Objective: This study aimed to explore the readability and comprehensibility of the drug information on a patient leaflet for the senior by employing performance-based user-testing. Methods: We included 36 elderly (65 years old or older) as the senior group (intervention group) and 36 adults (40~59 years old) as the adult group (control). We developed a questionnaire to test if participants could access to drug information. After completing a questionnaire, the participant was interviewed about their understanding over the patient leaflet. We performed t-test, ${\chi}^2$-test or Fisher's exact test to examine differences between two groups in primary outcomes. Results: The senior were less likely able to find information (78%) than the adult (91%); they were much less likely able to understand information (42%) than the adult (69%). While we found differences between the ability of finding and understanding drug information in both groups, the senior group had greater difficulties in understanding all kinds of drug information. They had significant difficulties to remember information after reading the patient leaflet and frequently failed to find proper information even though they were allowed to access freely to the leaflet during interviewing. Conclusion: To secure safe and effective use of drugs for the senior, it is necessary to develop drug leaflets for the senior.

Background: South Korea is rapidly being an aging-society and the demand of long-term care insurance services for elderly patients is rising. In addition, because the elderly taking multiple medicines, the adherence is lowered and the adverse events are easily occurred. Therefore, many are interested in introducing the geriatric pharmacy specialist to manage this situation. Purpose: By applying a similar program such as the geriatric pharmacy specialist working in nursing home, we conducted this study to evaluate the potential contribution to both the health insurance services and financial savings for the elderly patients. Methods: We conducted a trial in an elderly nursing home to collaborate between doctor and pharmacist making a checklist for improving medication adherence and establish a consultation system. Also we applied a smart phone application in the pharmaceutical care processes. Results: Thereby completing the drug therapy related checklist apply to nursing facilities in South Korea. And we got a performance that improves medication adherence when used in the clinical practice settings. Conclusion: By introducing a training program of pharmacy care managers and geriatric professionals such as the United States and Japan, we revealed the elderly nursing home residents and vulnerable elderly people living alone were improved the medication adherence and it will contributed to the health and quality of life of the patients.

Objective: The visually impaired have limited access to health care services and related information, and thus, they can have serious hurdles against properly taking medications. Despite that it is important to improve self-care ability of the visually impaired for correct medication use, there have been few studies investigating their needs for health care services in Korea, particularly focusing on proper medication usage. This study is to explore safety-related issues regarding mediation usage among the visually impaired based on in-depth interview. We particularly focus on any obstacles for safe use of medicines including experience on medication-related adverse effects in order to provide preliminary evidence for policy measures to improve proper medication use among the visually impaired. Methods: Study sample was visually impaired individuals who resided in Seoul area and were registered in the National Association of Visually Impaired. The association helped the process of recruiting the study participants. In-depth interview for each study participants was conducted. Each interview was recorded and later converted into a written script to extract core contents for the analysis. Results: The study participants comprised of three women (42.9%) and four men (57.1%). One was in his 20's, and there were four participants in 30's and two in 40's. Fully impaired participants were majority (5 out of 7). Limitation to physical access to health care providers and health information were the key factors to hamper safe medication utilization among the study participants. Difficulty reading medication information and may take the wrong medication or incorrect doses of medication, resulting in serious consequences, including overdose or inadequate treatment of health problems. Visually impaired patients report increased anxiety related to medication management and must rely on others to obtain necessary drug information. Pharmacists have a unique opportunity to pursue accurate medication adherence in this special population. This article reviews literature illustrating how severe medication mismanagement can occur in the visually impaired elderly and presents resources and solutions for pharmacists to take a larger role in adherence management in this population. Conclusion: The visually impaired had difficulties reading medication information and identifying medicines, and took incorrect doses of medications. Public support for safe medication use and medication management among the visually impaired is necessary.

Background: Elements of informed consent including capacity, disclosure, understanding, voluntariness, and permission of the participant, are all crucial for clinical trials to be legally and ethically valid. During the informed consent process, the patient information leaflet is an important information source which prospective research subjects can utilize in their decision-making. In the adequate provision of information, KGCP guideline necessitate 20 specific items, as well as the use language that individuals can understand. This study measures the vocabulary level of patient information leaflets in an effort to provide an objective evaluation on the readability of such material. Methods: The word difficulty of 13 leaflets was quantitatively evaluated using Kim kwang Hae's vocabulary grading framework, which was compared to the difficulty level of words found in the $6^{th}$ grade Korean textbook. The quantitative outcomes were statistically analyzed using chi-squared tests and linear by linear association for ordinal data. Results: There was a statistically significant difference between the vocabulary level and frequency of words in leaflets and the 6th Korean textbook. The leaflets were on average 260 sentences and about roughly 15 pages long, including lay language (easier or equal to language used in primary school) of around 12% less; technical language of around 4.5% more. As the vocabulary grades increase, there was a distinct difference in vocabulary level between Korean textbook and each information leaflet (p < 0.001). Conclusion: Patient information leaflets may fail to provide appropriate information for self-determination by clinical trial subject through the difficulty level of its wording. Improvements in the degree of patients' understanding and appropriate use of information leaflets are collaboratively equipped to strengthen patient's autonomy and therefore guaranteeing participant's rights.

Objective: The increasing use of imaging examinations such as computed tomography (CT) results in increased contrast media use, which increases contrast media-induced adverse reactions (AR). This study investigated the risk factors of ARs to nonionic iodinated contrast media. Methods: This study evaluated patients who were administered iodinated contrast media during CT scanning in Yeouido St. Mary's Hospital in Seoul, Korea in 2012. Among the subjects, those with contrast media-induced ARs were classified as the AR group. The control group included individuals without ARs who were selected through simple random sampling. The effects of sex, age, contrast media type and dose, CT region, previous contrast media administration, allergy history, and comorbidity were analyzed in the AR and control groups. Results: Multivariate logistic regression analyses were performed to evaluate the identified AR risk factors in 103 subjects in the AR group and 412 subjects in the control group. The results confirmed that the risk of developing ARs was significantly higher in females [odds ratio (OR): 2.206; 95% confidence interval (CI): 1.353-3.598], in individuals administered Iohexol (OR: 9.981; 95% CI: 2.361-42.193), in individuals with an allergy history (OR: 3.982; 95% CI: 1.742-9.101), and in individuals with comorbid asthma (OR: 6.619; 95% CI: 1.377-31.826). Most of the ARs were mild and immediate. Conclusion: In patients who were administered contrast media during CT scans, female gender, Iohexol use, allergy history, and asthma were risk factors for ARs. Therefore, special care is required for patients with such risk factors to prevent ARs.

Background: The use of acid suppressive agents became a standard therapy in an intensive care unit (ICU) to prevent stress related gastrointestinal mucosal damage. However, the risk of infectious diseases has been concerned. Objective: The study was to determine the differences between histamine 2 receptor antagonists (H2RA) and proton pump inhibitors (PPI) in incidence of nosocomial pneumonia and pseudomembranous colitis (PMC) by Clostridium difficile with patients in ICU. Methods: This is a retrospective comparative study including patients admitted to the ICU who were at least 18 years of age and stayed for more than 48hrs from August 1, 2014 to January 31, 2015. The propensity score analysis and propensity matched multivariable logistic regression were used in analyzing data to control for confounders. Results: A total of 155 patients were assessed. H2RA were prescribed in 110 (53.9%) and PPI were in 45 (22.1%). Nosocomial pneumonia developed in 37 (23.9%); 25 (22.7%) were on H2RA and 12 (26.7%) were on PPI. The unadjusted incidence of nosocomial pneumonia was slightly higher in the patients with PPI (odds ratio (OR) 1.24; 95% confidence interval (CI): 0.54-2.71) compared to them with H2A. After adjusting with propensity score, the adjusted OR with PPI was 1.35 (95% CI: 0.44-4.11). The propensity score matched analyses showed similar results. Conclusion: The uses of PPI and H2RA as a stress ulcer prophylaxis agent showed similarity in the incidence of nosocomial pneumonia and PMC.

Objective: To estimate the association between ABCG2 C421A polymorphism and response to imatinib in chronic myeloid leukemia. Methods: A systematic review was conducted to evaluate the effect of ABCG2 C421A polymorphism on imatinib response. The databases of PubMed, Embase, Web of science, CINAHL with FullText, and Cochrane Library were searched for all published studies from inception to December 2015. The following terms were used with functions of 'AND' and 'OR': 'chronic myeloid leukemia', 'CML', 'drug transporter', 'ABCG2', 'BCRP', 'polymorphisms', 'SNPs', and 'imatinib'. The studies reporting the association between ABCG2 polymorphism and imatinib response were evaluated. Results: A total of 7 studies were included in the present meta-analysis. The pooled analysis showed that ABCG2 c.421CC genotype was significantly associated with poor response to imatinib under the dominant model (CC vs CA+AA; OR: 0.56; 95% CI: 0.41, 0.77; p = 0.0004). The subgroup analysis of Asian studies demonstrated a significantly lower response in c.421CC genotype than in c.421CA or c.421AA genotype (OR: 0.52; 95% CI: 0.37, 0.73; p = 0.0002). In subgroup analyses of 5 studies, the patients with the c.421CC genotype exhibited higher risk for worse response than the patients with c.421CA or c.421AA genotype (heterozygote codominant model: CC vs. AC; OR: 0.49, 95% CI: 0.33, 0.73; p = 0.0006; homozygote codominant model: CC vs AA; OR: 0.43; 95% CI: 0.25, 0.75, p = 0.003). Conclusion: The ABCG2 c.421CC genotype was significantly associated with poor response to imatinib compared to the c.421CA and c.421AA genotypes in chronic myeloid leukemia, especially in Asian patients.

Background: The subcutaneous formulation of biologic disease-modifying antirheumatic drugs (DMARDs) was preferred due to favored self-administration and would be an economical treatment option for patients with rheumatoid arthritis. This study was to compare the economic impact of biologic DMARDs administered by subcutaneous injection in patients with rheumatoid arthritis who had inadequate response to conventional DMARDs. Methods: The cost-minimization analysis was conducted to estimate the lifetime health care costs of treatment sequences with subcutaneous biologic DMARDs as first-line therapy from a health care system perspective. The Markov model was developed to represent the transitions through treatment sequences based on American College of Rheumatology response rate and discontinuation rate. The health care costs comprised the cost of medications, administration, dispensing, outpatient visits, test/diagnostic examination, palliative therapy and treatment of serious infection. All costs were expressed in 2016 Korean Won (KRW) and discounted at 5%. Results: The mean lifetime health care cost per patient was lowest in the etanercept sequence, which was estimated at KRW 63,441,679. The incremental costs of the treatment sequence started with adalimumab, golimumab, abatacept, and tocilizumab were KRW 7,985,730, KRW 4,064,669, KRW 2,869,947, and KRW 4,282,833, respectively, relative to etanercept sequence. These differences in costs mainly were attributable to medication costs. One-way and probabilistic sensitivity analyses confirmed that etanercept represented the option with the lowest cost compared with comparators. Conclusion: This study found that etanercept is likely a cost-saving treatment option among subcutaneous biologic DMARDs in patients with rheumatoid arthritis.

Background: The use of the extracts from evening primrose seeds as a health functional food has been gradually increased. Therefore, the monitoring and screening process has been considerably required for its quality control. Objective: This study aimed to estimate the measurement uncertainty associated with determination of penta-o-galloyl ${\beta}$-D-glucose (PGG) in extracts from evening primrose seeds by high-performance liquid chromatography. Methods: The sources of measurement uncertainty was expressed in accordance with mathematical/statistical theories of GUM & EURACHEM Guide. The expanded uncertainty was calculated by using the relative standard uncertainty between analytical result and sources of uncertainty in measurement (sample weight, final volume, extraction volume, standard solution, matrix and instrument etc). Results: In the results of 95% confidence interval, the uncertainty in measurement was $10,253.34{\pm}1,844.50{\mu}g/kg$ (k = 2.0). Conclusion: In this study, it showed that the value of uncertainty in measurement for determination of PGG in extracts from evening primrose seeds by HPLC has about 18.0% influence on PGG contents of the analytical results. The results would be very useful for the monitoring and screening of evening primrose seeds marketed in Korea for its quality control as dietary supplement.

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

Objective: Atrial fibrillation (AF) guidelines have been published in the USA and Europe. Recently, the USA and Europe have updated their guidelines, respectively. These new AF guidelines help in addressing key management issues in clinical situations. This study, therefore, systematically compared guidelines for rate and rhythm control pharmacotherapy of patients with AF between the USA (American College of Cardiology and American Heart Association, ACC/AHA) and Europe (European Society of Cardiology, ESC). Methods: This study investigated and compared American guidelines (2014) and European guidelines (2010 and 2012). Results: Generally, there are four meaningful differences between ACC/AHA and ESC guidelines. Important differences are treatment classification system, level of recommendation, drug list, and dosage. In addition, ACC/AHA described pharmacokinetic drug interactions for antiarrhythmic drugs. ESC emphasized ECG and atrioventricular nodal slowing as feature of antiarrhythmic drugs. Conclusion: This research addresses important use of anti-arrhythmic drugs and movement to accept recent recommendations in Korea. For the successful application of the guidelines, a role of pharmacists is crucial in clinical situation.