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英国医院药剂科是否已为基因治疗药物的兴起做好准备?

Are UK hospital pharmacy departments ready for the rise of gene therapy medicinal products?

机构信息

a Pharmacy Department , Oxford University Hospitals NHS Foundation Trust , Oxford , UK.

出版信息

Expert Opin Biol Ther. 2018 Aug;18(8):837-840. doi: 10.1080/14712598.2018.1495192. Epub 2018 Jul 17.

Abstract

The first gene therapy medicines are licensed and National Institute for Health and Care Excellence approved for use in the NHS. UK Hospital pharmacy departments will need to work with multidisciplinary colleagues to ensure that there are facilities available to handle this new group of medicines. Areas Covered: UK licensed and National Institute for Health and Care Excellence gene therapy medicinal products (GTMP) and requirements for handling. Review of pharmacy facilities and implementation of advanced therapy medicinal products (ATMP) in the UK. Expert Opinion: Most hospital pharmacy departments do not have aseptic facilities for the reconstitution of gene therapy medicines, or have the appropriate freezers in place. Staff do not have the understanding or training of these products unless they are experienced in using them in clinical trials. Chief Pharmacists will need to ensure that governance process are in place as they will ultimately be responsible for the implementation and safe handling of these product. Therefore, work needs to continue to highlight the importance of pharmacy departments and their role in the implementation of this new group of medicines. As more GTMPs are licensed and become standard medicines being handled in pharmacy departments, there will be more hospital pharmacy departments ready to handle them. Initially it will just be the centers of excellence, ATMP centers, and research centers with the expertise and facilities. In the long-term, other hospitals will plan and build the facilities they require.

摘要

第一批基因治疗药物已获得许可,并获得英国国家卫生与保健优化研究所(NICE)批准在国民保健制度(NHS)中使用。英国医院药剂科需要与多学科同事合作,确保有设施可用于处理这一新类别的药物。涵盖领域:英国许可的和 NICE 基因治疗药物(GTMP)以及处理要求。审查英国的药剂设施和先进治疗药物(ATMP)的实施情况。专家意见:大多数医院药剂科没有用于基因治疗药物复溶的无菌设施,或者没有适当的冷冻设备。除非员工在临床试验中使用过这些产品,否则他们对这些产品没有了解或培训。首席药剂师需要确保治理流程到位,因为他们最终将对这些产品的实施和安全处理负责。因此,需要继续努力强调药剂部门的重要性及其在实施这一新类药物方面的作用。随着更多的 GTMP 获得许可并成为药剂科处理的标准药物,将有更多的医院药剂科准备好处理这些药物。最初,只有卓越中心、ATMP 中心和有专业知识和设施的研究中心能够处理。从长远来看,其他医院将规划和建造他们所需的设施。

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