Healthcare workers handling hazardous medications face significant occupational risks, from skin problems to reproductive health concerns. At the NCODA Fall Summit in Orlando, Florida, Mayo Clinic pharmacy technician instructor Liz Vogel, CPhT-Adv, CSPT, outlined crucial safety protocols for hazardous drug compounding, emphasizing the importance of proper engineering controls and adherence to USP <800> standards.
Understanding Hazardous Drug Classifications
Hazardous drugs encompass a broad range of medications that can damage DNA, interfere with cell growth, or disrupt cellular function. The National Institute for Occupational Safety and Health categorizes these into three groups:
- Antineoplastic drugs (e.g., cisplatin, cyclophosphamide)
- Non-antineoplastic medications (e.g., estrogen, tacrolimus)
- Drugs with reproductive risks (e.g., oxytocin, warfarin)
Critical Engineering Controls and Facility Requirements
The safe handling of hazardous drugs requires three levels of engineering controls:
- Primary Engineering Controls
- Biosafety cabinets (BSCs) with external ventilation
- Compounding aseptic containment isolators
- ISO-5 or better air quality environment
- Secondary Engineering Controls
- Negative pressure ISO-7 buffer rooms
- Minimum 30 air changes per hour
- Pressure differential of 0.01-0.03 inches water column
- Supplemental Engineering Controls
- Closed-system drug transfer devices (CSTDs)
- Additional containment measures for vapor control
Environmental Monitoring and Certification
Strict environmental monitoring protocols include:
- Regular airflow and HEPA filter integrity testing
- Pressure differential monitoring
- Microbial air and surface sampling
- Certification renewal every 6 months
"It's going to tell you how clean or how dirty the area is that you're compounding in," explains Vogel regarding environmental monitoring. "It is performed using agar plates and then incubated for a set period of time."
Enhanced Safety Protocols and PPE Requirements
Comprehensive personal protective equipment requirements include:
- Double gloves (sterile, powder-free)
- Front-closing gown with laminated back
- Hair/beard covers
- Face masks
- Eye protection
- Double shoe covers
Cleaning and Decontamination Procedures
Hazardous compounding areas require a four-step cleaning process:
- Deactivation
- Decontamination
- Cleaning
- Disinfection with sporicidal agents
"First, you want to try to eliminate it," Vogel emphasizes regarding hazard control. "If you can't do that, you're going to want to substitute... and then if you can't do that, you move down to engineering controls, administrative controls... And then lastly is your PPE."
Breaking the Stigma Through Education
Despite initial fears among healthcare workers, proper education and implementation of safety protocols are helping to overcome the stigma associated with handling hazardous drugs. "Patients do need these hazardous medications," notes Vogel, highlighting the importance of well-trained personnel who can safely handle these crucial therapies.
The implementation of these comprehensive safety measures not only protects healthcare workers but also ensures the safe and effective preparation of vital medications for patients. Regular training, strict adherence to protocols, and ongoing environmental monitoring create a foundation for safe hazardous drug handling in modern healthcare facilities.
