Place of ready-to-use pockets of Gemcitabine in a unit of anti-cancer drugs preparations

In 2017, the Sun Pharma Pharmaceutical company offers in France ready-to-use (RTU) preparations of gemcitabine with 6 different dosages: 1200, 1400, 1600, 1800, 2000 and 2200 mg. Since January 2012, our Centralized Compounding Unit (CCU), with an activity of approximately 13000 preparations / year, practices the "dose banding" concept on six molecules including gemcitabine. This allows us to anticipate some preparations and thus, smooth our activity on the day. Our « dose banding » is identical to that proposed by Sun Pharma, with additional doses of 1000, 1500 and 2500 mg. Our medical oncology department treats all types of cancers, and the 2 posologies of gemcitabine (1000 mg / m² and 1250 mg / m²) are therefore used.
We will compare retrospectively the number of preparations that could have been proposed in RTU preparations and evaluate the proportion on overall activity. Then we will study the advantages and the drawbacks of this solution and the feasibility of their integration in our activity.
 
Between January 2012 and July 2017, we have prepared a total of 3380 Gemcitabine infusion bags. Among them, 1372 were anticipated in rounded doses, either 40.6% of gemcitabine prescriptions. The number of preparations corresponding to the 6 dosages proposed by the manufacturer is 1140, whether 83% of our anticipated preparations and 34% of the total prescriptions of gemcitabine. The distribution of these prepared rounded doses is : 1800 mg - 24%, 1600 mg - 23%, 1400 mg - 19%, 2000 mg - 16%, 1200 mg - 13%.

The benefits of RTU are the preparation time saving, the manipulation reduction by the preparers (potential decrease in musculoskeletal disorders), the analytical batch control (absent for our unit), a 24 months expiry date and a possible reduction in patient waiting.
 
The main limitations of the RTU for our unit are the installation of a perfuser under isolator (absence of hood) and the increase of the references to be stored. Similarly, the preparation of out-of-band doses requires us to co-exist 2 production modes for the same molecule. IT management of manufacturing and inventory must be secured.

Over the past five and a half years, only 34% of total prescriptions could have been proposed for RTU, despite a fairly broad and well-targeted dosage range. This figure probably does not represent the optimal rate since not all of the anticipated doses have been systematically applied. Similarly, the time of acceptance by the prescribers of the principle of "dose banding" may explain this figure. Nevertheless, it represents a non-negligible rate of production of gemcitabine, which makes it possible to envisage a real impact on our activity. A medico-economic evaluation will have to be carried out in a second stage to decide their integration in our production process.