• 한국임상약학회지
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• 제26권2호
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• pp.121-127
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• 2016

Objective: Until now, there is minimal number of research for overall domestic status of orphan drug use in Korea. The purpose of this study is to identify the list of orphan drugs available in Korea and to understand the status of orphan drug usage in tertiary Hospitals and rare incurable disease Hospital. Methods: We made domestic orphan drug lists based on available orphan drugs in Korea. Based on this lists, we conducted e-mail survey from August, 2014 to September, 2014 to identify domestic status of orphan drug usage including the availability and management of orphan drugs. Results: There are three hundred and eighteen orphan drugs (184 ingredients) registered in Ministry of Food and Drug Safety. Among the three hundred and eighteen orphan drugs, Two hundred and twenty-eight drugs (102 ingredients) were selected. Information on each item was collected and documented with generic and brand names, manufacturers, wholesalers, indications, FDA approval status and insurance coverage. Forty-three tertiary hospitals and thirty-two rare incurable hospitals responded to the survey questionnaire (57.3%). According to the survey result, the antineoplastics and immunomodulating agents group has the highest percentage (40%) usage in the hospital. Of fortythree tertiary hospitals, thirteen hospitals manage orphan drugs separately (30.2%). Based on the reply, most of the healthcare professionals commented the drug information related to efficacy and safety including medication counseling of orphan drugs is insufficient. Conclusion: Through this study we anticipate providing an understanding of orphan drug usage status in Korea. We found the limited resources to the information on orphan drugs and this information requires updating on a regular basis. This can be the basis for further studies about preparing drug information, educational resources for rare disease patients.

• 한국임상약학회지
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• 제24권1호
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• pp.26-32
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• 2014

Purpose: The aim of this study was to investigate drug prescription patterns for the treatment of asthma and chronic obstructive pulmonary disease (COPD) patients in Korea. Methods: Ambulatory adult patients who were diagnosed and received treatment for the asthma (ICD-10 code J45) or COPD (ICD-10 code J44) from January 2009 to September 2011 in two independent secondary hospitals in Korea were enrolled in this study. Prescribed drug lists were generated based on the evidence-based guidelines and prescribed drug dosage forms were identified from the patient medical records and computerized drug prescription databases of the study centers. Results: Total numbers of asthma and COPD patient enrolled in this study were 2,432 and 2,615, respectively. Individual prescription-based accumulated numbers of patient were 12,021 for asthma and 16,584 for COPD. The most commonly prescribed three drugs were oral predisolone, oral formoterol and oral montelukast for asthma and oral formoterol, oral doxofylline and inhaled tiotropium for COPD. Frequencies of oral drugs were 83.4% and 63.3% while inhalers were 16.4% and 30.2%, for asthma and COPD, respectively. Conclusion: The oral treatment was prescribed more in asthma and COPD patients than inhalers. To enhance the compliance of evidence-based guidelines for these chronic airway diseases, more realistic and specific strategies to increase the use of inhalers recommended as primary treatment options for asthma and COPD would be required.

• 한국임상약학회지
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• 제24권1호
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• pp.15-25
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• 2014

Background: Elderly patients with gastrointestinal (GI) and cardiovascular (CV) risk factors may be more easily exposed to NSAID-related side effects (SEs). Based on the ACG guideline of year 2009, the aim of the study is to evaluate proper use of NSAIDs and gastroprotective drugs according to the degree of GI and CV risk strengths in the patients. Methods: Retrospectively surveyed 410 elderly patients with NSAIDs for more than 30 days at a general hospital in Korea. GI risk factor includes age, ulcer history, high-dose NSIADs, concurrent aspirin use, steroids or anticoagulants. CV risk factor includes angina, myocardial infarction, cerebral infarction, atrial fibrillation or coronary intervention requiring low-dose aspirin. These factors were classified as high/low cardiovascular groups and high/moderate/low GI groups. Results: There were 14 patients in high CV risk group and high GI risk group. The group was recommended not to use NSAIDs as it is not adequate. There were 101 patients in high CV risk group and moderate GI risk group. This group was recommended to use naproxen and PPI/misoprostol. But all patients except one were not adequate. There were 9 patients in low CV risk group and high GI risk group. This group was recommended to use selective COX-2 inhibitor and PPI/misoprostol. 5 cases were proper while 4 cases did not. There were 285 patients in low CV risk and moderate GI risk group who were recommended to use non selective NSAIDs and PPI/misoprostol or selective COX-2 inhibitor only. 103 patients were proper while 182 patients not adequate. Overall, the SEs were higher in those cases for inadequate use of drugs comparing to the adequate. CV SEs were statistically significant. However, SEs for each risk groups were different. For the case of low CV risk group and high/moderate GI risk group, the inadequate use of drugs makes the SE high and the other groups are not. Also, it was not statistically significant. Conclusions: In elderly patients, the inappropriate use of NSAIDs can increase the risk of the disease. Therefore, GI and CV risk must be considered simultaneously, and the proper use of NSAIDs and gastroprotective drugs for each risk groups should be reconsidered.

• 한국임상약학회지
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• 제24권1호
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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.

• 한국임상약학회지
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• 제24권1호
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• pp.9-14
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• 2014

Background: It is known to reduce the mortality when glutamine is supplied to patients during the surgery or in intensive care unit through intravenous nutrition supply. The purpose of this study is to establish the appropriate basis for use of glutamine and guidelines of nutrition supply for critically ill patients in the hospital by examining the clinical effects of administration of glutamine with subjects of elderly critically ill patients receiving intravenous nutrition in one hospital in Korea. Method: Among elderly patients with age of 60 or more hospitalized in Yeuido St. Mary's Hospital from August 2012 to July 2013, those who stayed in the intensive care unit for more than a week and received TPN (Total Parenteral Nutrition) for more than 3 days during staying in the intensive care unit were classified to a test group using glutamine and a control group without glutamine. Duration of use of mechanical ventilator, duration of hospitalization, occurrence of infectious disease and death were compared between two groups. We would like to identify the clinical test figures affected by the use of glutamine by examining changes in SCr, Total Protein, Albumin, AST, ALT, TB, DB and GFR at the time of admission and discharge. Results: At the time of admission to intensive care unit, gender, physical measurement information and clinical test figures did not show any significant difference between 72 subjects in a test group and 24 subjects in a control group. Thus, two groups began in the same condition. There were no significant difference in duration of hospitalization, duration of intensive care unit, use of mechanical ventilator, occurrence of infectious disease and death. As the results of statistical analysis of the average changes of clinical test figures at the time of admission and discharge of intensive care unit, SCr and GFR were significantly changed in the test group. GFR was significantly changed in a control group. As the result of analysis of the clinical test figures at the time of discharge with reflection of average changes after clinical test figures were corrected at the time of admission of intensive care unit, TB and GFR were significantly increased in a test group compared with those in a control group. Other clinical test figures were not significantly changed. Conclusion: If glutamine is administered to critically ill patients over age 60 receiving TPN and careful monitoring for total bilirubin is made in the future, it is expected to give the positive effect on renal function andminimize the side effect of arise in total bilirubin.

• 한국임상약학회지
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• 제24권1호
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• pp.33-38
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• 2014

Background: Diabetes is accompanied by complications. One of the chronic complications, diabetic retinopathy is the most common cause of the loss of eyesight and thus has enormous impacts on the quality of life to the patients. It has been reported that thorough glucose regulation can prevent or postpone the outset of diabetic retinopathy in diabetic patients and that the patients who received anti-diabetic manage & care education would be capable of more thorough glucose-level regulation than those who did not. Method: This study set out to investigate the current state of education on anti-diabetic manage & care in South Korea and connections between anti-diabetic manage & care education and occurrence of diabetic retinopathy in diabetic patients based on the Korea National Health and Nutrition Examination Survey of 2011. Results: Of the 410 diabetes patients, 74 received anti-diabetic manage & care education, which means that only 15% of diabetic patients benefited from the education in the nation. The occurrence rate of diabetic retinopathy was 28% in the education group and 24% in the non-education group with no significant differences between them. The anti-diabetic manage & care education group recorded a higher occurrence rate of diabetic retinopathy, one of the chronic diabetic complications, than the non-education group contrary to the hypothesis. One of the reasons was that the educated group had a significantly longer duration of diabetes and significantly higher HbA1c than the noneducated group, which indicates that anti-diabetic manage & care education is provided to those who have progressed farther along the course of diabetes instead of the early stage and cannot regulate their glucose-level well in the nation. Conclusion: Those findings raise a need for active educational policies in order to provide anti-diabetic manage & care education under the goals of preventing complications through anti-diabetic education for many patients in early stages of diabetes.

• 한국임상약학회지
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• 제27권2호
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• pp.92-98
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• 2017

Background: Nebulized colistimethate is increasingly used, because there are problems such as renal dysfunction and low distribution within the lungs when colistimethate is administered intravenously. This study was designed to compare and analyze the changes in renal function by of nebulized colistimethate treatment for its safe administration. Methods: This study retrospectively reviewed the electronic medical records of adult patients above 19 years old, receiving only the nebulized colistimethate at least 4 days in Yonsei university health system from Nov 2014 to Aug 2015. Acute kidney injury (AKI) was determined by using the RIFLE criteria (Risk, Injury, Failure, Loss and End-stage renal disease) according to serum creatinine (SCr) levels before and after use of nebulized colistimethate. Results: 48 patients were included our study and their SCr increased significantly after nebulized colistimethate treatment ($SCr_0$ vs. $SCr_1$; $0.85{\pm}0.80$ vs. $1.00{\pm}0.82mg/dL$, n=48, p<0.001), but the changes were in normal range according to the standards at Yonsei university health $system^a$. Among 48 patients, 38 patients were in the non-AKI group (79.2%), and 10 patients developed AKI (20.8%). Within the AKI group, 2 patients were in the Injury group (20%) and the other 8 in the Risk group (80%). Conclusion: There was no significant difference in age, dosage and duration of treatment between AKI group and non-AKI group (p>0.05). The study has a significance in that it reviewed the safety of nebulized colistimethate only treatment to national patients, analyzing its nephrotoxicity. It has confirmed that nebulized colistimethate is a safer method than intravenous injection, and requires to establish a guideline for the use of nebulized colistimethate in further studies with broader patient groups. $^a$ : SCr Male 0.68-1.19 mg/dL, Female 0.49-0.91 mg/dL.

• 한국임상약학회지
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• 제27권2호
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• pp.99-104
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• 2017

Objectives: This study aimed to compare effects on glycemic control and weight loss between the metformin/dapagliflozin combination and the metformin/sitagliptin combination in type 2 diabetic patients. Methods: This study retrospectively reviewed the medical records, from January $1^{st}$ 2015 to March $31^{st}$ 2016, of type 2 diabetic patients who were older than 18 and were prescribed with dapagliflozin or sitagliptin in combination with metformin. Hemoglobin $A_{1c}$ ($HbA_{1c}$) levels and weights were measured every 3 months. Results: The dapagliflozin group showed a greater decrease in $HbA_{1c}$ levels after 3 months (-0.75% vs. 0.01%, P<0.001), 6 months (-0.36% vs. 0.08%, P=0.029), and 9 months (-0.53% vs. 0.08%, P=0.046) compared to the sitagliptin group. Also, the dapagliflozin group showed a greater significant decrease in the rate of change in $HbA_{1c}$ levels after 3 months (-0.09 vs. 0.01, P<0.001), 6 months (-0.04 vs. 0.01, P=0.031), 9 months (-0.07 vs. 0.02, P=0.029), and 12 months (-0.05 vs. 0.05, P=0.047). Furthermore, the dapagliflozin group showed a greater decrease in amount of weight change after 3 months (-2.46 kg vs. 0.37 kg, P<0.001), 6 months (-3.02 kg vs. 0.13 kg, P<0.001), and 9 months (-2.27 kg vs. 0.50 kg, P=0.002). Finally, the dapagliflozin group showed a greater decrease in the rate of change in weight after 3 months (-3.10% vs. 0.52%, P<0.001), 6 months (-3.83% vs. 0.21%, P<0.001), 9 months (-2.84% vs. 0.79%, P=0.002), and 12 months (-4.91% vs. 0.44%, P<0.001). Conclusions: It was concluded that dapagliflozin is more effective than sitagliptin for type 2 diabetic patients.

• 한국임상약학회지
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• 제28권3호
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• pp.167-173
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• 2018

Background: In July 2016, the Infectious diseases society of america and the american thoracic society (IDSA & ATS) published a guideline recommending piperacillin/tazobactam (Pip/Tazo) 18 g/day as the anti-pseudomonal dose for the treatment of pathogenic pneumonia. After the guideline was published, the Pip/Tazo dose used for the treatment of pathogenic pneumonia was changed from 13.5 g/day to 18 g/day in a superior general hospital intensive care unit (ICU). In this study, we analyzed the effectiveness and safety of the new dose. Methods: Adult patients aged ${\geq}19years$ who were diagnosed with pneumonia in ICU and who received Pip/Tazo for 7 days or more from September 1, 2015 to May 31, 2017 were included in the study. The electronic medical record (EMR) was retrospectively analyzed. Results: At baseline, there was a significant difference between 44 patients treated with 13.5 g/day and 31 patients treated with 18 g/day of Pip/Tazo. The 18 g/day-treatment group comprised more elderly patients than the 13.5 g/day-treatment group (p=0.028). The results of the treatment-effects analysis showed no significant difference between the two groups. In case of safety data, there were significant differences in two parameters related to blood count, namely hemoglobin (p=0.016) and platelet count (p=0.011). Conclusion: Based on the significant difference in baseline age, there is a possibility that high-dose Pip/Tazo showed improved therapeutic effect. However, when high-dose Pip/Tazo was used, the blood cell count was found to drop from the reference value more frequently. Therefore, blood cell count should be monitored carefully when high-dose Pip/Tazo is administered.

• 한국임상약학회지
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• 제28권3호
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• pp.230-237
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• 2018

Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-the-counter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, "possible" (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while "possible" (44.0%) and "unlikely" (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-the-counter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.