Hazardous Drug Handling Deep Dive
USP Chapter 800 establishes standards for the safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare workers. This guide provides comprehensive coverage of hazardous drug identification, handling procedures, and safety protocols for the CPHT exam.
Defining Hazardous Drugs
NIOSH (National Institute for Occupational Safety and Health) maintains a list of hazardous drugs. A drug is classified as hazardous if it exhibits one or more of the following characteristics in humans or animals:
- Carcinogenicity
- Teratogenicity or developmental toxicity
- Reproductive toxicity
- Organ toxicity at low doses
- Genotoxicity
- Structure and toxicity profiles of new drugs that mimic existing hazardous drugs
NIOSH Hazardous Drug Groups
The NIOSH list organizes drugs into groups based on their properties:
| Group | Description | Examples |
|---|---|---|
| Group 1 | Antineoplastic drugs | Cyclophosphamide, methotrexate, cisplatin, doxorubicin, fluorouracil, vincristine |
| Group 2 | Non-antineoplastic drugs that meet NIOSH criteria | Ganciclovir, mycophenolate, ribavirin, tacrolimus |
| Group 3 | Drugs with adverse reproductive effects | Finasteride, dutasteride, warfarin, some hormonal agents, spironolactone |
Important: Not all hazardous drugs are chemotherapy agents. Many routine medications appear on the NIOSH list.
Routes of Exposure
Healthcare workers can be exposed to hazardous drugs through:
- Inhalation: Breathing in drug dust or aerosols during crushing, reconstitution, or spills.
- Skin absorption: Contact with drug residue on surfaces, vials, or through gloves.
- Ingestion: Hand-to-mouth contact after handling drugs without proper hand hygiene.
- Injection (needlestick): Accidental puncture with a contaminated needle.
Assessment of Risk
USP 800 requires each facility to perform an assessment of risk (AoR) to determine the types of engineering controls and procedures needed based on the hazardous drugs used and the activities performed. The AoR should consider:
- Types of HDs handled and their dosage forms
- Volume and frequency of HD handling
- Activities performed (receiving, storing, compounding, administering, disposing)
- Available engineering controls
Engineering Controls
Primary Engineering Controls (C-PEC)
A C-PEC is a ventilated device that provides ISO Class 5 air while containing HD particulates and vapors. Types include:
- Class II Biological Safety Cabinet (BSC): Vertical laminar airflow with HEPA filtration. Protects both the product and the worker. Required for sterile HD compounding.
- CACI (Containment Aseptic Containment Isolator): An enclosed unit for HD sterile compounding. Provides ISO Class 5 air with containment.
- CVE (Containment Ventilated Enclosure): Used for non-sterile HD manipulation (crushing, counting). Does not provide sterile conditions.
A standard horizontal LAFW must never be used for hazardous drugs because it blows contaminated air directly toward the worker.
Secondary Engineering Controls (C-SEC)
The C-SEC is the room housing the C-PEC. Requirements include:
- Externally vented (air is exhausted to the outside, not recirculated).
- Negative pressure relative to surrounding areas (air flows INTO the room, not out).
- Minimum of 12 air changes per hour (ACPH) for rooms with a BSC.
- Physically separated from other preparation areas.
Personal Protective Equipment (PPE)
PPE requirements vary by activity:
Receiving and Storage
- Chemotherapy-tested gloves when unpacking.
- Inspect shipments for damage. If a package is damaged or leaking, do not open it in a general area - use PPE and contain the spill.
Non-Sterile HD Handling (counting, repackaging intact dosage forms)
- Chemotherapy-tested gloves.
- Use a dedicated counting tray for HDs (do not use the same tray as non-HDs).
- A CVE should be used if available.
Sterile Compounding of HDs
- Two pairs of chemotherapy-tested gloves (double gloving).
- Chemotherapy-protective gown (tested per ASTM standards, closed-front, long sleeves with elastic cuffs).
- Eye and face protection (if not using a CACI with a sealed front).
- Hair cover and shoe covers.
- Respiratory protection if the C-PEC does not fully contain vapors or if the room ventilation is inadequate.
Non-Sterile Compounding of HDs
- Two pairs of chemotherapy-tested gloves.
- Chemotherapy-protective gown.
- Eye/face protection.
- Respiratory protection (N95 or elastomeric respirator) if a CVE is not available.
Closed-System Transfer Devices (CSTDs)
A CSTD is a device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of drug or vapor out of the system. They are used as a supplemental engineering control during compounding and administration of HDs. CSTDs do not replace the need for a C-PEC.
Spill Management
Every area where HDs are handled must have a spill kit readily accessible. The spill kit should contain:
- Chemotherapy-tested gloves (two pairs)
- Protective gown
- Eye protection and face shield
- Respirator
- Absorbent pads and spill pillows
- Disposal bags labeled for HD waste
- A scoop for broken glass (do not pick up glass with hands)
- Caution signs
Spill cleanup procedure:
- Restrict the area and alert others.
- Don full PPE before approaching the spill.
- For liquid spills: cover with absorbent material, working from the outside inward.
- For powder spills: dampen with wet towels to prevent aerosolization before wiping.
- Clean the area with detergent, followed by clean water.
- Dispose of all contaminated materials in HD waste containers.
- Document the spill incident (type, amount, location, personnel involved, cleanup actions).
- Report any personal exposure to occupational health for evaluation.
Waste Disposal
- HD waste (trace contaminated): Empty vials, used gloves, used gowns, IV tubing - place in yellow chemotherapy waste containers.
- HD sharps: Needles and syringes contaminated with HDs go in HD-designated sharps containers.
- Bulk HD waste (unused or expired drugs): Must be managed as hazardous waste per EPA/RCRA regulations. May require a licensed hazardous waste disposal company.
- Do NOT place HD waste in regular trash, regular sharps containers, or red biohazard (infectious waste) bags.
Decontamination, Cleaning, and Disinfection
Surfaces in HD handling areas should be cleaned using a three-step process:
- Decontamination: Use an appropriate deactivating agent or detergent to neutralize or remove drug residue.
- Cleaning: Use a detergent or cleaner to remove visible contamination.
- Disinfection: Use sterile 70% IPA or another approved disinfectant (for sterile compounding areas).
Medical Surveillance
USP 800 recommends medical surveillance for personnel who handle HDs, which may include:
- Baseline health assessment before beginning HD handling.
- Periodic health monitoring.
- Post-exposure assessment after any HD exposure incident.
- Exit evaluation when an employee leaves HD handling duties.
Exam Tips
- USP 800 is the standard for hazardous drug handling - know this number.
- NIOSH publishes the list of hazardous drugs - not all are chemotherapy agents.
- A BSC or CACI (not a LAFW) is required for sterile HD compounding.
- Double gloving with chemotherapy-tested gloves is required for HD compounding.
- C-SEC must be negative-pressure and externally vented.
- HD waste goes in yellow containers; sharps go in HD-labeled sharps containers.
- A dedicated counting tray must be used for oral HD dosage forms.
- Know the spill cleanup procedure and what a spill kit contains.