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How can a CSTD be chemically incompatible with a HD? –
ANSWER-Depending on chemical composition of drug being
compounded and the composition of the CSTD, chemical
incompatibilities may exist. In March 2015, FDA warned against
use of bendamustine with CSTD containing polycarbonate or
acrylonitrile-butadiene-styrene (ABS)
What PPE is required for administering HDs? - ANSWER-
For administering
antineoplastic HDs, Two pairs ASTM D6978 gloves
must be worn. For
administering injectable antineoplastic HDs, gowns shown
to resist permeability
my HDs must be worn in addition to 2 pairs of
chemo gloves
Are PPE and Environmental controls specified in Table 5 of
NIOSH required?
ANSWER-No, the list is a recommendation and may be used to
help guide the
development of the entity's
policy.
, -
Does USP certify or validate PPE or equipment for HD
handling? - ANSWER-
No, USP does not validate or certify PPE, equipment, or
other products for
compliance with
USP 800
What is required to show that a gown will resist permeability by
HDs? - ANSWER-Manufacturers of gowns used for handling
HDs should provide results of ASTM F739-12 testing. The gown
manufacturer should be able to provide permeability data for
commonly used HDs
Can NIOSH listed Table 2 or 3 HDs be compounded in a positive
pressure CSEC, and if so, what are the labeling requirements? -
ANSWER-Yes if AOR performed. If a BSC or CACI used for prep
of HDs is used for prep on nonHD then nonHD prep must be
placed into protective outer wrapper and labeled to require PPE
handling precautions
Where should HD APIs be handled prior to sterilization when
compounding sterile HDs? - ANSWER-Can occur in HD ISO 7
negative pressure buffer room if C-PEC is sufficiently effective
that room can maintain ISO 7. Presterilization procedures shall
be completed in no worse than ISO 8 environment. An ISO 7
,negative pressure room is necessary if it leads directly into the
HD ISO 7 negative pressure buffer room
PPE requirements for receiving HDs - ANSWER-At least 1 pair of
chemo gloves
must be worn when unpacking HDs. Entity's policy must
address if any
additional PPE
required
Are suppliers required to ship HDs in impervious plastic? -
ANSWER-No. The chapter recommends that suppliers ship HDs
in impervious plastic to segregate the from other drugs and
allow for safety in the receiving and internal transfer process
Can my unpacking or receiving area be within an existing room
of my pharmacy? - ANSWER-Yes. Antineoplastic HDs and all
HD APIs must be unpacked in an area that is normal or negative
pressure relative to the surrounding areas. This can be a
designated area and is not required to be a separate room
Does a pre/m-filled syringe with an existing system of
reconstitution need to be manipulated inside a C-PEC? -
ANSWER-No. A strong that is designed to be predilection
and/or have a self-contained system of reconstitution May be
considered a final dosage form.
Can an employee keep their medical records private from
the employer? -
, ANSWER-Medical surveillance is recommended but
not required
Baseline assessment for medical surveillance - ANSWER-Initial
baseline assessment of a workers health status, medical
history, and collection of data elements including medical
(including reproductive) history and work history to assess
exposure to HDs, physical exam, and lab testing
What is the purpose of USP 800? - ANSWER-Describe
practice and quality
standards for handling HDs to promote patient safety,
worker safety, and
environmental
protection
What does handling HDs include? - ANSWER-Includes but is
not limited to, the
receipt, storage, compounding, dispensing, administration,
and disposal of
sterile and nonsterile products and
preparations
Who does USP 800 apply to? - ANSWER-All healthcare
personnel who handle
HD preps and all entities that store, prepare, transport or
administer HDs