我院静脉药物配置室审方结果统计与分析

目的通过药师审方,发现并分析我院静脉药物配置室的不合理用药,为临床合理用药提供依据。方法对我院2008年7月-12月静脉药物配置室审方结果进行分类统计与分析。结果发现不合理用药处方466张,包括配伍、溶媒、给药剂量、给药浓度、给药频次、给药途径、电脑录入失误等不当的问题。经反馈给临床,大部分不合理用药医嘱得到纠正。结论通过药师审核静脉药物配置室静脉用药医嘱,可提高静脉用药的安全性和有效性。     

Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies

This article describes procedural elements involved in ensuring the integrity of bioanalytical data. These elements can be divided into 3 areas. First, there are those ensuring the integrity of the analyte until analysis, through correct sample collection, handling, shipment, and storage procedures. Incorrect procedures can lead to loss of analyte via instability, addition of analyte through contamination or instability of related metabolites, or changes in the matrix composition that may adversely affect the performance of the analytical method. Second, the integrity of the sample identity needs to be maintained to ensure that the final result reported relates to the individual sample that was taken. Possible sources of error include sample mixup or mislabeling, or errors in data handling. Finally, there is the overall integrity of the documentation that supports the analysis, and any prestudy validation of the method. This includes a wide range of information, from paper and electronic raw data, through standard operating procedures and analytical procedures and facility records, to study plans and final reports. These are critical to allow an auditor or regulatory body to reconstruct the study.     

The effects of teamwork and system support on colorectal cancer screening in primary care practices

Background: While cancer screening is generally increasing in the U.S., colorectal cancer (CRC) screening remains low. Most CRC screening interventions focus either on patients or individual clinicians without examining the office context in which CRC screening is implemented. This study examines whether primary care practices that involve staff in general forms of health education have higher CRC screening rates than practices that do not. Methods: Cross-sectional data from 22 New Jersey and Pennsylvania family medicine practices were analyzed. Data include chart audits for 795 men and women eligible for CRC screening (age 50–70) and practice information surveys for each practice. Generalized estimating equations were used to determine CRC screening correlates. Results: Overall, 31.3% (n = 249) of patients received CRC screening. Practices that reported using nursing or health educator staff to provide behavioral counseling to patients on topics such as diet, exercise or tobacco use were significantly more likely to also have higher CRC screening rates (z = 7.30, p < 0.0001). Their patients had 2.96 times increased odds of CRC screening than those in other practices (95% C.I., 2.21–3.96). Reminder system use was also associated with higher CRC screening (z = 4.96, p < 0.0001). In practices that used reminder systems, patients had 2.57 times increased odds of CRC screening than others (95% C.I., 1.77–3.74). Conclusions: These findings suggest that interventions to achieve better CRC screening rates do not need to focus solely on CRC. Higher CRC rates may be achieved by capitalizing on the enhancing contributions of non-physician practice members providing more general health behavior change patient education.     

BI‐RADS 3 (short‐interval follow‐up) assessment rate at diagnostic mammography: Correlation with recall rates and utilization as a performance benchmark

The purpose of this study was to identify a correlation between the screening BI‐RADS 0 (recall) rates and diagnostic BI‐RADS 3 (short‐interval follow‐up) rates of individual interpreting radiologists, with the goal of utilizing the BI‐RADS 3 rate as an acceptable performance metric in the diagnostic population. A multicenter retrospective analysis of medical audit statistics was conducted on annual radiologist performance data collected over a 14‐year period in a community hospital‐based practice. Mixed regression models were used to estimate the association between screening BI‐RADS 0 and diagnostic BI‐RADS 3 examinations while adjusting for calendar year, annual radiologist screening volume, annual radiologist diagnostic volume, and diagnostic examination indication. A moderate statistically significant positive correlation was established between the screening BI‐RADS 0 rates and Diagnostic BI‐RADS 3 rates (Pearson correlation coefficient + 0.349, P ≤ .001). Furthermore, when utilizing a national benchmark range of 8%‐12% as an acceptable BI‐RADS 0 rate within a screening population, the correlative BI‐RADS 3 assessment rate was demonstrated to be approximately 16%. We propose that this BI‐RADS category 3 rate may represent an additional acceptable performance metric in the diagnostic population. Routine inclusion of an interpreting mammographer's diagnostic BI‐RADS 3 rate in the annual medical audit may help reduce inappropriate and/or excess use of the BI‐RADS 3 category, which may lead to significant potential reductions in follow‐up examinations with their associated healthcare‐related costs, resource expenditure, and induced patient anxiety.     

医院内外来器械公司人员及器械的程序化管理

目的 探讨医院内外来器械公司人员、器械的管理模式,加强对医院内外来器械公司人员、器械的管理,保证外来手术器械的消毒灭菌质量,有效预防医院感染.方法 制定医院、科室对外来器械公司的器械、人员管理制度,建立消毒供应中心(CSSD)、手术室质控小组,质控员负责公司人员在医院内相关配合工作的培训、考核、处罚及动态的监测,并把实施程序化管理后的情况与历史性工作进行比较.结果 实施程序化管理后,外来器械送货及时性达到99.9％；器械的功能、数量及清洗质量明显提高,整体合格率由82.6％上升至99.8％,两组比较差异有统计学意义(P＜0.01)；同期手术量增加前提下,违纪次数反而由157次减少至4次,违纪率从21.7％下降至次0.4％；术后污染器械的消毒处理率达100.0％.结论 对医院外来器械公司的工作状况实施高质量管理,有效地提高了医疗安全、医疗工作质量和服务质量,在医院的医疗安全管理中发挥着重要作用.     

动态药品供应商选择问题研究

目的:解决动态药品供应商选择问题.方法:给出了灰色多层次评价的分析方法.即首先对不同阶段的决策矩阵进行集结,并根据灰色理论,计算关联系数矩阵.然后,分别确定药品供应商关于一级指标的单层次评价和药品供应商的多层次评价,以选出最优供应商.结果和结论:通过实例分析证明了该方法的有效性和实用性.     

Critical parameters in targeted drug development: the pharmacological audit trail

The Pharmacological Audit Trail (PhAT) comprises a set of critical questions that need to be asked during discovery and development of an anticancer drug. Key aspects include: (1) defining a patient population; (2) establishing pharmacokinetic characteristics; (3) providing evidence of target engagement, pathway modulation, and biological effect with proof of concept pharmacodynamic biomarkers; (4) determining intermediate biomarkers of response; (5) assessing tumor response; and (6) determining how to overcome resistance by combination or sequential therapy and new target/drug discovery. The questions asked in the PhAT should be viewed as a continuum and not used in isolation. Different drug development programmes derive different types of benefit from these questions. The PhAT is critical in making go-no-go decisions in the development of currently studied drugs and will continue to be relevant to discovery and development of future generations of anticancer agents.