Établissement d’un cahier des charges pour la mise en place d’une unité centralisée de reconstitution des cytotoxiques (URCC)

Abstract

Introduction: The increasing use of cytotoxic drugs, in parallel with the rising incidence of cancer, requires strict safety regulations to protect patients, healthcare staff, and the environment. In Algeria, the absence of national regulations has led to heterogeneous practices and significant risks. This study aims to develop a technical specification document as a reference tool for the implementation of centralized cytotoxic drug preparation units in hospitals, in compliance with international safety and quality standards. Materials and Methods: The methodology of this work is based on a comparative analysis of regulatory and technical requirements from USP 800, the ANSM Good Preparation Practices (BPP), WHO guidelines, and ISO standards. After thematic extraction of recommendations, a synthesis was adapted to the Algerian context, considering local constraints. The resulting specification document is structured into two complementary parts: a regulatory section and a technical section. Results: This study resulted in the development of a structured specification document, serving as a decision-making tool for the design, audit, and renovation of URCCs (Centralized Cytotoxic Reconstitution Units), based on the USP 800, ANSM, WHO guidelines, and ISO standards. It includes a regulatory section covering architectural, organizational, human, and safety aspects, and a technical section detailing the required equipment and materials. A simulated case study at the CLCC of Sétif was conducted, including 2D/3D plans, a technical datasheet, cost estimation, and a validation grid with criteria categorized by domain. Discussion: This specification document provides a concrete and structured tool to guide the design and management of URCCs, addressing a critical regulatory gap in Algeria. It offers a normative basis tailored to local realities and could support the development of future national regulations. The document also highlights the central role of hospital pharmacists as key actors in quality and safety. A simulated 120 m² URCC at the CLCC of Sétif was developed, with plans, a technical datasheet, cost estimates, and 3D modeling. However, limitations remain, such as the lack of current institutional validation and the potential challenges in implementing the recommendations in resource-limited facilities. This work opens tangible prospects for regulatory framing, capacity building, and improved practice standards. Conclusion: This document consolidates the regulatory and technical requirements essential for establishing units that meet international quality and safety standards, and could serve as a foundation for drafting a formal Algerian regulatory framework for cytotoxic drug preparation in hospitals.