Management of Advanced Therapy Medicinal Products (ATMP) in hospitals: circuits considered at the University Hospital of Lille
6 October 2017M. Pinturaud1, C. Nassar1, M. Vasseur1, P. Odou1,2 1 CHU Lille, Institut de Pharmacie, 59000 Lille, France
2 Université de Lille, EA 7365 - GRITA - 59000 Lille, France
The arrival of ATMP seems to be a pivotal and revolutionary step in the management of cancer. It is one of the new challenges for hospital pharmacy and pharmacotechny and requires multidisciplinary care in hospitals. We wished through this work to present the circuit considered in our pharmacy.
Some texts helped us to build our circuit: Recommendations of the French Society of Pharmacy Oncology, the Good Practices Tissue Cells, as well as the regulations associated with the handling of nitrogen. We conducted meetings with the biomedical and technical departments of the hospital and thinked about a very short-term, medium-term and long-term circuit for both gene therapy (GT) and cell therapy (CT) from reception to patient’s administration.
For ATMP of CT: in a very short term dry-shippers will be stored in a ventilated room equipped with a portable oxygen sensor. In medium term, a storage room with a nitrogen tank is provided in the local of the PUI. Defrosting, a key stage of the circuit, will be carried out within the PUI before transport in the healthcare service. For ATMPs of GT: freezers will be stored in a ventilated room separated from CT. An autoclave will allow viral inactivation on site. For ATMP requiring preparation: in a very short term, it will be managed in a controlled atmosphere area with isolators. In medium term, this room will undergo work to separate CT flows from GT with the addition of a laminar airflow hood.
The circuit of these ATMP is complex in view of the diversity of the products handled and requires specific management at each stage of the medicinal circuit. It is essential to set up these circuits to allow access to these innovative therapies for patients of the region.