Référentiel qualité en radiopharmacie : création d’un outil d’analyse des risques

Abstract

The medical management of patients, which involves securing the drug circuit, is a major public health objective. As part of quality management, a number of risk assessment and risk management tools in care units are validated and available. However, medication management in radiopharmacy departments represents a complex and specific process. The aim of the "Quality guidelines for radiopharmacy" working group of the French society of radiopharmacy (SoFRa) was to develop a risk-assessment tool that is a priori adapted to radiopharmacy activity. A qualitative risk matrix was developed, based on available analysis tools and current regulations concerning radiopharmacy practice. The tool was then programmed to obtain a summary and scoring for each risk category, as well as a quantitative analysis of the risks identified in radiopharmacy. Our tool contains 262 issues. The qualitative study integrates the risks related to the circuit of radiopharmaceuticals, but also risks related to personnel. The quantitative study makes it possible to carry out an automated analysis of the actions to carry out in priority to improve the practices. This work led to the development of a self-assessment tool for the a priori analysis of risks that are adapted to the practice of radiopharmacy. It allows easy analysis of the entire circuit of radiopharmaceuticals from a single tool and meet the expectations of health authorities. This common and validated tool is available to the pharmaceutical community.