Hazardous Drug Handling Quick Reference
USP Chapter 800 provides standards for the safe handling of hazardous drugs (HDs) in healthcare settings. Pharmacy technicians must understand proper procedures for receiving, storing, compounding, dispensing, administering, and disposing of hazardous drugs.
What Makes a Drug Hazardous?
The NIOSH (National Institute for Occupational Safety and Health) publishes a list of hazardous drugs. A drug is considered hazardous if it exhibits one or more of the following properties:
- Carcinogenicity (causes cancer)
- Teratogenicity (causes birth defects) or developmental toxicity
- Reproductive toxicity
- Organ toxicity at low doses
- Genotoxicity (damages DNA)
- New drugs with structural or toxicity profiles similar to existing hazardous drugs
Examples of Hazardous Drugs
| Category | Examples |
|---|---|
| Antineoplastics (chemotherapy) | Cyclophosphamide, methotrexate, fluorouracil, doxorubicin, cisplatin |
| Hormonal agents | Tamoxifen, estrogen-containing products |
| Antivirals | Ganciclovir, ribavirin |
| Immunosuppressants | Mycophenolate, tacrolimus |
| Other | Finasteride, dutasteride, warfarin, spironolactone |
Note: Not all hazardous drugs are chemotherapy agents. Many commonly dispensed medications appear on the NIOSH list.
USP 800 Key Requirements
Receiving and Storage
- Hazardous drugs should be received in a designated area.
- Shipments should be inspected for damage upon arrival.
- HDs should be stored separately from non-hazardous drugs in a negative-pressure area (if feasible).
- Antineoplastic drugs requiring refrigeration should be stored in a dedicated refrigerator.
- Storage areas should have appropriate signage indicating hazardous drug storage.
Personal Protective Equipment (PPE)
| Activity | Required PPE |
|---|---|
| Receiving and unpacking | Chemotherapy-tested gloves (two pairs recommended if risk of spill) |
| Counting or repackaging intact oral forms | Chemotherapy-tested gloves; use a dedicated counting tray |
| Non-sterile compounding of HDs | Two pairs of chemotherapy-tested gloves, protective gown, eye/face protection, respiratory protection (N95 or better if no engineering controls) |
| Sterile compounding of HDs | Two pairs of chemotherapy-tested gloves, chemotherapy-protective gown, eye/face protection, hair cover, shoe covers, respiratory protection as needed |
| Spill cleanup | Two pairs of chemotherapy-tested gloves, protective gown, eye/face protection, respiratory protection |
Engineering Controls
- C-PEC (Containment Primary Engineering Control): Provides ISO Class 5 air while containing hazardous drug particulates. Examples include a Class II Biological Safety Cabinet (BSC) or a Containment Aseptic Containment Isolator (CACI).
- C-SEC (Containment Secondary Engineering Control): The room in which the C-PEC is located, with negative pressure relative to adjacent areas and appropriate air exchanges.
- A standard laminar airflow workbench (LAFW) must not be used for hazardous drug compounding because it blows air toward the compounder.
- Closed-system transfer devices (CSTDs) may be used as a supplemental control during compounding and administration.
Spill Management
- Alert others in the area immediately.
- Don appropriate PPE before cleaning (double gloves, gown, face/eye protection, respiratory protection).
- Use a spill kit designed for hazardous drug cleanup.
- Contain the spill: for liquids, use absorbent pads or pillows; for powders, use damp cloths to prevent aerosolization.
- Clean the area thoroughly, working from the outside of the spill inward.
- Place all contaminated materials in a hazardous waste container.
- Document the spill incident according to facility policy.
- Report any exposure to occupational health.
Waste Disposal
- Hazardous drug waste must be placed in designated hazardous waste containers (typically yellow with appropriate labeling).
- This includes used gloves, gowns, cleanup materials, empty vials, and any items contaminated with HDs.
- Trace-contaminated items (empty vials, gloves from routine handling) go in yellow HD containers.
- Bulk HD waste (unused drugs, expired HDs) may require separate handling per EPA/state regulations.
- HD waste should not be placed in regular trash, red biohazard (infectious) waste containers, or sharps containers (unless also sharps).
- Needles and syringes contaminated with HDs go in HD-labeled sharps containers.
Exposure Management
- Skin contact: Remove contaminated clothing immediately. Wash affected skin thoroughly with soap and water (not hot water). Do not scrub.
- Eye contact: Flush eyes with water or normal saline for at least 15 minutes. Seek medical attention.
- Inhalation: Move to fresh air immediately. Seek medical attention if symptoms persist.
- Needlestick: Allow the wound to bleed freely. Wash with soap and water. Report to occupational health.
- All exposures must be documented and reported per facility policy.
Exam Tips
- Know that USP 800 specifically governs hazardous drug handling.
- A Biological Safety Cabinet (BSC) is used for HD compounding, NOT a horizontal LAFW.
- Two pairs of chemotherapy-tested gloves are required for compounding HDs.
- Hazardous drug waste goes in yellow containers, not regular trash or red biohazard bags.
- The NIOSH list includes many non-chemotherapy drugs - finasteride, warfarin, and some hormones are on the list.
- Spill kits must be readily available wherever HDs are handled.