Sécurisation du circuit du médicament expérimental dans les services investigateurs en cas de dispensation non nominative par la méthode AMDEC.

Abstract

Background: Clinical studies in critical care sometimes require very short time frames for study inclusion and drug administration, which may occur at any time. To optimize patient management, experimental drugs can be made directly available within the study unit.

Objective: To determine key areas of focus for controlling the non-patient-specific drug dispensing process for experimental drugs used in clinical trials.

Methods: After a preliminary survey, 3 pilot units were selected: the surgical intensive care unit, the post-intervention surveillance unit (PISU), and the cardiology unit. The failure modes, effects, and criticality analysis (FMECA) risk assessment method was applied.

Results: A total of 281 risks were identified. The majority were "acceptable" - 123 (44%), 110 (39%), and 147 (52%) - or "tolerable" - 139 (49%), 148 (53%), and 130 (46%) - in surgical intensive care, the PISU, and cardiology, respectively. The number of "unacceptable" risks was 19 (7%), 23 (8%), and 4 (1%) in the 3 units, respectively. Communication was identified as the most critical process across all 3 units. Following risk prioritization, 17 corrective measures were proposed.

Conclusions: This study helped identify potential areas for intervention to control the non-patient-specific drug dispensing process. Once the proposed actions are implemented, a reduction in overall risk criticality is expected, with all remaining risks falling within acceptable or tolerable levels. In the long term, this project aims to improve the management of patients enrolled in critical care clinical trials and promote research within the units involved.