Application of Failure Mode, Effects, and Criticality Analysis to the Medication-Use Process for Temperature-Sensitive Drugs in a University Hospital.

Background: In the hospital setting, the medication-use system for temperature-sensitive drugs is a high-risk process.

Objectives: To analyze the risks associated with the hospital-based medication-use process and to propose corrective and preventive actions for the most critical failure modes.

Methods: A multidisciplinary team was trained to analyze the medication-use process for temperature-sensitive drugs and to identify potential failures using a risk analysis method known as failure mode, effects, and criticality analysis (FMECA). The medication-use process, from initial supply to administration to patients, was investigated using "the 5 Ws and How" method (Who? What? Where? When? Why? How?), and the causes of the failure modes were analyzed using Ishikawa diagrams. The most critical failure modes were selected using the Pareto law, and relevant improvement actions were proposed.

Results: This analysis identified 41 failure modes for the 9 stages of the medication-use process, of which only 36 were deemed assessable by the participants. Eighteen (50%) of these failure modes were critical, according to the Pareto law, with criticality indices between 12 and 60. The stage of tidying up and storage in patient care units had the highest number of critical failures (n = 5). A total of 48 corrective actions were proposed.

Conclusion: The proposed action plan prioritized 3 areas for improvement: the documentation system, staff training, and equipment acquisition. A second FMECA should be carried out to reassess the medication-use process after implementation of these improvement actions. The second FMECA, allowing detection of residual risks and identification of new risks, will be part of a continuous improvement process.