No abstract

Background When pharmacy staff is not available, nurses used to prepare diluted busulfan solution from commercial vials just before administration because of its low stability. Doing this without protection may cause occupational exposure to this cytotoxic drug. Purpose To devise a new protocol and perform a preliminary evaluation. Materials and Methods Literature and technical studies were performed to choose the best devices. Nurses and physicians performed a clinical evaluation using a 5-item satisfaction form. Results Medical devices containing polycarbonate must be avoided because of the interaction with N,N-dimethylacetamide used as an excipient. The new protocol consists of an individual kit with the commercial solution packed in a syringe, an infusion bag with the exact volume of diluent and a closed system transfer device (CSTD). Nurses just have to dilute the solution into the bag under a laminar air-flow hood using the CSTD. Although 2-part syringe methods were found in the literature, 3-part syringes with limited contact between the elastomeric tip and busulfan solution (reference 62.8426, Codan) were chosen because leaks were observed with the 2-part syringes during the technical study. PhaSeal devices: Injector to close the syringes and a Connector-Luer for infusion bags were selected as CSTDs. All these devices are polycarbonate free. 7 new kits were prepared for a period of 8 days without contact. The results of the evaluation show that nurses and physicians (n = 14) were overall dissatisfied by the previous protocol (neither good nor bad: 35.7%, bad: 21.4% and very bad: 35.7%) while the majority preferred the new one (very satisfied: 28.6%, satisfied: 42.9%, neither good nor bad 7.14%, no response: 21.4%). Overall nurses and physicians answered that new modalities limit the risk of dose errors (93%) and occupational exposure (86%). Conclusions Implementing this procedure has improved handling practise with good satisfaction. No conflict of interest.