• 한국임상약학회지
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• 제23권3호
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• pp.256-268
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• 2013

Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.

• 한국임상약학회지
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• 제24권1호
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• pp.45-52
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• 2014

Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.

• 대한한의학회지
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• 제36권1호
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• pp.45-60
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• 2015

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

• 약학회지
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• 제53권6호
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• pp.328-333
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• 2009

Contrast media are substances that are used to enhance the contrast of structures or fluids within the body in medical imaging. Those are commonly used to enhance the visibility of blood vessels and the gastrointestinal tract. The aim of this study is to evaluate patients who got injected iopamidol, developed as one of contrast medium regarding changes in cardiovascular system and especially, adverse drug reactions. This study were performed on randomly selected a total of 51 patients (range of 15~85 years old) who got injected contrast medium, Iopamidol at a P hospital in Gyeonggi province from September 22nd, 2008 to January 24th, 2009. Data were collected by questionnaire though person to person. We analyzed the data by SPSS (Version 12. for windows). Methods of analysis were frequency and cross analysis. In results, 19.6% (n=10) were founded for adverse drug reactions of contrast medium. 25.0% (n=4) of 10 patients who had adverse drug reactions of contrast medium had took abdomen contrast test. 2 patients of those took contrast test for chest. Also, 3.9% (n=2) patients felt vomiting and nausea after injection of contrast medium. In conclusion, 19.6% patients experienced adverse drug reaction of contrast medium. Therefore, when taking radiation test, we should make efforts to minimize adverse drug reactions to achieve suitable and effective treatment.

• 한국임상약학회지
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• 제30권2호
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• pp.92-101
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• 2020

Background: Delirium is a neuropsychiatric disorder characterized by sudden impairments in consciousness, attention, and perception. The evidence of successful pharmacological interventions for delirium is limited, and medication recommendations for managing delirium are not standardized. This study aimed to provide evidence of antipsychotics for symptomatic treatment of delirium in cancer patients receiving palliative care. Methods: We retrospectively reviewed adult cancer patients in palliative care who received antipsychotic delirium treatment at Severance Hospital between January 2016 and June 2019. The efficacy was evaluated primarily by resolution rates. The resolution of delirium was defined as neurological changes from drowsiness, confusion, stupor, sedation, or agitation to alertness or significant symptomatic improvements described in the medical records. The safety was studied primarily by adverse drug reaction incidence ratios. Results: Of the 63 enrolled patients, 60 patients were included in the statistical analysis and were divided into three groups based on which antipsychotic medication they were prescribed [quetiapine (n=27), haloperidol (n=25) and co-administration of quetiapine and haloperidol (n=8)]. The resolution ratio showed quetiapine to be more effective than haloperidol (p=0.001). No significant differences were seen in adverse drug reaction rates among the three groups (p=0.332). Conclusions: Quetiapine was considered the most effective medication for delirium, with no significant differences in adverse drug reaction rates. Therefore, quetiapine may be considered a first-line medication for treating delirium in cancer patients receiving palliative care. However, further studies comparing more diverse antipsychotics among larger populations are still needed.

• 대한예방한의학회지
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• 제9권2호
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• pp.107-123
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• 2005

Traditional herbal medicine is widely used among the Korean people, and other eastern Asian countries employ similar therapies as well. In recent years, due to increasing interest in herbal medicine, many researches have been made on the toxicity and adverse drug reactions of herbal medications. Through private and public media, there have been many opinions that taking herbal medicine is very harmful, especially, to liver and kidney. We face upon evaluation of herbal medication, safe, and efficacy. Furthermore, we need to control quality of herbs. This study aims to verify the evidence that taking herbal medicine will yield equal reaction in 2 lab animal groups (A and B). One frequently prescribed herbal medication, Yugmijihwangtang, was used to test the evaluation of quality on lab animals (SD-Rat). There were no significant differences in body, visceral weight, and serum analysis test results after herbal medication for 1 month. But, AST and ALT scores were raised in 2 subjects in group A (over reference range). It seems to be an adverse drug reaction, and this finding was restricted in group A herbal medicine. These results suggest that we need to qualify herbal plants in Korea, and study which herbs would cause specific reactions in human.

• 대한지역사회영양학회지
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• 제3권1호
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• pp.76-93
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• 1998

Three hundred sixty-two(male 131, female 231) elderly aged over 65 in Chungb- uk area were interviewed to determine the disease states and drug usage patterns. The prebalence of disease was 78% and women reported more chronic diseases(83%) than men(71%). Elderly who live with spouse and have an occupation have a lower rate of disease. Average number of diseases of the elderly was $1.8\pm{1.1}$, and women$(2.1\pm{1.3)}$ have significantly higher average number of diseases than that of men$(1.4\pm{0.7)}$. Also the elderly in urban areas$(2.1\pm{1.4)}$ have significantly higher number of diseases than that of the elderly in rural areas$(1.6\pm{0.9)}$. Arthritis, hypertension, cardiovascular and gastric diseases were the most frequently listed chronic diseases in order for both men and women. Anemia and fracture of bone were relatively higher in women than in men. Particularly, the arthritis of the urban elderly have a rate of 1.5 times higher than that of the rural elderly. Fifty-two percent of the elderly were currently using drugs ; among drug users 71.2% used prescription drugs and 20.5% used nonprescription drugs. The average number taken per person was 2.1$\pm$1.4 and there was no sex or age difference. However, the elderly in rural areas $(2.7\pm{1.7)}$ consumed a significantly higher number of drugs than those in urban areas$(1.7\pm{0.7)}$. The average number of prescripti- on drugs taken was 2.0$\pm$1.4 while the average of nonprescription drugs taken was $(1.3\pm{0.6)}$. Analgesics and antihypertensive drugs were most commonly used. Vitamin and analgesics were the most frequently used self-prescribed drugs. It was noted that potential adverse drug interaction by concominant drug consumption for arthritis and antihypensive drug, abuse of digestants and antiacid without treatment of the underlying disease, and misuse of quick-acting bowel medications were problematic for the elderly. In addition drugs used for the elderly have some adverse effect on the digestive system. The types and composition of drugs used by the elderly were identified and presented. Medication compliance was poor and 13.5% reported adverse reactions such as edema, heartburn, nausea, and difficulty with eating. Seventeen percent of the elderly obtained drugs arranged by those other than medical staff. Also, even among those elderly who obtained drugs prescribed by a doctor, 69.1% of subjects had not receive instruction about potential adverse reactions. These results suggest that nutritional problems related to drug usage might exist and so dietitians, either individually or as members of health teams, need to have a better understanding of drug-nutrient interaction and closer supervision, and drug information/education service should therefore be provided to prevent or minimize adverse drug reaction in elderly users of medication.

• 한국임상약학회지
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• 제29권2호
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• pp.125-132
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• 2019

Objective: To examine the perceptions and attitudes toward spontaneous adverse drug reaction (ADR) reporting system among community pharmacists and identify factors that influence reporting, by implementing a survey. Methods: A structured questionnaire was developed and distributed online. Request for the survey was posted on the website of pharmacy's billing program, and the survey was conducted for 8 days. We collected the participants' response on their work environment, experience of ADR reporting, and their perception and attitude on the reporting system. Multivariate logistic regression was used to evaluate factors influencing ADR reporting. Results: A total of 382 pharmacists participated in the survey. Significant contributing factors for reporting level were age (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84-0.96), knowledge of reporting method (OR, 53.56; 95% CI, 9.10-315.41), installation of reporting program (OR, 31.92; 95% CI, 4.16-244.75), and encouragement from the Korean pharmaceutical association (OR, 4.13; 95% CI, 1.11-15.35). Regarding the attitude toward spontaneous ADR reporting system, 'lack of time for reporting' (OR, 0.29; 95% CI, 0.15-0.53) and 'complexity of reporting procedure' (OR, 0.51; 95% CI, 0.31-0.84), were associated with a low likelihood of reporting. Conclusion: Our results indicated that the knowledge of ADR reporting method, installation of the reporting program, and encouragement from the Korean Pharmaceutical Association contribute to active reporting. It is necessary to simplify the reporting method, make the ADR reporting program user-friendly, and provide educational interventions to increase participation in spontaneous reporting by the community pharmacists.

• Tuberculosis and Respiratory Diseases
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• 제78권1호
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• pp.27-30
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• 2015

The drug reaction with eosinophilia and systemic symptom (DRESS) syndrome is a severe adverse drug-induced reaction which includes a severe skin eruption, fever, hematologic abnormalities (eosinophilia or atypical lymphocytes) and internal organ involvement. The most frequently reported drug was anticonvulsants. The diagnosis of DRESS syndrome is challenging because the pattern of cutaneous eruption and the types of organs involved are various. The treatments for DRESS syndrome are culprit drug withdrawal and corticosteroids. Here we report a 71-year-old man with skin eruption with eosinophilia and hepatic and renal involvement that appeared 4 weeks after he had taken anti-tuberculosis drugs (isoniazid, ethambutol, rifampicin, and pyrazinamide), and resolved after stopping anti-tuberculosis drugs and the administration of systemic corticosteroids. DRESS recurred after re-challenging isoniazid, we identified isoniazid was causative drug.

• 한국임상약학회지
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• 제20권2호
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• pp.128-137
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• 2010

This review summarizes gender differences in pharmacokinetics, pharmacodynamics, and adverse drug reactions. Gender differences in pharmacokinetics are categorized by four major factors: absorption/bioavailability, distribution, metabolism, and elimination. There are sex-based differences in gastric emptying time, gastric alcohol dehydrogenase activity, apparent volume of distribution, ${\alpha}1$-acid glycoprotein level, phase I (CYP) and phase II metabolizing enzymes, glomerular filtration rate, and drug transporters. This review also reports gender differences in pharmacokinetics and pharmacodynamics of cardiovascular agents, central nervous system acting agents and antiviral agents. In addition, it has been reported that females experience more adverse reactions such as coughing, tachycardia, nausea, vomiting, rash, hypersensitivity, hepatotoxicity, and metabolic disorder after taking cardiovascular, central nervous system acting and antiviral agents. Therefore, in order to provide optimal drug dosage regimens both in male and female, gender differences in pharmacokinetics, pharmacodynamics, and adverse drug reactions must be considered.