Methotrexate®, Velcade® and Vidaza® syringes preparations : which of closed drug reconstitution and transfer systems are to protect the staff and environment?

Y. Brasleret , M.A. Zilavec, G. Svrcek, C. Naine, D. Pecquenard, J. Grimaux 46, avenue du Général de Gaulle, Service Pharmacie, CH Soissons, France

Objectives

In order to protect the staff (pharmacy technician and nurse) and the environment from the risks related to cytotoxics, a study for a medical device (MD) in closed drug reconstitution and transfer systems for the preparation (CDRATS) under isolator subcutaneous administrations of Methotrexate®, Velcade® and Vidaza ® was undertaken.

Material and Methods

We conduct a comparative study between 4 suppliers (BD, MacoPharma, Teva, Vygon) commercializing MD for injectables preparations in CDRATS. A performance analysis was carried out taking into account the notion of "true" CDRATS, vials’adaptors, the MD size, the dead volume, the possible rest in case of fully vial picking, ease to manipulate and job safety.
The financial impact of these MD has been evaluated for an annual quantity of 1000 syringes from the list price of the different MD and consumables.

Results

All 4 devices have been tested.

The MD commercialized by MacoPharma and Vygon distinguishes itselfs from their “true” CDRATS: no possibility of disadapting the vial, and by their ability to collect the entire volume of the vials.

The different MD dead volumes are 0.09 mL; 0.12 ml; 0.12 ml and 0.35 ml for MacoPharma, BD, Teva and Vygon respectively.

BD and Teva DM are the ones which require the least consumables. For an annual quantity of 1000 syringes, the additional cost excluding tax calculated is 4127 €, 5871 €, 7072 € and 9977 € for Vygon, Teva, BD and MacoPharma respectively.

Discussion / Conclusion

This study was conducted together with the oncology department of our institution. It made all staff aware of the risks related to cytotoxics and the importance of environmental risk management.

The CDRATS commercialized by MacoPharma and Vygon were chosen for their simplicity of use and for lower risk of misuse thanks to their effective CDRATS.

Vygon laboratory showed an economic advantage according to our study.

No choice has been made in our institution for now but it is a topical issue in the context of the Grouping Hospital Territory (GHT) and the recent cytotoxics production for another hospital.

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