Brown Alex M, Blind Jill, Campbell Katie, Ghosh Sumit
Department of Research Safety, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.
Department of Pharmacy, Nationwide Children's Hospital, Columbus, OH, USA.
Appl Biosaf. 2020 Dec 1;25(4):184-193. doi: 10.1177/1535676020934917.
Health care workers who work daily with human body fluids and hazardous drugs are among those at the highest risk of occupational exposure to these agents. The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) prescribes safeguards to protect workers against health hazards related to bloodborne pathogens. Similarly, the United States Pharmacopeia General Chapter 800 (USP <800>), a standard first published in February 2016 and implementation required by December 2019, addresses the occupational exposure risks of health care workers at organizations working with hazardous drugs. With emerging technologies in the field of gene therapy, these occupational exposure risks to health care workers now extend beyond those associated with bloodborne pathogens and hazardous drugs and now include recombinant DNA. The fifth edition of the () and the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) mostly govern work with biohazardous agents and recombinant DNA in a laboratory research setting. When gene therapy products are utilized in a hospital environment, health care workers have very few resources to identify and reduce the risks associated with product use during and after the administration of treatments.
At the Abigail Wexner Research Institute at Nationwide Children's Hospital, a comprehensive gap analysis was executed between the research and health care environment to develop a program for risk mitigation. The , NIH Guidelines, World Health Organization Biosafety Manual, OSHA Bloodborne Pathogens Standard, and USP <800> were used to develop a framework for the gap analysis process.
The standards and guidelines for working with viral vector systems in a research laboratory environment were adapted to develop a program that will mitigate the risks to health care workers involved in the preparation, transportation, and administration of gene therapies as well as subsequent patient care activities. The gap analysis identified significant differences in technical language used in daily operations, work environment, training and education, disinfection practices, and policy development between research and health care settings. These differences informed decisions and helped the organization develop a collaborative framework for risk mitigation when a gene therapy product enters the health care setting.
With continuing advances in the field of gene therapy, the oversight structure needs to evolve for the health care setting. To deliver the best outcomes to the patients of these therapies, researchers, Institutional Biosafety Committees, and health care workers need to collaborate on training programs to safeguard the public trust in the use of this technology both in clinical trials and as FDA-approved therapeutics.
每天接触人体体液和危险药物的医护人员是职业接触这些物质风险最高的人群之一。美国职业安全与健康管理局（OSHA）的《血源性病原体标准》（29 CFR 1910.1030）规定了保护工人免受与血源性病原体相关健康危害的防护措施。同样，美国药典通则第800章（USP <800>）于2016年2月首次发布，2019年12月起实施，涉及使用危险药物的医疗机构中医护人员的职业接触风险。随着基因治疗领域新技术的出现，医护人员面临的这些职业接触风险现已超出与血源性病原体和危险药物相关的风险，还包括重组DNA。（）第五版以及美国国立卫生研究院《涉及重组或合成核酸分子的研究指南》（NIH指南）主要规范实验室研究环境中生物危害剂和重组DNA的操作。当基因治疗产品在医院环境中使用时，医护人员在识别和降低治疗给药期间及之后与产品使用相关风险方面的资源非常有限。
在全国儿童医院的阿比盖尔·韦克斯纳研究所，对研究和医疗环境进行了全面的差距分析，以制定一个风险缓解计划。使用（）、NIH指南、世界卫生组织生物安全手册、OSHA血源性病原体标准和USP <800>来制定差距分析过程的框架。
对研究实验室环境中病毒载体系统操作的标准和指南进行了调整，以制定一个计划，该计划将降低参与基因治疗制备、运输和给药以及后续患者护理活动的医护人员所面临的风险。差距分析确定了研究和医疗环境在日常操作中使用的技术语言、工作环境、培训与教育、消毒措施以及政策制定方面存在显著差异。这些差异为决策提供了依据，并帮助该组织在基因治疗产品进入医疗环境时制定了一个合作性的风险缓解框架。
随着基因治疗领域的不断进步，医疗环境中的监管结构需要不断发展。为了给接受这些治疗的患者带来最佳治疗效果，研究人员、机构生物安全委员会和医护人员需要就培训计划展开合作，以维护公众对该技术在临床试验和作为FDA批准的治疗方法使用中的信任。
