• Title/Summary/Keyword: drug management

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Agreement of Label Information of Antihistamine, Anti-allergy Medications in Pregnancy among Korea, the USA, the UK, and Japan (임신부에서 항히스타민제와 알레르기용약의 국가별 안전정보 일치도 분석 : 한국, 미국, 영국, 일본 허가사항을 중심으로)

  • Park, Mi-Ju;Shin, Ju-Young;Kim, Hong-Ah;Park, Hyo-Ju;Kim, Mi-Hee;Shin, Sun-Mi;Park, Byung-Joo
    • 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.

Variations on Drug Utilization between the Types of Hospital in Some Frequent Diseases (일부 다빈도 질환에서 의료기관 유형별 의약품 사용의 변이)

  • 박실비아
    • Health Policy and Management
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    • v.9 no.2
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    • pp.118-138
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    • 1999
  • This study presents the variations on drug utilization for outpatients' URI, gastritis. and hypertension by the type of hospital- tertiary hospital. general hospital. hospital. clinic. It investigated drug expenses. daily drug expenses. days of medication. the highest price of the drugs used. and the number of the different drugs used for each disease and type of hospital. This study also performed analysis to see how much the variations of variables related to drug use affect the variations of drug expenses. The dependent variable was drug expenses and the independent variables were days of medication. the average price of the drugs used. and the number of the different drugs used. Analysis of the drug utilization was performed on NFMI(National Federation of Medical Insurance) 1994 medical expense claim data. Patients with secondary diseases were excluded. In this study. 379 patients with URI, 386 patients with gastritis. 1.257 patients with hypertension were included. It was founded that there were large variation on drug utilization between the types of hospital for same diseases. Days of medication were longest in tertiary hospitals and shortest in hospitals or clinics. Clinics showed the lowest daily drug expenses in all of the diseases investigated. Daily drug expenses were highest in general hospitals or hospitals. which also tended to use drugs of higher price than other types of hospital. General hospitals and hospitals had larger variations in daily drug expenses and the highest price of drugs. It suggested that drug might be utilized overly in general hospitals and hospitals and some other factors might influence on drug utilization in these hospitals. It was found that the variations of drug expenses were affected by the variations of drug price and days of medication rather than the number of the different drugs. Then the strategy to reduce the variations of drug utilization and to improve the quality of drug utilization should focus on the drug price and days of medication. Further study is needed to assess the quality as well as the variation of drug utilization and to show the factors which affect them.

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A Study on Improving Korea's Regulatory System for Pharmaceutical Safety Management (의약품 안전성 관리를 위한 연구 - 의약품 안전관리 제도개선 방안을 중심으로 -)

  • Chae, Gyu Han;Cho, Gi Won;Nagata, Ryuji;Park, Ji Sun;Hong, Chong Hui;Kang, Jong Seong
    • 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.

Promotion of Adverse Drug Reactions Report through Expansion of Drug Utilization Review (의약품 사용평가(DUR) 확대를 통한 의약품 부작용 보고 활성화 방안)

  • Jeong, Su-Cheol
    • The Journal of the Korea Contents Association
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    • v.19 no.1
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    • pp.234-241
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    • 2019
  • The side effects of using drugs can greatly threaten the health of the public. The reality is that there are very few reports of current side effects. This can be activated by linking adverse drug reactions reporting to the Drug Utilization Review (DUR) currently used by pharmacies. A study of the U.S. medication management system, where drug use assessment is activated, can find ways to activate adverse drug reactions reporting. In 'Pharm IT 3000', which is used as a medication management program in pharmacies, we examined how to enable reporting of adverse drug reactions. The literature study and research on actual program operation have found a convenient way to report side effects by linking the Pharm IT 3000 prescription preparation assessment to the item.

Absorption Study of Genistein Using Solid Lipid Microparticles and Nanoparticles: Control of Oral Bioavailability by Particle Sizes

  • Kim, Jeong Tae;Barua, Sonia;Kim, Hyeongmin;Hong, Seong-Chul;Yoo, Seung-Yup;Jeon, Hyojin;Cho, Yeongjin;Gil, Sangwon;Oh, Kyungsoo;Lee, Jaehwi
    • Biomolecules & Therapeutics
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    • v.25 no.4
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    • pp.452-459
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    • 2017
  • In this study, the effect of particle size of genistein-loaded solid lipid particulate systems on drug dissolution behavior and oral bioavailability was investigated. Genistein-loaded solid lipid microparticles and nanoparticles were prepared with glyceryl palmitostearate. Except for the particle size, other properties of genistein-loaded solid lipid microparticles and nanoparticles such as particle composition and drug loading efficiency and amount were similarly controlled to mainly evaluate the effect of different particle sizes of the solid lipid particulate systems on drug dissolution behavior and oral bioavailability. The results showed that genistein-loaded solid lipid microparticles and nanoparticles exhibited a considerably increased drug dissolution rate compared to that of genistein bulk powder and suspension. The microparticles gradually released genistein as a function of time while the nanoparticles exhibited a biphasic drug release pattern, showing an initial burst drug release, followed by a sustained release. The oral bioavailability of genistein loaded in solid lipid microparticles and nanoparticles in rats was also significantly enhanced compared to that in bulk powders and the suspension. However, the bioavailability from the microparticles increased more than that from the nanoparticles mainly because the rapid drug dissolution rate and rapid absorption of genistein because of the large surface area of the genistein-solid lipid nanoparticles cleared the drug to a greater extent than the genistein-solid lipid microparticles did. Therefore, the findings of this study suggest that controlling the particle size of solid-lipid particulate systems at a micro-scale would be a promising strategy to increase the oral bioavailability of genistein.

Multi-class, Multi-residue Analysis of 59 Veterinary Drugs in Livestock Products for Screening and Quantification Using Liquid Chromatography-tandem Mass Spectrometry

  • Yu Ra Kim;Sun Young Park;Tae Ho Lee;Ji Young Kim;Jang-Duck Choi;Guiim Moon
    • Korean Journal of Environmental Agriculture
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    • v.41 no.4
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    • pp.288-309
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    • 2022
  • BACKGROUND: The objective of this study was to develop a comprehensive and simple method for the simultaneous determination of 59 veterinary drug residues in livestock products for safety management. METHODS AND RESULTS: For sample preparation, we used a modified liquid extraction method, according to which the sample was extracted with 80% acetonitrile followed by incubation at -20℃ for 30 min. After centrifugation, an aliquot of the extract was evaporated to dryness at 40℃ and analyzed using liquid chromatography combined with tandem mass spectrometry. The method was validated at three concentration levels for beef, pork, chicken, egg, and milk in accordance with the Codex Alimentarius Commission/Guidelines 71-2009. Quantitative analysis was performed using a matrix-matched calibration. As a results, at least 52 (77.6%) out of 66 compounds showed the proper method validation results in terms of both recovery of the target compound and coefficient of variation required by Codex guidelines in livestock products. The limit of quantitation of the method ranged from 0.2 to 1119.6 ng g-1 for all matrices. CONCLUSION(S): This method was accurate, effective, and comprehensive for 59 veterinary drugs determination in livestock products, and can be used to investigate veterinary drugs from different chemical families for safety management in livestock products.

Role of Catheter's Position for Final Results in Intrathecal Drug Delivery. Analysis Based on CSF Dynamics and Specific Drugs Profiles

  • De Andres, Jose;Perotti, Luciano;Villanueva, Vicente;Asensio Samper, Juan Marcos;Fabregat-Cid, Gustavo
    • The Korean Journal of Pain
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    • v.26 no.4
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    • pp.336-346
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    • 2013
  • Intrathecal drug delivery is an effective and safe option for the treatment of chronic pathology refractory to conventional pain therapies. Typical intrathecal administered drugs are opioids, baclofen, local anesthetics and adjuvant medications. Although knowledge about mechanisms of action of intrathecal drugs are every day more clear many doubt remain respect the correct location of intrathecal catheter in order to achieve the best therapeutic result. We analyze the factors that can affect drug distribution within the cerebrospinal fluid. Three categories of variables were identified: drug features, cerebrospinal fluid (CSF) dynamics and patients features. First category includes physicochemical properties and pharmacological features of intrathecal administered drugs with special attention to drug lipophilicity. In the second category, the variables in CSF flow, are considered that can modify the drug distribution within the CSF with special attention to the new theories of liquoral circulation. Last category try to explain inter-individual difference in baclofen response with difference that are specific for each patients such as the anatomical area to treat, patient posture or reaction to inflammatory stimulus. We conclude that a comprehensive evaluation of the patients, including imaging techniques to study the anatomy and physiology of intrathecal environment and CSF dynamics, could become essential in the future to the purpose of optimize the clinical outcome of intrathecal therapy.

Drug holiday as a prognostic factor of medication-related osteonecrosis of the jaw

  • Kim, Yoon Ho;Lee, Ho Kyung;Song, Seung Il;Lee, Jeong Keun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.40 no.5
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    • pp.206-210
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    • 2014
  • Objectives: To identify post-treatment prognostic factors for medication-related osteonecrosis of the jaw (MRONJ). Materials and Methods: We evaluated 54 MRONJ patients who visited the Department of Dentistry, Ajou University Hospital, from May 2007 to March 2014. Twenty-one patients were surgically managed with debridement or sequestrectomy and 33 patients were conservatively managed using antibiotics. Correlations of age, sex, stage, bisphosphonate duration and type, and drug holiday with the prognosis of MRONJ were investigated. Correlations were verified by logistic regression analysis and t-tests with a significance level of 0.05. Results: Clinical outcomes were evaluated on the basis of both clinical and radiographic findings. Twelve out of 21 surgically managed patients showed a favorable prognosis and nine patients relapsed. Thirty-one of the 33 conservatively managed patients showed no specific change in prognosis, and two patients worsened. Statistical analyses of the conservative management group did not reveal any correlation of the above factors with the prognosis of conservative management. Drug holiday was the only prognostic factor in the surgical management group (P=0.031 in logistic regression analysis, P=0.004 in t-test). Conclusion: Drug holiday is a prognostic factor in the surgical management of MRONJ. Because the drug holiday in the patients of the poor prognosis group occurred 1.5 to 4 months prior to surgical management, we recommend a drug holiday more than 4 months before surgery.

A Study on the Health Management of Polypharmacy Use in the Elderly

  • Choi, Keum-Bong
    • International journal of advanced smart convergence
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    • v.10 no.4
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    • pp.206-214
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    • 2021
  • The purpose of this study is to identify the level of polypharmacy use, drug knowledge, and drug misuse behavior in the elderly, and to understand the correlation between them and their effect on drug misuse behavior. The study design was a descriptive survey study, and the participants of the study were 215 elderly people from the local community center. The research tool used drug knowledge, drug misuse behavior, and the data collection period was from February 8 to 19, 2021. The data analysis were descriptive statistics, t-test, one-way ANOVA, Pearson's correlation coefficient, and regression analysis. As a result of the study, a significant correlation variable for the drug knowledge of the elderly showed a significant correlation with prescription and non-prescription, r=.145 (p<0.05), and r=.-. 136, which showed a negative significant correlation (p<0.05). As for the significant correlation variable in the drug misuse behavior of the elderly, when prescription and non-prescription were combined, there was a significant correlation with r=.256 (p<0.01), and when not using drugs, r=.-.225 was negative. showed a significant correlation (p<0.01). In terms of the effect on drug misuse behavior, chronic disease =.145, prescription and non-prescription use = .233, which had a positive effect, and non-prescription = -.328, indicating a negative and significant effect. The provision of education on the safe use of drugs by the elderly should first be provided in the community. In addition, we need systematic education and social support for the transmission of correct knowledge on multi-drug use by the elderly and for health management.

A Descriptive Research on Drug Use Pattern of Narcotic Analgesics: a Case of University Hospital in Korea (마약성 진통제의 사용양상에 관한 서술적 조사연구: 한 대학병원의 경우)

  • Rah, Mi-Sook;Yoo, Bong-Kyu
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.1
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    • pp.30-35
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    • 2011
  • The objective of this study was to find out drug use pattern of narcotic analgesics in university hospitals in Korea. A university hospital located in Kyungbuk province was chosen for this study. The drug use pattern was analyzed in terms of ingredient, administration route, patient type, and attending department. Amount of drug usage was counted by unit dose defined by the number of ampule or vial for injectable, tablet or capsule for oral, and each for patch preparations. Result showed that 11 narcotic analgesic ingredients were used during 2007-2009, and the drug usage was increased by about 20% annually during the period. Proportion of oral preparations used for pain management was about two third of all narcotic analgesics usage and kept increasing during the period. Proportion of the drug usage for outpatients was also steadily increased. Notably, the usage of oral preparations of oxycodone, morphine, and hydromorphone was rapidly increased for the management of cancer pain while the usage of codeine and codeine-containing composite preparations for cancer pain were minimal (<10%). About 90% of all narcotic analgesics were used by physicians in Internal Department, especially in Oncology Division of the Department. These findings suggest that pain management is becoming more aggressive and in agreement with WHO's guidelines regarding selection of administration route. However, in terms of 3-step ladder for cancer pain management, the drug use pattern was not congruent to WHO's guidelines. Therefore, in conclusion, it appears that physicians need to try to be congruent to the guidelines when using narcotic analgesics for cancer pain.