• 제목/요약/키워드: Clinical Pharmacy

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임부의 약물 노출 관련 등록지침 개발 연구 (Development of Drug Exposure Registries on Pregnant Women)

  • 김수희;노혜진;지은희;윤정현;김경임;신완균;오정미
    • 한국임상약학회지
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    • 제20권2호
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    • pp.114-119
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    • 2010
  • Objectives: We developed a registry guidance to provide a standard for data collection, analysis and methodical management of information on the influence of drug exposure on pregnant women and fetus. Methods: We surveyed guidances and regulations of clinical trials and the pharmaceutical affairs law, compared them with Pregnancy Exposure Registry of other countries and in addition, investigated related references. We found the flaws of the present registry and supplemented it based on better results from other countries. Results: We developed a concrete and detailed report that included pregnancy drug exposure cases necessary for close monitoring, types and characteristics of data on pregnancy drug exposure, the requirements of registry data, and essential items needed to be researched. Conclusions: Information on pregnancy drug exposure in Korea can be effectively collected by using this report which provides a comprehensive assess to drug's influence on pregnant women and fetus, and in addition, accurate information about safety and effectiveness of drug use in pregnant women and fetus can be obtained by sharing data globally and managing it synthetically and systematically.

Therapeutic Duplication as a Medication Error Risk in Fixed-Dose Combination Drugs for Dyslipidemia: A Nationwide Study

  • Wonbin Choi;Hyunji Koo;Kyeong Hye Jeong;Eunyoung Kim;Seung-Hun You;Min-Taek Lee;Sun-Young Jung
    • 한국임상약학회지
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    • 제33권3호
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    • pp.168-177
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    • 2023
  • Background & Objectives: Fixed-dose combinations (FDCs) offer advantages in adherence and cost-effectiveness compared to free combinations (FCs), but they can also complicate the prescribing process, potentially leading to therapeutic duplication (TD). This study aimed to identify the prescribing patterns of FDCs for dyslipidemia and investigate their associated risk of TD. Methods: This was a retrospective cohort study involving drugs that included statins, using Health Insurance Review & Assessment Service-National Patient Sample (HIRA-NPS) data from 2018. The unit of analysis was a prescription claim. The primary outcome was TD. The risk ratio of TD was calculated and adjusted for patient, prescriber, and the number of cardiovascular drugs prescribed using a multivariable Poisson model. Results: Our study included 252,797 FDC prescriptions and 515,666 FC prescriptions. Of the FDC group, 46.52% were male patients and 56.21% were aged 41 to 65. Ezetimibe was included in 71.61% of the FDC group, but only 0.25% of the FC group. TD occurred in 0.18% of the FDC group, and the adjusted risk ratio of TD in FDC prescriptions compared to FC was 6. 44 (95% CI 5. 30-7. 82). Conclusions: Prescribing FDCs for dyslipidemia was associated with a higher risk of TD compared to free combinations. Despite the relatively low absolute prevalence of TD, the findings underline the necessity for strategies to mitigate this risk when prescribing FDCs for dyslipidemia. Our study suggests the potential utility of Clinical Decision Support Systems and standardizing nomenclature in reducing medication errors, providing valuable insights for clinical practice and future research.

알츠하이머병, 파킨슨병 및 혈관성치매 환자들의 우울증에 대한 약물 치료 평가 (Evaluation of Pharmacotherapy for the Patients with Depression in Alzheimer's Disease, Parkinson's Disease or Vascular Dementia)

  • 이효진;이옥상;정선회;박미숙;임성실
    • 한국임상약학회지
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    • 제23권1호
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    • pp.33-41
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    • 2013
  • Background: Prevalence of depression comorbid with neurologic disorders such as Alzheimer' disease (AD), Parkinson's disease (PD) and vascular dementia (VD) is higher than that of primary depression. Antidepressant medications, suggested by many researches for depression comorbid with neurologic disorders such as AD, PD and VD, are mainly selective serotonin reuptake inhibitors (SSRI). Objective: The primary objective of this study is the evaluation of antidepressant drug therapy for AD, PD and VD. Method: This study was a retrospective study based on medical records, carried out for 3 years and 6 months (Jan. 2007~Jul. 2010). Patients, diagnosed as comorbid depression through Beck Depression Inventory (BDI), Cornell Depression Scale (CDS), Geriatric Depression Scale (GDS) among neurologic out-patients of Chungnam National University Hospital because of AD, PD and VD, were selected. The results were evaluated by efficacy and safety of antidepressant drug therapy. Results: In result, the prescribing rates of antidepressants were 30%, 55% and 40% for each AD, PD and VD. Depression cure rates of patients receiving antidepressants vs patients not receiving antidepressants were 40% vs 39%, 33% vs 23% and 38% vs 30% for AD, PD and VD. The frequencies of prescriptoin of SSRI were 21%, 11% and 27% for each AD, PD and VD. The frequencies of prescriptoin of benzodiazepine (BZD) was 61%, 82% and 61% for each AD, PD and VD. The ratio of single BZD prescription was more than that of combination prescription of antidepressants. Tricyclic antidepressants (TCA) were rarely prescribed. The rate of patients with BZD-related side effects was 54%. The most frequent side effects of BZD were dizziness (30%), drowsiness (21%) and headache (16%). Side effects of SSRI were rare. Conclusion: In conclusion, the frequencies of prescription of antidepressants were not common for AD, PD and VD. There was little difference in depression cure rate between patient receiving antidepressants and not receiving. Even though SSRI has to be the highest priority of usage, the frequencies of prescription of SSRI were lower than those of BZD. Additional researches and efforts are required to improve antidepressant drug therapy for neurologic disorders such as AD, PD and VD.

국내 및 해외의 임상시험 데이터모니터링위원회 지침의 현황 (Independent Data Monitoring Committees: Review of Current Guidelines)

  • 이보람;이경은
    • 한국임상약학회지
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    • 제26권2호
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    • pp.181-186
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    • 2016
  • Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

국내 병원약사의 중재활동과 성과에 대한 체계적 문헌고찰 (A Systematic Review of Outcomes Research in the Hospital Pharmacists' Interventions in South Korea)

  • 이소영;조은
    • 한국임상약학회지
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    • 제29권3호
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    • pp.193-201
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    • 2019
  • Background and Objective: Since the introduction of hospital pharmacy residency programs in 1983, hospital pharmacists in South Korea have been expected to expand their roles. However, their services and the outcomes have not been fully understood. In this study, we conducted a systematic review of Korean hospital pharmacist-provided interventions with regard to intervention type, intervention consequences, and target patient groups. Methods: A literature search of the following databases was performed: Embase, PubMed, Medline, KoreaMed, RISS, KMbase, KISS, NDSL, and KISTI. The search words were "hospital pharmacist", "clinical pharmacist", and "Korea". Articles reporting clinical or economic outcome measures that resulted from hospital pharmacist interventions were considered. Numeric measures for the acceptance rate of pharmacist recommendations were subjected to meta-analysis. Results: Of the 1,683 articles searched, 44 met the inclusion selection criteria. Most articles were published after 2000 (81.8%) and focused on clinical outcomes. Economic outcomes had been published since 2011. The interventions were classified as patient education, multidisciplinary team work, medication assessment, and guideline development. The outcome measures were physicians' prescription changes, clinical outcomes, patient adherence, economic outcomes, and quality of life. The acceptance rate was 80.5% (p < 0.005). Conclusion: Studies on pharmacist interventions have increased and showed increased patient health benefits and reduced medical costs at Korean hospital sites. Because pharmacists' professional competency would be recognized if the economic outcomes of their work were confirmed and justified, studies on their clinical performance should also include their economic impact.