Earticle

희귀질환이란 일반적으로 그 유병율이 인구 일만 명당 5명 이하인 질환을 말한다. 세계에는 약 7,000여종의 희귀질 환이 알려져 있고 학술지에 매 주 대략 5종의 새로운 희귀질환이 보고되고 있다. 희귀 의약품(orphan drug)이란 희 귀질환치료제 또는 수익성이 없어 개발을 기피하는 일반질환 치료제로서 정부가 지정한 의약품을 말한다. Orphan 의 약품의 개발에는 많은 장점이 있다. Orphan 의약품으로 정부의 지정을 받으면 세금감면을 통한 연구비 지원, 임상시 험 비용 지원, 신약허가 심사비 면제, 시장독점권 부여 등의 특혜가 주어진다. 희귀질환의 대부분은 단순한 유전적 결함에 의하는 경우가 많아 치료제의 표적발견이 비교적 쉬우므로 개발 성공률이 높고, 임상시험기간이 짧으며, 시판 허가를 받을 확률이 높아 연구개발비용이 적게 든다. 그 결과 전세계 orphan 의약품 시장은 최근 매년 6%씩 성장 하여 2014년에는 약 1,120억달러의 시장을 형성할 것으로 추정된다. Orphan 의약품 시장은 현재 매년 8.9%씩 성장 하고 글로벌 시장의 51%를 점유하는 미국을 중심으로 확장되어 가고 있으며, 총매출액의 64.3%가 유전자재조합의약 품에 의한 것으로 알려져 있다. 이러한 의약품시장의 변화와 사회적 요구에 부응하여 한국 또한 희귀질환 치료제 개 발의 활성화를 위해 재정적 지원체계를 구축하고, 허가관리를 개선하며, 법률적 제도를 완비하는 과정에 있다. 현재 희귀질환의 치료적 타겟을 찾아 신물질이나 기존의 약물을 발굴하는 과정이 주로 대학이나 연구 중심 병원에서 이루 어지고 있다. 제도가 잘 정립되어 있는 미국 시장을 겨낭하여 orphan 의약품 개발을 전략적으로 수행한다면 큰 성공 을 거둘 수 있을 것으로 기대된다.

Background :긴 측쇄의 트리글리세라이드(long chain triglyceride, LCT)는 대두 또는 홍화씨로부터 제조된 지방유제 의 주요 성분이다. 중 측쇄 트리글리세라이드(medium chain triglyceride, MCT)는 LCT와 다른 물리적 성질을 가지 고 있다. MCT의 지방산은 LCT의 지방산 보다 작은 분자량을 가지기 때문에 물에 더 잘 녹으며 다른 경로를 통하 여 더 빨리 대사된다. Objectives & Methods :본 연구에서는 지방산의 길이에 따른 고영양수액제(total nutrient admixture, TNA)의 안정성을 비교하기 위하여 서로 다른 LCT와 MCT 조성을 가지는 4 가지 TNA 처방의 안정성 을 실온 및 냉장 조건에서 측정하였다. Results :그 결과 MCT와 LCT의 혼합 조성의 TNA는 LCT 단독 조성의 TNA 와 유사한 안정성을 나타내었다. MCT와 LCT 혼합 TNA는 LCT 단독 TNA에 비하여 작은 입자크기를 보였 지만 외관, 산도, 과산화수소가, 삼투농도, 아연 농도, 니코틴아미드 및 리보플라빈 농도에서는 의미 있는 차이를 보이 지 않았다. Conclusion : 따라서 MCT와 LCT의 혼합 TNA는 LCT 단독 조성 TNA에 상응하는 안정성을 가지고 LCT단독 TNA을 대체제로 사용할 수 있다. 결론적으로, TNA의 2가지 타입 모두 3일 동안 실온과 냉장에서 안정하 고, MCT와 LCT의 혼합 TNA는 LCT 단독 조성 TNA보다 생리화학적으로 더 안정하므로 환자들에게 좀 더 효과 적인 에너지원이 될 것으로 전망된다.

Background & Objectives: Burn injury mortality and septic complication are frequent and well-known in burned pediatric patients. The overuse of antibiotics is the base for development of wound infection by resistant microorganisms as well as opportunist agents. Methods: We have carried out a study of the bacterial profile and antimicrobial resistance clinically important bacteria isolated from burn wound infections in children patients. The most common isolate from burn wound cultures was Pseudomonas aeruginosa (26.8%), followed by Staphylococcus aureus (25.4%), Acinetobacter baumannii (12.7%), coagulase negative staphylococcus (12.0%), Enterococcus faecium (7.7%), Escherichia coli (4.9%), Enterococcus faecalis (3.7%), Burkholderia cepacia (3.0%), Enterobacter cloacae (2.3%) and Klebsiella pneumonia (2.3%). Colistin was very significantly effective drug in gram negative organism, such as Pseudomonas aeruginosa and Acinetobacter baumannii. Results & Conclusion: The resistance rates were 65% and 98% to piperacillin, 63% and 97% to ceftazidime, 28% and 50% to levofloxacin. The most effective antibiotic in gram positive organism, such as Staphylococcus aureus, coagulase negative staphylococcus were moxifloxacin. The resistance rates were 83% and 64% to ciprofloxacin, 80% and 17% to clindamycin.

Objective: This study was to define the clinical effect on the clinical decision support system (CDSS) for prescribing antibiotics integrated with the order communication system in a National Hospital. Method: We extracted data collected before integrating the CDSS of 4,406 adult patients in 2007 and data collected after integrating the CDSS of 4,278 adult patients in 2009. These patients were 50.4% and 45.2% of all patients admitted in 2007 and 2009, respectively. The clinical effect was defined as the proportion of prescribed antibiotics, the length of antibiotics use, and the DDDs (defined daily doses) of antibiotics per 1,000 patient-days using these retrospective data. Results: There were a significant change in the proportion of patient prescribed penicillins with extended spectrum (OR=0.55, p=001), penicillins included beta-lactamase inhibitors (OR=0.75, p<.001), 3rd cephalosporin (OR=1.47, p<.001). The mean of the length of antibiotics use was decreased statistically from 6.09±5.48 to 5.85±5.51 days (p=.003). The DDD of glycopeptides was decreased from 24.43 DDD to 19.55 DDD per 1000 patient-days. The DDD of 3rd cephalosporins was also decreased from 15.88 to 11.65. Conclusion: Therefore, the clinical decision support system for prescribing antibiotics was effective for the clinical outcomes.

Background: Prevalence of depression comorbid with neurologic disorders such as Alzheimer' disease (AD), Parkinson's disease (PD) and vascular dementia (VD) is higher than that of primary depression. Antidepressant medications, suggested by many researches for depression comorbid with neurologic disorders such as AD, PD and VD, are mainly selective serotonin reuptake inhibitors (SSRI). Objective: The primary objective of this study is the evaluation of antidepressant drug therapy for AD, PD and VD. Method: This study was a retrospective study based on medical records, carried out for 3 years and 6 months (Jan. 2007~Jul. 2010). Patients, diagnosed as comorbid depression through Beck Depression Inventory (BDI), Cornell Depression Scale (CDS), Geriatric Depression Scale (GDS) among neurologic out-patients of Chungnam National University Hospital because of AD, PD and VD, were selected. The results were evaluated by efficacy and safety of antidepressant drug therapy. Results: In result, the prescribing rates of antidepressants were 30%, 55% and 40% for each AD, PD and VD. Depression cure rates of patients receiving antidepressants vs patients not receiving antidepressants were 40% vs 39%, 33% vs 23% and 38% vs 30% for AD, PD and VD. The frequencies of prescriptoin of SSRI were 21%, 11% and 27% for each AD, PD and VD. The frequencies of prescriptoin of benzodiazepine (BZD) was 61%, 82% and 61% for each AD, PD and VD. The ratio of single BZD prescription was more than that of combination prescription of antidepressants. Tricyclic antidepressants (TCA) were rarely prescribed. The rate of patients with BZD-related side effects was 54%. The most frequent side effects of BZD were dizziness (30%), drowsiness (21%) and headache (16%). Side effects of SSRI were rare. Conclusion: In conclusion, the frequencies of prescription of antidepressants were not common for AD, PD and VD. There was little difference in depression cure rate between patient receiving antidepressants and not receiving. Even though SSRI has to be the highest priority of usage, the frequencies of prescription of SSRI were lower than those of BZD. Additional researches and efforts are required to improve antidepressant drug therapy for neurologic disorders such as AD, PD and VD.

Background: Patients diagnosed with cancer tend to have multiple risk factors for drug related problems such as old age, comorbid conditions, self-medication, additional medications for supportive therapy, and the cancer treatment itself. Objective: The aim of this study was to investigate notable polypharmacy and related problems in oncology patients during hospitalization or following clinic visit. Method: The electronic medical records of patients who were discharged from oncology division at Seoul National University Hospital (SNUH) from June 1st to June 30th, 2011 were retrospectively reviewed. Results: A total of 334 discharged patients were included in this study. Among them, 221 patients had pre-admission medications. Forty percent of the patients, including 60.3% of elderly patients (over 65 years of age) were prescribed more than 5 kinds of medications. Twenty percent of the patients were prescribed to take medications more than 7 times a day. Medication duplications were observed in 2.4% of patients. In 10.5% of the reviewed patients, 47 cases of potential drug-drug interaction including 3 cases of contraindication and 17 cases of major clinical implication according to Micromedex were detected. Medication changes were made in 88% of patients during hospitalization and in 94.7% of patients at their first visit after discharge. Antidiarrheal agent (loperamide) was prescribed along with laxatives in 18.5% of the prescriptions and inadequate instructions on how to take it were observed in 63% of the prescriptions. Conclusion: This study identified the prevalence of polypharmacy and related problems in cancer patients, which presents the need for an active role of pharmacists in pharmaceutical care in oncology wards.

Objective: The purpose of this study was to evaluate the patterns of Over-the-Counter (OTC) drugs and their interactions with prescription drugs in adults visiting a community pharmacy. Method: The subjects were 151 adults aged over 20 years visiting a community pharmacy in Asan-si from December 16th 2011 to February 1st 2012. We used a survey questionnaire. The survey inquired about the prevalence and the details of any OTC drug use and the characteristics of the study subjects. The drug interaction classification system from Lexicomp’s Lexi-interact data fields was used to identify OTC drugs likely to have clinically significant interactions with prescription drugs. Results: The patterns of OTC drug use were related to thirties (from 30 to 40 years old), female gender, higher education, non-smoking, sometimes use of alcohol, and self-perceived normal health status. The most commonly used OTC drug category was antipyretic-analgesics (n=104, 53.3%), and the most commonly used ingredient was acetaminophen (n=67, 64.4%). The biggest motivation for taking OTC drugs was suggestion by pharmacists, reported by 55.6%. After reviewing each patient’s prescription drugs and OTC drugs, 14 patients (36.8%) of 38 patients using prescription drugs were taking drug combinations with potential for clinically significant interactions. The concomitant use of OTC drugs with prescription drugs may lead to increased potentially harmful interactions. Conclusion: It is suggested that health-care professionals should be more aware of the potential and possible interactions and take into better account their patients’ OTC drug use.

Purpose: Drug can be hazardous for people if misused although they are useful for their indication. In urgent incidences such as overdose, proper treatment for intoxication can save patients’ lives. In emergent case regarding drug overdose, pharmacists should know how to provide correct information including antidote to other healthcare providers. However, in Korea, there is neither regular class nor education material regarding detoxification. Therefore, the object of our study is to investigate the perception of pharmacists about it. Method: We surveyed hospital pharmacists by means of self-reporting questionnaire in order to investigate the pharmacists’ perception of detoxification treatments from May 12th 2012 to August 10th 2012. The questionnaire comprised of demographic information, interest in detoxification treatment (inquiry from patients and education about antidote), knowledge of antidote, effective drug search route and perception of the need for education and stocking materials about antidotes). Results: It included total 281 hospital pharmacists from 30 hospitals in S. Korea. Of them, only 16.7% have been questioned about drug overdose from patient or representative and 35% have learned about antidotes in case of drug overdose through education program of Korean association of hospital pharmacist or university. About 98% thought that education and stocking materials about frequently overdosed drug and antidotes are helpful for patients in emergent case. Also, the percentage of correct answer of each questions about antidotes were higher in educated group (p≤0.001). The more work years are, the percentage of correct answer of each questions are higher (p≤0.001). Conclusion: In conclusion, it will be helpful for reducing damage by drug overdose that pharmacists take regular education about antidote for all pharmacist and pharmacy student. In addition, preparing and keeping booklet for Korean Style-antidote in pharmacy is needed currently for protecting public health.

Background: Colleges of Pharmacy in Korea have increased the number of years required for the degree from 4 years to 6 years in 2009. These changes are demanding revolution of education in pharmacology. The center of gravity is moving from medicine to application, theory to work. Problem-Based Learning is “learn to learn” working cooperatively in groups to seek solutions to real problems. PBL process cheers students to think critically to find optimal solution using appropriate learning resources. Method: Eighteen students in college of pharmacy are selected to participate in PBL lecture and take part in the survey about the effect of PBL in clinical pharmacy education. Results: General satisfaction score was high as four on a five-point scale, and students have improved on anxious about communication since the PBL classes compared to before of the lecture (P=0.037). Conclusion: PBL could be applied in clinical pharmacy education to progress student’s participation and satisfaction. In addition this is improved communication skill in medical team during pharmacy practice.

Background (Purpose): The objective of this study was to investigate regulations on pharmacist and other healthcare professional license examination in Korea. Specific aim was focused on the implementation of new regulatory system governing pharmacist license examination particularly on naming of the subjects, method of the examination, and discrimination of pass or fail. Method: Laws and regulations of Korea on the examination system were retrieved from sources posted in Ministry of Government Legislation. Results: Two major regulatory differences were found between pharmacist and other healthcare professionals license examination systems. Firstly, the regulation on pharmacist license examination was ruled by the enforcement ordinance of parent law (Pharmacy Law) while it was ruled by enforcement regulation of parent law (Medical Law). Secondly, minimum grade requirement for pharmacist and other healthcare professionals was differently set up: 40% for each single subject in pharmacist and average of 40% for each group of several subjects in other healthcare professionals. Conclusion: Since pharmacist profession has drastically changed from drug-makers to drug-users during the recent decades, it is desirable to have the regulations on pharmacist license examination system amended in harmony with other laws and regulations of Korea and other major developed countries. Two-step examination for pharmacist license appears worthwhile to implement for balancing the two key functions of the pharmacist being drug-makers and drug-users.

메치실린 저항성 황색 포도상구균(MRSA)에 감염된 환자에게 단기간 연속적으로 반코마이신을 투여했을 때 비정상적으 로 호중구의 수치가 감소한 약인성 부작용 사례를 보고하고자 한다. 해당 여성 환자는 61세로서 MRSA 감염증을 판 정받고 반코마이신 투여와 더불어 점차 백혈구(WBC)와 절대호중구수치(ANC)가 감소하였고, 제10일째에 이르러 호중구 감소증이 발생하여 ANC가 최저 430 cells/mm3까지 낮아졌으나, 반코마이신의 투여를 중단하자 곧 정상수준으로 회복되 었다. 본 사례는 Naranjo Probability Scale과 Korean Algorithm Score(Ver. 2.0)로 각각 평가하였을 때 반코마이신의 투여와 호중구감소증의 발현 사이에 모두 ‘가능한(probable)’ 정도의 인과관계를 가진 것으로 평가되었다. 이는 통상적 으로 20일 이상 연속투여를 할 때 임상적으로 관측되던 반코마이신-유래 호중구감소증이 단지 10일 정도의 단기간 투 여만으로도 발생할 수 있다는 임상적 약물부작용의 사례로서, 향후 MRSA환자에게 반코마이신을 선택할 때에는 이와 같은 부작용을 고려하여 환자의 WBC와 ANC를 면밀히 관찰하면서 투여할 필요성이 있음을 시사한다.