Development and implementation of a standardized audit tool for cytotoxic drug preparation practices in oncology

IntroductionEnsuring the safety and quality of cytotoxic drug preparation is a core component of oncology pharmacy practice. In emerging settings, structured audit tools are essential to assess practices and support continuous quality improvement.ObjectiveTo develop a standardized audit tool for assessing compliance with current standards for hospital cytotoxic drug preparation and to apply it in a specialized oncology hospital.MethodsA working group developed a structured audit tool based on 2023 Good Preparation Practices and international recommendations. The tool included domains, subdomains, and explicit compliance criteria. A 15-day audit was conducted using direct observation, document review, and staff interviews. Deviations were classified by criticality. Data were analyzed quantitatively using a standardized Excel-based framework.ResultsA total of 913 criteria were included in the audit tool, of which 289 were deemed not applicable at the hospital level. Consequently, 624 criteria were assessed across seven thematic areas. The overall compliance rate was 70%. Among the evaluated criteria, 23% were non-compliant and 7% were partially compliant. Among the non-compliant criteria, 27.4% were associated with a potential risk of adverse events. The proposed improvement actions were categorized into short-term and long-term measures.ConclusionsThis study provides a structured audit framework for evaluating compliance with current Good Preparation Practices in hospital cytotoxic drug preparation. Its application highlighted priority areas for improving the quality and safety of preparation practices.