국내 의약품 임상시험 실시기관에서의 임상시험 관리약국 운용 현황

장유정 ( Yoo Jeong Jang ),강원구 ( Wonku Kang ),이주미 ( Joomi Lee ),이혜원 ( Hae Won Lee ),박민수 ( Min Soo Park ),윤영란 ( Young Ran Yoon ) 영남대학교 약품개발연구소 2013 영남대학교 약품개발연구소 연구업적집 Vol.23 No.0

Background: There is a lack of research on the status of clinical trial pharmacy and clinical trial pharmacist (CTP) in Korea. This study was aimed to investigate the current status of clinical trial pharmacy and clinical trial pharmacists. Methods: The survey was performed using the 41-item questionnaire designed to investigate information on the following; (1) current status of clinical trial pharmacy designated by Korea Food and Drug Administration, (2) current status of working condition, management, and satisfaction index of CTP. Data collected was analyzed by t-test and χ². Results: Among the CTPs who responded, 92.7 % belonged to department of pharmacy, and 7.3 % to clinical trial center. 90.2 % of the respondents were women. Forty-two point seven percents of the respondents had more than 3 years of experience in the clinical trial field. 36.6 % answered that the current number of CTPs in the institution was ‘2’. Sixty-three point four percents answered that they subsumed an additional post. Regarding the question on “whether the equipment and working environment of your clinical trials pharmacy is adequate”, 65.1 % of the respondents answered as ‘Inadequate’. Ninety-eight point eight percents answered that work-related education is needed. Ninety-three point nine percents answered that the quality of clinical trials is related to the improvement of the working environment of CTP. Conclusion: Clinical trial pharmacy`s facility and number of actually working CTP were insufficient. Proper and continuous education and training for CTPs are needed to improve the quality of clinical trials conducted in Korea, with strong institution support and timely regulation change.

국내 의약품 임상시험 실시기관에서의 임상시험 관리약국 운용 현황

장유정,강원구,이주미,이혜원,박민수,윤영란 대한임상약리학회 2013 Translational and Clinical Pharmacology Vol.21 No.1

Background: There is a lack of research on the status of clinical trial pharmacy and clinical trial pharmacist (CTP) in Korea. This study was aimed to investigate the current status of clinical trial pharmacy and clinical trial pharmacists. Methods: The survey was performed using the 41-item questionnaire designed to investigate information on the following; (1) current status of clinical trial pharmacy designated by Korea Food and Drug Administration, (2) current status of working condition, management, and satisfaction index of CTP. Data collected was analyzed by t-test and χ². Results: Among the CTPs who responded, 92.7 % belonged to department of pharmacy, and 7.3 % to clinical trial center. 90.2 % of the respondents were women. Forty-two point seven percents of the respondents had more than 3 years of experience in the clinical trial field. 36.6 % answered that the current number of CTPs in the institution was ‘2’. Sixty-three point four percents answered that they subsumed an additional post. Regarding the question on “whether the equipment and working environment of your clinical trials pharmacy is adequate”, 65.1 % of the respondents answered as ‘Inadequate’. Ninety-eight point eight percents answered that work-related education is needed. Ninety-three point nine percents answered that the quality of clinical trials is related to the improvement of the working environment of CTP. Conclusion: Clinical trial pharmacy’s facility and number of actually working CTP were insufficient. Proper and continuous education and training for CTPs are needed to improve the quality of clinical trials conducted in Korea, with strong institution support and timely regulation change.

혈액내과 임상약사의 처방중재 활동 평가

유지선,이소영,김재송,손은선,유윤미 한국병원약사회 2020 병원약사회지 Vol.37 No.4

Background : The significance of the pharmacist’s clinical role has been demonstrated through several studies, and its importance is further emphasized through medication therapy management in hematology. Although many hematology clinical pharmacists operate in various hospitals domestically and abroad, few studies have evaluated the value of the pharmacists’ prescription interventions. The only domestic study to analyze the prescription interventions by hematology clinical pharmacists was published in 2014. However, it does not use the current revised classification criteria. Thus, the purpose of this study was to re-examine the prescription interventions of hematology clinical pharmacists in the current clinical context. Methods : The details of drug-related interventions were studied among patients admitted to a hospital’s hematology department July 2018-June 2019. The intervention cases were analyzed using the Pharmaceutical Care Network Europe (PCNE) version 9.0 criteria to determine the type of prescription interventions, the cause of drug-related problems, and if accepted. The Overhage criteria was applied to assess the significance of the interventions. Results : A total of 394 cases of drug prescription intervention were identified for analysis. The study results revealed that the most prescription-mediated drugs were antiemetics (15.3%), followed by antibiotics (13.4%), and antifungal agents (10.2%). According to the PCNE, the most frequently observed prescription intervention was “Effect of drug treatment not optimal (36.3%)”. The most frequent cause for the prescription intervention was “No or incomplete drug treatment in spite of existing indication (31.3%)”. The prescription intervention was accepted in 68.5%, of which 94.7% had clinical significance. Conclusion : This study confirmed that the clinical pharmacist in hematology conducts various and clinically significant interventions which optimize patient care. Thus, the results affirmed the positive/health-promoting role of the clinical pharmacist and we expect such results to serve as a basis for increasing in awareness of the role and importance of the clinical pharmacist.

상급종합병원 병동담당약사 업무 현황 및 의료인의 인식과 기대 분석

김정은,백시진,최나예,전수정,남궁형욱,이정화,김은경,이주연,Kim, Jeongun,Baek, Sijin,Choi, Nayae,Jeon, Sujeong,Namgung, Hyung Wook,Lee, Junghwa,Lee, Euni,Lee, Ju-Yeun 한국임상약학회 2022 한국임상약학회지 Vol.32 No.1

Background and objective: The Seoul National University Bundang Hospital (SNUBH) implemented ward-based clinical pharmacy system with designated pharmacists in 10 general wards. Designated pharmacists conduct inpatient medication review, medication intervention, and medication consultation, and provide drug information for health care providers. This study aimed to evaluate the clinical pharmacy services and to examine the perception and expectations of health care providers on the services provided by the designated pharmacists in general wards. Methods: A survey was constructed to include questions on the health care providers' recognition, satisfaction, and perceived needs of designated pharmacists. We determined the frequency and type of interventions of ward pharmacist and their acceptance rate through a retrospective observational study using electronic medical records. Results: A total of 59 health care providers responded the questionnaire and 79.7% of the respondents reported moderate to high levels of satisfaction. Satisfaction with the services was positively associated with clinical interventions and nutrition support team (81.4%). Of 59 respondents, 88.1% agreed that preventing drug-related problems by designated pharmacists' activities were effective. The most common interventions included inadequate dosage (27.4%), omission and additional prescription (14.6%) and inadequate drug form (9.6%). The acceptance rate of intervention was 91.5%, and 151 potentially serious risks and 523 significant risks were prevented by the intervention. Conclusion: Positive results were confirmed in the awareness, satisfaction, and perceived needs of the health care providers for designated pharmacists. Expansion of the ward-based clinical pharmacy system with designated pharmacists to other wards may be considered.

국내 병원약사의 중재활동과 성과에 대한 체계적 문헌고찰

이소영,조은 한국임상약학회 2019 한국임상약학회지 Vol.29 No.3

Background and Objective: Since the introduction of hospital pharmacy residency programs in 1983, hospital pharmacists in South Korea have been expected to expand their roles. However, their services and the outcomes have not been fully understood. In this study, we conducted a systematic review of Korean hospital pharmacist-provided interventions with regard to intervention type, intervention consequences, and target patient groups. Methods: A literature search of the following databases was performed:Embase, PubMed, Medline, KoreaMed, RISS, KMbase, KISS, NDSL, and KISTI. The search words were “hospital pharmacist”, “clinical pharmacist”, and “Korea”. Articles reporting clinical or economic outcome measures that resulted from hospital pharmacist interventions were considered. Numeric measures for the acceptance rate of pharmacist recommendations were subjected to meta-analysis. Results: Of the 1,683 articles searched, 44 met the inclusion selection criteria. Most articles were published after 2000 (81.8%) and focused on clinical outcomes. Economic outcomes had been published since 2011. The interventions were classified as patient education, multidisciplinary team work, medication assessment, and guideline development. The outcome measures were physicians’ prescription changes, clinical outcomes, patient adherence, economic outcomes, and quality of life. The acceptance rate was 80.5% (p < 0.005). Conclusion: Studies on pharmacist interventions have increased and showed increased patient health benefits and reduced medical costs at Korean hospital sites. Because pharmacists’ professional competency would be recognized if the economic outcomes of their work were confirmed and justified, studies on their clinical performance should also include their economic impact.

소아 약물처방 스크린프로그램과 임상약사 활동이 drug safety 향상에 미치는 효과

김승란,김재연,강민경,안숙희,신혜영,오주연,이순교,박성종,송영천 한국병원약사회 2007 병원약사회지 Vol.24 No.3

Computerized physician order entry(CPOE) system requires an adequate clinical decision support system(CDSS). Pediatric drug ordering calls for an informational backup at the drug ordering stage for several reasons such as a dosage adjustment due to children's weight, maximum dose changes due to their growth, and the risk of ten fold dosage mistakes. Noticing the needs of CDSS on maximum dose limits in the pediatric drug ordering system, clinical pediatric pharmacists developed a new screening system and monitored it. In this study, we evaluate the effects on drug safety improvement. The study was conducted in Asan Medical Center. We developed and monitored CDSS after the consultation with the department of pediatrics, drug information center, and Performance Improvement. Using the screening program, the warning massages pops up on the computer screen when high risk orders(overdose, underdose) are given and the program informs clinicians with the drug information. Then, the pediatric clinical pharmacists monitor the ultimate drug adjustment of the high risk orders and give feedbacks to the clinician if necessary. This monitoring was analyzed and evaluated. The inclusion criteria was patients under 16 years old, weighed less than 40kg who were hospitalized or visited the following departments of Asan medical Center.: Pediatrics, Pediatric Surgery, Pediatric thoracic Surgery, and Neonatal (outpatients only). Data were collected from August 1, 2005 to September 15, 2005. Total screened drugs were 181 ingredients, 324 products. 1491 high risk orders with warning signs were collected during 46 days and 352 orders were changed. Improvement of drug safety was achieved through Changed Order and adequately monitored by the clinical pharmacist's monitoring of ultimate drug dosage adjustment. The feedback of pharmacists' activities to physicians by the warning message increased the ordering compliance. Changed Order has increased from 6.53(3.33) cases per day during early 15days to 9.47(3.93) later 15 days(p<0.05). Stored Set Orders has decreased from 21.53(11.17) to 9.60(2.44)(p<0.05) per day. In conclusion, the screening program effectively informed the appropriate drug dosage information and the clinical pharmacist activities contributed to increasing the ordering compliances and supporting the drug safety in pediatric drug order.

다학제 중환자 팀의료에서의 중환자약료 담당약사 역할에 대한 중요도 및 수행도 평가 설문연구 : 국내 임상의 및 약사 측면

손유민,이혜령,박은정,최은영,문채원,송영주,허은정,사은영,류수현,정선미,이경아,최은정,민명숙,김정미,김은영 한국병원약사회 2022 병원약사회지 Vol.39 No.4

Background : The objective of this study was to survey critical care pharmacists’ role by importance- performance analysis in multidisciplinary ICU teams. Methods : This multicenter prospective cross-sectional questionnaire study was conducted through direct mailing. Questionnaires and return envelopes were mailed to heads of hospital department of pharmacy. These questionnaires were designed to request for importance, performance of fundamental, desirable, and optimal services of pharmacy services for ICU pharmacists and satisfaction for clinicians. Data were subjected to importance-performance analysis. Results : Forty-one item pharmacy questionnaires and 25-item for clinicians were developed and distributed to ICU pharmacist and clinicians. Forty-seven (90%) pharmacists and 51 (66%) clinicians returned questionnaires. Clinicians generally rated satisfaction of pharmacy services more favorably than pharmacists in clinical function in both patient care and non-patient care. Means ± standard deviations (SDs) of importance and performance were 6.20±0.17 and 5.37±0.38, respectively, for the evaluation of clinical activities of patient-care by critical care pharmacist. In the case of pharmacists’ evaluation of non-patient care, means ± SDs of importance and performance were 4.86±0.70 and 4.78±0.21, respectively. The evaluation of importance for non-patient care tasks was significantly lower than that of patient-care tasks (p=0.001). The IPA analysis of clinician’s scores of importance and performance were 6.27±0.25 and 6.11±0.21, respectively for the evaluation of clinical activities of patient-care by critical care pharmacist. In the case of clinician’s evaluation of clinical activities of non-patient care, means ± SDs of importance and performance were 5.49±0.45 and 5.74±0.27, respectively. Conclusion : In conclusion, it was evaluated as important or appropriate performance and highly evaluated for satisfaction with the clinicians for critical care pharmacists’ role on importance- performance in ICU multidisciplinary team activity.

심장외과 중환자실에서 임상약사의 약처방 중재 활동 분석

손유민,고민지,박효정,이재현,이용석,이후경,김정미,조양현,민명숙 한국병원약사회 2021 병원약사회지 Vol.38 No.2

Background : It has been reported that clinical pharmacists’ participation in the multidisciplinary intensive care unit (ICU) team reduces the number of medication errors and improves the clinical outcome. However, studies assessing the role of pharmacists in a cardio-surgical ICU (CSICU) are limited. The aim of this study was to analyze pharmacologic interventions and identify pharmacologic problems that require pharmacist intervention in a CSICU. Methods : The research was conducted by retrospectively reviewing the electronic medical records of patients aged 18 years or older who were admitted to the CSICU of Samsung Medical Center from April 1 2019 to June 30 2019. Results : During the study, the clinical pharmacist monitored 12,021 drug prescriptions for 205 patients and conducted 379 pharmacologic interventions. The most common pharmacologic intervention recommended by the pharmacist was nutritional support (19.0%), followed by therapeutic drug monitoring (TDM) (18.5%) and provision of drug information (14.8%). The most frequently mediated group of drugs was antibiotics (31.1%), and the causes for pharmacologic intervention of antibiotics were mostly TDM (51.7%) and inappropriate dosage (20.3%). The intervention rate of ‘pain, sedation and delirium-related drugs’ was 17.2%, while the intervention rate of ‘antiarrhythmics, anticoagulant, and antiplatelet agents’ was 13.2%. The most common reason for intervention in both groups was missed prescriptions, followed by adverse drug events and inappropriate dosages. The acceptance rate of intervention was 92.2%. Conclusion : Clinical pharmacists’ participation in the ICU has enabled active drug prescription monitoring, proper nutrition support, and TDM. The acceptance rate of intervention is high. The CSICU requires pharmacologic intervention of pain, sedation and delirium-related drugs specific to critically ill patients, as well as drugs indicated for cardio-surgery.

중환자실 임상약사의 약물처방 검토 시 필요한 필수점검 항목 개발

손유민,박효정,정지은,인용원,김정미,이영미,이숙향 한국병원약사회 2019 病院藥師會誌 Vol.36 No.1

Background and purpose : Clinical pharmacists are core members of a multidisciplinary team in critical care, playing a pivotal role in improving patient treatment. The responsibility of pharmacists for pharmacotherapeutic outcomes in South Korea has increased over the years. However, different interventional approaches or points of view in regard to patient medication exist among pharmacists, especially new team members. The purpose of this study was to set up principles of medication interventions, to develop an evidence-based checklist to minimize the difference of intervention levels, and to standardize tasks in interventions provided by pharmacists. Methods : After a comprehensive review of the literature, guidelines and protocols, the relevant items were identified. They were then structured in the form of a checklist. The consistency of the checklist was checked by a group of pharmacists involved in critical care. Cronbach’s alpha, a measure of internal consistency, was used to validate the checklist. Pharmacists’satisfaction with the checklist was assessed using Likert scales as a questionnaire survey. Results : We established an evidence-based checklist composed of seven categories for use in pharmaceutical interventions in critical care. A total of 69 pharmacists completed a questionnaire surveying satisfaction with the checklist. Consistency between two groups of pharmacists was 99.3 percent. The reliability of the checklist was Cronbach’s alpha 0.899, which validated the checklist. There was high satisfaction (4.32 on the Likert scale) with the checklist among pharmacists. Conclusions : The checklist may provide a useful tool for clinical pharmacists to conduct a highly-specialized critical care pharmaceutical intervention with evidence-based reliability.

외래환경에서 고협압환자에 대한 임상약사의 복약지도활동이 약물복용 순응도에 미치는 영향

김승은,신현택,유태우 한국병원약사회 1992 병원약사회지 Vol.9 No.1

In ambulatory settings in Korean hospitals, pharmacists have had quite few chances to teach and councel patients on medication to increase drug compliance which is most vital to successful drug therapy. In most cases, these medication teachings are performed by primary physicians or nurses, but many times ignored or not so efficient to assure patients' compliance to medications. Clinical pharmacy services in the ambulatory settings such as family practice have been proved to be effective and essential to increase patients' drug compliance and consequently successful drug therapy in other countries. However, this type of service has not been initiated or evaluated in Korean hospital settings. A pharmacy residency program was initiated in family practice of Seoul National University Hospital to implement a clinical pharmacy service since march, 1991, Within this program, a specific medication teaching model was designed for the patients with essential hypertension whose diastolic blood pressures were above 90㎜Hg. The selected patients were referred to the pharmacist by primary physicians after medical evaluations and allocated to either study(n=11) or control group(n=14). On the first visit, the pharmacist obtained a medical and medication history, a blood pressure recording and lastly questioned about drug compliance. The study group patients were provided with both written and oral medication teachings by attending pharmacist. Medication compliance and blood pressure changes were monitored. As the results, mean percentage of medication compliance(95.6±10.7%) in study group was significantly larger than that of control group(70.6±37.9%)(p<0.05). In study group, the diastolic blood pressures of initial and last visit were 101.6±10.9㎜Hg and 96.4±8.6㎜Hg respectively whereas, in control group, 96.3±12.3㎜Hg and 95.3±9.5㎜ Hg.