• 보건의료기술평가
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• 제5권1호
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• pp.31-41
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• 2017

Objectives: To explore prevalently used types of medication error and the types of medication error which would be appropriate to be used in Korea. Methods: In depth literature review was performed to explore the mostly used types of medication error in the United States, Canada, Europe, Australia, and Japan. We intended to examine experts' view on the suitability of the types of medication error to be used in Korea. The types of medicati0on error were classified by activity criteria, severity criteria, process criteria, and responsible person criteria based on literature reviews. Results: According to the result of literature review, activity criteria was the most commonly used type of medication error. Ten experts in the area of patient-safety and medication error responded and the top two types of medication error which were appropriate and suitable to be used in Korea were severity criteria and activity criteria. Conclusion: Severity criteria and activity criteria could be recommended to be used as the standard types of medication error in Korea although there are other types of criteria such as process criteria and responsible person criteria.

• 한국임상약학회지
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• 제31권3호
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• pp.237-246
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• 2021

Background: Pembrolizumab, an anti-cancer drug, is known to increase the activity of the immune system, leading to side effects called immune-related adverse events (irAE), including type 1 diabetes. This study analyzed the correlation between blood glucose level and pembrolizumab administration and investigated the covariates that affect those changes in cancer treatment. Methods: The information of 133 adult cancer patients was obtained from the electronic medical record (EMR) to identify the changes in random blood glucose (RBG) levels during the pembrolizumab treatment. Subjects were classified into subgroups according to their baseline RBG level, history of diabetes, and the use of steroids, and linear regression analysis was conducted. In addition, a secondary analysis was performed within the group of subjects having a strong correlation to glycemic change, which was based on the Pearson correlation coefficient being less than -0.7 or greater than +0.7. Univariate and multivariate logistic regressions were conducted to identify the risk factors to glycemic increase. Results: The RBG level tended to descend without significant differences in total patients during the administration period of pembrolizumab. Despite the insignificance, the logistic regression analysis presents that the odds ratios of baseline RBG less than 130 mg/dL, prophylactic steroid use, and higher dose of pembrolizumab per cycle (mg/kg/cycle) were greater than 1. Conclusions: Prophylactic administration of steroids and a higher dose of pembrolizumab per cycle may increase the blood glucose level as irAE in cancer patients with a strong tendency to glycemic change.

• 한국임상약학회지
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• 제29권3호
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• pp.173-185
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• 2019

Objective: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. Methods: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. Results: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. Conclusion: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.

• 한국임상약학회지
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• 제31권2호
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• pp.104-114
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• 2021

Objective: To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. Methods: We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. Results: Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. Conclusion: We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.

• 생약학회지
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• 제52권1호
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• pp.1-12
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• 2021

Platycodon (Platycodon grandiflorum) is used as a food and medicinal ingredient worldwide, particularly in Northeast Asia. Although a large number of studies have been conducted to determine its medicinal efficacy, there is still a paucity of literature summarizing the clinical activity of Platycodon. In this systematic review, we aimed to summarize the clinical efficacy of Platycodon. All literature describing the clinical efficacy of Platycodon was collected from international databases, and relevant papers were carefully evaluated for eligibility. Data were extracted from the selected papers and quality evaluation was conducted in accordance with the standards provided by the National Institutes of Health (NIH), with all procedures being conducted in accordance with PRISMA 2009 checklist guidelines. After the removal of 342 papers, 644 studies were fully screened for their titles and abstracts, among which, 19 studies were finally selected for full summarization. Extraction of data indicated evidence of the effectiveness of Platycodon in the treatment of respiratory system-related diseases and cancer, and in the provision of immunity. However, we found that the quality and objectivity of evaluation, management of variable factors, sample size, and reproducibility were generally poor. Although Platycodon has shown potential antiviral, antibacterial, anticancer, and antidepressant effects, and promotion of immunity in clinical settings, it was not possible to integrate objective indicators to conduct a meta-analysis due to the lack of literature and insufficient studies. More investigations in the clinical setting should be conducted to confirm the functional effects of Platycodon.

• 한국임상약학회지
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• 제32권3호
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• pp.260-269
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• 2022

Background: Comprehensive medication management is essential to achieve safe and optimal drug use for the elderly in long-term care facilities (LTCF). This study aimed to develop eligibility criteria for "Comprehensive medication management program in LTCF" using the RAND/UCLA Appropriateness Method (RAM). Furthermore, we attempted to estimate the number of beneficiaries who met the criteria by analyzing the National Health Insurance claims data. Methods: Twelve criteria were selected initially. We composed a panel of 14 experts with expertise in long-term care. We conducted two survey rounds to reach a consensus. Rating for appropriateness and decision regarding agreement were applied per RAM. We analyzed the National Health Insurance data to estimate the number of LTCF residents who met each eligibility criterion. Results: Of the 11 items agreed upon, ten items were determined to be appropriate. In 2018, 83.6% of 165,994 residents of LTCF met one or more eligibility criteria. The largest number of subjects met the "New residents of LTCF" criterion, followed by "Take high-alert drugs" and "Chronic excessive polypharmacy." Since the items evaluated as most appropriate by the expert panel and those with a large number of subjects were similar, we confirmed the external validity of our criteria. Conclusion: It is worth noting that this is the first attempt to establish the eligibility criteria for medication management in LTCF. Further preliminary research is needed to identify the selected subjects' drug-related problems and revise the criteria according to the results.

• 생명과학회지
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• 제33권9호
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• pp.736-745
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• 2023

노화란 세포 및 생리 기능이 점진적으로 손상되는 복잡한 과정이다. 알츠하이머, 동맥경화 및 갱년기와 같은 노화와 관련된 질병은 노화가 진행이 되면서 발생된다. 노화와 관련된 질환은 다양한 원인에 의해 발생된다. 그 중 유전적인 변화 없이 유전자 발현을 조절하는 후성유전의 변화는 노화, 그리고 노화와 관련된 질환의 발생에 중요한 조절자로 알려져있다. 이 리뷰에서는 후성유전의 변화가 노화 및 노화와 관련된 질병의 발전과 진행에 어떠한 역할을 하는지에 대해 서술하였다. 노화 중에 일어나는 유전적 변화의 분자적 기전과 이러한 변화가 노화와 관련된 질병에 미치는 영향, 특히 노화와 관련된 질환과 관련된 유전자 발현 양식을 조절하는 RNA 메틸화, DNA 메틸화 및 miRNA에 대해 중점적으로 초점을 맞추었다.

• 한국임상약학회지
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• 제32권1호
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

• 한국임상약학회지
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• 제34권1호
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• 약학회지
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• 제17권2호
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• pp.55-70
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• 1973