• Korean Journal of Clinical Pharmacy
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• v.32 no.2
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• pp.116-124
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• 2022

Background: High-alert medications (HAMs) are medications that bear a heightened risk of causing significant patient harm if used in error. To facilitate safe use of HAMs, identifying specific HAM lists for clinical setting is necessary. We aimed to develop the national level HAM list for acute care setting. Methods: We used three-step process. First, we compiled the pre-existing lists referring HAMs. Second, we analyzed medication related incidents reported from national patient safety incident report data and adverse events indicating medication errors from the Korea Adverse Event Reporting System (KAERS). We also surveyed the assistant staffs to support patient safety tasks and pharmacist in charge of medication safety in acute care hospital. From findings from analysis and survey results we created additional candidate list of HAMs. Third, we derived the final list for HAMs in acute care settings through expert panel surveys. Results: From pre-existing HAM list, preliminary list consisting of 42 medication class/ingredients was derived. Eight assistant staff to support patient safety tasks and 39 pharmacists in charge of medication safety responded to the survey. Additional 44 medication were listed from national patient safety incident report data, KAERS data and common medications involved in prescribing errors and dispensing errors from survey data. A list of mandatory and optional HAMs consisting of 10 and 6 medication classes, respectively, was developed by consensus of the expert group. Conclusion: We developed national level HAM list for Korean acute care setting from pre-existing lists, analyzing medication error data, survey and expert panel consensus.

• Korean Journal of Biological Psychiatry
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• v.4 no.2
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• pp.265-271
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• 1997

Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

• Journal of Gastric Cancer
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• v.17 no.2
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• Journal of the korean academy of Pediatric Dentistry
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• v.34 no.2
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• pp.234-246
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• 2007

The combination of chloral hydrate and hydroxyzine is one of the safest and most commonly used drug regimens for sedating young, uncooperative pediatric dental patients. Midazolam IM or IN and $N_2O/O_2$ inhalation is sometimes administered with chloral hydrate and hydroxyzinecombination when deeper and longer sedation is needed. The purpose of this study was to assess the outcome and safety of chloral hydrate, hydroxyzine and $N_2O/O_2$ in the sedation of a large number of uncooperative pediatric dental patients and to identify variables associated with their effectiveness. In a nine-month retrospective study, 171 records of sedation performed in 94 healthy children(male 46, female 48) with mean age of $30{\pm}8$ months were reviewed. The authors analyzed several variables such as age, sex, weight, methods of drug delivery, waiting time after drug delivery, treatment rendered, treatment time, adverse events, sedation outcome. Eighty five percent of sedation had success behavioral outcome. Sedation sessions rated success used more $N_2O/O_2$ administration and had longer treatment duration than sedation sessions rated failure. A children patient under 36 months of age had enough sleep by only oral administration and the mean waiting time of this case was significantly shorter than that of a children patient over 36 months of age. There was a clear correlation between age and $N_2O/O_2$ using tine, but no correlation between weight and $N_2O/O_2$ using time. There was no statistically significant difference among variables of treatment duration, $N_2O/O_2$ administration and adverse event.

• Childhood Kidney Diseases
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• v.13 no.2
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• pp.197-206
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• 2009

Purpose : Limited information is available on experiences of intravenous iron treatment in children. In this study, iron sucrose was administered intravenously to determine its effect, the factors predicting outcome, and safety in children on chronic dialysis. Methods : Twenty-one children whose serum ferritin levels were less than 100 ng/mL or transferrin saturations (TSAT) were less than 20% were enrolled. In 12 children on peritoneal dialysis (PD), the drug was infused intravenously as 200 mg/$m^2$ ($\leq$200 mg) at week 0, 2, 4, and 6. In 9 children on hemodialysis (HD), it was given intravenously as 8 weekly doses of 3 mg/kg ($\leq$100 mg) through week 0-7. Results : After treatment, serum ferritin levels increased significantly in both groups, and TSAT rose significantly in PD group. However, hemoglobin level did not rise significantly in both groups. Children with baseline hemoglobin less than 10 g/dL or baseline TSAT less than 20% showed significantly higher rise of hemoglobin after intravenous iron treatment. To the contrary, those with higher baseline hemoglobin and TSAT levels displayed higher rise in serum ferritin after the treatment. Although no serious adverse event occurred, TSAT levels exceeding 50% were noted in 6 patients in PD group. Conclusion : This suggests that 3 mg/kg/week of intravenous iron sucrose can be used safely in children on chronic HD, but 200 mg/$m^2$ every other week may incur excessive TSAT level in some patients on chronic PD.

• Journal of Oriental Neuropsychiatry
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• v.32 no.2
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• pp.81-93
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• 2021

Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

• Journal of Digestive Cancer Research
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• v.5 no.2
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• pp.113-119
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• 2017

Background: Second line chemotherapy is often considered in advanced gastric cancers. We assessed irinotecan in combination with fluorouracil in patients experienced diseases progression after first line chemotherapy. Methods: Prospective trial was done at 7 centers in republic of Korea. Patients aged 18 years or older with advanced gastric adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy were assigned to receive irinotecan 180 mg/m² and 5-fluorouraicl 400 mg/m² intravenously bolus injection on days 1 and leucovorin 200 mg/m² for 2 hours and 5-fluorouracil 600 mg/m² for 22 hours intravenously infusion on day 2 of a 14-day cycle (FOLFIRI group). The primary endpoint was objective tumor response (OR). Efficacy analysis was by per-protocol, and safety analysis included all patients who received at least one treatment with study drug. Results: Between January 1, 2014 and December 31, 2016, 28 patients were assigned to FOLFIRI treatment. Of those 20 patients were completed the study protocol. Per-protocol analysis, two patients among 20 subjects (10.0%) showed partial response. Overall survivals of FOLFIRI group; median 10.1 months [95% CI 4.9-15.3] Grade 3 and higher adverse event that occurred about 5%, but grade 3 or higher febrile neutropenia or life threatening complication was not reported. Conclusion: Combination chemotherapy with irinotecan, 5-FU, and LV is feasible in gastric cancer patients previously treated with platinum-based chemotherapy