关键词: Aseptic technique Compounded sterile preparations Gloved fingertip testing Laboratory education Media fill testing USP <797>

Mesh : Curriculum Drug Compounding / methods Education, Pharmacy / methods Humans Pharmacy Students, Pharmacy

来  源:   DOI:10.1016/j.cptl.2021.11.033

Abstract:
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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:
目的:在符合《美国药典》第797章标准的药学课程中引入无菌技术验证测试并没有得到很好的描述。在分配卫生系统入门和高级药学实践经验之前,验证测试处于最佳位置。
方法:实施与隔离复合区域一致的环境和工程控制。纳入中等风险介质填充和戴手套的指尖测试(GFT)测试,以实现第二和第三课程年的初始和后续培训,分别。
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。介质填充测试失败并不常见。最初的GFT测试失败发生在16.1%至22.1%的二年级学生和3.2%至5.8%的三年级学生中。三个连续的学生班级之间没有显着差异。
结论:合并验证测试是成功的,结果一致。程序和结果提供有关学生班级规模的指导,可用的设施/设备需求,验证协议的实施,和相关资源。为每个学生提供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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