French state of play in dose-banding

Introduction

In our center we want to improve the production of antineoplastic chemotherapy with the implementation of dose banding (DB). The literature analysis highlights many disparities. We conducted an investigation in order to collect recent data on dose banding practices in French centers.

Material and method

The survey consisted of 20 questions divided into different sections: global activity, conditions and method of production, mandatory status, process validation, microbiologic study, sterility test on batch, quality controls. This survey was conducted with the site Survey Monkey® (1) and made available, after validation by the GERPAC(2) scientific committee, on the association’s web platform for one month.

Results

43 institutions responded, producing 1000 to 100000 preparations. 37% (16) of centers practice DB. 100% of centers with an annual activity over 50000 preparations practice DB and 60% those with an activity between 30000 and 50000. The rate of activity prepared in DB varies from 4% to 100%. Three centers standardize 4 drugs and 1 center 11 drugs. The most frequently standardized drugs are 5FU, paclitaxel, gemcitabine and cyclophosphamide. Several centers produce monoclonal antibodies in DB. Different modes of production are found: non nominative with no batch production (14%), anticipated production according to a prescription (33%) and non nominative with batch production (53%). For this latter production mode, we find 2 regulatory statuses: hospital (67%) and magistral (33%) preparation. 95% of the centers produce DB in bags. Only 3 centers specify that they conduct a microbiological stability study to validate extended storage periods.

Discussion

DB is predominantly used in important production units (>30 000/year). Non nominatives preparations with batch are the most used mode of production, it permits an automatization. We find the same disparities in the regulatory status of the preparation than in our literature analysis: depending on center the same mode of production can correspond to a magistral or hospital preparation. One limit of our survey is the unknown rate of responders comparatively to the entirety of French unity.

Conclusion

Our survey confirms the disparities observed in the literature. We think that guidelines elaboration will be interesting to harmonize French centers practices, particulary for regulatory status of preparations and quality controls.