Abstract: Objective: To construct and evaluate a whole process closed-loop management model of injectable drugs in outpatient Maintenance Hemodialysis (MHD) patients, and to provide references for patient medication safety management. Methods: The Healthcare Failure Mode and Effects Analysis was applied to improve the management of injectable drugs for MHD patients, and a new whole-process closed-loop management model was implemented from November 1, 2023. Totally 235 MHD patients and 22 hemodialysis nurses in a tertiary grade A hospital in Shanghai were selected by convenience sampling method. Patients from May to October 2023 were used as the control group, and patients from November 2023 to April 2024 were used as the intervention group. The incidence rate of injectable drug safety hazard events, rate of drug non-use, compliance rate for hemoglobin and ferritin levels, and satisfaction of patients and nurses were compared respectively before and after the application of the closed-loop management model. Results: The incidence rate of drug safety hazard events decreased from 2.60% (6 cases) to 0. The number of unused injectable drugs decreased from 2829 cases (10.73%) to 0. The hemoglobin compliance rate increased from 65.96% to 82.13% and ferritin compliance rate increased from 18.30% to 31.06%. Both patients' and nurses' satisfaction increased significantly. The differences above were all statistically significant (P<0.001). Conclusion: The implementation of a whole-process closed-loop management model for injectable drugs ensures the effective execution of prescriptions for MHD patients, significantly reduces drug-related safety hazards, and improves anemia-related indicators. These improvements contribute to increase satisfaction among both patients and nurses.

Key words: closed-loop management; Maintenance Hemodialysis; injectable drug; medication safety