Statistical process control (SPC): application to a cytotoxic reconstitution unit

The reconstitution of injectable cancer drugs is a high-risk activity. The demographics of the cancer population, combined with advances in diagnosis and therapeutic management, represent an ever-increasing activity for Cytotoxic Reconstitution Units (CRU). In this context, the use of Statistical Process Control (SPC) offers a promising approach to improve the quality and safety of preparations. The following exploratory study describes the implementation and evaluation of SPC in the field of aseptic production of chemotherapies and related preparations in a hospital pharmacy. The primary objective of this work is to assess the feasibility of SPC in this field by validating the choice of indicators. The secondary objective is to analyze these indicators before and during the two months of production in a mobile unit. We implemented SPC tools, such as control charts and capability analysis, to monitor anti-cancer drugs reconstitution process in a hospital unit. Process performance data were collected and analyzed to identify gaps and opportunities for improvement. The results show that the use of SPC can detect variations in the reconstitution process, thereby reducing the risk of errors. This work also demonstrated the reliability, quality and safety of the process during the production period in the mobile unit. SPC has proven to be an effective tool for optimizing the quality of the reconstitution process for injectable anti-cancer drugs. This method could be applied to other areas of hospital pharmacy.