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

摘要

Introduction: 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.