Development of a Pharmacy-Led Root Cause Analysis Framework for Medication Safety Events
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Yanli Ning1, Hui Liu2, Qing Shao3
1Drug Supply Center, Tai'an Central Hospital.
Abstract:
Medication-related safety events are a key concern in healthcare quality. Their systemic nature demands effective analytical approaches. Root cause analysis (RCA) is vital for identifying system flaws and preventing recurrence, yet traditional methods often lack comprehensiveness, necessitating a more systematic framework. From a pharmacy perspective, this study developed a closed-loop management framework with four stages: preparation, cause analysis, solution implementation, and outcome evaluation. It innovatively proposes a three-dimensional "Fishbone Diagram-5Why-SEIPS" model. By integrating panoramic scanning, in-depth excavation, and system positioning, it balances analytical breadth and depth for systematic medication safety analysis. Pharmacy departments play four core RCA roles: technical expert/analyst, communication coordinator, system improvement driver, and safety culture advocate. This evolution reflects a shift from "product-centered" to "patient-centered" pharmacy services. The study provides methodological guidance for pharmacy-led safety improvement, supporting a shift from passive response to active prevention in medication safety. Healthcare institutions should recognize the strategic value of pharmacy in quality management to build a safer medication environment.
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