Background Azacitidine (Vidaza) is a powder to be made up into a suspension for injection whose stability, after reconstitution, does not exceed 45 min at room temperature. This is a very short time considering that the drug is prepared in the pharmacy department and injected in another department. This stability can extended up to 22 h if the preparation is made and kept between 2 and 8°C (Vidaza EPAR EMEA/H/C/000978 -II/0009).
Purpose The authors here describe a method for preparing Vidaza injection syringes that ensures an unbroken cold chain, from preparation to storage.
Materials and methods Our chemotherapy preparation unit is equipped with two Isocyt Freja rigid isolators (Getinge). Sterile DPTE (Double Door Leaktight Transfer) containers can be safely connected and disconnected to these isolators without breaking containment. Sterile anticancer drug vials that should be stored between 2 and 8°C after opening are put in such containers
Vidaza is administered daily for 7 days. On the first day The authors sterilise all the materials needed for the first and the second injection (drug phial(s), syringes, water for injection vials). On the next day the sterile products are put in a sterile container and placed in our refrigerator. The following days: 1/ The authors sterilise and put in a container what is necessary for the next day's injection. 2/ The authors use the previously sterilised, cold-stored medicine, material and solvent for the current day's injection. And so The authors proceed until the end of the cycle (from day 2 to day 7).
Results All the Vidaza injection syringes for a given day are prepared at the same time, sealed in sterile bags and stored between 2 and 8°C. The cold chain is uninterrupted throughout this process and The authors can ensure 22-h stability for our Vidaza injection syringes. So when the patients come back (day 2 to day 7), their injection syringe is already prepared and given to them immediately.
Conclusions Going from 45-min stability to 22-h stability is a huge improvement. This makes us more flexible towards the patients' consultation hours: they can come at any time during the day, the syringes are waiting for them. It has really improved the way patients are taken care of in the Haematology Department. The authors should also mention that it greatly helped us optimise the chemotherapy production flow.
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