• 한방재활의학과학회지
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• 제31권4호
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• pp.157-166
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• 2021

Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

• 한국간호교육학회지
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• 제30권2호
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• pp.170-181
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• 2024

Purpose: This study aims to assess the importance and performance of patient safety activities for inpatients in small- and medium-sized hospitals. The objective is to identify the need for patient safety education by analyzing differences in importance and performance ratings. Methods: The study involved 300 patients hospitalized in three small- and medium-sized hospitals. Data collection took place in October 2023, focusing on investigating the importance and performance of patient safety activities. Descriptive statistics and an Importance-Performance Analysis (IPA) were conducted using the IBM SPSS statistics 25.0 program. Results: The average importance of patient safety activities was 3.51±0.41, and the average performance was 3.37±0.43, indicating that the importance of patient safety activities was higher than their performance. According to the IPA, the components of patient safety activities that fell into the second quadrant of high importance but low performance included three medication-related items and one test/procedure/surgery-related item. Conclusion: In this study, it was found that inpatients in small- and medium-sized hospitals had a higher importance on patient safety activities than performance and needed ways to increase their performance. Therefore, it is necessary to develop a customized educational program that can increase the practical performance of inpatients' patient safety activities based on the contents that were determined to need improvement.

• 한국포장학회지
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• 제10권1호
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• pp.15-26
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• 2004

Pharmaceuticals require more detailed packaging than do other sensitive products, such as foods, although there are several similarities in their requirements. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods. Therefore, security and integrity of the package are more important and are controlled by licensing arrangements. To achieve levels of safety, reliability, and quality, pharmaceutical firms must identify and correct potential problems with packaging functions. Purpose of this study is to identify the present issues pharmaceutical packaging and to forecast their future for the development of pharmaceutical packaging.

• 약학회지
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• 제56권3호
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• pp.204-209
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• 2012

The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman's terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA's ongoing initiative to address and promote the safe use of medications for the public.

• Asian Pacific Journal of Cancer Prevention
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• 제17권9호
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• pp.4341-4347
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• 2016

Background: Patient safety is one of the key components of nursing care for cancer cases. Valid and reliable context-based instruments are necessary for accurate evaluation of patient safety in oncology units. The aim of the present study was to develop and evaluate the psychometric properties of the Patient Safety Violation Scale in medical oncology units in Iran. Materials and Methods: In this methodological study, a pool of 58 items was generated through reviewing the existing literature. The validity of the 58-item scale was assessed through calculating impact score, content validity ratio, and content validity index for its items as well as conducting exploratory factor analysis. The reliability of the scale was evaluated by assessing its internal consistency and testretest stability. Study sample consisted of 300 oncology nurses who were recruited from thirteen teaching hospitals affiliated to Tehran University of Medical Sciences, Tehran, Iran. Results: Sixteen items were excluded from the scale due to having low impact scores, content validity ratios, or content validity indices. In exploratory factor analysis, the remaining 42 items were loaded on five factors including patient fall, verification of patientidentity, harm during care delivery, delay in care delivery, and medication errors. These five factors explained 62% of the total variance. The Cronbach's alpha of the scale and the test-retest interclass correlation coefficient were equal to 0.933 and 0.92, respectively. Conclusions: The 42-item Patient Safety Violation Scale is a simple and short scale which has acceptable validity and reliability. Consequently, it can be used for assessing patient safety in clinical settings such as medical oncology units and for research projects.

• 한국의료질향상학회지
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• 제3권1호
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• pp.78-93
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• 1996

Background : The goal of this study was to establish the QA items and guidelines for preventing and improving of safety management. Therefore we investigated the nurses' recognition and knowledge of the safety and risk procedures and policies, and the agreement between the nurses beliefs on the degree of importance of those procedures and policies, with actual implementation in hospitals. Method : The subjects of this study were 201 nurses who participated in a program called continuing education for nurses, which held in December, 1993. Result: The results of this study were as follows: 1. Among 18 types of hospital risks, the items that scored highest or the need of closer attention in safety management was the needle stick, medication errors, falling, and bed sores. 2. In most questions of the 18 incidences, the nurses showed that the estimated result would have positive signs except for hospital infections, burns, and bed sores. 3. Even though the survey shows that incidences and types of occurences varies according to the person's age and the time of incident, they mostly occur between midnight to 6AM. Falls and bed sores can be seen more in the elderly. Medications errors, hospital infections and burns are frequently found between the ages of one through twenty. 4. There was a higher mean score for recognizing the importance of those items than the importance of implementing them. Conclusion : In summary, nurses did perceive the need of safety management but the hospital policy for proper safety management was not established. So we recommended that the hospital administration would undertake an early detection and proper management system for hospital precautions, based on QA items & guidelines presented in this study.

• 한국식품위생안전성학회지
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• 제12권3호
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• pp.228-233
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• 1997

Drug Dclivcry system (DDS) purpose to getting better remedial result by improving medication from ordinary methods. Applied for DDS, to improve selectivity and comtinuity during absorbing and delivery step, polmer drug (prodrug) was prepared by the esterification with dextran in such of biodegradable polymer and phthalylsulfathiazole with is efficient for entilitis. The polymer durg was prepared with dextran and phthalylsulfathiazole by the esterification. The synthetic procedures of polymer drug was performed by acid chloride and DCC methods. Polymer drug was synthesized in high yield by acid chloride method than DCC method. The antibiotic activities of polymer drug exhibited growth-inhibitory activity against Staphylococcus aureus, Staphylococcus epidermidis, E. coli, Salmonella typhimurium, Klebsiella pneumoniae at the concentration of 500 *g/m* in general through in vitro. As a result of test, polymer drug has 1/2 MIC than phthalylsulfathiazole. Also, it has high level MIC as much as phthalylsulfathiazole with Proteus, Pseudomonas. We conducted possibility of DDS as an applied for medicine with synthesized polymer drug by using natrural polymer. We consider that clinical research must be followed to verify safety and efficacy for controlled release, activity and toxicity.

• 대한한의학회지
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• 제30권1호
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• pp.137-149
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• 2009

Objectives: Pregnant women could have various diseases, but the treatment of medication has the limitation that could cause fetal injury. So pregnant women have used complementary and alternative medicine in the world, but korean medicine had not been actively studied on obstetrics. This study is to investigate efficacy and safety of complementary and alternative medicine on obstetrics. Methods: We searched for papers which had pregnancy, obstetrics, complementary medicine, acupuncture and herb in the pubmed since 2000. Results: 41 papers were found. Acupuncture have the efficacy and safety on nausea, pelvic pain in pregnancy and breech presentation. Complementary alternative medicine had been studied as randomized controlled trial at various diseases in obstetric. But the method were without coordination, results were different from methods. So more clinical trials about complementary and alternative medicine would be needed. Massage and acupressure would be helpful for pregnant mood complaint. Conclusion: Complementary and alternative medicine has been proved as efficacy and safety in obstetrics, so complementary and alternative medicine would be helpful method in pregnant women. For making guidelines on complementary and alternative medicine treatment during pregnancy, more research will be needed.

• 한국콘텐츠학회논문지
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• 제17권10호
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• pp.268-279
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• 2017

본 연구는 응급실 간호사를 대상으로 환자안전문화에 대한 인식, 환자안전역량, 안전간호활동의 관계를 파악하기 위하여 시도되었다. 연구대상은 9개 종합병원에서 근무하는 1년 이상의 경력간호사 중 응급실에서 근무하는 간호사 121명을 대상으로 하였으며, 연구도구는 환자안전문화, 환자안전역량, 안전간호활동의 구조화된 설문지를 이용하였다. 본 연구 결과 환자안전문화에 대한 인식은 5점 만점에 3.51, 개인차원의 환자안전 지식/태도가 가장 높게 나타났다. 환자안전역량은 5점 만점에 3.60으로 나타났으며, 하위영역은 태도 3.91, 기술 3.47, 지식 3.24 순이었다. 안전간호활동은 5점 만점에 3.85로 나타났으며 하위영역은 투약 간호가 가장 높게 나타났다. 안전간호활동과 환자안전문화에 대한 인식(r=.40, p<.001), 환자안전역량과 안전간호활동(r=.70, p<.001), 환자안전역량과 환자안전문화(r=.40, p<.001) 모두 정적상관이 있는 것으로 나타났다. 특히 환자안전문화에 대한 인식, 환자안전역량, 안전간호활동에 차이를 보이는 특성 중 최근 1년 이내 안전교육을 받은 것이 영향을 미치는 것으로 나타나 임상현장에서 이루어지는 안전교육의 중요성이 부각되었다. 또한 환자안전역량의 하위영역 중 지식 영역의 점수가 가장 낮게 측정되어 환자안전 관련 지식수준을 높이기 위한 노력이 필요하다.

• 정신신체의학
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• 제13권2호
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• pp.85-94
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• 2005

연구목적 : 본 전향적 개방형 연구는 섬망에 대한 quetiapine과 haloperidol의 효과와 안전성을 평가하기 위하여 시행되었다. 방법: DSM-lV에 의하여 섬망으로 진단된 40명(quetiapine군 19 : haloperidol군 21)을 대상으로 순차적으로 quetiapine과 haloperidol을 투여하였다. 약물의 1차적 효과를 평가하기 위하여 한국판 섬망 평가 척도를 매일 일주일간 시행하고, 약물에 의한 2차적 효과와 안전성을 평가하기 위해 전반적 임상 인상-심각도, 한국판 간이정신상태검사, 약물에 의한 추체외로 증상 평가 척도를 각각 연구 시작시와 7일째에 시행하였다. 자료의 수집은 2004년 11월부터 2005넌 6월까지 이루어졌다. 결과: 연구 기간 동안 두 군 모두 한국판 섬망 평가 척도의 점수가 유의하게 감소하였으며, 두 군간의 평균 척도점수는 유의한 차이가 없었다. 두 약물에 대한 치료 반응율에서도 유의한 차이가 없었다. 연구 기간 동안 임상적으로 심각하거나 위험한 부작용은 관찰되지 않았다. 결론: 본 연구 결과 섬망의 치료에 있어서 quetiapine은 haloperidol과 대등한 효과와 안전성을 보였다. 기존의 연구에서 haloperidol은 장기 복용시 운동성 부작용을 유발할 가능성이 크다고 알려져 있으므로, 그러한 부작용이 적다고 알려진 quetiapine이 장기간 지속될 수 있는 섬망의 치료에 있어 haloperidol을 대체할 수 있을 것으로 기대된다.