Department of Pharmacy, Nationwide Children's Hospital, Columbus, OH.
Department of Research Safety & Training Resources, The Research Institute at Nationwide Children's Hospital, Columbus, OH.
Am J Health Syst Pharm. 2019 May 17;76(11):795-802. doi: 10.1093/ajhp/zxz056.
The guidance documents applicable to the manipulation of viral vectors in a health-system pharmacy are reviewed to provide recommendations for occupational safe drug handling.
Biosafety handling principles should be drawn from 2 guidance documents essential in the manipulation of biological material: Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. and the National Institute of Health's NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Incorporating the biosafety guidance of these 2 documents into the pharmaceutical standards of United States Pharmacopeia chapter 800, "Hazardous Drugs-Handling in Healthcare Settings," will assist in the establishment of viral gene therapy handling guidelines in a health-system pharmacy.
Novel gene therapies and genetically modified therapeutic products will expose health-system pharmacists to classes of medications with unique biological handling requirements. Occupational safety data on the handling of these medications will be limited. The health-system pharmacy will need to rely on published biosafety recommendations to evaluate the infectious and genotoxic risks of these products while determining the necessary containment strategies to ensure safe work practice.
审查适用于医疗系统药剂科中病毒载体操作的指南文件，为职业安全药物处理提供建议。
生物安全处理原则应取自 2 份对生物材料操作至关重要的指南文件：《微生物和生物医学实验室生物安全》第 5 版和美国国立卫生研究院（NIH）的 NIH 指南，涉及涉及重组或合成核酸分子的研究（NIH 指南）。将这 2 份文件的生物安全指南纳入美国药典第 800 章“医疗环境中危害药物的处理”的制药标准，将有助于在医疗系统药剂科中建立病毒基因治疗处理指南。
新型基因疗法和基因修饰治疗产品将使医疗系统药剂师接触到具有独特生物处理要求的药物类别。这些药物的处理职业安全数据将受到限制。医疗系统药剂科将需要依靠已发表的生物安全建议来评估这些产品的感染和遗传毒性风险，同时确定必要的遏制策略，以确保安全的工作实践。
