Mise en place des PIC/S aux Cliniques Universitaires Saint-Luc : analyse d’écart et analyse de risques microbiologiques au sein du service de production des chimiothérapies

Details

Supervisors

Delsaux, Anne-Sophie ; Salvé Mallory

Faculty

Faculté de pharmacie et des sciences biomédicales

Degree label

Master de spécialisation en pharmacie hospitalière

Abstract

Background : Patient safety is the priority throughout the process of preparing cytotoxic and biological pharmaceutical products, which are administered by the intravenous route. In order to continuously improve patient safety, the hospital pharmacy sector will undergo major changes, as Belgian hospitals will have to comply with the PIC/S 010-4 standards by January 1st, 2026. Objectives : The objective is to highlight the points of non-compliance in the process of preparing cytotoxic and biological pharmaceutical products, to prioritise the non-compliances and to define the corrective measures to be implemented in the production area of Cliniques Universitaires Saint-Luc (CUSL). Method : A gap analysis based on the comparison between the requirements of Appendix 1 of the PIC/S 010-4 standard regarding the preparation of sterile drugs and the current practice used in the production area and a risk based analysis were carried out. The failure modes and effects analysis (FMEA) tool was used to perform this analysis, which focused on the risk of microbiological contamination during the production process. Results : The 82 paragraphs of appendix 1 of the PIC/S 010-4 standards are evaluated: 27 paragraphs, (33%) are fully compliant however 26 (32%) and 12 (15%) paragraphs are respectively partially compliant and not compliant with PIC/S 010-4 standards. The risk analysis revealed 77 potential risks for failure divided into 5 different processes. The majority of the failures have a criticality score “vigilant” or “critical”. The corrective actions identified were mainly the introduction of routine microbiological tests, ongoing training and more rigorous documentation. Conclusion : Complying with PIC/S 010-4 standards is a real challenge for both university and non-university hospitals. This work will enable us to establish the current situation in order to prioritise the actions to be taken to achieve compliance with PIC/S 010-4 standards by January 1st, 2026. The aim is to repeat these analyses and evaluate the corrective actions put in place.