Quality control issues not detected by chemotherapy video monitoring system

Introduction
Preparing chemotherapies (CT) in a pharmacy compounding unit is a high-risk process, due to the administration of these sterile drugs with a narrow therapeutic index to vulnerable patients. Our unit is equipped with a video automatic error recognition system (Drugcam^®) used to assist and monitor the preparation and release of the CT. As part of a review of the limits of our process, we analyzed a sample of preparations and looked for quality control (QC) issues undetected by Drugcam®.

Material and method
We analyzed the complete videos of a sample of preparations carried out over 2023. The preparations concerned were made by both the unit’s pharmacy technicians (PPH) and on-call pharmacists. We analyzed 5 types of preparations, due to the diversity of their preparation steps: carfilzomib (requiring a reconstitution step), busulfan (requiring use of a needle and air intake), paclitaxel (requiring the use of a specific infusion line), cytarabine (prepared in syringes) and 5-fluorouracil (5-FU) (prepared in an infusor).

Results
199 preparations prepared by 12 PPH and 11 pharmacists were assessed, of which 2 % (4) showed a non-compliance that could have a clinical impact on the patient and should have been destroyed and re-made correctly. During the preparation of 2 carfilzomib bags, the operator injected the product without showing the volume of solution to the camera, and pleased the system by showing a syringe filled with air. A 5-FU portable infusor preparation was underdosed, due to injection of the solvent instead of the product (50 mL out of a theoretical volume of 87 mL of 5-FU, leading to a bag containing only 57 % of the prescribed dose). Moreover, during a busulfan preparation, an operator used a polycarbonate access device (PAD) instead of a needle and an air intake.

Discussion and conclusion
The automatic error recognition system of Drugcam^® is not 100 % reliable. In fact, it does not detect whether the syringe contains a liquid or not, only the position of the plunger. With regard to our non-compliant preparations, there is a lack of traceability for the 2 carfilzomib bags prepared and therefore no proof of conformity of the final product. Regarding the 5-FU infusor, there is no way the system could automatically detect this error. For the busulfan preparations, there is a risk of particles being released from the PAD due to the incompatibility between the polycarbonate and the excipients of the busulfan. Three of these non-conformities could have been detected by checking the full preparation video before product release, or by using an analytical QC of the finished preparation. Unfortunately, the current work load does not allow the pharmaceutical team to watch the complete videos of all the preparations checked by this system. The operators will be reminded of the procedures, particularly for busulfan. This work will also be presented to the unit to discuss improvements to be made.