Sécurisation et mise en conformité à la réglementation du processus de production des préparations magistrales et officinales au CHU UCL Namur : Apport d’un logiciel, état des lieux et proposition de pistes d’amélioration du logiciel AMO®

Details

Supervisors

Lombet, Louise ; Anrys Pauline

Faculty

Faculté de pharmacie et des sciences biomédicales

Degree label

Master de spécialisation en pharmacie hospitalière

Abstract

Introduction: Errors in pharmaceutical preparations in hospital can occur at any stage of the process (from 5,4 % to 25%) leading in some cases to a risk for the patient. Several measures can be taken to reduce these errors, such as the use of magistral and officinal preparations management software. Objectives: The primary objective is to evaluate the contribution of software to the compounding process. The secondary objectives are on the one hand, to evaluate a software currently under development (AMO®) and suggest areas for improvement, and on the other hand, to assess the current situation at the three sites of the CHU UCL Namur in relation to the Royal Decree (RD) of 30/09/2020 and PIC/S standards. Methodology: Legal criteria (according to RD and PIC/S), safety criteria (according to a FMEA) and optional criteria (through a survey of hospital pharmacists) linked to the magistral and officinal process were identified in order to subsequently determine the criteria on which the software will have an impact. Areas of improvement for AMO® software were proposed based on legal, safety and optional criteria that AMO® software does not actually address. In order to assess the current situation at the three sites, an identification of the criteria specific to the magistral and officinal process according to the RD and PIC/S standards was carried out, followed by site visits. Results: Compounding management software could influence 64.6% of the RD criteria, 34.6% of the PIC/S criteria (mainly the 'Production' and 'Documentation' chapters) and 91.4% of the failure modes identified during the FMEA (including 100% critical failures). On software-sensitive criteria and failures, the AMO® software had an impact on 80.6% of RD criteria, 51% of PIC/S criteria and 62.5% of failures (including 16.6% critical failures). Fifty areas of improvement were proposed (19 required and 31 optional). Conclusion: Thanks to improved traceability at every stage of the process, the software helps to make the process safer and facilitates practices. However, software cannot resolve all non-compliance criteria and other actions are required. AMO® software meets some of these criteria, but still requires some improvements.