USP 800 Flashcards
who maintains the list of antineoplastics and other HDs
NIOSH
how often is the list of HD reviewed
every year
how is the risk assesement of a HD done by NIOSH
type of HD
dosage form
risk of exposure
packaging
manipulation
at which points are people at risk of exposure to HD
receipt, dispensing, compounding, admin, patient care activities, spills, transport, waste management
who is responsible for ensuring proper precautions are taken at a sight for HDs
a designated person must ensure compliance with USP 800 and ensure all personnel who handle drugs understand the practices and precautions required
what designated areas are required for storage of HDs
receipt and unpacking
storage of HDs
non sterile HD compounding
sterile HD compounding
when unpacking HDs, what are the pressure requirements of that room/area
negative or normal pressure relative to the surrounding area
where can HDs not be unpackaged
sterile compounding areas or positive pressure
antineoplastic HDs storage requirements if required for manipulation (not just counting and repackaging)
externally ventilated
negative pressure room
12+ air changes per hr (ACPH)
what are the storage requirements for refrigerated antineoplastic HDs
dedicated refrigerator
negative pressure room
12+ air exchanges per hour
what are the requirements of refrigerated antineoplastics that are stored in a buffer room
exhaust adjacent to refrigerator’s compressor and behind the fridge should be considered…
where must sterile and non-sterile HDs be compounded
within a C-PEC located in a C-SEC where the C-SEC is…
externally ventilated
physically separated (another room or area)
appropriate air exchange (ACPH)
negative pressure between a 0.01 and 0.03 inches of water column relative to all adjacent areas
how far must a sink for handwashing and an eye wash station be from the C-PEC
1 meter
what is the difference between the 2 allowed C-SEC engineering controls? (ISOI class 7 buffer room w ISO 7 anteroom vs. C-SCA)?
ISO 7 buffer and anteroom requires 30 ACPH
C-SCA requires only 12 ACPH and has shorter BUDs
refer to BUD info in 797
what are the C-SEC general requirements
externally ventilated
physically separated (another room or area)
appropriate air exchange (ACPH)
negative pressure between a 0.01 and 0.03 inches of water column relative to all adjacent areas
what are the C-PEC requirements
externally ventilated
ex) Class II or III BSC, CACI
what is a C-SEC
containment supplemental engineering controls
- ex) CSTDs (closed system drug transfer device)
- provide adjunct controls/additional level of protection during compounding or admin
- can limit aerosol generation when compounding
-
CACI is the abbreviation for
compounding aseptic contamination isolator
can a C-STD be used in place of a C-PEC when compunding?
no
if the dosage form allows, does a C-STD NEED to be used when administering a HD?
yes
at what points in the process of handling HDs does PPE need to be worn
at every step!
receipt
storage
transport
compounding (sterile and non sterile)
administration
deactivation/decontamination, cleaning and disinfection
spill control
waste disposal
what does PPE for HDs entail
chemotherapy gloves
gowns that close in the back, long sleeve, elastic or knit cuffs, seamless
head and hair covers
shoe covers
sleeve covers
face shield PLUS goggles
(another option is a full facepiece respirator)
N-95 or respirator
when are handlers at risk of respiratory exposure to a HD?
attending a spill that is larger than what can be contained w a spill kit
deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC
known or suspected airborne exposure to powders or vapors
when should training occur for employees involved in any part of the HD process
before the employee independently handles HDs
