Drugcam^®: How to qualify it?

Objectives
Acquired in December 2023, Drugcam^® helps combat medication errors in oncology. How can we qualify its operation as expected (OQ: Operational Qualification) and in real-life conditions (PQ: Performance Qualification)?

Materials and methods
For OQ, specificity, sensitivity and accuracy are calculated: 50 vials of anticancer agent different from the expected one are tested by Drugcam^®. Specificity is the ratio of true negatives (TN) to TN plus false positives (FP). An expected anticancer agent is checked 50 times by Drugcam^®. Sensitivity is the ratio of true positives (TP) to TP plus false negatives (FN). Accuracy is the ratio: (TP+TN) / (TP+TN+FN+FP). Repeatability and accuracy are evaluated for syringes. Minimum, maximum and average volumes are tested 30 times for each type of syringe used: 3, 5, 10, 20, 30, 50 mL.
For PQ, Drugcam^® is compared with the double visual check (DCV). For each preparation, vial and syringe volumes are checked both visually and by Drugcam^®. Compliant and non-compliant checks are recorded in an Excel table.

Results
For the OQ, the frequently used Carboplatin vial was chosen for its detection difficulty: brown, film-coated glass. Out of 50 vials of anticancer drugs tested by Drugcam®, TN = 50 and FP = 0. Specificity is 100%. On 50 Carboplatin vial controls, TP = 50 and FN = 0. Sensitivity is 100%. Accuracy is 100%. For syringes, the coefficient of variation (CV) is 1.8%. The average of the 30 Drugcam^® controls for each volume is identical to the expected volume.
For PQ, over 2 weeks of production, 267 preparations were carried out. Of 594 vials, 100% were checked for compliance by the DCV, 78 vials were not detected by Drugcam^®, but no non-compliant checks were carried out on the 516 vials detected. Of 387 syringe volumes inspected, 100% were DCV-compliant, 87% Drugcam^®-compliant.

Conclusion/discussion
The new Drugcam^® equipment is qualified in our hospital pharmacy, with 100% specificity, sensitivity and accuracy. The CV of less than 3% shows that the Drugcam^® control method is repeatable and accurate. On a routine basis, Drugcam^® and DCV report 100% compliant controls for both vials and syringes. However, 13% of vials and 16% of volumes are not detected by Drugcam^®. What could be improved by adjusting the camera and contrast.

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