Objective To systematically review the scope of application, key outcomes, and existing challenges of Failure Mode And Effects Analysis (FMEA) in pharmacy intravenous admixture services (PIVAS), and to consolidate the evidence and provide references for practice and research.

Methods A scoping review methodology was employed. Chinese and English databases, including China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, SinoMed, PubMed, Embase, and the Web of Science Core Collection, were systematically searched from database inception to July 31, 2026. Original studies focusing on the application of FMEA in PIVAS were included, and relevant data were extracted for descriptive synthesis and analysis.

Results A total of 58 studies were included. FMEA in PIVAS primarily encompassed overall process optimization, specialized management of high-risk medications, and targeted interventions for specific workflow segments. Methodologically, traditional FMEA and Healthcare Failure Mode And Effects Analysis (HFMEA) were predominant. All studies reported positive outcomes, including a significant reduction in the Risk Priority Number, decreased rates of compounding errors and irrational medical orders, and improved operational efficiency. However, considerable methodological heterogeneity and a lack of standardized procedures were observed. Major challenges included reliance on subjective experience in risk scoring, inability to handle inter‑failure mode correlations, lack of dynamic tracking capability, and insufficient research on regarding long‑term effectiveness and cost‑effectiveness.

Conclusion FMEA has clear application value in PIVAS risk management, can effectively identify risks and optimize workflows, and improve medication safety. Future efforts should prioritize methodological standardization, subjective bias control, dynamic upgrading exploration, and long-term benefit evaluation to promote its scientific and sustainable application.

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