Cyclophosphamide reconstituted in advance : Could Drug Cam® provide a solution ?

Introduction

The Drug Cam® video system has been established in Hospital in 2017 (95% of the production). It is a tool for tracing and securing the manufacture of anticancer drugs. The scenario includ bottle recognition, reconstitution and extraction of anticancer drugs. The cyclophosphamide (CPM) vial is a lyophilisate. It requires a long shaking time to dissolve the powder in the solvent. This constraint extends preparation duration. The objective has consisted in developing a method to secure the cyclophosphamide reconstitution in advance and evaluate time saving to make it available for patients.

Material and method

The Drug Cam® (DC) video system ® is composed by 2 module : DC Assist® which guide the hospital pharmacy technician (PPH) during every manufacturing steps, et DC Control which permit the control and the release by the pharmacist. We have used the module “Dose Standard” (DS) of DC Control® for prescribing cyclophosphamide reconstitution in advance. First, pharmacists configured in DC Control® a vial of CPM like an administration conditioning. Once a week, they prescribed in DC Control® a predefined number of DS of CPM. A DS corresponded to the reconstitution of one CPM vial. DS were available for PPH in the Drug Cam Assist® waiting list. Then, PPH could reconstituted the vial of CPM by anticipation according the programming. At the end of the preparation, PPH put an on-label on the reconstituted vial mentioning the anticancer drug name, the scheduler number, the manufacture and expiry date. The pharmacist controlled and released the anticancer drug preparation in DC Control. In the end, each DS is used to CPM bag manufacture for a given patient. The CPM vial had to be set in Chimio® software as ready for use.

Results

The manufacturing time of a CPM bag whose vial has been previously reconstituted with the DS module is 4 minutes and 50 seconds. The average duration of a CPM bag scenario with extemporaneous reconstitution is 11 minutes and 26 seconds. The time saving is approximately 6 minutes and 36 seconds per preparation with the same level of security.

Conclusion

The CPM vial reconstitution in advance with Drug Cam® requires a reorganization of production. It generates a considerable time saving to make CPM bag available for hospitalized patients. It also ensures complete traceability of the preparation. In the future, we wish to generalize this practice to other anticancer drugs requiring a significant dissolution time such bortezomib.