Quality risk management for prepared sterile products in hospital pharmacy

Background A hospital pharmacy (HP) prepares compounded sterile preparations (CSPs) following the current good manufacturing practice (cGMP) requirements. A quality risk management (QRM) is needed for the assessment, control, communication and review of risk for the quality of medicinal products. Purpose To assess the quality risk of different CSPs in our HP in order to prioritise the preventive measures implementation. Materials and methods The failure mode and effects analysis (FMEA) was applied. Risk was defined as the combination of the probability of occurrence of harm (O), its severity (G), and the ability to detect it (D). Occurrence, severity and detectability value guidelines range 1–10 with the following lowest and highest values: ▶Occurrence: very unlikely to occur(1).Very likely to occur(10). ▶Severity: not noticeable(1).The item unusable(10). ▶Detectability: no detection method(DM) available(1).There is a DM highly effective(10). They were rated according to our experience. Four CSPs were assessed: total parenteral nutrient solutions (TPNs), analgesia/anaesthesia mixtures, cytostatics and antibiotics preparations. In addition, three failure modes (FM) were evaluated for each CSP according to the compounding process: compounding (C), packaging (P) and sterility (S). Each FM was evaluated for occurrence, severity and detectability. The multiplication of these values leads to the risk priority number (RPN). The total score for the CSPs is the sum of the RPN of each FM. The authors established RPN≤100 for low risk preparations and RPN>100 for high risk preparations. Results All CSPs except antibiotics preparations have RPN values above 100, thus correspond to high risk preparations. The cytostatics compounding has the highest RPN value, that is, entails the highest quality risk for patients and therefore our efforts will be focused primarily in these products. Conclusions The application of FMEA as a tool for the QRM provides with a score for each CSPs assessed, what helps classify them according to the potential quality risk that hold, facilitating the prioritisation of future preventive measures and the evaluation of the applied measures.