Cytotoxic Drug Handling Practices Among Pharmacy Technicians in Portugal: The Dig Deeper Study

葡萄牙药剂师对细胞毒性药物的处理规范:深入研究

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Abstract

Background: Occupational exposure to cytotoxic drugs remains a major concern for pharmacy personnel, due to their well-established, carcinogenic, mutagenic and organ-specific effects. Despite the existence of robust international guidelines, evidence suggests substantial variability in compliance, training quality and operational conditions across healthcare settings. Objective: This study aimed to characterise current handling practices, assess working conditions, training, safety procedures, exposure patterns, and perceived risk factors among pharmacy technicians involved in the preparation of cytotoxic drugs in Portugal. Methods: A cross-sectional descriptive study was conducted using a structured questionnaire grounded in international standards (ISOPP, NIOSH, ASHP, USP <800>). The instrument was developed through literature review, expert panel validation (n = 42), and pre-testing. Data were collected electronically between April and May 2025 from pharmacy technicians actively handling cytotoxic drugs in Portugal. Results: A total of 124 valid responses were analysed. Most participants were female (78%) and under 50 years, with nearly one-third having less than one year of experience. Prolonged daily exposure (31.5% participants worked ≥ 5 h/day) extended uninterrupted handling periods (28.2% worked > 120 min), and high preparation workloads were common. While adherence to core protective measures-such as reinforced gowns, double gloves, and Class II B2 biological safety cabinets-was high, important gaps were identified, including incomplete use of closed system transfer devices, inconsistent respiratory and foot protection, limited automation, and insufficient environmental monitoring. Structured competency assessment, periodic training, and formal documentation were frequently absent. Institutional policies on reproductive risk showed strong protection for women but less clarity for male workers. Conclusions: Cytotoxic drug handling practices in Portugal demonstrate satisfactory adherence to fundamental protective measures but reveal significant structural and organisational gaps related to workload management, environmental monitoring, and continuous training. The absence of unified national guidance contributes to variability across institutions. These findings highlight the need for greater standardisation of occupational safety practices.

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