notes

Question 1

which organization creates the list of hazardous drugs

Answer 1

NIOSH

national institute of occupational safety and health

Question 2

which organization sets the standards to how to work safely with HD?

Answer 2

USP 800

federally enforced in July 2018

Question 3

which organization publishes guidance for hospital pharmacists to implement USP 800 standards?

Answer 3

ASHP

American Society of Hospital Pharmacists

Question 4

what types of drugs are considered hazardous?

Answer 4

teratogenic
carcinogenic
genotoxic
cause organ toxicity at low doses
reproductive toxicity

Question 5

what drugs require special handling to avoid toxicity to workers?

Answer 5

pregnancy category X drugs including paroxetine, misoprostol, mifepristone, methotrexate, ribavirin

anti-neoplastics

5-alpha reductase hormones (dutasteride, finasteride)

hormones (estradiol, contraceptives, testosterone)

transplant (mycophenolate, tacrolimus, everolimus, sirolimus)

colchicine, dronedarone, fluconazole, spironolactone, risperidone, raloxifene, rasagiline, ziprasidone

Question 6

separate compounding rooms are required for what types of drugs/duties?

Answer 6

sterile HD
non-sterile HD
sterile non-HD
(non-sterile & sterile HD can be in the same room as long as ISO 7 in non-sterile HD and the C-PECs are placed at least 1 meter apart)
non-sterile non-HD
dispensing/other pharmacy function

Question 7

how should the contaminated air in C-SECs be vented?

Answer 7

externally and changed frequently (air changes per hour)

Question 8

what pressure must the C-SEC be when compounding HD?

Answer 8

negative pressure

Question 9

how often should the C-PEC hood be running when compounding sterile HD?

Answer 9

at all times

Question 10

what is a plastic-backed preparation mat?

Answer 10

should be placed on C-PEC and disposed of after spills, periodically and end of day

Question 11

if the C-PEC is in a buffer room, what does the ACPH (air changes per hour) need to be in the buffer and ante room?

Answer 11

30 acph

Question 12

if the C-PEC is in a C-SCA, what does the ACPH need to be?

Answer 12

12 ACPH

Question 13

when reconstituting hazardous drugs in vials, how do you manually keep pressurization?

Answer 13

negative pressure technique
must use smallest syringe and cannot be >75% full when filled with solution

draw up diluent –> plunge needle into vial –> drawback a small amount of air –> transfer diluent in small amounts equal to the air pulled back

this keeps equal pressure in vial

Question 14

what are closed system transfer devices (CSTDs)

Answer 14

keep HD contained and block entry of contaminants. They are recommended when compounding HDs, but REQUIRED when administering HDs as long as formulation allows. Has a built-in pressure equalizer. do not need to do negative pressure technique if using CSTDs.

Question 15

what is the ACPH of the C-SEC when non-sterile HD compounding?

Answer 15

at least 12 ACPH

Question 16

What kind of C-PEC must nonsterile HDs be compounded?

Answer 16

containment ventilator enclosure (CVE) or class I biological safety cabinet (Class I BSC)

can also use CACI or Class II BSC (not common)

Question 17

how often is staff training of HD handling is assessed?

Answer 17

at least annually and documented

Question 18

what respirator mask is appropriate for protection against airborne particles if not using a C-PEC?

Answer 18

N95 respirator mask

Question 19

What type of chemotherapy gown is appropriate?

Answer 19

polyethylene-coated polypropylene or other laminate material

Question 20

how often does the chemo gown need to be changed?

Answer 20

per manufacterer’s guideline
q2-3h
immediately after spill/splash

Question 21

what standards does do the chemotherapy gloves have to meet?

Answer 21

american society of testing and materials (ASTM) D6978

Question 22

how often do gloves need to be changed?

Answer 22

q30min or whenever contaminated

Question 23

when compounding HD, when does the outer layer have to be sterile?

Answer 23

only when compounding sterile HD

always where 2 gloves when compounding HD (sterile or non-sterile)

Question 24

what should be used when unpacking HDs without plastic wrapping?

Answer 24

an elastomeric half mask with a multi-cartidge gas and P100 filter

Question 25

what should be used when cleaning up large HD spills, cleaning under the C-PEC or when there is known exposure to powders or vapors?

Answer 25

a full face, chemical cartridge respirator or a powered air purifying resprator

Question 26

in areas with known earthquakes should have what type of shelves?

Answer 26

raised front lips

Question 27

how should API HDs and anti-neoplastics that need to be manipulated be stored?

Answer 27

in a separate room from non-HD drugs, in an externally ventilated, negative pressure room with ACPH 12

Question 28

what kind of HD can be stored with other inventory?

Answer 28

non-neoplastic HD, reproductive risk only HD, in final dosage form neoplastic drugs in impervious plastic

Question 29

where should refrigerated anti-neoplastics be stored?

Answer 29

in a designated refrigerator in a negative pressure area with ACPH 12

Question 30

what is the order of sanitization of HD area and equipment?

Answer 30

deactivate & decontaminate with bleach or peroxide (Peridox RTU is a combo)

(neutralize bleach with sodium thiosulfate, sterile alcohol, germicidal detergents)

clean with germicidal detergent: quat. ammonium or phenolics

disinfect w/ 70% IPA

always use wipes not sprays

Question 31

what needs to be in every area a HD spill can occur?

Answer 31

a spill kit with all required materials

Question 32

how often should a wipe environmental monitoring in HD areas be done?

Answer 32

at benchmark and at least q6 months