notes Flashcards
which organization creates the list of hazardous drugs
NIOSH
national institute of occupational safety and health
which organization sets the standards to how to work safely with HD?
USP 800
federally enforced in July 2018
which organization publishes guidance for hospital pharmacists to implement USP 800 standards?
ASHP
American Society of Hospital Pharmacists
what types of drugs are considered hazardous?
teratogenic carcinogenic genotoxic cause organ toxicity at low doses reproductive toxicity
what drugs require special handling to avoid toxicity to workers?
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
separate compounding rooms are required for what types of drugs/duties?
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
how should the contaminated air in C-SECs be vented?
externally and changed frequently (air changes per hour)
what pressure must the C-SEC be when compounding HD?
negative pressure
how often should the C-PEC hood be running when compounding sterile HD?
at all times
what is a plastic-backed preparation mat?
should be placed on C-PEC and disposed of after spills, periodically and end of day
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?
30 acph
if the C-PEC is in a C-SCA, what does the ACPH need to be?
12 ACPH
when reconstituting hazardous drugs in vials, how do you manually keep pressurization?
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
what are closed system transfer devices (CSTDs)
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.
what is the ACPH of the C-SEC when non-sterile HD compounding?
at least 12 ACPH
What kind of C-PEC must nonsterile HDs be compounded?
containment ventilator enclosure (CVE) or class I biological safety cabinet (Class I BSC)
can also use CACI or Class II BSC (not common)
how often is staff training of HD handling is assessed?
at least annually and documented
what respirator mask is appropriate for protection against airborne particles if not using a C-PEC?
N95 respirator mask
What type of chemotherapy gown is appropriate?
polyethylene-coated polypropylene or other laminate material
how often does the chemo gown need to be changed?
per manufacterer’s guideline
q2-3h
immediately after spill/splash
what standards does do the chemotherapy gloves have to meet?
american society of testing and materials (ASTM) D6978
how often do gloves need to be changed?
q30min or whenever contaminated
when compounding HD, when does the outer layer have to be sterile?
only when compounding sterile HD
always where 2 gloves when compounding HD (sterile or non-sterile)
what should be used when unpacking HDs without plastic wrapping?
an elastomeric half mask with a multi-cartidge gas and P100 filter
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?
a full face, chemical cartridge respirator or a powered air purifying resprator
in areas with known earthquakes should have what type of shelves?
raised front lips
how should API HDs and anti-neoplastics that need to be manipulated be stored?
in a separate room from non-HD drugs, in an externally ventilated, negative pressure room with ACPH 12
what kind of HD can be stored with other inventory?
non-neoplastic HD, reproductive risk only HD, in final dosage form neoplastic drugs in impervious plastic
where should refrigerated anti-neoplastics be stored?
in a designated refrigerator in a negative pressure area with ACPH 12
what is the order of sanitization of HD area and equipment?
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
what needs to be in every area a HD spill can occur?
a spill kit with all required materials
how often should a wipe environmental monitoring in HD areas be done?
at benchmark and at least q6 months
