USP 800, Hazardous Drugs - Constantino

USP 800

Responsible for the safe handling of hazardous drugs

Minimize risk exposure

Protect healthcare personnel and environment

Applies to the drug its whole life (from manufacturer to dispensing)

Applies to everyone that deals with hazardous drugs

What is special about hazardous drugs

They can cause toxicity to healthcare workers that handle them. They require spaces, equipment and devices that reduce exposure of the drug according to USP requirements.

HD definition

1. Carcinogenic

2. Teratogenic

3. Reproductive toxicity

4. Toxic to organs at low doses

5. Labeled by the manufacturer with special handling instructions

Who determines which drugs are hazardous

The National Institute of Occupational Safety (NIOSH)

Safety data sheets

Are documents required by OSHA for employees working with hazardous materials and provide safety information including PPE, first aid procedures, spill cleanup procedures

What aspects of handling HD must be addressed in institutional policies

1. Hazard communication program

2. Occupational safety program

3. Designated HD receiving, storage, and compounding areas

4. Receipt, including handling of damaged shipping containers

5. Storage

6. Compounding

7. Use and maintenance of proper engineering controls

8. Hand hygiene and use of PPE based on activity

9. Deactivation, decontamination, cleaning and disinfection

10. Dispensing

11. Transport, including packaging and labeling

12. Administering

13. Disposal

14. Spill control

15. Environmental monitoring

What is a Hazardous communication program

Includes a written plan that details implementation of HD safety procedures, proper training of personnel, competency assessment and maintaining all HD documentation.

Designated person

Each facility must have a designated individual who is responsible for SOPs focuses don worker safety during all aspects of HD handling.

What must pharmacies do consider Hazardous drugs

Maintain a list of all hazardous drugs stocked. It must be reviewed every 12 months or whenever a new drug or dosage form is stocked or used.

Medical Surveillance Program for Occupation Safety

OSHA requirement that must be performed annually

Staff are surveyed, must get a physical, exposure risk reviewed, blood work and urinalysis

Assessment of Risk for HD drugs

A pharmacy can conduct an Assessment of Risk to determine if drugs with lower risk can avoid having to follow all USP 800 requirements if they are only dispensed and not manipulated

Low risk activities

Counting, packaging, dedicated counting tray and spatula for HDs and decontaminating after use, using gloves when counting or packing, HDs placed in sealed bag

Unpackaging of HD

they must be unpacked in negative pressure with at least 12 air changes per hour. Staff must wear PPE in the event of a breakage. Single pair of chemo gloves to unpack. Staff should also be trained on how to use a spill kit

Storing of HDs

Must be stored separately from other drugs. In a well-ventilated area with appropriate signage.

Spill Kit protocol

Isolate the area and alert personnel

Don PPE

Contain and absorb the spill

Clean up and collect debris

Decontaminate and neutralize the surface

Doff PPE and dispose of Waste

Air handling for HDs in PEC

Must have negative pressure in the C-PEC to keep air flowing into the room that externally vents air

How many ACPH does a non-sterile HD compounding room need

12

How many ACPH do sterile HD compounding room need

30

How many ACPH do containment segregated compounding areas need

12

Which PECs can be used for HD compounding - all negative

Biological safety cabinet - sterile compounding need class 2 or 3

Containment ventilated enclosures - powder containment hoods for non sterile compounding

Compounding aseptic containment isolators (CACIs) - closed front glove boxes located in a buffer room or C-SCA

Laminar Airflow Bench Picture

Can be used for sterile compounding

Not for hazardous drugs

Biological safety cabinet picture

Class 3 has the arm holes

Can be used for sterile compounding (class 2-3, not 1)

Class 2 can be for HD if appropriately configured

Class 3 can be for HD

Compounding aseptic isolator picture

Can be used for sterile compounding

For hazardous drugs

Compounding Aseptic Containment Isolator

Similar to Compounding aseptic isolator but for HD

Containment Ventilated Enclosure picture

Designed for non-sterile hazardous drugs, specifically powders and aerosols

PEC Comparison chart

Characteristics of BSC or chemotherapy hood

Vertical air flow, blows top down to maintain sterility and protect the worker

Used to make chemotherapy

Compounding sterile and non-sterile in the same place

Preferable to keep spaces separate. The C-SEC must maintain ISO 7 air even for non-sterile compounding. If there are separate C-PECs in the same space they must be one meter apart. Non-sterile compounding can not be performed when sterile compounding is being performed.

Non-sterile compounding in steril C-PEC

Need to decontaminate afterwards

3 steps of sanizations

Deactivation + decontamination: bleach or peroxide

Cleaning: germicidal

Disinfection: Sterile isopropyl alcohol

Deactivation and Decontamination

Reduces HD toxicity and removes HD residues

Cleaning

Removes dirt and microbial containment

Disinfection

Inhibits or destroys microorganisms

Hand hygiene and PPE for non-sterile hazardous drugs

For AoR identified drugs one pair of gloves can be used.

Repeated cutting or crushing of tablets poses a higher risk of exposure so if a BSC or CACI is not available double glove, mask, and gown.

Hand hygiene and PPE for sterile hazardous drugs

Head covers, face mask, beard cover, gown impermeable to liquid, 2 pairs of chemo rate gloves, full face respirator or face shield with goggles if there is risk of spill or splash

Garbing for HD compounding

1. Need a respirator N95 or CPAP

2. Chemotherapy gloves 2 pairs one under the cuff of the gown and the other pair over the cuff

3. Face mask

4. Hair cover

5. Eye protection

6. Chemo gown with impermeable coating

7. Shoe covers - 2 pair needed for sterile compounding

Donning for BSC and CACI

Remove all jewelry, makeup and outer clothing.

No artificial nails are allowed

Don shoe covers while stepping over the line of demarcation. Add 2nd pair of shoe covers if HD compounding

Don head and facial coverings and mask

Perform hand hygiene. Clean under fingernails

Dry hands with lint free disposable towels

Don a non-shedding gown over hospital scrubs

Apply an alcohol based surgical scrub to hands

Don 1 pair of chemo rated gloves

Enter the HD buffer area and don chemo gown

Don second pair of chemo rated gloves before compounding.

Gloves should be changed every 30 minutes.

Doffing sterile compounding

When compounding is complete, all garb except the gown goes in the disposal container

The gown can be worn again during the current shift but must stay in the ante area

Doffing HD sterile compounding

When compounding is complete, the chemo gown, exterior gloves and top pair of the shoe covers are removed and placed in a waste container in the hazardous buffer room upon exiting.

Transport of HDs

Need to be properly labeled. Sterile HDs should be transported in a hard sided container that has a lid and is labeled to prevent the risk of breakage or spillage. Pneumatic tubes can not be used.

HD Disposal

All PPE that is worn when handling HDs are considered contaminated. All should be placed in yellow waste binds. All trace antineoplastic waste (syringes, empty vials, gloves) go in yellow waste. Bulk antineoplastic (partial vials, chemo bags) are thrown in black waste bins

Wipe sampling of hoods

Done every 6 months

Closed system transfer devices

Mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor outside the system.