技术辅助技术人员对复合静脉注射无菌制剂的验证与药剂师验证的评估
1Northwestern Memorial Hospital, Chicago, IL, USA.
概括
复合无菌产品 (CSP) 的技术辅助技术员验证 (TATV) 与药剂师验证一样准确. 这种方法不会对CSP的验证或处理时间产生负面影响.
科学领域:
- 制药科学 制药科学
- 临床药房实践 临床药房实践
- 在复合中进行质量保证.
背景情况:
- 药剂师验证是确保复合无菌产品 (CSP) 安全和有效性的关键一步.
- 评估替代验证方法可以优化无菌复合药房的工作流程和资源配置.
研究的目的:
- 评估技术辅助技术员验证 (TATV) 作为CSP传统药剂师最终验证的潜在替代方案.
- 将TATV的准确性和效率与药剂师验证进行比较.
主要方法:
- 一个2阶段,单中心的非劣势性研究,每阶段涉及4000剂量.
- 第一个阶段:药剂师准确性验证. 第二阶段:TATV准确性和效率评估.
- 统计分析包括法林顿-曼宁测试准确度非劣等性和威尔科克森等级总和测试时间差异.
主要成果:
- TATV证明了药剂师验证的非劣质性,精度差异为0.025% (95% CI, -0.26%至0.31%).
- 第一阶段的药剂师准确率为99.600%;第二阶段的TATV准确率为99.575%.
- 总验证时间和总剂量处理时间通过TATV显著减少.
结论:
- 技术辅助技术人员验证 (TATV) 是一个可行的,不低于药剂师最终验证的CSP的替代方案.
- TATV不会影响准确性,并且可以显著提高处理效率.
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