Risk-based analytical quality control of chemotherapy preparations: A simulation and FMECA approach.

Abstract

IntroductionEnsuring the analytical quality control of chemotherapy preparations is essential to patient safety and treatment efficacy. However, the risk of preparation errors remains a critical concern in hospital pharmacy. Failure Mode, Effects, and Criticality Analysis (FMECA) is a structured risk assessment tool that can help identify, evaluate, and mitigate potential failures. This study integrates FMECA within a simulation-based training approach to enhance the safety and reliability of chemotherapy preparation quality control.Materials and MethodsA simulation-based learning program was implemented at the Faculty of Medicine and Pharmacy of Marrakech. Pharmacy students performed quality control steps, including limpidity testing, sterility testing, dosage uniformity, content verification, ingredient identification, and labeling accuracy. Analytical techniques such as UV-visible spectrophotometry, microbiological culture, and barcode verification were used. FMECA was applied at each critical step to assess failure risks. Statistical analysis measured pre- and post-training performance improvements.Results and DiscussionSimulation-based training significantly improved quality control performance across all parameters (p < 0.05). Notably, labeling errors decreased (p = 0.005), sterility compliance improved (p = 0.02), and dosage accuracy increased (p = 0.01). FMECA identified high-risk failure modes, reinforcing the need for standardized protocols and advanced analytical techniques.ConclusionIntegrating FMECA with simulation-based training enhances analytical quality control, reduces human errors, and strengthens adherence to Good Preparation Practices (GPP). These findings highlight the importance of proactive risk management in hospital pharmacy.