建立一个全系统的风险评估过程,对研究药物进行风险评估
Kevin Zinchuk1, Helen Volf1, Kay Li2
1Investigational Drug Service, Brigham and Women's Hospital, Boston, MA, USA.
概括
一个标准化药房主导的过程被开发,以评估危险药物风险的研究产品 (IPs),确保符合美国药典 (USP) 章节<800>. 该系统增强了学术卫生网络的安全性和监管遵守.
科学领域:
- 制药科学 制药科学
- 职业健康和安全问题 职业健康和安全问题
- 临床研究管理 临床研究管理
背景情况:
- 美国药典 (USP) 第800章要求危险药物管理,但缺乏针对研究产品 (IP) 的具体指导.
- 美国国家职业安全与健康研究所 (NIOSH) 的危险药物清单中已有过时的信息,为新兴药物创造了空白.
- 学术卫生网络需要标准化的方法来评估研究人员的风险.
研究的目的:
- 描述药房主导的研究产品 (IP) 风险评估 (AOR) 过程的开发和实施.
- 确保在一个大型的学术健康网络中遵守USP第800章标准.
- 建立一个一致和透明的系统来评估IPs的危险药物特性.
主要方法:
- 一个由药房服务部门领导的多学科工作组开发了一个全系统的IP AOR流程.
- 创建了两个不同的评估工具,包括小分子和生物制药剂的毒理学和生物安全标准.
- 为了保持一致性和监管合规性,建立了一个集中数据库和一个监督委员会.
主要成果:
- 截至2025年7月,已评估了255个专业项目:8个高风险危险项目,126个低风险危险项目,121个非危险项目.
- 该过程为IPs提供了适当的标签和安全处理程序.
- 对于管理IP的研究药房,建立了有效的审查工作流程.
结论:
- 药房主导的IP AOR流程对于对研究药物的USP<800>要求进行操作至关重要.
- 该模型增强了职业安全,监管合规性,并支持在卫生系统中可扩展的实施.
- 描述的过程可以适应新上市的药物,尚未由NIOSH审查.
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