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<p>In China, anesthetic drugs and class I psychotropic drugs are among the most stringently managed special medications within medical institutions. In this study, we aimed to use Failure Mode and Effects Analysis (FMEA) to conduct a proactive risk assessment of management models for these drugs, addressing their unique management requirements. We established a multidisciplinary team and identified five main stages of the process. Each stage was divided into micro-activities to identify potential failure modes and their possible consequences. A risk priority number for each failure mode was calculated. The management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy revealed 15 types of failure modes, with Risk Priority Numbers (RPN) ranging from 4.21 to 38.09. The very high-/high-priority errors identified included two key categories with specific quantitative risks: (1) Patients’ inability to receive medications in a timely manner (2) Discrepancies between empty ampule collection and dispensing quantities. The latter category posed significant management risks, as evidenced by RPN values exceeding 30, which indicated a high likelihood of regulatory non-compliance and increased circulation vulnerabilities. FMEA proved effective in identifying key vulnerabilities in the management of anesthetic and Class I psychotropic drugs. These findings can guide the development of a targeted information management system that will leverage modern digital tools to improve drug compliance and patient safety.</p>

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Using failure mode and effects analysis for risk management of anesthetic and class I psychotropic drugs in inpatient pharmacy: a pilot study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月13日

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  • Lulu Zhang,
  • Xiuling He,
  • Yimeng Wang,
  • Li Huang,
  • Xiaoxia Du,
  • Mingzhou Liu

摘要

In China, anesthetic drugs and class I psychotropic drugs are among the most stringently managed special medications within medical institutions. In this study, we aimed to use Failure Mode and Effects Analysis (FMEA) to conduct a proactive risk assessment of management models for these drugs, addressing their unique management requirements. We established a multidisciplinary team and identified five main stages of the process. Each stage was divided into micro-activities to identify potential failure modes and their possible consequences. A risk priority number for each failure mode was calculated. The management of anesthetic drugs and class I psychotropic drugs in inpatient pharmacy revealed 15 types of failure modes, with Risk Priority Numbers (RPN) ranging from 4.21 to 38.09. The very high-/high-priority errors identified included two key categories with specific quantitative risks: (1) Patients’ inability to receive medications in a timely manner (2) Discrepancies between empty ampule collection and dispensing quantities. The latter category posed significant management risks, as evidenced by RPN values exceeding 30, which indicated a high likelihood of regulatory non-compliance and increased circulation vulnerabilities. FMEA proved effective in identifying key vulnerabilities in the management of anesthetic and Class I psychotropic drugs. These findings can guide the development of a targeted information management system that will leverage modern digital tools to improve drug compliance and patient safety.