• Title/Summary/Keyword: good pharmacy practice

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Comparison of TPN use with hospital admixtured and industrial manufactured formular TPN in Seoul national university

  • Kim, Kui-Sook;Choi, Mi-Young;Lee, Jin-Ju;Son, In-Ja;Suh, Ok-Kyung
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.275.2-275.2
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    • 2002
  • There have been many changes in hospital pharmacy after division of medical practice and dispensing. Many pharmacist leave hospital pharmacy to drugstore. Because reduced number of pharmacist, many of hospital pharmacies are placed in difficulty. Restructuring of hospital pharmacy made us consider substitution hospital admixtured TPN(total parenteral nutrition) with industrial manufactured TPN. But we have no data established to support that, so we have sarried out the comparison of two kinds of TPn formulary. We have divided into groups receiving hospital admixtured TPN and industrial manufactured TPN patients in august. 2002. We have compared with each groups in nutritional related dose, parameters and complication before and after TPN administration and also invertigated the reason of formulary change in each groups. We expect that this study will be good data for selection TPN formulary and substitution hospital admixtured TPN with industrial manufactured TPN.

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Comparison of Pharmacist License Examination between Korea and Canada (우리나라와 캐나다 약사면허 국가시험제도 비교)

  • Kang, Minku
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.1
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    • pp.1-8
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    • 2015
  • A newly-structured Korean pharmacist license exam has been launched in 2015, reflecting upon the changes in the pharmacy curriculum from a 4 year program to a 6 year program in 2009. In order to provide new ideas to ensure that the new exam is one of the most effective pharmacist evaluations that have taken place thus far, this study was done to compare the pharmacy exams in Korea and Canada. One of the major differences noted between the two countries' exams is that along with paper based MCQ portion of the exam, Canada's exam also includes a performance-based section, known as OSCE, which the Korean Pharmacy Exam (KPE) does not have. Furthermore, with the MCQ portion of the exam, the Canadian exam asks about 300 questions, with 450 minutes of test time allocated and taken during a period of two consecutive days, the KPE asks 350 questions, with 325 minutes of test time allocated in one day. Although, similarly, many of the questions in both exams place emphasis on clinical or patient care, Canada's exam puts significantly more emphasis (50.5% of exam questions) on these types of questions than Korea (29.7% of exam questions). However, this percentage does not reflect the exact weight placed for the specific areas of knowledge it requires to answer these questions, since the types of questions asked in this section in Canada could be placed in another section on the KPE. Canada's exam also has more questions (10% +150 questions for BC) on the topics of law and ethics compared to the KPE (5.7%). The reason for this may be that the Canadian society puts emphasis on the legal and ethical duties of pharmacists as a leader. However, since each country is unique in their social, economical, and cultural points of view, comparing the KPE to the Canadian licensing exam and applying these differences to the new KPE may not be appropriate. One last thing to consider is that, as WHO/FIP mentioned, in good pharmacy practice, continually updating and developing an appropriate pharmacy exam with consideration of societal changes, is key to success in developing the scope of practice for current and future pharmacists.

Long Term Assessment of Outcome of Essential Competencies in CPPE at Tertiary and Secondary Hospitals Located in Seoul and Gyeonggi-do: College of Pharmacy Students' Evaluation from 2014 to 2018 (서울과 경기도 소재 상급종합병원과 종합병원의 필수실무실습 핵심역량교육 성과에 대한 장기적인 고찰)

  • Chun, Pusoon;Sin, Hye Yeon
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.300-307
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    • 2018
  • Objective: As the demands of healthcare environment change, it is necessary to advance human health care by improving students' essential competencies including knowledge, skills, abilities, inter-professional collaboration and patient centered care. This study identified long term accomplishment and improvement of the essential competencies in clinical pharmacy practice education (CPPE) at Korean hospitals over time. Methods: This study was conducted for pharmacy students who completed CPPE evaluation related to tertiary hospitals and secondary hospitals located in Seoul and Gyeonggi-do regional area from 2014 to 2018. Results: Over the past 5 years, overall results of student evaluation on the essential competencies in CPPE at both tertiary and secondary hospitals showed a decreasing trend or did not change. Essential competency in CPPE at tertiary hospitals had been identified as superior on 'Learn clinical knowledge in the treatment of diseases' to secondary hospitals [average number of students (%): 210 (72.9%) vs 68 (68.0%)]. On the other hand, essential competencies in CPPE at secondary hospitals had been identified as better at 'inter-professionals collaborative teamwork and direct patient care' than tertiary hospitals [average number of students (%): 64 (64.0%) and 56 (56.0%) vs 121 (42.0%) and 90 (31.3%)]. A total of 176 (61.1%) students in tertiary hospitals and 66 (66.0%) in secondary hospitals evaluated that 'patient-centered care' education was good. Conclusion: In tertiary hospitals, all six essential competency outcomes have not been improved, whereas four essential competency outcomes showed an increasing trend in secondary hospitals. It will be necessary to develop outcome-based CPPE education program to better reflect the essential competencies.

Good Agriculture Practice (GAP) and Sustainable Resource Utilization of Chinese Materia Medico

  • Wenyuan Gao;Wei Jia;Hongquan Duan;Luqi Huang;Xiaohe Xiao;Peigen Xiao;Peak, Kee-Yoeup
    • Journal of Plant Biotechnology
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    • v.4 no.3
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    • pp.103-107
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    • 2002
  • The Good Agriculture Practice (GAP) program, being established in China, is an optimal way for the sustainable utilization of the medicinal plant and animal resources. Most frequently used Chinese materia medica will be mainly produced from the GAP bases in the future. To assure the successful operation of GAP program, standard operating procedure (SOP) should be implemented for specific plants or animals. Both GAP and SOP include the requirements in many aspects from the ecological environment of cultivation place, germplasm and varieties, seedling and transplant, fertilization, irrigation, and field care, to harvest and process, package, transport and storage. As a complex system, GAP demands strong commitment from the pharmaceutical industry, local administrative involvement, long term R&D support, and years of time of development before a satisfactory result can be achieved.

Hindi version of short form of douleur neuropathique 4 (S-DN4) questionnaire for assessment of neuropathic pain component: a cross-cultural validation study

  • Gudala, Kapil;Ghai, Babita;Bansal, Dipika
    • The Korean Journal of Pain
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    • v.30 no.3
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    • pp.197-206
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    • 2017
  • Background: Pain with neuropathic characteristics is generally more severe and associated with a lower quality of life compared to nociceptive pain (NcP). Short form of the Douleur Neuropathique en 4 Questions (S-DN4) is one of the most used and reliable screening questionnaires and is reported to have good diagnostic properties. This study was aimed to cross-culturally validate the Hindi version of the S-DN4 in patients with various chronic pain conditions. Methods: The S-DN4 is already translated into the Hindi language by Mapi Research Trust. This study assessed the psychometric properties of the Hindi version of the S-DN4 including internal consistency and test-retest reliability after 3 days' post-baseline assessment. Diagnostic performance was also assessed. Results: One hundred sixty patients with chronic pain, 80 each in the neuropathic pain (NeP) present and NeP absent groups, were recruited. Patients with NeP present reported significantly higher S-DN4 scores in comparison to patients in the NeP absent group (mean (SD), 4.7 (1.7) vs. 1.8 (1.6), P < 0.01). The S-DN4 was found to have an AUC of 0.88 with adequate internal consistency (Cronbach's ${\alpha}=0.80$) and a test-retest reliability (ICC = 0.92) with an optimal cut-off value of 3 (Youden's index = 0.66, sensitivity and specificity of 88.7% and 77.5%). The diagnostic concordance rate between clinician diagnosis and the S-DN4 questionnaire was 83.1% (kappa = 0.66). Conclusions: Overall, the Hindi version of the S-DN4 has good internal consistency and test-retest reliability along with good diagnostic accuracy.

Study on the Clinical Trial Practice of Drugs at the Designated Hospitals (국내 임상시험 실시기관의 의약품 임상시험 관리현황 분석)

  • Lee Eui-Kyoung;Jang Sun-Mee;Huh Soon-Im
    • Korean Journal of Clinical Pharmacy
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    • v.5 no.2
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    • pp.33-49
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    • 1995
  • The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

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Risk Factors of Postoperative Nosocomial Pneumonia in Stage I-IIIa Lung Cancer Patients

  • Wang, Zeng;Cai, Xin-Jun;Shi, Liang;Li, Fei-Yan;Lin, Neng-Ming
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.7
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    • pp.3071-3074
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    • 2014
  • Background: To investigate the related risk factors of postoperative nosocomial pneumonia (POP) in patients withI-IIIa lung cancer. Methods: Medical records of 511 patients who underwent resection for lung cancer between January 2012 to December 2012 were retrospectively reviewed. Risk factors of postoperative pneumonia were identified and evaluated by univariate and multivariate analyses. Results: The incidence of postoperative pneumonia in these lung cancer patients was 2.9% (15 cases). Compared with 496 patients who had no pneumonia infection after operation, older age (>60), histopathological type of squamous cell carcinoma and longer surgery time (>3h) were significant risk factors by univariate analysis. Other potential risk factors such as alcohol consumption, history of smoking, hypersensitivity, hypertension, diabetes mellitus and so on were not showed such significance in this study. Further, the multivariate analysis revealed that old age (>60 years) (OR 5.813, p=0.018) and histopathological type of squamous cell carcinoma (OR 5.831, p<0.001) were also statistically significant independent risk factors for postoperative pneumonia. Conclusions: This study demonstrated that being old aged (>60 years) and having squamous cell carcinoma histopathological type might be important factors in determining the risk of postoperative pneumonia in lung cancer patients after surgery.

Inhibitory Activities of Palmatine from Coptis chinensis Against Helicobactor pylori and Gastric Damage

  • Jung, Joohee;Choi, Jae Sue;Jeong, Choon-Sik
    • Toxicological Research
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    • v.30 no.1
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    • pp.45-48
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    • 2014
  • Helicobacter pylori (H. pylori) is the most important factor of gastric disease in clinical practice. Moreover, smoking, stress and a poor diet may be additive factors for gastric damage. With these factors, increasing infection of H. pylori triggers gastritis, gastric ulcers and gastric cancer. To develop a new protective agent, we are concerned with plant-derived extract. The extract of Coptis chinensis (C. chinensis) and its constituents were investigated to assess their protective activities against gastric damage. The C. chinensis extract showed a scavenging effect against 2, 2-diphenyl-1-picrylhydrazyl (DPPH) and superoxide radicals, inhibition of H. pylori colonization and antiulcerogenic activities in rat. In particular, palmatine derived from C. chinensis was found to be the novel protective agent. It is better than the C. chinensis extract, berberine, a well-known constituent of C. chinensis. We suggest that palmatine from the root cortex of C. chinensis may be a good candidate for the development of new pharmaceuticals to prevent gastric disease.

A Comparative Analysis of Barriers for Korean Pharmaceutical Companies in Global Regulatory Affairs by Company Size (기업 규모별 의약품 해외 인허가 과정에서의 장애요인 비교분석)

  • Hong, Yoon-Na;Ha, Dong-Mun
    • The Korean Journal of Health Service Management
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    • v.14 no.1
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    • pp.55-65
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    • 2020
  • Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs. Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents' companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion. Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes. Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies' expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.

Usefulness of four commonly used neuropathic pain screening questionnaires in patients with chronic low back pain: a cross-sectional study

  • Gudala, Kapil;Ghai, Babita;Bansal, Dipika
    • The Korean Journal of Pain
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    • v.30 no.1
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    • pp.51-58
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    • 2017
  • Background: Recently symptoms-based screening questionnaires have gained attention for screening for a neuropathic pain component (NePC) in various chronic pain conditions. The present study assessed the usefulness of four commonly used NePC screening questionnaires including the Self-completed douleur neuropathique 4 (S-DN4), the ID Pain, the painDETECT questionnaire (PDQ), and the Self-completed Leeds Assessment of neuropathic Symptoms and Signs (S-LANSS) questionnaire in patients with chronic low back pain (CLBP) to assess the presence of NePC. Methods: This is a single-center cross-sectional study where patients with CLBP, with or without leg pain, were included. Participants were initially screened for NePC presence by a physician according to the regular practice, and later assessed using screening questionnaires. The diagnostic accuracy of these questionnaires was compared assuming the physician-made diagnosis as the gold standard. Results: A total of 215 patients with CLBP of which 164 (76.3%, 95% CI, 70.2-81.5) had a NePC were included. S-DN4, ID Pain, and PDQ have an area under the curve (AUC) > 0.8 indicating excellent discrimination. However, S-LANSS has an AUC of 0.69 (0.62-0.75), indicating low discrimination. S-DN4 has a significantly higher AUC as compared to ID Pain (d(AUC) = 0.063, P < 0.01) and S-LANSS (d(AUC) = 0.197, P < 0.01). But the AUC of S-DN4 does not significantly differ from that of PDQ (d(AUC) = 0.013, P = 0.62). Conclusions: S-DN4, ID Pain, and PDQ, but not S-LANSS, have good discriminant validity to screen for NePCs in patients with CLBP. Despite using all the tests, 20-30% of patients with an NePC were missed. Thus, these questionnaires can only be used as an initial clue in screening for NePCs, but do not replace clinical judgment.