A recent study has shown how employing failure mode and effect analysis (FMEA) can considerably mitigate risks associated with the management of monoclonal antibody (mAb) drugs, thereby enhancing patient safety within the Pharmacy Intravenous Admixture Services (PIVAS) of hospitals. Monoclonal antibodies have revolutionized cancer treatment and are pivotal immunotherapeutic agents, yet their handling is fraught with potential risks due to the complexity of their preparation, storage, and administration.
This comprehensive study was conducted by a multidisciplinary team at the Zhejiang Xiaoshan Hospital Pharmacy Department from September 2023 to May 2024. Tasked with improving the management of mAb drugs, the team addressed the imperative need for strict protocols, particularly as these agents often require cold-chain logistics and careful compounding to maintain their efficacy and safety.
The methodology utilized FMEA to identify and assess various failure modes throughout the drug management process. The team mapped out major steps—including mAb drug reception, storage, order auditing, preparation, compounding, and delivery—and evaluated each subprocess for severity, occurrence, and detection probabilities to calculate risk priority numbers (RPN). Initially, the total RPN for identified risks stood at 3375. After implementing targeted corrective measures, the RPN decreased dramatically to 51.
The study identified thirteen high-risk failure modes within the seven main processes associated with mAbs. Notably, the risk assessment demonstrated the need for improved procedures and staff training to handle these drugs safely. With the initial focus on areas most susceptible to complications, including storage and compounding, the research underscored the necessity of detailed monitoring and adherence to established protocols. A key factor to improve safety included rigorous order auditing and enhanced communication among pharmacists, nurses, and physicians.
Results from the FMEA implementation showed remarkable improvement. By systematically redesigning processes around the identified high-risk areas, continuous monitoring facilitated the near-elimination of incidents related to mAb mishandling. The proactive identification of risks—coupled with the establishment of clear processing guidelines and regular training—proved instrumental.
Importantly, the results signified not only compliance with regulatory needs but also demonstrated effective patient care, aligning with the broader goal of minimizing adverse drug reactions associated with mAb therapies. The study concludes with optimism for the method's broader application, advocating for FMEA as a valuable tool for continuously enhancing drug management processes.
Future advancements will likely center on integrating more comprehensive data sets, refining risk assessment tools, and sharing findings to bolster pharmacy operations across healthcare systems globally. Continuous education and evolution of practices surrounding mAb drug management position healthcare providers to improve outcomes for patients receiving these innovative therapies.