0.05)] between the first visit and the last visit. Critical number of elderly patients who are at the high risks of drug-disease and drug-laboratory interaction is exposed to the inappropriate metformin use in violation of black box warning. The periodic evaluation of metformin use and monitoring prescription through drug utility review (DUR) system is needed to improve patients' safety and to reduce adverse drug events.

• Tuberculosis and Respiratory Diseases
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• v.83 no.3
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• pp.218-227
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• 2020

Background: The national Public-Private Mix (PPM) tuberculosis (TB) control project provides for the comprehensive management of TB patients at private hospitals in South Korea. Surveillance and monitoring of TB under the PPM project are essential toward achieving TB elimination goals. Methods: TB is a nationally notifiable disease in South Korea and is monitored using the surveillance system. The Korea Centers for Disease Control and Prevention quarterly generates monitoring indicators for TB management, used to evaluate activities of the PPM hospitals by the central steering committee of the national PPM TB control project. Based on the notification date, TB patients at PPM hospitals were enrolled in each quarter, forming a cohort, and followed up for at least 12 months to identify treatment outcomes. This report analyzed the dataset of cohorts the first quarter of 2016 through the fourth quarter of 2017. Results: The coverage of sputum, smear, and culture tests among the pulmonary TB cases were 92.8% and 91.5%, respectively. The percentage of positive sputum smear and culture test results were 30.7% and 61.5%, respectively. The coverage of drug susceptibility tests among the culture-confirmed cases was 92.8%. The treatment success rate among the smear-positive drug-susceptible cases was 83.2%. The coverage of latent TB infection treatment among the childhood TB contacts was significantly higher than that among the adult contacts (85.6% vs. 56.0%, p=0.001). Conclusion: This is the first official report to analyze monitoring indicators, describing the current status of the national PPM TB control project. To sustain its effect, strengthening the monitoring and evaluation systems is essential.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• Korean Journal of Clinical Pharmacy
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• v.26 no.4
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• pp.306-311
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• 2016

Objective: This study was performed to compare the changes in the blood concentrations of tacrolimus when either itraconazole or voriconazole is together with tacrolimus to prevent or treat invasive aspergillus pneumonia (IAP) in patients with lung transplants. Therefore we can compare the degree of drug-drug interactions between tacrolimus and itraconazole against tacrolimus and voriconazole. Methods: Patients who were admitted and had lung transplants in a territory referral hospital from September 2012 to May 2015 were analyzed retrospectively. The effects of itraconazole and voriconazole on the plasma concentrations of tacrolimus were analyzed. Results: Mean tacrolimus concentrations was $10.49{\pm}2.35ng/mL$ vs. $10.95{\pm}2.98ng/mL$ (p=0.722), and mean concentration of tacrolimus over the dose of tacrolimus per day was $8.510{\pm}5.890(ng/mL)/(mg/d)$ vs. $15.45{\pm}28.47(ng/mL)/(mg/d)$ (p=0.947) in itraconazole vs. voriconazole group each. The ratio of the number of the results out of target tacrolimus concentrations to the total number of tacrolimus concentration results was $18.0{\pm}13.3%$ vs. $24.4{\pm}18.5%$ (p=0.185). Conclusion: There were no significant differences between itraconzaole and voriconazole to have influences on mean concentrations of tacrolimus over tacrolimus dose per weight per day. However voriconazole tended to raise tacrolimus plasma concentrations more than itraconazole. Safer and more effective drug management to prevent and treat fungal infections should be done by therapeutic drug monitoring not only of tacrolimus but of itraconazole and voriconazole in lung transplant patients.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.55-61
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• 2020

Recently, there have been many research on fever management using u-healthcare technology. Especially, fever of infants requires continuous monitoring of body temperature by parents. For infants between 4 weeks and under 5 years old, it is recommended to use an electronic thermometer or chemical thermometer in the axilla, or to use an infrared thermometer. However, in order to overcome the reality of not being able to waste significant time on continuous monitoring, there have been demands of patch type thermometers with the internet of things (IoT) and wireless communication technologies. Existing IoT thermometers are difficult to attach to infants' body because they do not take into account its size, and their interoperability is not guaranteed because they do not comply with standards in communication. Therefore, in this study, a patch-type thermometer with a diameter of 20 mm and a weight of 2.9 g was developed to manage the fever of infants, while it communicates wirelessly with Bluetooth Low Energy (BLE) communication protocol and complies with IEEE 11073 PHD(Personal Health Device) at the same time. We verified its performance under the requirements of thermometers regulated by the Korean Ministry of Food and Drug Safety.

• Korean journal of food and cookery science
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• v.19 no.1
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• pp.24-33
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• 2003

The purpose of the study was to investigate the HACCP systems of contract foodservice establishments by surveying HACCP plans and prerequisite programs from the twelve HACCP-implemented contract foodservice establishments appointed by KFDA. All the subjects (100%) appeared to develop HACCP plans with their own hazard analysis. Except the two giving no response, it turned out that two establishments had 2 CCPs (20%), four had 4∼5 CCPs (40%) and another four had 9 CCPs (40%). Especially, 'cleaning and sanitizing of raw vegetables and fruits (90%)' and 'cooking (temperature) (100%)' were monitored as CCPs by all the subjects. Only one subject (8.3%) answered that continuous monitoring was not conducted. But the verification, record keeping and internal audits were maintained by all the subjects (100%). Most of the surveyed foodservice establishments maintained various prerequisite programs enough to back up HACCP system.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• Korean Journal of Clinical Pharmacy
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• v.8 no.1
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• pp.35-46
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• 1998

A retrospective study was conducted to evaluate the appropriateness of total parenteral nutrition (TPN) for 200 hospitalized adult patients in Samsung Medical Center from January 1st in 1995 to June 31st in 1997. Standard criteria were modified and determined from those stated by AJHP (American Journal of Health System Pharmacy) and ASPEN (American Society of Parenteral and Enteral Nutrition). The justification for indications was appropriate in $35\%,\;44\%,\;and\;32\%$ of the patient's in 1995, 1996, and 1997, respectively, without significant improvement over the last two and half years. Before and during the administration of TPN, several monitoring indicators were well documented, and monitoring frequencies were increased over two and half years period. However, the majority of the monitoring indicators were not found in the standard criteria range of $90\%$. The monitoring indicators for electrolyte balance, $PO_4$ and Mg, were not measured appropriately and resulted in the complications which could have been prevented. The indicator for lipid tolerance, triglyceride and the indicator for hemorrhagic incidence, prothrombin time (PT), were not well documented in comparison with other indicators. The indicators for the improvement in nutritional status, albumin and total protein, were appropriate in $90\%$ of the patients. Determination of TPN formula was based on the laboratory data and chart reviews, and it was appropriate in $98\%$. But the administration of lipid and vitamin K for the prevention of essential fatty acid deficiency and hemorrhage, respectively, was not carried out appropriately when the administration of TPN was prolonged, lasting more than 7 days. When a patient returned to oral or enteral feeding, TPN was terminated. However, increase in albumin level or weight was rarely observed. In conclusion, healthcare professionals should all work as a team and active participation to provide optimized nutrition support for partners.

• Journal of Food Hygiene and Safety
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• v.23 no.3
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• pp.257-263
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• 2008

As Standards and Specifications of the Saengsik-classes has been established since 2005 by KFDA. The microbial Standards and Specifications of the Saengsik-classes is as follows; no detection in Escherichia coli, colony forming unit less then 1,000/g in Bacillus cereus, colony forming unit less then 100/g in Clostridium perfringens respectively. Contamination levels of Total aerobic bacteria, Escherichia coli, Bacillus cereus and Clostridium perfringens in Saengsik-classes were monitored. Total aerobic bacteria counts in Saengsik-classes was $1{\times}10^1{\sim}5.3{\times}10^7cfu/g$, for Bacillus cereus $1{\times}10^2{\sim}9{\times}10^2cfu/g$, for Clostridium perfringens $1{\times}10^1cfu/g$. Escherichia coli, was not isolated from all Saengsik-classes. Thess results will provide information for introduction of HACCP system to ensure microbial safety of Saengsik-classes.