임상시험의 품질관리체계 (Quality Management System)

나현오 대한임상약리학회 2006 Translational and Clinical Pharmacology Vol.14 No.1

A quality is a set of characteristics that a product and service have to satisfy requirements of the customers; research subjects, sponsors, regulatory authorities worldwide, hospitals and IRB/IECs. In Clinical Research, products are information from the clinical research process and requirements are law & regulations, GCP, ethical standards, trial protocol, budget and timeline. Quality Control(QC) of Clinical Research is activity that checks on the compliance of the trial process & reliability and credibility of data. QC is performed at every step of the clinical trial process and applied to each stage of data handling. Quality Assurance (QA) of Clinical Research is independent audits of all trial-related processes & functions. QA is performed by QA team not involved in the research process and assess efficiency of sponsors` QC processes. Quality Management System(QMS) is a set of tools to ensure, control, maintain, and improve quality. QMS supports continuous Quality Improvement(QI). QI is performed by FOCUS-PDLA cycle.

임상시험과 병원약사

나현오 한국병원약사회 2005 병원약사회지 Vol.22 No.1

L-asparaginase 약물 유해 반응 보고 분석

고경미,나현오 한국임상약학회 2017 한국임상약학회지 Vol.27 No.3

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.

비고령 성인환자의 만성폐쇄성폐질환 약물사용 현황과 영향인자

문채원,나현오,이정연 한국임상약학회 2016 한국임상약학회지 Vol.26 No.4

Background: This study is to investigate the prescription patterns and factors related to the number of medications treating chronic obstructive pulmonary disease (COPD) in patients under 65 years old according to GOLD guidelines. Methods: We retrospectively analyzed the medical records of patients aged 40-64 years with a diagnosis of COPD from January to March 2016. Patients were classified by combined assessment of COPD (grades A, B, C, D) using spirometry, exacerbation history, mMRC, and/or CAT results. We analyzed prescribed medications, treatment options and factors related to the numbers of COPD medications. Results: The total number of prescriptions were 251. About 35.5% of patients were classified as GOLD A, 34.2% as GOLD B, 17.1% as GOLD C and 13.2% as GOLD D. Inhaled bronchodilator was prescribed for 86.9% of patients and the most frequent COPD medication was longacting muscarinic antagonist (LAMA) followed by inhaled corticosteroids/long acting beta agonist (ICS/LABA). The majority of low risk patients (GOLD A/B) were prescribed a monotherapy with LAMA or LABA. For high risk patients (GOLD C/D), combination treatment with ICS+LAMA+LABA was mostly prescribed. The 21.2% of patients in GOLD D received systemic corticosteroid. The average number of medications per prescription was 3.7, and this number increased with increasing COPD grade, COPD duration and lung function reduction (FEV1, FEV1/FVC). Conclusion: Generally high adherence to GOLD guideline recommendations was reported. Given the progressive nature of the disease, results suggest that closer attention to respiratory symptoms for early detection, diagnosis, and appropriate treatment of COPD is warranted.

고관절치환술 후의 Rivaroxaban의 국내임상적용

유옥리,나현오,이정연 한국임상약학회 2014 한국임상약학회지 Vol.24 No.1

Quinidine 병용투여시 Digoxin의 Clearance 변화

김호순,나현오,신완균,이민화,서정돈 대한순환기학회 1994 Korean Circulation Journal Vol.24 No.3

일개 임상시험에서 피험자 순응도에 영향을 미치는 요인 분석

박민지,나현오,김영인,김경수 대한임상약리학회 2009 Translational and Clinical Pharmacology Vol.17 No.1

Background: Due to the strong relationship between successful clinical trial result and subject's high compliance to protocol, this research aimed to provide the basic information of the key factors affecting subject's compliances to improve the quality of the clinical trial . Method: The cross sectional study was retrospectively investigated with the result of the phase III clinical trial which had been conducted with co-participation of investigators belonged to two different medical specialties involving 15 university affiliated hospitals from October 2007 to April 2009. The factors were classified into subject factor, institution factor, principal investigator factor, study staff factor and clinical research associate (CRA) factor. The collected data was tested at significance level of 5% using SAS program (Version 8.0). To investigate the correlation between subject's compliance and the suggested factors, chi-square test and multiple logistic regression analysis were tested. Specifically, stepwise multiple regression analysis was conducted to analyze the factors affecting the final subject's compliances. The data for nine subjects from two institutions which had made poor progress during the trial was excluded from the analysis. Result: Among subject's compliances, the factors affecting the visit completion and medication compliance were come out differently. In terms of the visit completion, as a result of stepwise multiple regression analysis, the rate of visit completion was 4.9 times higher in the group of subjects taking corticosteroids than others, which is significant. In addition, the rate of visit completion was 10 times and 6.5 times respectively higher with principal investigators and clinical research coordinators belonging to the department in charge of the subject enrollment with subject's underlying disease treatment than the department in charge of the tests during the clinical trial, which is significant. Particularly, in terms of medication compliance 80% of investigational product medication compliance was shown in the group of no CRA change which is 4.0007 times significantly higher than others. Conclusion: Among subject's compliances, the significantly high influential factor for the visit completion was the subjects taking corticosteroids which were one of the risk factor for peptic ulcer and the specialty factor in charge of the continuous treatment for subjects and its principal investigator. Also, the factor which had significantly highly affected subject's medication compliance was CRA factor. Since subject's compliances were limited with the visit completion and medication compliance in this study, further investigations about subject's compliance are required. Also, it will be necessary to investigate CRA's indirect influence to subject's medication compliance in detail in the future. Background: Due to the strong relationship between successful clinical trial result and subject's high compliance to protocol, this research aimed to provide the basic information of the key factors affecting subject's compliances to improve the quality of the clinical trial . Method: The cross sectional study was retrospectively investigated with the result of the phase III clinical trial which had been conducted with co-participation of investigators belonged to two different medical specialties involving 15 university affiliated hospitals from October 2007 to April 2009. The factors were classified into subject factor, institution factor, principal investigator factor, study staff factor and clinical research associate (CRA) factor. The collected data was tested at significance level of 5% using SAS program (Version 8.0). To investigate the correlation between subject's compliance and the suggested factors, chi-square test and multiple logistic regression analysis were tested. Specifically, stepwise multiple regression analysis was conducted to analyze the factors affecting the final subject's compliances. The data for nine subjects from two institutions which had made poor progress during the trial was excluded from the analysis. Result: Among subject's compliances, the factors affecting the visit completion and medication compliance were come out differently. In terms of the visit completion, as a result of stepwise multiple regression analysis, the rate of visit completion was 4.9 times higher in the group of subjects taking corticosteroids than others, which is significant. In addition, the rate of visit completion was 10 times and 6.5 times respectively higher with principal investigators and clinical research coordinators belonging to the department in charge of the subject enrollment with subject's underlying disease treatment than the department in charge of the tests during the clinical trial, which is significant. Particularly, in terms of medication compliance 80% of investigational product medication compliance was shown in the group of no CRA change which is 4.0007 times significantly higher than others. Conclusion: Among subject's compliances, the significantly high influential factor for the visit completion was the subjects taking corticosteroids which were one of the risk factor for peptic ulcer and the specialty factor in charge of the continuous treatment for subjects and its principal investigator. Also, the factor which had significantly highly affected subject's medication compliance was CRA factor. Since subject's compliances were limited with the visit completion and medication compliance in this study, further investigations about subject's compliance are required. Also, it will be necessary to investigate CRA's indirect influence to subject's medication compliance in detail in the future.

심방세동 환자에서 Warfarin 반응성에 이뇨제가 미치는 영향

박희주,나현오,곽혜선 한국임상약학회 2013 한국임상약학회지 Vol.23 No.2

항응고제 투여 환자에서 약사의 효과적인 ACS를 통한 방광암 조기발견 사례

안성심,방준석,나현오 한국임상약학회 2010 한국임상약학회지 Vol.20 No.1

국내 8개 종합병원에 근무하는 병원약사를 대상으로 한 직무스트레스와 직무만족도 분석

이정선,한옥연,나현오 한국병원약사회 2013 病院藥師會誌 Vol.30 No.1

This research was conducted to look into the relationship between job stress and job satisfaction perceived by a hospital pharmacist, and to identify the influencing factors for providing fundamental data to increase their job satisfaction. A self-filling survey questionnaire was distributed to 196 hospital pharmacists working at 8 general hospitals in Korea, between October 4 and October 10, 2011. The contents of the questionnaire were composed of general and professional characteristics as the baseline, job stress, and job satisfaction. The participants’job stress and satisfaction were measured using a 4-point Likert scale. The data were analyzed by using the SPSS WIN 17.0. The response rate was 80.1%, and 77.0% was included in the analysis except for questionnaires having incomplete answers. There were significantly negative correlations in the score of job stress and job satisfaction and the average level of job stress was 2.59 and of their job satisfaction was 2.47. In job stress, it was found that the respondents significantly were more stressed in job demand and occupational climate. In job satisfaction, respondents get less satisfaction in work environment and personal outlook. As a result of multiple regression analysis, it was found that reward and job stress most influenced job satisfaction, and the descriptive power on these factors influencing their job satisfaction was found to be 72.2% (p<0.0001). According to the results, strategies to improve hospital pharmacists’job satisfaction should focus on promoting diverse challenging work duties, facilitating work environment and the appropriate rewards. In addition, the systemic and multi-dimensional improvement will be needed. Further research is needed to understand which aspects of the jobs in different settings are more or less satisfying.