• Title/Summary/Keyword: Clinical Pharmacy

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Development and Evaluation of Anticoagulation Clinical Pharmacy Sevice for Ambulatory Patients in a Community Hospital (병원 외래환자를 대상으로 한 항응고임상약학업무의 개발과 평가에 대한 연구)

  • Choi Soo Im;Shin Hyun Taek;Choi HaeMi;Kim Jung Sun;An JungSoon;Choi Kyoung Eob
    • Korean Journal of Clinical Pharmacy
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    • v.5 no.2
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    • pp.17-31
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    • 1995
  • Pharmacist-managed Anticoagulation Service(ACS) was estabilished and the effectiveness of warfarin monitoring by ACS in maintaining therapeutic INR was evaluated. The primary goal of ACS is to maximize the control of therapy, to maintain therapeutic INR and to decrease morbidity and hospitalization caused by inadequate dosage regimen. Clinical pharmacists performed chartreview, laboratory interpretation, recommendations for warfarin dosage adjustments, physician and patient education, and coordination of follow-up in ACS. Patients receiving warfarin sodium were evaluated via retrospective chart review. Sixty-two patients were referred to ACS by primary physicians were compared with 117 patients in the physician-amtrolled group. The ACS patients maintained $88.6\%$ in the therapeutic range for anticoagulant therapy and the control group maintained $63.7\%$, where the difference was statistically significant.(P<0.001) The ACS improved warfarin dose determination, PT stability, patient compliance and provided improved therapy compared with the control group. ACS offers safe and efficient anticoagulant therapy in the ambulatory setting.

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Regulations and Guidelines for Planning and Design of Multi-regional Clinical Trials (다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석)

  • Song, Yun-Kyoung;Sohn, Minji;Jeon, Ah Young;Kim, Jae Hyun;Ji, Eunhee;Oh, Jung Mi;Kim, In-Wha
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.146-153
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    • 2018
  • Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

Growth Inhibitory and Pro-Apoptotic Effects of Hirsuteine in Chronic Myeloid Leukemia Cells through Targeting Sphingosine Kinase 1

  • Gao, Shan;Guo, Tingting;Luo, Shuyu;Zhang, Yan;Ren, Zehao;Lang, Xiaona;Hu, Gaoyong;Zuo, Duo;Jia, Wenqing;Kong, Dexin;Yu, Haiyang;Qiu, Yuling
    • Biomolecules & Therapeutics
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    • v.30 no.6
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    • pp.553-561
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    • 2022
  • Chronic myeloid leukemia (CML) is a slowly progressing hematopoietic cell disorder. Sphingosine kinase 1 (SPHK1) plays established roles in tumor initiation, progression, and chemotherapy resistance in a wide range of cancers, including leukemia. However, small-molecule inhibitors targeting SPHK1 in CML still need to be developed. This study revealed the role of SPHK1 in CML and investigated the potential anti-leukemic activity of hirsuteine (HST), an indole alkaloid obtained from the oriental plant Uncaria rhynchophylla, in CML cells. These results suggest that SPHK1 is highly expressed in CML cells and that overexpression of SPHK1 represents poor clinical outcomes in CML patients. HST exposure led to G2/M phase arrest, cellular apoptosis, and downregulation of Cyclin B1 and CDC2 and cleavage of Caspase 3 and PARP in CML cells. HST shifted sphingolipid rheostat from sphingosine 1-phosphate (S1P) towards the ceramide coupled with a marked inhibition of SPHK1. Mechanistically, HST significantly blocked SPHK1/S1P/S1PR1 and BCR-ABL/PI3K/Akt pathways. In addition, HST can be docked with residues of SPHK1 and shifts the SPHK1 melting curve, indicating the potential protein-ligand interactions between SPHK1 and HST in both CML cells. SPHK1 overexpression impaired apoptosis and proliferation of CML cells induced by HST alone. These results suggest that HST, which may serve as a novel and specific SPHK1 inhibitor, exerts anti-leukemic activity by inhibiting the SPHK1/S1P/S1PR1 and BCR-ABL/PI3K/Akt pathways in CML cells, thus conferring HST as a promising anti-leukemic drug for CML therapy in the future.

Clinical pharmacist services in general wards and perception and expectation of healthcare providers towards the services at a tertiary healthcare center (상급종합병원 병동담당약사 업무 현황 및 의료인의 인식과 기대 분석)

  • Kim, Jeongun;Baek, Sijin;Choi, Nayae;Jeon, Sujeong;Namgung, Hyung Wook;Lee, Junghwa;Lee, Euni;Lee, Ju-Yeun
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.1
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    • pp.20-26
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    • 2022
  • Background and objective: The Seoul National University Bundang Hospital (SNUBH) implemented ward-based clinical pharmacy system with designated pharmacists in 10 general wards. Designated pharmacists conduct inpatient medication review, medication intervention, and medication consultation, and provide drug information for health care providers. This study aimed to evaluate the clinical pharmacy services and to examine the perception and expectations of health care providers on the services provided by the designated pharmacists in general wards. Methods: A survey was constructed to include questions on the health care providers' recognition, satisfaction, and perceived needs of designated pharmacists. We determined the frequency and type of interventions of ward pharmacist and their acceptance rate through a retrospective observational study using electronic medical records. Results: A total of 59 health care providers responded the questionnaire and 79.7% of the respondents reported moderate to high levels of satisfaction. Satisfaction with the services was positively associated with clinical interventions and nutrition support team (81.4%). Of 59 respondents, 88.1% agreed that preventing drug-related problems by designated pharmacists' activities were effective. The most common interventions included inadequate dosage (27.4%), omission and additional prescription (14.6%) and inadequate drug form (9.6%). The acceptance rate of intervention was 91.5%, and 151 potentially serious risks and 523 significant risks were prevented by the intervention. Conclusion: Positive results were confirmed in the awareness, satisfaction, and perceived needs of the health care providers for designated pharmacists. Expansion of the ward-based clinical pharmacy system with designated pharmacists to other wards may be considered.

Prescribing Patterns of Antidepressants and Their Associated Factors in Breast Cancer Patients (유방암 환자의 항우울제 처방 현황 및 영향요인 연구)

  • Lee, Hye Min;Kang, Rae Young;Kim, Su Yeon;Lee, Yu Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.213-222
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    • 2013
  • Purpose: The aim of this study was to investigate the current state of antidepressant prescriptions in breast cancer patients and factors affecting the prescription of antidepressants. Methods: This study targeted female breast cancer patients who were prescribed antidepressants by a psychiatrist at least once between August 2010 and July 2011 at the Asan Medical Center in Seoul. The prescription history of each study subject was investigated to analyze the current state of antidepressant prescriptions in breast cancer patients. Results: The analysis of the prescription histories of 136 subjects in the antidepressant group determined that escitalopram, mirtazapine, and trazodone were the three most commonly prescribed medications with an average of 1.54 antidepressants prescribed per patient. A logistic regression analysis showed a statistically significant increase in antidepressant prescriptions in patients who were divorced or widowed, had sleep disturbances, or had undergone oncologic surgery for the breast cancer (p<0.050). In contrast, the prescription rate was lower for patients with tumour sizes greater than 50 mm (p<0.050). Conclusion: The sociodemographic factor of marital status, clinical factors of sleep disorders and tumour size, and a treatment-specific factor of the use of surgical therapy were identified as affecting the prescription of antidepressants in female breast cancer patients.

Measuring the Seriousness of Adverse Drug Reactions : Comparisons between Korean Experts and WHO Working Group Members (의약품 부작용의 심각도 조사 비교분석)

  • Rhee, Jin-Nie;Park, Se-Young;Heo, Ji-Haeng;Park, Mi-Hae;Ha, Ji-Hye;Lee, Eui-Kyung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.3
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    • pp.237-242
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    • 2011
  • This study measures seriousness of adverse drug reactions (ADRs) among Korean physicians and pharmacists using two times surveys based on Delphi technique. Each participant scored 20 ADR terms on a scale of one to ten (10 being the most serious). We repeated the exercise for the 49 first survey respondents and 32 re-evaluated score. We compared the results of our survey with those of WHO CIOMS (Council for International Organization of Medical Sciences) working groups members conducted in 1995. The overall mean ADR seriousness score was 6.49 for Koreans and 5.12 for WHO CIOMS members, presenting Korean experts perceived more seriously for each ADR. Mean score changes for the same respondents showed similar trends regardless of access to the first survey results. There were no statistically significant score differences between the physicians and the pharmacists. The high consensus of seriousness for each ADR between the Korean experts and the WHO CIOMS members implies that the similar results are reproducible, suggesting the possibility of developing standardized tools for measuring the seriousness of individual ADRs in the future.

Influence of Genotype and Haplotype of MDR1 (C3435T, G2677A/T, C1236T) on the Incidence of Breast Cancer - a Case-Control Study in Jordan

  • Abuhaliema, Ali M;Yousef, Al-Motassem F;El-Madany, Nirmeen N;Bulatova, Nailya R;Awwad, Nemah M;Yousef, Muhammad A;Al Majdalawi, Khalil Z
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.1
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    • pp.261-266
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    • 2016
  • Background: Breast cancer is the leading cause of cancer death among women and the second in humans worldwide. Many published studies have suggested an association between MDR1 polymorphisms and breast cancer risk. Our aim was to study the association between genetic polymorphism of MDR1 at three sites (C3435T, G2677A/T, and C1236T) and their haplotype and the risk of breast cancer in Jordanian females. Materials and Methods: A case-control study involving 150 breast cancer cases and 150 controls was conducted. Controls were age-matched to cases. The polymerase chain reaction/restriction fragment length polymorphism (PCR-RFLP) technique and sequencing were performed to analyse genotypes. Results: The distribution of MDR1 C3435T genotypes differed between cases and controls [cases, CC 45.3%, CT 41.3%, and TT 13.3%; controls, CC 13.4%, CT 43.3%, and TT 30.2%, p < 0.001]. Similarly, the distribution of G2677A/T significantly differed [cases, GG 43.1 %, GT+GA 50.9% and AA+TT 6%; controls, GG 29.6 %, GT+GA 50.9%, and AA+TT 19.4%, p = 0.004]. On the other hand, genotype and allelotype distribution of C1236T was not statistically different between cases and controls (p=0.56 and 0.26, respectively). The CGC haplotype increased the risk to breast cancer by 2.5-fold compared to others, while TGC and TTC haplotypes carried 2.5- and 5-fold lower risk of breast cancer, respectively. Conclusions: Genetic polymorphisms of MDR1 C3435T and G2677A/T, but not C1236T, are associated with increased risk of breast cancer. In addition, CGC, TGC and TTC haplotypes have different impacts on the risk of breast cancer. Future, larger studies are needed to validate these findings.

NHS Hospital Pharmacist Training Programme in UK (영국의 NHS 병원약사 수련 현황)

  • Kim, Yun Jung
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.4
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    • pp.209-215
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    • 2015
  • The aim of the research was to explore post-registration training opportunities for NHS hospital pharmacists which contributes to promote structural reform of the professional development and lifelong learning for Korean hospital pharmacists. In UK, all pharmacists are required to complete at least 9 Continuing Professional Development (CPD) entries per each year to maintain their professional registration. Types of accredited postgraduate qualification (part-time) in Pharmacy Practice available for hospital pharmacists are Postgraduate Certificate (PgCert, year 1), Postgraduate Diploma (PgDip, year 2), Master of Science (MSc year 3), and Professional Doctorate in Pharmacy programme (DPharm, 4-5 years or more). Clinical pharmacy diploma is more likely to become a minimum qualification in order to progress whilst working for the NHS. Pharmacy independent prescribers are allowed to prescribe all medications except cocaine, dipipanone, and diamorphine for the purpose of treating addiction within their competencies. NHS pharmacists are also classified by band point system depending on their practical/clinical knowledge and skills which starting from band 5 (Pre-registration pharmacist) up to band 9. Various learning and development options are also offered including teaching sessions, conferences and local forums.

Pandanus amaryllifoius Roxb. Leaves Ethanol Extract Ameliorates Lipid and Proinflammatory Cytokines Profiles in a Rat Model of Dyslipidemia

  • Martohap Parotua Lumbanraja;Kusnandar Anggadiredja;Neng Fisheri Kurniati;Hubbi Nashrullah Muhammad
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.101-109
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    • 2024
  • Objectives: Dyslipidemia has currently become a major health challenge that still opens for safer and more effective modes of treatment. The plant Pandanus amaryllifolius Roxb. (pandan) has been indicated to contain active ingredients that interfere with the pathological pathway of dyslipidemia. The aim of the study was to test the effects of pandan leaves ethanol extract on lipid and proinflammatory profiles in a rat dyslipidemic model. Methods: Dyslipidemia was induced by administration of high-fat feed for 8 weeks. Treatments (vehicle, the reference drug simvastatin at 1.8 mg/kg, and extract at 200, 300 or 600 mg/kg) were given for 4 weeks following the completion of induction. Results: Significant post-treatment decreases in total cholesterol, low density lipoprotein (LDL), and triglyceride levels in groups receiving all doses of extract and simvastatin were observed. Similar results were also found in regards to proinflammatory cytokines levels. Pandan extracts significantly lowered the concentrations of IL-6, TNF-α, and NFκB p65. Characterization of metabolite contents of the extract confirmed the presence of the previously suggested active alkaloids pandamarilactonine-A and B. Conclusion: Taken together, results of the present study implied the ameliorating effects of pandan leaves ethanol extract in dyslipidemic condition which is potential for opening an avenue in combating this essential component of metabolic disorder.