Evaluation of the effectiveness of pharmaceutical supply in a medical organization based on the integration of quality management and lean management systems

Abstract

Background: This study evaluated scientific and methodological approaches for evaluating the effectiveness of pharmaceutical supply in medical organizations, including the Sverdlovsk Regional Clinical Psychiatric Hospital, and developing measures for its optimization by integrating a quality management system (QMS) and a lean management system (LMS).

Materials and methods: Content analysis, structural and functional analysis, logical analysis, and observation, comparison, and descriptive methods were utilized in this study. Furthermore, process design and modeling approaches were applied to evaluate pharmaceutical supply management. The study focused on pharmaceutical and medical device supply processes within medical organizations (using the Sverdlovsk Regional Clinical Psychiatric Hospital as an example).

Results: Considering the specifics of the hospital’s operations and applying the provisions of the ISO 9001:2015 standard (Quality Management Systems—Requirements) and ICH Q10 (Pharmaceutical Quality System), an internal quality management policy was developed to regulate the pharmaceutical supply process within hospitals. The study identified the primary responsibilities of a pharmaceutical quality officer in overseeing compliance with internal pharmaceutical protocols in hospital departments, units, and branches. As part of QMS and LMS implementation in pharmaceutical supply management, an original checklist was designed to facilitate multistage compliance monitoring at temporary storage areas, nurse stations, and procedure rooms. The core principles of lean management are integrated at each stage of the internal quality control of pharmaceutical supply, demonstrating the integration of QMS and LMS.

Conclusions: Thus, the study demonstrates that integrating QMS and LMS allows medical organizations to optimize pharmaceutical supply processes and achieve a synergistic effect by eliminating functional and documentation redundancies. This enhances the efficiency of medical organizations and improves the quality of healthcare delivery without increasing resource consumption.

Keywords

integrated management system / pharmaceutical supply / pharmaceutical product / medical organization / lean management system / quality management system / checklist / healthcare quality / pharmaceutical regulation

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