Établissement d’un guide algérien de bonnes pratiques de préparation BPP des médicaments dangereux et hautement actifs

Abstract

The handling of cytotoxic drugs, classified among hazardous drugs (HDs), represents a major public health concern due to the risks they pose to patients, healthcare workers, and the environment. This situation calls for the centralization of their compounding and the standardization of procedures. In Algeria, the absence of a regulatory framework specific to Good Preparation Practices (GPP) for cytotoxic drugs is a critical gap, especially given the disparity in practices observed across Algerian hospitals. This work aims to propose the foundational elements of an Algerian guide for good cytotoxic drug preparation practices. The development of this Good Preparation Practices (GPP) guide for cytotoxic drugs is based on a documentary and comparative approach. It relies on a cross-analysis of several international reference standards, namely those issued by the ANSM, USP <800>, and the WHO. This work involved compiling and analyzing the requirements and recommendations from these three references, conducting a comparative analysis of the standards to highlight their commonalities, specificities, and technical divergences or similarities, and finally evaluating the transferability and adaptability of these recommendations to the Algerian context. This was done while taking into account the country’s structural, economic, human, and regulatory realities, allowing us to adopt a pragmatic approach by integrating high-priority, immediately applicable requirements and proposing a progressive roadmap toward compliance with international standards. The comparative analysis of the international standards (USP <800>, ANSM GPP 2023, WHOrecommendations) revealed key areas of convergence, such as the necessity for dedicated preparation zones, the requirement for trained personnel, the use of closed systems for handling cytotoxic agents, and rigorous waste management, all with a shared emphasis on traceability and systematic documentation. However, some significant divergences were identified: USP <800> emphasizes worker protection through strict containment and ventilation systems, while ANSM GPP focuses on pharmaceutical quality, including traceability, documentation, validation, and environmental control. The WHO, on the other hand, adopts a more pragmatic approach tailored to low-resource settings. Given Algeria’s technical and logistical development level, this guide primarily draws on the recommendations of the ANSM and USP <800>, while those of the WHO were less frequently adopted, being deemed less suitable for the national context. Establishing an Algerian Guide to Good Preparation Practices (GPP) is a key step toward structuring, harmonizing, and securing hospital practices related to the handling of cytotoxic drugs. This reference framework will not only help reduce errors and contamination risks but also optimize the use of human and material resources in a continuous quality improvement approach. Beyond its methodological contribution, this work also serves an educational purpose: to raise awareness among healthcare professionals about the importance of rigorously adhering to Good Preparation Practices for cytotoxic drugs through the recommendations provided at the end of this work.