Occupational risks evaluation in a centralized antineoplastic agent preparation unit

Area of Science:

• Occupational Health and Safety
• Pharmaceutical Compounding
• Risk Management

Background:

• European legislation mandates risk assessments for handling antineoplastic agents.
• Centralized preparation units require specific safety evaluations for staff.
• Previous assessments may not have fully captured all occupational hazards.

Purpose of the Study:

• To conduct a global professional risk assessment for a centralized antineoplastic agent preparation unit.
• To identify hazardous situations and develop an occupational prevention plan.
• To ensure worker safety and regulatory compliance.

Main Methods:

• Employed a global risk analysis methodology.
• Identified hazardous situations and estimated risk levels using severity and frequency.
• Developed a risk reduction plan based on criticality scores.

Main Results:

• Identified 33 unacceptable hazardous situations, primarily related to product/emissions/waste (55%), psychosocial factors (24%), and work equipment (18%).
• Implemented corrective actions including HR reorganization, updated protocols, and ergonomic improvements.
• Established annual medical monitoring, surface contamination testing, and updated training programs.

Conclusions:

• The risk assessment identified system failures and enabled effective corrective actions.
• The implemented prevention plan successfully controlled all identified hazardous situations.
• Enhanced staff safety was achieved through a systematic approach to occupational risk management.