A Quantifiable 3D Closed-Loop Framework for Controlled Substance Safety in a HIMSS Electronic Medical Record Adoption Model (EMRAM) Stage 7 Hospital: Pre-Post Quality Improvement Study.

BACKGROUND

Controlled substances require strict life cycle management, but manual workflows can lead to documentation errors, traceability gaps, and delays in empty-ampoule recovery.

OBJECTIVE

This study aimed to construct a quantifiable 3D closed-loop framework integrating technology, process redesign, and organizational accountability and to examine whether implementation was temporally associated with changes in controlled substance process indicators.

METHODS

A single-center pre-post quality improvement study was conducted in a Healthcare Information and Management Systems Society (HIMSS) Electronic Medical Record Adoption Model (EMRAM) stage 7 hospital. The preintervention period was September 2024 to November 2024, and the postintervention period was December 2024 to February 2025. The intervention combined unique drug identifiers, personal digital assistant (PDA)-based bedside verification, smart medication cabinets, predispensing prescription review rules, batch-number traceability, daily reconciliation, tiered alerts, staff training, and anomaly-handling standard operating procedures (SOPs). Outcomes were prescription dispensing record compliance, batch-number management noncompliance, failure to complete empty-ampoule recovery and electronic documentation within 24 hours, and implementation fidelity. Proportions were reported with Wilson 95% CIs. Between-period absolute differences and 95% CIs were calculated using the Wald normal approximation for independent proportions. Comparisons used the chi-square test or Fisher exact test, as appropriate.

RESULTS

The analysis included 3264 prescription dispensing records before implementation and 3311 prescription dispensing records after implementation. Prescription dispensing record compliance increased from 94.82% (3095/3264) to 98.7% (3268/3311). Batch-number management noncompliance decreased from 2.4% (24/1000) to 0.6% (6/1000). The rate of failure to complete empty-ampoule recovery and electronic documentation within 24 hours decreased from 5.61% (68/1213) to 0.78% (10/1274). Implementation fidelity indicators generated from operational logs were high across system stability, scanning execution, and anomaly closure.

CONCLUSIONS

Implementation of the 3D closed-loop framework was temporally associated with improvements in controlled substance process indicators in a digitally mature hospital. The implementation parameters may serve as a reference for local feasibility testing in other wards or institutions, but transferability remains to be evaluated. Multicenter studies are still needed to confirm sustainability and transferability.