Hazardous drugs and USP <800>

What Are Hazardous Drugs?

Hazardous drugs (HDs) are medications that pose a risk of harm to people who prepare, handle, or administer them. The National Institute for Occupational Safety and Health (NIOSH) publishes and periodically updates a list of hazardous drugs used in healthcare settings. Drugs appear on the NIOSH list because they have one or more of these properties: carcinogenicity (ability to cause cancer), genotoxicity (damage to DNA), reproductive or developmental toxicity, organ toxicity at low doses, or structural and toxicological similarity to known hazardous agents.

Common examples include many antineoplastic (chemotherapy) agents, certain antiviral drugs, some hormones, and select immunosuppressants. As a pharmacy technician, you will encounter HDs in many practice settings, so understanding how to protect yourself and your colleagues is essential to your safety and your patients' safety.

USP Chapter <800>: The Standard You Must Know

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings establishes legally enforceable standards for receiving, storing, preparing, dispensing, administering, and disposing of HDs. It applies to all healthcare settings that handle HDs. The goals are to minimize occupational exposure and protect personnel, patients, and the environment.

USP <800> works alongside USP <795> (non-sterile compounding) and USP <797> (sterile compounding). When an HD is also a compound, all applicable chapters apply simultaneously.

Receiving Hazardous Drugs

Hazardous drugs must be received in a dedicated area that is neutral or negative-pressure relative to surrounding spaces, or in a way that limits exposure. Upon delivery:

• Inspect containers for damage or leakage before unpacking.
• Wear at minimum chemotherapy-tested gloves when handling HD shipping cartons.
• Do not open damaged packages in public areas; follow your facility's spill and exposure procedures.
• Document the receipt, noting any discrepancies in quantity or packaging.

Storage Requirements

HDs must be stored separately from non-hazardous drugs to prevent confusion and limit exposure. Storage areas should be clearly labeled with warning signage. Many HDs require negative-pressure storage rooms or ventilated cabinets. Refrigerated HDs must be stored in a dedicated refrigerator or a segregated section of a refrigerator used only for HDs. Access should be limited to trained personnel.

Personal Protective Equipment (PPE)

USP <800> specifies PPE requirements based on the activity and the HD involved. Key PPE components include:

Gloves: Chemotherapy (chemo) gloves are the gold standard. They must be tested and labeled for chemotherapy use. Double-gloving is required when compounding HDs and is strongly recommended for any HD handling. Gloves must be changed at regular intervals, after a breach, or when the integrity is in question.

Gowns: Disposable, lint-free gowns that close in the back (no open fronts), made of low-permeability material. They must not be worn outside the work area.

Respiratory Protection: A fit-tested N95 respirator or higher is required for certain tasks involving HDs that may generate aerosols or vapors. A standard surgical mask is not adequate protection against HD exposure.

Eye and Face Protection: Safety goggles or a face shield protect against splashes. This is required when there is a risk of splash or aerosol generation.

Head and Shoe Covers: Required when compounding sterile HDs.

Donning (Putting On) PPE

The correct donning sequence prevents contamination of clean items. A general sequence is: gown → first pair of gloves (tucked under gown cuff) → respiratory protection → eye protection → second pair of gloves (over gown cuff).

Doffing (Removing) PPE

Doffing is the higher-risk step because the outer surfaces of PPE are contaminated. Remove in a way that avoids touching your skin or clothing. A common sequence is: outer gloves → eye protection → gown (roll inward, contaminated side in) → respiratory protection → inner gloves. Perform hand hygiene immediately after.

Containment Devices

Biological Safety Cabinets (BSCs) and Compounding Aseptic Containment Isolators (CACIs) provide primary engineering controls for HD compounding. These devices use HEPA filtration and negative-pressure airflow to capture HD particles and protect the compounder. Work should be performed in these devices whenever compounding sterile or non-sterile HDs.

Closed System Drug Transfer Devices (CSTDs) create a physical barrier that prevents HD vapors or liquid from escaping during transfer. CSTDs are required when compounding and when the dosage form and patient-care setting allow their use during administration.

Spill Response

Spills must be handled immediately and only by trained personnel using a pre-assembled HD spill kit. A standard spill kit contains chemotherapy gloves, a gown, eye protection, a respirator, absorbent pads or granules, a scoop, a puncture-resistant container for sharps, waste bags labeled as hazardous waste, and warning signs.

Steps for a small HD spill (consult your facility's policy for specific procedures):

1. Alert others in the area and post warning signs to prevent entry.

2. Don full PPE from the spill kit before approaching the spill.

3. Contain liquids with absorbent pads (place gently, do not wipe outward).

4. Absorb solids with damp absorbent material.

5. Clean the area at least three times with appropriate detergent, then rinse.

6. Place all contaminated materials in a labeled hazardous-waste bag and then into a labeled container.

7. Document the spill and complete an incident report.

8. Report any skin or eye contact immediately to a supervisor and seek medical evaluation.

Disposal

HD waste must be disposed of as hazardous pharmaceutical waste according to federal and state regulations. Never place HD waste in regular trash or flush it. Use designated, labeled, sealable containers. CSTDs and other contaminated equipment are also hazardous waste.

Your Role as a Technician

You are responsible for following your facility's HD policies, completing required training before handling HDs, wearing all required PPE correctly, reporting spills and exposures immediately, and never handling HDs outside your training and scope. Patient safety and worker safety depend on strict adherence to these standards.