• Korean Journal of Clinical Pharmacy
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• v.23 no.4
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• pp.327-333
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• 2013

Background: Antihistamine and anti-allergy medications are widely used during pregnancy. Reading label information is one of the easiest ways to get safety information. But there are content gaps among countries. Objective: To compare the risk level and the recommendation level of antihistamine/anti-allergy drug's label information in pregnant women among Korea, the USA, the UK, and Japan. Method: Study drugs of antihistamine/anti-allergy medications were selected according to Korea drug classification codes. Based on the label information of selected product, risk level was classified into 5 categories as follows: 'Definite', 'Probable', 'Possible', and 'Unlikely', 'Unclassified' according to the level of evidence. Recommendation level was classified into 4 categories as follows: 'Contraindicated', 'Cautious', 'Compatible', and 'Unclassified'. Frequency and proportion were presented according to the each category. To estimate agreement of each category among 4 countries, percent agreement and kappa (k) coefficient were calculated. Results: Total 13 drug ingredients were selected for antihistamine/anti-allergy medications. In risk level, Korea (46%) and Japan (69%) were mostly classified in the category of 'Unclassified', but 'Unlikely' category was more frequent in the UK (62%) and the USA (46%). In recommendation level, the proportion of 'Contraindicated' was highest in Korea (46%) compared to other countries. In contrast, the category of 'Cautious' was 77%-85% in the USA, the UK, and Japan. The percent agreement for risk level was highest in the USA-UK (54%). The recommendation level of Korea-USA showed lowest agreement for percent agreement (46%) and kappa coefficient (k=0.02). Conclusion: We confirmed the differences among safety information provided by four different countries. 'Contraindicated' was more likely in Korea compared with other countries.

• YAKHAK HOEJI
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• v.57 no.3
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• pp.173-186
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• 2013

To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

• Journal of Korean Academy of Fundamentals of Nursing
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• v.20 no.2
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• pp.137-146
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• 2013

Purpose: The purposes of this study were to identify and compare various types of post operative pain management and the costs for pain management following 4 different types of surgery. Methods: Data were collected from 325 medical charts which were extracted from the billing databases of a tertiary hospital and analyzed using numbers, percentages, one way ANOVA, and Scheff$\acute{e}$ test. Results: For pain management, 10.5% of patients used PCA only, but the other patients combined other methods with PCA. The average length of PCA use was significantly different by operation. Almost one third (32.9%) of patients experienced at least one of side effects due to analgesics used for pain management, with highest incidence being for nausea and vomiting. For patients who underwent a total abdominal hysterectomy, 34.7% used PCA less than 2 days due to side effects of the analgesics and the ratio of analgesia cost to total hospital cost and total pharmacy cost were highest compared to other operations. Conclusion: The results of this study indicate a need to develop new strategies to more effectively manage postoperative pain to decrease incidences of side effects without increasing medical costs.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.71.2-72
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• 2003

This presentation is to enhance the pharmacist's role in Over-The-Counter(OTC) drug selection and patient counseling for diversification of pharmacy management after the separation of prescribing and dispensing practice in Korea. Self-medication by OTC drugs may be viewed as one element of the broader self-care treatment. The patient may use a OTC drug to manage a minor ailment, a process that may be supported by counseling from a pharmacist. Pharmacists involved in self-medication decisions have a greater involvement with patients and an enhanced professional role. (omitted)

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.49 no.1
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• pp.53-54
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• 2023

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.235-241
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• 2010

Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active ${\beta}_2$-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, $Bambec^{(R)}$ tablet 10 mg (Yuhan Co., Ltd.) and Bambucol tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, $23.86{\pm}1.65$ years in age and $68.98{\pm}9.58$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test with K-BE Test 2002 was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Bambec^{(R)}$, were -8.10%, -3.82% and 12.65% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to $Bambec^{(R)}$ tablet 10 mg.

• Journal of Pharmaceutical Investigation
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• v.31 no.1
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• pp.57-62
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• 2001

Azelastine, a phthalazinone derivative, is an antiallergic agent which demonstrates histamine $H_1-receptor$ antagonist activity and also inhibits histamine release from mast cells following antigen and non-antigen stimuli. Thus, azelastine may be useful in the management of both asthma and allergic disorders. The purpose of the present study was to evaluate the bioequivalence of two azelastine hydrochloride tablets, $Azeptin^{TM}$ (Bu Kwang Pharmaceutical Co., Ltd.) and $Azela^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $22.44{\pm}2.01$ years in age and $61.99{\pm}6.18\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 1 mg of azelastine hydrochloride per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of azelastine in serum were determined using HPLC with fluorescence detector. Pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets were -6.45%, -2.60% and -7.14%, respectively, when calculated against the $Azeptin^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 96.65% and 88.47%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 14.40% and 17.65% for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g., $-14.87{\sim}1.97$ and $-12.92{\sim}7.72$ for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Azela^{TM]$ tablet is bioequivalent to $Azeptin^{TM}$ tablet.

• Experimental and Molecular Medicine
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• v.50 no.11
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• pp.6.1-6.12
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• 2018

Morphine tolerance remains a challenge in the management of chronic pain in the clinic. As shown in our previous study, the dopamine D2 receptor (D2DR) expressed in spinal cord neurons might be involved in morphine tolerance, but the underlying mechanisms remain to be elucidated. In the present study, selective spinal D2DR blockade attenuated morphine tolerance in mice by inhibiting phosphatidylinositol 3 kinase (PI3K)/serine-threonine kinase (Akt)-mitogen activated protein kinase (MAPK) signaling in a ${\mu}$ opioid receptor (MOR)-dependent manner. Levo-corydalmine (l-CDL), which exhibited micromolar affinity for D2DR in D2/CHO-K1 cell lines in this report and effectively alleviated bone cancer pain in our previous study, attenuated morphine tolerance in rats with chronic bone cancer pain at nonanalgesic doses. Furthermore, the intrathecal administration of l-CDL obviously attenuated morphine tolerance, and the effect was reversed by a D2DR agonist in mice. Spinal D2DR inhibition and l-CDL also inhibited tolerance induced by the MOR agonist DAMGO. l-CDL and a D2DR small interfering RNA (siRNA) decreased the increase in levels of phosphorylated Akt and MAPK in the spinal cord; these changes were abolished by a PI3K inhibitor. In addition, the activated Akt and MAPK proteins in mice exhibiting morphine tolerance were inhibited by a MOR antagonist. Intrathecal administration of a PI3K inhibitor also attenuated DAMGO-induced tolerance. Based on these results, l-CDL antagonized spinal D2DR to attenuate morphine tolerance by inhibiting PI3K/Akt-dependent MAPK phosphorylation through MOR. These findings provide insights into a more versatile treatment for morphine tolerance.

• Journal of Korean Society for Quality Management
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• v.39 no.3
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• pp.365-376
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• 2011

Robust design (RD) has emerged as a key feature in process design and development for more than twenty years. Many researchers and industrial engineers around the world have invested their intensive efforts to develop and apply RD in many fields in order to improve quality of output products. However, there is also room for improvement. The primary objective of this research is to determine "robust formulation" of a medicine by checking its gelation index. In order to achieve this target, based on the nature of problem, at first, a customized experimental format is designed for obtaining data. Second, time-depended responses based models are developed by the proposed inverse problem (IP) methodology. Third, an RD model based on mean square error (MSE) concept is introduced for time-depended responses. Finally, the proposed approach is illustrated by a case study while comparing obtained results to the response surface methodology (RSM) approach.

• International Journal of Computer Science & Network Security
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• v.21 no.7
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• pp.257-266
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• 2021

This article examines the features of improving the public management of the market of medical and social services using information technology to improve the efficiency of public activity in modern conditions. The interpretation of the essence of the categories "information technologies" and "information support" is analyzed. The importance of the organization of information support of public authorities in the insurance of the state apparatus of information management for the adoption and solution of state issues of the market of medical and social services has been studied. Issues and system of information support of public management of the market of medical and social services are considered. The stages of the ICT implementation process in the market of medical and social services are described. The tools of state regulation in the market of medical and social services and the introduction of targeted programs for the development of the social sphere and health care are highlighted. Recommendations for improvement are formulated public management of the market of medical services and social way introduction of ICT tools, which provide for the implementation of a set of measures aimed at intellectualizing the entire system public data management spheres. The necessity of development of innovative tools of public management of the market of medical and social services of Ukraine for the purpose of working out of strategies of increase of quality of medical and social services in the XXI century is substantiated. A number of benefits from the implementation of an effective process of application of information support of public management of the market of medical and social services to ensure the efficiency of public authorities of Ukraine. It is proposed to create a "Department of information support of self-government" and electronic health care system (e-Health) to improve the management decision-making process, which will provide an opportunity to accumulate, process, analyze, and as a result, get the expected effect in the form of balanced management decisions by public authorities of Ukraine.