• Quality Improvement in Health Care
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• v.1 no.1
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• pp.32-43
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• 1994

The 'Pharmacy and Therapeutic Committee' decided to restrict the use of vancomycin which was categorized into restricted antimicrobials, among general, reserved and restricted antimicrobials. The committee also established prescribing guidelines of vancomycin in Seoul National University Hospital, May, 1991. Especially, the restricted antimicrobials should be used after approval by infectious disease specialist physician. A retrospective drug use evaluation (DUE) on vancomycin has been conducted to compare with the previous vancomycin DUE study in 1990. 'Criteria for DUE on vancomycin' was modified from Am J Hosp Pharm. Total 65 charts of patients were retrospectively reviewed from July 1991 to June 1992 in Seoul National University Children's Hospital. The justification of use was improved from 56% to 75% comparing with the previous study. In analyzing process indicators, several criteria including body temperature monitoring, WBC monitoring and use of concomitant antibiotics were well documented, but serum creatinine monitoring, culture and sensitivity test and level monitoring were infrequently performed, while the accepted level has been improved. Accepted level for appropriate initial dosage and duration of therapy were decreased. In outcome analysis, blood culture after discontinuing the drug was relatively well documented compared with the previous study. As the results, the approval vancomycin use was shown to be effective and rational in antibiotic therapy. And it is suggested that the above findings should be communicated to the medical staff, and a active intervention, such as feedback control, also be necessary for rational drug use.

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.272.2-273
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• 2002

The safety of blood and blood products is ensured by careful selection of donors. screening of donated blood and the use of validated viral inactivation and/or removal steps during the manufacture of blood products. Serologic screening procedures have substantially reduces the risk of transmission of blood-bone viruses. However, there are still residual risks despite these measures due to the inclusion of 'window period'donations. (omitted)

• Korean Journal of Clinical Pharmacy
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• v.19 no.2
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• pp.105-109
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• 2009

In July 2008, The National Police Hospital has developed the CPOE system(Computerized Physician Order Entry system) which links the medicine master and introduced the new program for the injectable antimicrobial agents. After introducing new system, we wanted to check the management of oral antimicrobial agents. Because new system has limitation that new system control only the use of the injectable antimicrobial agents. So we tried to evaluate the use of oral levofloxacin, which was chosen by a medical specialist of the infection. We retrospectively analyzed the appropriateness of oral levofloxacin through EMR(Electric Medical Record) of 72 inpatients who received oral levofloxacin in National Police Hospital in December 2008. We applied the modified ASHP(American Society of Health- System Pharmacists) DUE(Drug Use Evaluation) criteria, which is composed of justification of drug use, critical indicators, complications and outcome measures. Acceptable cases of use of levofloxacin were 67(93.01%) and 57cases(79.2%) showed good outcome. However critical indicators were not performed very well. We want to suggest the new system for the management of the medical therapeutics by the pharmacist in charge.

• Korean Journal of Environmental Agriculture
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• v.41 no.4
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• pp.261-275
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• 2022

BACKGROUND: Prior to implementing a positive list system (PLS), there is a need to establish acceptable daily intake (ADI) and maximum residue limit (MRL) for veterinary drugs that have been approved a few decades ago in South Korea. On top of that, chronic dietary exposure assessment of veterinary drug residues should be performed to determine whether the use of these veterinary drugs would cause health concerns or not. METHODS AND RESULTS: To establish the ADI, the relevant toxicological data were collected from evaluation reports issued by international organizations. A slightly modified global estimate of chronic dietary exposure (GECDE) model was employed in the exposure assessment owing to the limited residual data. Therefore, only the ADI of ephedrine was established due to insufficient data for the other veterinary drugs. Thus, instead of ADI, the threshold of toxicological concern (TTC) value was used for the other drugs. Lastly, the hazard index (HI) was calculated, except for etizazole hydrochloride, due to the potential of mutagenicity. CONCLUSION(S): The HI values of ephedrine, menichlopholan, and anacolin were found to be as high as 6.4%, suggesting that chronic dietary exposure to the residues from these uses was unlikely to be a public health concern. Further research for exposure assessment of veterinary drug residues should be performed using up-todate Korean national health and nutrition examination survey (KNHANES) food consumption data. In addition, all relevant available data sources should be utilized for identifying the potentials of toxicity.

• Korean Journal of Clinical Pharmacy
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• v.9 no.1
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• pp.35-43
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• 1999

Over the last 50 years, a number of antibiotic agents have been developed and clinically used in the area of infectious diseases. Due to antimicrobial resistance problems and increasing health care costs, the rational use of antibiotics has been required. As a drug of choice to treat infections caused by MRSA, vancomycin has been extensively prescribed since the late 1970's. Recently, reports of vancomycin-resistant organisms such as VRE and VRSA have been increased to draw medical concerns. The objectives of this study were to evaluate the rational use of vancomycin and the appropriateness of the Restrictional Program of Antibiotic Utilization (RPAU) which has been operated at Samsung Medical Center. A retrospective chart review was performed in 132 hospitalized patients treated with vancomycin in the surgery departments from. January to June 1998. The guidelines of ASHP and HICPAC for vancomycin were modified and used as our criteria to determine the vancomycin DUE. In one hundred out of the patients, uses of vancomycin were approved by the Department of Infectious Diseases (DID) based on the RPAU. Vancomycin was appropriately used in $62.5\%$ of the 100 patients according to the criteria of justification of use, while $60.0\%,\;60.0\%,\;79.0\%,\;and\;51.0\%$ of the patients showed appropriate according to those of lab reports such as applicable culture obtained, pretreatment SCr, WBC and serum drug concentration monitoring, respectively. Although the rest 32 patients were not approved to receive vancomycin by the DID, twenty two percent continued receiving vancomycin treatment. This might result from the fact that the RPAU was started not before the use of antibiotics but in the middle of antimicrobial therapy. Continual education should be provide to the related health professionals and the RPAU should be simultaneously modified in order to increase the rate of appropriate uses of antibiotics.

• Quality Improvement in Health Care
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• v.1 no.1
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• pp.44-54
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• 1994

A drug use evaluation (DUE) program has been defined as an "authorized a quality assurance process designed to ensure that drugs are used appropriately, safely, and effectively". A retrospective DUE study on ceftazidime has been conducted by reviewing patients charts following criteria for drug use evaluation established by Am.S.Hosp.Pharm. Total 60 charts of patient treated with ceftazidime in Seoul National University Hospital from Jan. 1.1993 to July.31.1993 were retrospectively reviewed. As a result, 44 cases(73%) were met with the criteria for the justification of use. In analysing process indicators including culture and sensitivity test, CBC, LFT, history of anaphylaxis monitoring before initial dose, vital sign monitoring were relatively well documented showing the accepted level above 80%, while appropriated dose were infrequently documented with low accepted level. In outcome analysis, blood culture after discontinuing drug were rarely documented, with accepted level of 46%. For using effectively and safely, ceftazidime is recommended to be administrated to optimal indication, and monitored actively for preventing adverse effect.

• Design & Manufacturing
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• v.14 no.3
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• pp.57-62
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• 2020

In the drug delivery system industry, the technology with even split injection becomes important for maximizing efficiency and minimizing the side effects. In conventional drug delivery system, infection can occur due to pain and splashing. Also, various applications are impossible due to disposable use, and it is the reason to avoid to use this system because of the complexity of the driving method. Therefore, in this study, a painless drug delivery device is developed for non-pain with electrical insulation breakdown method. Finite elements analysis was used to evaluate the ejection characteristics of drugs according to the shape of the micro ejection nozzle. The effect of the number of holes in the micro nozzle, the length of the nozzle and the inner shape of the nozzle on the drug discharge characteristics were analyzed.

• Food Science of Animal Resources
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• v.44 no.4
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• pp.873-884
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• 2024

Flunixin is a veterinary nonsteroidal anti-inflammatory agent whose residues have been investigated in their original form within tissues such as muscle and liver. However, flunixin remains in milk as a metabolite, and 5-hydroxy flunixin has been used as the primary marker for its surveillance. This study aimed to develop a quantitative method for detecting flunixin and 5-hydroxy flunixin in milk and to strengthen the monitoring system by applying to other livestock and fishery products. Two different methods were compared, and the target compounds were extracted from milk using an organic solvent, purified with C₁₈, concentrated, and reconstituted using a methanol-based solvent. Following filtering, the final sample was analyzed using liquid chromatography-tandem mass spectrometry. Method 1 is environmentally friendly due to the low use of reagents and is based on a multi-residue, multi-class analysis method approved by the Ministry of Food and Drug Safety. The accuracy and precision of both methods were 84.6%-115% and 0.7%-9.3%, respectively. Owing to the low matrix effect in milk and its convenience, Method 1 was evaluated for other matrices (beef, chicken, egg, flatfish, and shrimp) and its recovery and coefficient of variation are sufficient according to the Codex criteria (CAC/GL 71-2009). The limits of detection and quantification were 2-8 and 5-27 ㎍/kg for flunixin and 2-10 and 6-33 ㎍/kg for 5-hydroxy flunixin, respectively. This study can be used as a monitoring method for a positive list system that regulates veterinary drug residues for all livestock and fisheries products.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.300.1-300.1
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• 2003

Salmon calcitonin (sCT) is a therapeutic polypeptide hormone consisting of 32 amino acids (3432 Da). As with other bioactive peptide therapeutics, however, therapeutic use of sCT has been limited due to the problems of short circulating half-life and rapid proteolytic degradation. To get over this problem, the three positional isomers of mono-PEGylated sCT were prepared and among these, the best drug candiate for nasal application was chosen. (omitted)

• Journal of Biomedical Engineering Research
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• v.31 no.4
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• pp.280-284
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• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.