Implementation of dose-banding in our hospital: ready-to-infuse bags or standardized dose batches

Introduction
In 2021, our chemotherapy production has increased by 13.9%. To face it and fluidify the circuit, we are considering dose banding (DB) as a solution. Two methods exist: the manufacture of standardized dose batches (SDB) and the use of ready-to-infuse bags (RIB). Our objective is to evaluate the relevance of the implementation of these DB methods for gemcitabine in our hospital.

Materials and Methods
We analyzed the regulatory context of DB (Good Manufacturing Practices). Gemcitabine prescriptions for 2021 were extracted via CHIMIO^® to select dose range of standardization and to use the GERPAC dose banding tools(1) (ADoC, ADoST, Detal, OSS).
Then a comparison between RIB and SDB was made:
* estimated cost of preparation
* time to prepare a gemcitabine bag (data from DRUGCAM^®) versus the time needed to insert a tubing on a RIB
* necessary adaptations on CHIMIO^®

Results
RIB require no regulatory adjustment or new equipment. SDB have a complex status between magistral and hospital pharmaceutic preparation and would require an analytical control machine.
In 2021, 1348 bags of gemcitabine were prepared in our unit. The dose ranges chosen are ±100mg around the dose of existing gemcitabine RIB, except for the first dose to reduce the deviation, which is of 7.69% at most. Using this method, 93% of prescriptions could have been standardized.
The DB tools confirmed our choice of range and showed that the size if the batches would be from 6 to 31 bags depending on the dose.
About the price, RIB would have cost around 41093€ in 2021 against 18866€ to prepare SDB.
For the preparation time, it takes an average of 255 seconds to prepare a gemcitabine bag against 45 seconds for a RIB, which means a theoretical time saving of 78 hours over the year.
SDB require the purchase of a specific module on CHIMIO^® whereas for RIB the version 6.0 is sufficient.
SDB would entail important financial and organizational investments while the current activity does not allow us to make large batches. RIB do not provide direct savings, but the time saved would benefit the rest of our activity.

Conclusion
We have decided to use gemcitabine RIB in view of its ease of implementation compared to SDB. RIB also reduce the risk of infection, preparation errors, medicine waste, patient waiting time and make the circuit safer.
SDB could be considered if the activity continues to increase, to extend the DB to other eligible molecules.

Reference
(1): Humbert M. Anticancer drugs preparation at hospital: proposition of tools to help in the implementation of dose banding, GERPAC conference

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