5PSQ-101 Oncolytic viruses risk and control assessment: talimogene laherparepvec experience. (2nd March 2018)

• Record Type: Journal Article
• Authors: Costanza, C Della; Saibene, G; Laganà, G; Ruffino, E; Antonacci, G; Langella, R; Mauro, C Di; Galassi, M; Re, B; Ladisa, V
• Is Part Of: European journal of hospital pharmacy. Volume 25(2018)Supplement 1
• Page Start: A211
• Page End: A211
• Publication Date: 2018-03-02
• Subjects: Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2018-eahpconf.454
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Background: The oncolytic virus (OV) Talimogene Laherparepvec (T-VEC) is a microorganism genetically modified (MOGM), since it is genetically engineered to no longer be capable of causing infection or of spreading in normal cells. Even if it was considered to have a minimal exposure risk, is there the need to take control measures? Purpose: To implement the shared procedures, already created for appropriate management of OV, for T-VEC management, in CT for squamous-cell head-neck carcinoma (SCHN), between the pharmacy clinical studies ward and head-neck ward in our Oncology Institute, and to evaluate the risk of possible contamination at every step of operation conducted following the procedures. Material and methods: The Internal Hospital Procedure of IMP Management, study protocol, national and European law for MOGM-type-2 (conteniment -level-2) management and revision of literature were examined. Each category of personnel involved, with their specific roles established, was documented and every step of the operation conducted. Results: The activity levels (AL) (four) began from the Pharmacy-Clinical Studies Unit that documented every step of the product: Receipt and control. Storage (under 80°C) and use of individual protection devices (IPD). Guidelines for preparation, operation control, instruction operation and decontamination (sodium hypochlorite). Transport in specific box. The AL (one) of intersection between pharmacists and clinical research nurses of the head-neck carcinoma ward was product preparation. The operation was conducted separately from others in a specific vertical-flow biologic-safety-cabinet, always in double and documented (date, time, signature). The AL (one) for nurses was product administration. The operation was in a specific one-patient-room separated and before eventual concomitant therapy (pembrolizumab). The AL (one) for the Hygiene Unit was in the management of residual vials, medical devices and IPD. These actions permitted the separation of instruments used in previous steps and avoiding using the same autoclave available in the hospital for sterilisation. No exposure of personnel and patients or contamination of other IV products, including chemotherapy, was detected with this procedure. Conclusion: Handling OV such as hazardous drugs in a coordinated method minimised the risk of exposure and therefore the risk of contamination. Furthermore, being aware in the future of the symptoms associated with infection due to virus will help in monitoring for possible exposure. No conflict of interest