JMIR Publications

ABSTRACT

Background:

Narcotic drugs require strict lifecycle management; however, traditional manual systems suffer from significant issues such as recording errors, gaps in traceability, and delays in the recovery of empty ampoules.

Objective:

This study aimed to develop and validate a three-dimensional closed-loop framework for controlled substance safety in a HIMSS EMRAM Stage 7 hospital, to address the deficiencies of traditional manual management (e.g., recording errors, traceability gaps, delayed empty ampoule recovery) and improve the quality and efficiency of anesthetic drug lifecycle management.

Methods:

A single-center, pre-post study was conducted at a HIMSS EMRAM Stage 7 hospital. The pre-intervention period (September–November 2024) utilized traditional manual management; the post-intervention period (December 2024–February 2025) implemented the three-dimensional framework.Key reproducible parameters of the framework were prospectively recorded (barcode encoding rules, prescription review rules, interface logic, and exception handling procedures). Outcome measures included prescription compliance rate, batch number management non-compliance rate, and empty ampoule non-recovery rate. Categorical variables were compared using the chisquare test; significance was set at P < 0.05.

Results:

A total of 3,264 prescriptions were included before the intervention and 3,311 prescriptions after the intervention. The prescription compliance rate increased from 94.83% to 98.71% (χ² = 95.79, P < 0.001); the batch number management non-compliance rate decreased from 2.4% to 0.6% (χ² = 10.96, P = 0.001);the empty ampoule non-recovery rate decreased from 5.6% to 0.79%, a relative reduction of 85.89% (χ² = 47.5, P < 0.001). The framework demonstrated high implementation fidelity (system uptime of 99.92%, and scan compliance >99.6%). The end-to-end batch number traceability mechanism within the framework was directly associated with the decrease in the unrecovered rate.

Conclusions:

The three-dimensional closed-loop framework proposed in this study enables refined control of anesthetic drugs, with end-to-end batch number traceability serving as the key mechanism driving the significant improvement in empty ampoule recovery rates (a relative decrease of 85.89%). This framework and the published implementation parametersis generalizable and replicable across hospitals with different levels of informatics infrastructure.