Background The implementation of technology for chemotherapy compounding is recommended by several organisations to improve patient safety. However, a careful evaluation of their benefits and risks is needed.
Purpose To evaluate the safety before and after the implementation of an imaged-based volumetric compounding workflow software system (PhocusRx), and stratification of residual risks to drive future developments.
Material and methods Setting: chemotherapy compounding pharmacy unit of a 1300-bed tertiary teaching hospital provided with a Computerised Prescription Order Entry program, online pharmacy validation and online printing of compounding order sheets. In the before phase, quality control was made by a pharmacy technician who verified starting products, number of vials used, aspects of the final product and label accuracy.
Design: comparative risk analysis of the chemotherapy compounding process before and after the implementation of PhocusRx, according to the Failure Modes, Effects and Criticality Analysis (FEMECA) method.
Measurements: the failure modes were defined and their critically index (CI) calculated on the basis of the likelihood of occurrence, potential severity for patients and detection probability. CI of the before and after phases were compared, and new measures were proposed.
Results In the pre-implementation phase, the sum of CI of 16 identified failure modes was 1999. After PhocusRx implementation, 21 failure modes were identified and the CI was reduced to 668 (a 67% reduction). According to the compounding subprocess, the material preparation CI was reduced by 46% (318 vs 171), the drug production by 76% (1411 vs 341) and the quality control by 48% (126 vs 240). The five failures modes exclusively detected after the implementation of the robot were associated with very low CI (CI <30).
After PhocusRx implementation, the failure modes with the highest CI reduction were: wrong vehicle type (−96.7%); incorrect label (−96%); forgotten bag preparation (−83.3%); incorrect drug packaging (−80%); incorrect drug measure (−77.8%); and incorrect drug (−75%).
High-priority recommendations defined were: improving barcode identification of the starting products vials and process improvements in the image-based quality control.
Conclusion PhocusRx implementation has increased the safety of the compounding process in the pharmacy department. FEMECA is a useful method for evaluating the impact of compounding technology implementation and identifying further improvement strategies.
References and/or acknowledgements No conflict of interest.
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