Failure Mode and Effects Analysis of the In-Hospital Medication Process: Identification of Systemic Risks and development of Improvement strategies
Christian Hermann, Ute Amann, Tobias Rüther, Stefan Kääb, Catherine Glocker, Vera Smolka, Isabel Brinkmann, Caroline Rösch, Josef Hollmann, Julian Steinbrech, Martin Göring, Angela Herold, Dorothea Strobach, Maximilian GüntherAbstract
Background
Flaws in the in-hospital medication process compromise patient safety. A structured evaluation of the process using Failure Mode and Effects Analysis (FMEA) can identify and prioritize potential risks and help to develop targeted measures to improve medication safety.
Methods
A prospective risk analysis using FMEA was conducted between February 2025 and February 2026 in a large tertiary care hospital by an interprofessional team including physicians, nurses, pharmacists, and a chief risk manager. In six structured workshops, the medication process was analyzed including admission, prescribing, order/delivery, dispensing, and discharge. Potential failure modes, their causes, and effects were identified based on expert experience and known errors from the hospitals critical incident reporting system. Each failure mode was independently rated for severity, occurrence, and detectability on a 5-point scale. Risk Priority Numbers (RPN) were calculated to prioritize risks. Based on these results, targeted mitigation strategies were developed.
Results
A total of 101 potential failure modes were identified, with the highest proportion in admission (n = 37; 36.6%). RPN values were moderate (median 22; IQR 14-29; range 8-53). The highest ranked risks were missing drug interaction checks (RPN = 53) and lack of dose adjustment in renal impairment (RPN = 46). Additional high-risk areas included incomplete medication histories and communication deficits at process interfaces. Contributing factors were predominantly related to human and communication domains. Mitigation strategies included standardized medication reconciliation procedures, training programs for medical staff, pharmacist consultation service, and system level interventions such as software improvements and improved communication processes.
Conclusion
The FMEA identified specific risks within the in-hospital medication process. Furthermore, it revealed interdependencies between process stages and system level vulnerabilities. The derived measures may contribute to improved medication safety across multiple stages of care in similar hospital settings. Future studies should evaluate their implementation and impact on medication errors.