USP 800

What is the risk of hazardous drug exposure?

fertility impairment and increased risk of cancers

What are the types of HD exposure?

compounding, disposal, receiving, cleaning, transport, storing, dispensing, administering, patient care, spills, managing waste

What is NIOSH?

national institute for occupational safety and health

What is NIOSH’s mission?

to develop new knowledge in the field of occupational safety and health to transfer that knowledge into practice

What characteristics would cause a drug to be considered NIOSH/hazardous?

• Carcinogenicity (cancer-causing)

• Teratogenicity/developmental toxicity

• Reproductive toxicity (infertility)

• Organ toxicity at low doses

• Genotoxicity (damages DNA, which can cause cancer)

• Structure and toxicity profiles of new drugs that mimic existing hazardous drugs

• Labeled by the manufacturer with special handling instructions

What is USP chapter 800?

provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment

True or False: USP 800 covers sterile and nonsterile HDs

true

What must the assessment of risk consider?

type of HD, dosage form, risk of exposure, packaging, manipulation

When is assessment of risk used?

only for low risk activities (counting/prepacking)

True or False: an entity must handle all NIOSH list drugs as hazardous

true

What is a C-PEC?

ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs; selection of type will depend on type of compounding and type of SEC

What are examples of types of C-PECs?

CVE: containment ventilated enclosure

BSC: biological safety cabinet

CACI: compounding aseptic containment isolator

What is a CVE used for?

nonsterile compounding only; powder containment hoods with HEPA-filtered air and negative air pressure

What is the role of a biological safety cabinet?

for sterile compounding, must be class II or III; vertical laminar airflow and negative air pressure

What is a CACI?

closed-front C-PECs that can be located in a buffer room or C-SCA

What is a C-SEC?

containment secondary engineering control; the room in which the C-PEC is placed; must be externally ventilated, physically separated, have an appropriate air exchange, have a negative pressure

Can nonsterile and sterile hazardous drugs be compounded in the same place?

IF:

• C-PECs used for nonsterile compounding are sufficiently effective that the room can
  maintain ISO 7 air throughout nonsterile compounding activity

• If there are separate sterile and nonsterile C-PECs in the same C-SEC, must be placed at
  least 1 meter apart

• Particle-generating activity must not be performed when sterile compounding occurs

• Occasional nonsterile HD compounding can be completed in a sterile C-PEC but must be
  decontaminated, cleaned and disinfected before using to compound sterile HDs

What air pressure must C-PECs, C_SECs, and C-SCAs have?

negative

What is the required air changes per hour for nonsterile hazardous drugs?

12 ACPH

What is the required air changes per hour for sterile C-SEC (same for sterile SEC for non-HD)?

30 ACPH

What is the required air changes per hour for C-SCA?

12 ACPH

True or False: air that has been contaminated with HDs must be externally exhausted?

true

What is the ISO Class for the buffer room and anteroom?

7

What is an example of a containment supplemental engineering control?

closed system transfer devices (CSTDs)

True or False: a closed system transfer device is a substitute for C-PEC?

false

How should hazardous drugs be stored?

stored separately, externally vented, negative pressure room, 12 ACPH

What is the required PPE for compounding HDs?

gowns, head, hair, show covers, and two pairs of gloves

True or False: PPE can be re-used during the same day if the compounder leaves the HD compounding area

false

What is required when administering antineoplastic HDs?

two pairs of chemitherapy gloves

What is required for administering injectable antineoplastic HDs?

two pairs of chemotherapy gloves AND chemotherapy gown

How often do gloves need to be changed when handling HDs?

every 30 minutes or when damaged

True or False: hands should be washed with soap and water after removing gloves

true

What standards must the gloves meet?

ASTM, standard D6978

True or False: gowns worn for HDs are disposable

true

How often do gowns need to be changed for HDs?

every 2-3 hours, or immediately after spill/splash

True or False: gowns worn in HD areas can be worn in other areas

false

When should a second pair of shoe covers be donned for HDs?

before entering C-SEC

What is the optimal eye and face PPE?

goggles in combination with face shields; case-by-case basis

What type of mask is sufficient for most hazardous drug compounding?

n95

What color container is used for all trace antineoplastic waste? (ex. empty vials, empty syringes, used PPE, chemo pads, etc.)

yellow

What color container is used for all bulk antineoplastic waste (ex. unused or partially used HD IV bags, syringes, and vials)?

black

What happens to the contents of both the yellow and black containers?

destroyed by incineration at waste facility

What is a hazard communication program?

written plan that details implementation of HD safety procedures, proper personnel training, competency assessment, and maintaining a list of all required HD

Who is responsible for the hazard communication program?

designated person

True or False: when compounding in C-PEC, a plastic backed preparation mat should be placed on the work surface of the C-PEC (“chemo pad”)

true

True or False: HD tablets/capsules can be put into automated counting or packaging machines

false

What types of HDs cannot be put in a pneumatic tube?

any liquid HDs or table 1 antineoplastics

What are the steps of sanitizing for HDs?

deactivation → decontamination → cleaning → disinfection

What is deactivation?

renders compound inert or inactive (peroxide formulations, sodium hypochlorite)

What is decontamination?

removed HD residue (variable; may include water, alcohol, peroxide, or sodium hypochlrite)

What is cleaning?

removes organic and inorganic material (germicidal detergent)

What is difinfection?

destroys microorganisms (EPA-registered disinfectant and/or sterile alcohol as appropriate)

True or False: all personnel who may clean up a HD spill must be trained in spill management and the use of PPE and NIOSH certified respirators

true

What is needed in the spill kit for HD spills?

• protective gown

• latex gloves

• N95 respirator mask

• goggles with side shields

• HD waste bag, scoop and scraper, chemo pads

• HD spill report exposure form (documentation)

How do you clean up a HD spill?

1. open the spill kit and don PPE

2. clean up large amounts of spilled drug and broken glass

3. cover liquid with absorbent spill pad

4. decontaminate the surfaces where the HD spilled

5. put trash in a hazardous waste bag and seal

6. doff PPE and perform hand hygiene

7. decontaminate respirator if needed

8. replace the spill kit

How often are environmental wipe sampling for HD surface residue required?

every 6 months

What needs to be included in the environmental wipe sampling?

interior of C-PEC and equipment contained within, pass through chambers, surfaces in staging or work areas near the C-PEC, areas adjacent to C-PECs, areas immediately outside the HD buffer room or the C-SCA, patient administration areas

What is medical surveillance?

minimizes adverse effects in personnel potentially exposed to HDs for healthcare workers who routinely handle HDs

What does medical surveillance used for?

to evaluate effectiveness of PPE and engineering controls

What is the role of the pharmacist in dispensing HDs?

appropriate labeling, containment, disposal; how does dosage form factor into decision making; think outside the chemo!