Safe Handling of Hazardous Drugs — Part 2: Personal Protective Equipment and Safe Handling Procedures

6. Personal Protective Equipment (PPE)

Personal protective equipment is the last line of defense in the hierarchy of controls but remains essential for all hazardous drug handling activities. PPE must be used in conjunction with, not as a substitute for, engineering controls. The type and extent of PPE required varies by the specific activity being performed and the dosage form of the hazardous drug being handled.¹

6.1 Chemotherapy-Tested Gloves

Gloves are the most fundamental PPE element for hazardous drug handling. Standard examination gloves are not acceptable — only gloves that have been tested for permeation by chemotherapy agents according to ASTM D6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) may be used.²

6.2 Protective Gowns

Unacceptable gowns: Standard isolation gowns, surgical gowns (unless specifically rated for chemotherapy permeability), and cloth lab coats do not provide adequate protection against hazardous drug exposure.

6.3 Eye and Face Protection

6.4 Respiratory Protection

Respiratory protection program requirements:

• Any use of respiratory protection (N95 or higher) requires enrollment in the facility’s respiratory protection program
• Workers must be medically cleared for respirator use
• Workers must be fit-tested annually for the specific N95 model used (qualitative or quantitative fit testing)
• Loose-fitting PAPRs do not require fit testing and are preferred for workers who cannot achieve adequate N95 fit
• Surgical masks do not provide respiratory protection against hazardous drug aerosols or vapors

6.5 Other PPE Considerations

6.6 PPE Requirements by Activity — Summary Table

7. Safe Handling Procedures by Activity

7.1 Receiving and Unpacking

Hazardous drug contamination exists on the exterior of drug vials and packaging as received from manufacturers and distributors. Receiving and unpacking procedures must account for this baseline contamination.³

Procedure:

1. Designate a specific area for receiving hazardous drug shipments, separate from general receiving
2. Personnel receiving HD shipments must wear, at minimum, one pair of chemotherapy-tested gloves
3. Inspect all shipping containers for signs of damage, breakage, or leakage before opening
4. If a shipping container shows external evidence of damage or leakage:
   • Do not open the container in the general receiving area
   • Don full PPE (double gloves, gown, eye protection, N95 respirator)
   • Move the container to a ventilated area or BSC
   • Open carefully, identify damaged contents, and initiate spill procedures if needed
   • Document the damage and notify the supplier
5. For intact shipments:
   • Unpack hazardous drugs separately from non-hazardous items
   • Wipe the exterior of drug containers with a damp gauze or towel to remove potential surface contamination (some institutions use decontamination wipes)
   • Place hazardous drugs in designated HD storage areas immediately
   • Do not leave unpacked hazardous drugs in general inventory staging areas
6. Dispose of all outer packaging materials in HD waste containers if they contacted drug containers directly, or in regular waste if no contact with drug containers and no visible contamination
7. Remove and discard gloves in HD waste; perform hand hygiene

7.2 Storage

Requirements for hazardous drug storage areas:⁴

1. Hazardous drugs must be stored in a dedicated area that is clearly identified with hazardous drug warning signage
2. Storage areas should be negative pressure relative to surrounding areas (or adequately ventilated to prevent accumulation of airborne drug)
3. Hazardous drugs must be stored at appropriate temperatures per manufacturer specifications
4. Shelving should be at a height that prevents drug containers from falling; bins or shelves with raised edges are preferred
5. Store hazardous drugs below eye level to reduce risk of containers falling on workers
6. Separate oral solid dosage forms from injectable products to prevent errors
7. Do not store food, beverages, or personal items in HD storage areas
8. Spill kits must be readily available in or immediately adjacent to all HD storage areas
9. Workers entering HD storage areas to retrieve or shelve drugs must wear, at minimum, one pair of chemotherapy-tested gloves
10. Final dosage forms that are labeled and ready for patient administration should be stored in a manner that prevents breakage and contamination during transport

7.3 Compounding and Preparation

Compounding of hazardous drugs encompasses all activities that involve manipulation of a hazardous drug to produce a sterile or non-sterile preparation for patient use. This includes reconstitution, dilution, mixing, pooling, and repackaging.⁵

7.3.1 Sterile Compounding

Required environment: Class II Type B2 BSC or CACI, located within a negative-pressure room that meets ventilation requirements (see Part 1, Section 4.4).

Required PPE: Double chemotherapy-tested gloves, chemotherapy-rated gown, hair cover, shoe covers (per institutional policy), surgical mask (aseptic technique).

Procedure:

1. Perform hand hygiene and garb in the anteroom or designated donning area per aseptic technique standards
2. Gather all materials needed for the compounding session; transport drugs and supplies to the HD compounding room
3. Don PPE in the correct sequence: shoe covers (if required) → hair cover → hand hygiene → inner gloves → gown → outer gloves over gown cuffs
4. Decontaminate and clean the BSC/CACI work surface per established procedure (see Part 3)
5. Place a plastic-backed, absorbent, disposable pad (chemo-rated) on the work surface
6. Arrange materials in the BSC work zone, at least 6 inches from the front edge and side intake grilles
7. Use a CSTD for all drug transfers from vials (required for antineoplastic agents)
8. Techniques to minimize aerosolization:
   • Equalize vial pressure using the CSTD or a venting device (hydrophobic filter vent) — do not pressurize vials
   • Use Luer-lock connections for all syringe and tubing connections
   • Prime IV tubing with drug-free solution before attaching the drug-containing bag/syringe
   • Attach the drug container to the IV set inside the BSC
   • Expel air from drug-filled syringes into a sterile gauze pad dampened with alcohol, not into the open air
9. Seal all final containers (IV bags, syringes) with tamper-evident seals or caps
10. Wipe the exterior of all final drug containers with moist gauze to remove potential surface contamination before removing from the BSC
11. Place finished preparations in sealed, labeled transport bags (zip-lock bags or other sealed containers clearly labeled with HD warning labels)
12. Replace the absorbent pad if contaminated; at end of session, discard the pad in HD waste
13. Change outer gloves every 30 minutes during continuous compounding or immediately if compromised
14. At the conclusion of compounding:
    • Discard all waste in HD waste containers within the BSC
    • Remove the absorbent pad and discard in HD waste
    • Decontaminate and clean the BSC work surface
    • Allow the BSC to purge for the manufacturer-specified time
    • Remove PPE in the correct sequence (outermost to innermost): outer gloves → gown (roll inward, contaminated side in) → shoe covers → inner gloves
    • Perform hand hygiene immediately after glove removal

7.3.2 Non-Sterile Compounding

Non-sterile hazardous drug compounding (e.g., preparing oral suspensions, crushing tablets for compounding) must be performed in a BSC or CACI within a C-SCA or negative-pressure room.⁶

Required PPE: Double chemotherapy-tested gloves, chemotherapy-rated gown, eye protection (if not in BSC), N95 respirator (if crushing or generating powder outside of a containment device).

Additional considerations:

• Tablet splitting, crushing, or capsule opening must be performed within a BSC, CACI, or other containment device
• Counting of intact oral solid HD dosage forms should use a dedicated counting tray that is not used for non-hazardous drugs; alternatively, count within the containment device
• Dedicated equipment (mortars, pestles, counting trays) must be used exclusively for hazardous drugs and decontaminated after each use

7.4 Administration

7.4.1 Intravenous Administration

Required PPE: Double chemotherapy-tested gloves, chemotherapy-rated gown, eye protection if splash risk exists, CSTD for Table 1 agents.⁷

Procedure:

1. Verify the patient, drug, dose, route, and rate per institutional chemotherapy administration policies
2. Don PPE before handling the drug
3. Inspect the drug container for integrity — check for leaks, discoloration, or precipitate
4. Administer using the CSTD connection system for Table 1 agents:
   • Connect the CSTD IV line adaptor to the patient’s IV access device
   • All connections must be Luer-lock
5. Use IV tubing that has been primed with drug-free solution (primed in the BSC during compounding if possible)
6. Place a plastic-backed absorbent pad under the IV connection site to catch any drips
7. Monitor the infusion site and connections regularly throughout the infusion
8. Upon completion:
   • Do not disconnect the IV set from the drug container — dispose of the entire set (bag, tubing, CSTD components) as a unit in HD waste
   • If the IV line must be flushed, flush with a compatible drug-free solution through the existing set before disconnecting
   • Discard all administration materials in HD waste containers
9. Remove PPE in the correct sequence; perform hand hygiene
10. Document administration per institutional protocol

7.4.2 Oral Administration

Intact solid dosage forms (tablets, capsules):

• Wear a minimum of one pair of chemotherapy-tested gloves
• Do not crush, split, or manipulate intact dosage forms unless clinically required
• If the patient cannot swallow, consult pharmacy for an alternative formulation rather than crushing
• Present the medication to the patient in a medicine cup; do not handle with bare hands
• If the patient refuses or spits out the medication, clean the area while wearing gloves and discard contaminated materials in HD waste

Manipulated dosage forms (crushed tablets, opened capsules, oral liquids):

• Double chemotherapy-tested gloves, protective gown, eye protection
• Prepare within a BSC or containment device
• Use oral syringes with caps to transport liquid formulations
• Administer using careful technique to avoid spills; place absorbent pad under the patient’s chin or administration site

7.4.3 Topical Administration

• Double chemotherapy-tested gloves (change immediately after application)
• Protective gown
• Apply using an applicator or gloved hand as appropriate; avoid skin contact
• Educate the patient to avoid skin-to-skin transfer of the drug to other individuals
• Contaminated application devices are HD waste

7.4.4 Subcutaneous and Intramuscular Injection

• Double chemotherapy-tested gloves, protective gown
• Use safety-engineered needles or needleless systems
• Activate the safety mechanism on the needle immediately after injection
• Place used syringes and needles immediately into HD sharps containers
• Apply pressure to the injection site with gauze; discard in HD waste

7.5 Patient Care — Handling Body Fluids

Patients who have received hazardous drugs excrete the drug and/or active metabolites in urine, stool, emesis, saliva, sweat, and other body fluids. The excretion period varies by drug but is commonly considered to extend for at least 48 hours after the last dose of a hazardous drug (some drugs may be excreted for longer periods — up to 7 days for some agents).⁸

Requirements:

1. All personnel handling body fluids from patients who have received hazardous drugs within the excretion period must wear:
   • Double chemotherapy-tested gloves
   • Protective gown
   • Eye/face protection if splash risk is present
2. Use standard precautions as a baseline; HD-specific precautions are in addition to, not a replacement for, standard precautions
3. Handle contaminated linens, pads, diapers, and other absorbent materials with gloved hands; place directly into labeled, sealed laundry bags or HD waste containers (per institutional policy — some institutions launder, some discard)
4. Toilet precautions:
   • Ambulatory patients should be instructed to flush twice with the lid down
   • For patients using bedpans, urinals, or commodes, the contents should be disposed of carefully to avoid splashing; the container must be rinsed and cleaned with appropriate decontaminant
   • Use disposable toilet seat covers or absorbent pads as applicable
5. Emesis management:
   • All emesis from patients within the excretion window is potentially contaminated
   • Use lined emesis basins; dispose of contents and liner in HD waste
   • Clean the basin per decontamination protocol

7.6 Patient Care — Linen Handling

1. Contaminated linen (bedding, gowns, towels) from patients within the HD excretion period should be handled with double chemotherapy-tested gloves and a protective gown
2. Place contaminated linen in water-soluble bags, then into labeled laundry bags
3. Do not shake contaminated linen — fold or roll carefully to contain contamination
4. Prewash contaminated linen separately from general laundry (twice through the wash cycle is recommended by some authorities)
5. Linen with gross contamination (visible drug spill) should be discarded as HD waste rather than laundered

7.7 Transport

Within the facility:

1. Finished hazardous drug preparations must be transported in sealed, labeled containers (e.g., zip-lock bags, rigid transport containers) that are clearly labeled with HD identifiers
2. The transport container must be designed to contain any leakage in the event of breakage
3. Use secondary containment for liquid formulations
4. Personnel transporting finished preparations must wear at minimum one pair of chemotherapy-tested gloves
5. Pneumatic tube systems should not be used for hazardous drugs, as breakage and contamination of the tube system can occur. If a facility’s assessment of risk allows pneumatic tube transport, only intact oral solid forms in sealed containers should be considered, and the tube system must be validated to prevent container damage

Between facilities:

1. Hazardous drugs shipped between facilities must be packaged in accordance with applicable Department of Transportation (DOT) and state regulations
2. Use rigid, impact-resistant outer containers with absorbent material sufficient to contain the full volume of the largest single container in the event of breakage
3. Label all outer shipping containers with HD warnings
4. Include spill response information and an SDS in or on the shipping container
5. Document chain of custody

8. Donning and Doffing PPE — Correct Sequence

8.1 Donning Sequence (Putting On)

Correct donning sequence prevents contamination of clean inner layers:

1. Remove personal items (jewelry, watches) from hands and wrists
2. Perform hand hygiene (wash with soap and water or use alcohol-based hand rub)
3. Don shoe covers (if required)
4. Don hair cover and head/neck cover
5. Don inner chemotherapy-tested gloves
6. Don protective gown — ensure cuffs cover inner gloves
7. Don outer chemotherapy-tested gloves over the gown cuffs, creating a sealed interface
8. Don eye/face protection (if required for the activity)
9. Don respiratory protection (if required — N95 should be donned and fit-checked before the gown)

Note: If an N95 respirator is required, it should be donned after hand hygiene and before the gown, as it requires a proper seal check. The gown is then donned over the respirator straps.

8.2 Doffing Sequence (Removing)

Correct doffing prevents self-contamination from the outer contaminated surfaces:

1. Remove and discard outer gloves in HD waste (the most contaminated layer)
2. Remove gown by untying/unsnapping at the back; pull forward off the shoulders, rolling the gown inward so that the contaminated exterior surface is contained; discard in HD waste
3. Remove shoe covers (if worn); discard in HD waste
4. Remove eye/face protection (if worn) by handling the earpieces or headband only (not the front surface); discard or clean per institutional policy
5. Remove inner gloves by peeling off inside-out; discard in HD waste
6. Perform hand hygiene immediately
7. Remove hair cover last (it is the least likely to be contaminated); discard
8. Perform hand hygiene again

References