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针对大二和大三药学专业学生的无菌复合制剂验证测试方案的实施与排序

Implementation and sequencing of a compounded sterile preparation validation testing protocol for second- and third-year pharmacy students.

作者信息

Dennis Vincent C, Kirkpatrick Alice E, Neely Stephen

机构信息

Associate Professor, University of Oklahoma College of Pharmacy, P.O. Box 26901, CPB 133, 1110 N. Stonewall Avenue, Oklahoma City, OK 73126, United States.

Clinical Assistant Professor, University of Oklahoma College of Pharmacy, 4502 East 41st St., #2C08, Tulsa, OK 74135, United States.

出版信息

Curr Pharm Teach Learn. 2022 Feb;14(2):222-228. doi: 10.1016/j.cptl.2021.11.033. Epub 2021 Dec 28.

DOI:10.1016/j.cptl.2021.11.033
PMID:35190165
Abstract

BACKGROUND AND PURPOSE

Incorporation of aseptic technique validation testing in a pharmacy curriculum consistent with United States Pharmacopeia Chapter 797 Standards is not well described. Validation testing is optimally placed prior to assignment to health-system introductory and advanced pharmacy practice experiences.

EDUCATIONAL ACTIVITY AND SETTING

Environmental and engineering controls consistent with a segregated compounding area were implemented. Medium risk media fill and gloved fingertip test (GFT) testing were incorporated to achieve initial and subsequent training in the second and third curricular years, respectively.

FINDINGS

For the graduating classes of 2018 through 2020, 234 students completed validation testing and knowledge assessment. Failure of the media fill test was uncommon. Failure of the initial GFT testing occurred in 16.1% to 22.1% of second-year students and 3.2% to 5.8% of third-year students. No significant differences were seen between three consecutive student classes.

SUMMARY

Incorporation of validation testing was successful, with consistent results. Procedures and results provide guidance with respect to student class size, available facility/equipment needs, implementation of validation protocols, and associated resources. Each student is provided with documentation of annual training and validation testing consistent with existing standards for health-system pharmacy practice.

摘要

背景与目的

在符合美国药典第797章标准的药学课程中纳入无菌技术验证测试的情况尚未得到充分描述。验证测试最好在分配到卫生系统入门级和高级药学实践经验之前进行。

教育活动与环境

实施了与隔离配药区一致的环境和工程控制措施。分别在课程的第二年和第三年纳入中等风险的培养基灌装和戴手套指尖测试(GFT),以进行初始培训和后续培训。

研究结果

对于2018年至2020年的毕业班,234名学生完成了验证测试和知识评估。培养基灌装测试失败的情况并不常见。第二年学生中初始GFT测试失败的比例为16.1%至22.1%,第三年学生中为3.2%至5.8%。连续三个学生班级之间未观察到显著差异。

总结

验证测试的纳入是成功的,结果一致。程序和结果为学生班级规模、可用设施/设备需求、验证方案的实施以及相关资源提供了指导。为每个学生提供了符合卫生系统药学实践现有标准的年度培训和验证测试文件。

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