Background: & objective: The Korean government has expanded its benefit coverage to enhance patients' access to orphan drugs and cancer medicines. However, the number of new drugs whose indications were not applied to reimbursement in health insurance was increased. This study aimed to understand the perspectives of experts and various stakeholders on the introduction of a new funding program for cancer treatment and orphan drugs. Methods: We conducted email surveys comprising 19 questions, from September 9 to 26, 2016. We distributed questionnaires to members of the Pharmaceutical Benefit Appraisal Committee and Cancer Assessment Committee. We also conducted a qualitative study through group interviews with stakeholders, including pharmaceutical companies and some patient groups for diseases. Results: A total of 35 survey respondents recommended the introduction of a funding program for orphan drugs, whereas 66% recommended the launch of funding for anticancer drugs. In addition, most pharmaceutical companies and patient groups recommended the introduction of new funding programs targeting patients with cancer and rare diseases. However, some participants asserted that it would be more appropriate to modify the existing reimbursement scheme than launch new funding. Conclusion This study concluded that introducing new funding needs a social consensus to relieve financial hardships at the patient level.

Background: & objective: The Korean government has expanded its benefit coverage to enhance patients' access to orphan drugs and cancer medicines. However, the number of new drugs whose indications were not applied to reimbursement in health insurance was increased. This study aimed to understand the perspectives of experts and various stakeholders on the introduction of a new funding program for cancer treatment and orphan drugs. Methods: We conducted email surveys comprising 19 questions, from September 9 to 26, 2016. We distributed questionnaires to members of the Pharmaceutical Benefit Appraisal Committee and Cancer Assessment Committee. We also conducted a qualitative study through group interviews with stakeholders, including pharmaceutical companies and some patient groups for diseases. Results: A total of 35 survey respondents recommended the introduction of a funding program for orphan drugs, whereas 66% recommended the launch of funding for anticancer drugs. In addition, most pharmaceutical companies and patient groups recommended the introduction of new funding programs targeting patients with cancer and rare diseases. However, some participants asserted that it would be more appropriate to modify the existing reimbursement scheme than launch new funding. Conclusion This study concluded that introducing new funding needs a social consensus to relieve financial hardships at the patient level.

PURPOSE: Maintaining body temperature is a key vital function of human beings, but little is known about how body temperature of high-risk infants is sustained during early life after birth. The aim of this study was to describe hypothermia in high-risk infants during their first week of life and examine demographic, environmental, and clinical attributors of hypothermia. METHODS: A retrospective longitudinal study was done from January 1, 2013 to December 31, 2015. Medical records of 570 high-risk infants hospitalized at Neonatal Intensive Care Units (NICU) of a university affiliated hospital were examined. Body temperature and related factors were assessed for seven days after birth. RESULTS: A total of 336 events of hypothermia (212 mild and 124 moderate) occurred in 280 neonates (49.1%) and most events (84.5%) occurred within 24 hours after birth. Logistic regression analysis revealed that phototherapy (aOR=0.28, 95% CI=0.10-0.78), Apgar score at 5 minute (aOR=2.20, 95% CI=1.17-4.12), and intra-uterine growth retardation or small for gestational age (aOR=3.58, 95% CI=1.69-7.58) were statistically significant contributors to hypothermia. CONCLUSION: Findings indicate that high-risk infants are at risk for hypothermia even when in the NICU. More advanced nursing interventions are necessary to prevent hypothermia of high-risk infants.
Apgar Score ; Body Temperature ; Gestational Age ; Humans ; Hypothermia* ; Infant* ; Infant, Newborn ; Intensive Care Units, Neonatal ; Logistic Models ; Longitudinal Studies ; Medical Records ; Nursing ; Parturition ; Phototherapy ; Retrospective Studies

BACKGROUND: Although a growing number of guidelines and clinical researches are available for immunosuppressive treatment of post-transplantation, there is no clinical practice guideline for the care of kidney transplant recipients in Korea. Selection of a researchable question is the most important step in conducting qualified guideline development. Thus, we aimed to formulate key questions for Korean guideline to aid clinical decision-making for immunosuppressive treatment. METHODS: Based on previous published guidelines review, a first survey was constructed with 29 questions in the range of immunosuppressive treatments. The experts were asked to rate the clinical importance of the question using a 5-point Likert scale. The questions reached 60% or more from the first survey and additional new questions were included in the second survey. In analyzing the responses to items rated on the 9-point scale, consensus agreement on each question was defined as 75% or more of experts rating 7 to 9. RESULTS: In the first survey, 50 experts were included. Among the 29 questions, 27 were derived to get 60% or more importance and 3 new questions were additionally identified. Through the second survey, 9 questions were selected that experts reached consensus on 75% and over of the options. Finally, we developed key questions using PICO (patient, intervention, comparison, and outcome) methodology. CONCLUSION: The experts reached a high level of consensus on many of key questions in the survey. Final key questions provide direction for developing clinical practice guideline in the immunosuppressive treatment of transplantation.
Clinical Decision-Making ; Consensus ; Kidney Transplantation ; Kidney ; Korea ; Transplant Recipients

Background/Aims: Drugs with anticholinergic properties (DAPs) are associated with adverse health outcomes in older patients. The objective of this study was to evaluate the factors that determine the prescribing of more DAPs in long-term care hospitals (LTCHs) in Korea. In addition, the current patterns of DAP prescription were explored using a novel platform, which can collect data from LTCHs. Methods: This was a Health-RESPECT (integrated caRE Systems for elderly PatiEnts using iCT) sub-study, which is a pragmatic, cluster-randomized, controlled trial. The Health-RESPECT platform was used to collect prescribed medication data of 466 patients (aged ≥ 65 years) from seven LTCHs. DAPs were identified using the Korean Anticholinergic Burden Scale (KABS). Physical frailty, cognitive function, functional status, and quality of life were evaluated. Results: Among 466 LTCH patients, 88.8% (n = 414) were prescribed DAPs, and the prevalence of high KABS (≥ 3) was 70.4% (n = 328). The drugs that contributed most to the total KABS were quetiapine (20.7%), chlorpheniramine (19.5%), tramadol (9.8%), cimetidine (5.8%), and furosemide (3.6%). Polypharmacy, higher body mass index, less dependence, better communication and cognitive functions, and poorer quality of life were associated with high KABS. Conclusions Although the patients with a high burden of DAPs were less dependent and had better cognitive and communication functions, they had poorer quality of life. DAP use in LTCH patients should be monitored carefully, and the risk/ benefit relationship for their use should be considered.

OBJECTIVE: This study aimed to examine the associations between depression and both coronary artery disease (CAD) and cardiovascular risk factors (CVRs) in Korean women. Furthermore, this study sought to determine whether depression was associated with use of healthcare services in women with CAD or CVRs. METHODS: This cross-sectional study was conducted on 26,335 women who were aged 19 years or older, and who participated in the Korean National Health and Nutrition Examination Survey (2007–2014). Associations of prior diagnosis of depression with CAD and CVRs and with nonutilization of healthcare services were investigated. RESULTS: Women with depression had a higher prevalence of CAD and CVRs including obesity, hypertension, dyslipidemia, and metabolic syndrome than those without depression. In addition, depression was significantly associated with nonutilization of healthcare services in women with most CVRs. CONCLUSION: Considering the high rate of comorbid depression with CAD or CVRs and the low lvels of health service utilization in depressed patients, screening for common CVRs, such as obesity, hypertension, and dyslipidemia, should be provided for patients with depression in mental health care settings.
Coronary Artery Disease ; Cross-Sectional Studies ; Delivery of Health Care* ; Depression* ; Diagnosis ; Dyslipidemias ; Female ; Health Services ; Humans ; Hypertension ; Mass Screening ; Mental Health ; Nutrition Surveys ; Obesity ; Prevalence ; Risk Factors

OBJECTIVE: People with depression often suffer from comorbid, chronic physical diseases. Little is known about how demographic characteristics such as age and sex influence the prevalence of chronic physical diseases comorbid with depression. Therefore, this study aimed to explore the age and sex differences in the prevalence of diverse, chronic physical diseases comorbid with depression. METHODS: This cross-sectional survey were conducted with the participants (n=45,598) of the Korean National Health and Nutrition Examination Survey (KNHANES). Using log-binomial regression, age adjusted prevalence ratios (APR) of chronic physical diseases of participants with depression and those without depression were estimated for each sex and age group. RESULTS: The APR of most chronic physical diseases were significantly higher among respondents with depression than those without depression. Chronic physical diseases that showed the highest APR were asthma in adult male respondents (APR=3.46) and adult female respondents (APR=2.19) and chronic renal failure in elderly male respondents (APR=8.36) and elderly female respondents (APR=1.94). CONCLUSION: Prevalence ratios of the chronic physical diseases comorbid with depression differed according to sex and age groups. Collaborative care strategies should be designed according to demographic characteristics of the population.
Adult ; Aged ; Asthma ; Comorbidity ; Cross-Sectional Studies ; Depression* ; Female ; Humans ; Kidney Failure, Chronic ; Korea* ; Male ; Nutrition Surveys ; Prevalence* ; Sex Characteristics ; Surveys and Questionnaires

OBJECTIVE: To compare the analgesic effects and adverse drug reactions (ADRs) of fentanyl intravenous patient-controlled analgesia (ivPCA) with nefopam, a centrally acting analgesic agent with demonstrated opioid sparing activity, as compared to ketorolac in a tertiary teaching hospital. METHODS: A retrospective evaluation of electronic medical records was conducted on patient records including either nefopam or ketorolac with opioid ivPCA for post-operative pain management in general surgery department from January to December 2014. The status of pain control and ADRs were collected. RESULTS: Out of 6,330 general surgery cases, nefopam was given in 153 prescriptions (6.9%) and ketorolac in 81 prescriptions (3.6%). The level of pain control was not different between two groups (70.9% vs. 75.3%; p = 0.51), but ADRs were more frequently reported in nefopam group (9.8% vs. 2.5%; p < 0.05). New ADRs of hot flushes (n = 1) and paresthesia in hands (n = 1) were reported in nefopam group and they were unlisted in the approved package insert. No serious ADRs were reported in both groups. CONCLUSION: Our findings presented that nefopam showed a similar analgesic effect and higher ADR rates compared to ketorolac as an adjuvant to fentanyl iv PCA for postoperative pain management in general surgery patients in South Korea.
Analgesia, Patient-Controlled ; Analgesics, Opioid ; Drug-Related Side Effects and Adverse Reactions ; Electronic Health Records ; Fentanyl ; Hand ; Hospitals, Teaching ; Humans ; Ketorolac* ; Korea ; Nefopam* ; Pain Management* ; Pain, Postoperative ; Paresthesia ; Passive Cutaneous Anaphylaxis ; Prescriptions ; Product Labeling ; Retrospective Studies

Src family kinases (SFKs), an important group of non-receptor tyrosine kinases, are suggested to be excessively activated during various types of tissue fibrosis. The present study investigated the effect of KF-1607, an orally active and a newly synthesized Src kinase inhibitor (SKI) with proposed low toxicity, in preventing the progression of renal interstitial fibrosis. Unilateral ureteral obstruction (UUO) surgery was performed in 6-week-old male C57BL/6 mice to induce renal interstitial fibrosis. Either KF-1607 (30 mg/kg, oral gavage) or PP2 (2 mg/kg, intraperitoneal injection), a common experimental SKI, was administered to mice for seven days, started one day prior to surgery. UUO injury-induced SFK expression, including Src, Fyn, and Lyn kinase. SFK inhibition by KF-1607 prevented the progression of tubular injury in UUO mice, as indicated by decreases in albuminuria, urinary KIM-1 excretion, and kidney NGAL protein expression. Renal tubulointerstitial fibrosis was attenuated in response to KF-1607, as shown by decreases in α-SMA, collagen I and IV protein expression, along with reduced Masson’s trichrome and collagen-I staining in kidneys. KF-1607 also inhibited inflammation in the UUO kidney, as exhibited by reductions in F4/80 positive-staining and protein expression of p-NFκB and ICAM. Importantly, the observed effects of KF-1607 were similar to those of PP2. A new pan Src kinase inhibitor, KF-1607, is a potential pharmaceutical agent to prevent the progression of renal interstitial fibrosis.

Background/Aims: Gastroesophageal reflux disease (GERD) is typically managed based on the clinical phenotype. We evaluated the efficacy and safety of potassium-competitive acid blockers (PCABs) in patients with various clinical GERD phenotypes. Methods: Core databases were searched for studies comparing PCABs and proton pump inhibitors (PPIs) in clinical GERD phenotypes of erosive reflux disease (ERD), non-erosive reflux disease (NERD), PPI-resistant GERD and night-time heartburn. Additional analysis was performed based on disease severity and drug dosage, and pooled efficacy was calculated. Results: In 9 randomized controlled trials (RCTs) evaluating the initial treatment of ERD, the risk ratio for healing with PCABs versus PPIs was 1.09 (95% CI, 1.04-1.13) at 2 weeks and 1.03 (95% CI, 1.00-1.07) at 8 weeks, respectively. PCABs exhibited a significant increase in both initial and sustained healing of ERD compared to PPIs in RCTs, driven particularly in severe ERD (Los Angeles grade C/D).In 3 NERD RCTs, PCAB was superior to placebo in proportion of days without heartburn. Observational studies on PPI-resistant symptomatic GERD reported symptom frequency improvement in 86.3% of patients, while 90.7% showed improvement in PPIresistant ERD across 5 observational studies. Two RCTs for night-time heartburn had different endpoints, limiting meta-analysis. Pronounced hypergastrinemia was observed in patients treated with PCABs. Conclusions Compared to PPIs, PCABs have superior efficacy and faster therapeutic effect in the initial and maintenance therapy of ERD, particularly severe ERD. While PCABs may be an alternative treatment option in NERD and PPI-resistant GERD, findings were inconclusive in patients with night-time heartburn.