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
when does an employee complete HD training
when they can demonstrate effectiveness of training
how often does personnel competency of HD handling be assessed
every 12 months
if a new HD is going to be received and dealt with, what has to occur?
re-training
what must be done after personnel demonstrate competency of HD handling
documentation of all training and competency assessments
what must training on HDs include
overview of list of HDs and their risks
review of SOPs
proper PPE use
proper equipment and device use
response to know or suspected exposure
spill management
proper disposal of trace-contaminated materials
how must HDs be packaged and received on arrival?
in impervious plastic
delivered directly to the HD storage area
WITH PPE, including chemotherapy gloves
spill kit accessible
what happens if the HD shipping container appears damaged
seal container without opening it
contact supplier
if returned, enclose in impervious container
if not returned, dispose of as hazardous waste
what happens if the HD shipping container is damaged, but must be opened
transport to C-PEC and place on a plastic-backed preparation mat
open and remove undamaged items
wipe down undamaged items
put damaged items in impervious container and label as hazardous
deactivate, decontaminate, and clean the C-PEC
what are the steps to closing down a C-PEC
deactivate
decontaminate
clean
disinfection
what are the requirements of SOPs for HDs
instruct on receipt, storage, labeling, compounding, packaging, transport, and disposal of HDs
prevention of accidental exposure or spills
response to exposure
spill kit use
C-PEC, C-SEC, CSTD maintenance
deactivating, decontaminating, cleaning, disinfecting
what must be placed on the work surface of a C-PEC
plastic-backed preparation mat
how often do SOPs need to be reassessed? how is this documented?
every 12 months by the designated person
document
personnel who transport, compound, or administer HDs must document training according to ______ standards
OSHA
CSTD stands for
closed-system drug-trasnfer devicde
HEPA
- what is the abbreviation for?
- what is it?
high efficiency particulate air
an extended-medium, dry-type filter in a rigid frame
minimum particle efficiency = 99.97% for particles with a mass median diameter of 0.3 um
if a room has negative pressure, where does air flow
into the room
what is an anteroom
an ISO class 7 or cleaner room where personnel hand hygiene, garbing procedures, and other activities that generate a high particulate level occur
what are BSCs
biological safety cabinets
BSCs
can be Class I, II, or III
Class II BSCs are further divided into A1, A2, B1, B2
what is a buffer room
a type C-SEC under negative pressure that meets ISO Class 7 or better air quality where the C-PEC that generates and maintains an ISO Class 5 environment is physically located
activities here include preparation and staging of components and supplies used when compounding HDs
