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Meeting the needs

Providing best compromise between safety requirements and ease of handling Title of study

Safer preparation of methotrexate syringe outside a centralised cytotoxic preparation unit

Authors Virginie Ribeiro-Crespel, Stephanie Poullain-Termeau, Caroline Jaskopwiec, Sophie Saizy-Callaert and Armelle Thebault


Centre Hospitalier Intercommunal de Creteil, 40 avenue de Verdun, Creteil, France


Hospital Pharmacy Europe Number 46, September/October 2009

Aim of study ● Whereas all cytotoxic preparations for cancer wards are centralised, syringes of methotrexate prescribed for ectopic pregnancy are prepared by nursing staff in the Gynaecological Emergency Unit without specific safety measures. Therefore, the aim of the study was to determine and then implement on the ward a safe drug-transfer device, to prevent contamination and ensure staff safety.

Method ● A system with a vented vial access (to avoid aerosols) and a luer lock syringe

adaptor (allowing connection with an intramuscular needle for administration) was acquired.

● A pharmaceutical evaluation was conducted based on the devices specifications supplied by the manufacturers and on practical experiments, including a fluorescein test. The evaluation was completed by an estimate of extra cost that would be incurred by the use of such devices.

● A technical assessment was performed by nursing staff on the ward, simulating a preparation, after training and instruction was provided by a pharmacist. Nurses were given a questionnaire with ten criteria to evaluate packaging (labelling, opening), handling and safety, with an overall rating out of ten.

● Empty drug vials filled with 2ml fluorescein and sealed with drug vial system caps were used.

Conclusions ● It was calculated that any of the three devices under consideration would result in a cost increase for the hospital: 65% for the SpirosTM the TexiumTM

220% for the PhaSealTM

system (Hospira), 90% for system (CareFusion) and system (BD

Medical). This calculation took into consideration the price of the device and of the cytotoxic drug.

● The PhaSealTM system was not

pursued, on the grounds that the nurses found its use counter-intuitive. With less than one preparation per month per nurse the expected frequency, it was thought that there was too great a risk of misuse.

● Nurses on the Gynaecological Emergency Unit found the TexiumTM device easier to handle, safer and more efficient than the SpirosTM


● Two significant benefits were that the SmartSiteTM

(TexiumTM technology)

vial access devices (1) enabled the easy removal of the entire low-level drug solution, and (2) kept perfectly connected to the vial, whereas the ClaveTM

vial access spike (SpirosTM technology) was unsteady.

● Nurses gave the CareFusion device a ten out of ten, and the Hospira device five out of ten.

● The TexiumTM system represented the

best compromise between safety and ease of handling.


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