USP 800 Flashcards
who determines which drugs are hazardous
NIOSH
who provides detailed guidance for hospital pharmacists on implementing USP standards
ASHP
who mandates the availability of MSDSs (material saftey data sheets) for any hazardous drugs
OSHA
who sets the standards on how to work safely with hazardous drugs
USP
**NIOSH divides hazardous drugs into ____ tables and explain each table
3 tables
1 - antineoplastic drugs (chemo)
2 - non-antineoplastic drugs (not chemo) BUT meet 1 or more NIOSH criteria for hazardous drugs (ie - teratogenic, genotoxic, etc)
3 - drugs that pose reproductive risk to men and women trying to conceive
**true or false
it is always required to follow USP 800 100%
name 3 scenarios
FALSE - there are exceptions
ie - AoR (assessment of risk) – test IN HOUSE
-non chemo
-ONLY reproductive risk
-final dosage form of any chemo drug – you’re ONLY counting. no other manipulations
true or false
for hazardous, pure API’s we CANNOT do our own assessment and we must follow USP 800 100%
true
differentiate between the PEC used for nonhazardous drugs vs hazardous drugs
for hazardous – uses C-PEC
C = containment
BUT STILL ALWAYS ISO CLASS 5
Explain buffer and ante room for hazardous drugs
buffer room 7 (always) with NEGATIVE PRESSURE
ISO class 7 ante room
important requirement for C-PEC for hazardous drug compounding**
must be running at ALL TIMES
if power outage, everything must stop
*2 examples of C-PEC for hazardous drug compounding
CACI
class 2 BSC
**state what employees must wear for compounding HAZARDOUS drugs
TWO pairs shoe covers
TWO gowns
TWO pairs of chemo gloves
hair covers
***_____ is required when handling hazardous drugs outside of a C-PEC
respiratory protection
ie - NIOSH certified N95 respirator mask (for AIRBORNE PARTICLES ONLY — NOT gas, vapors, or splashes – use face shield and goggles)
what must be placed on the work surface when preparing hazardous drugs????
a plastic-backed preparation met
BEST scenario for haz drug separation between ante area and buffer room
ideally should be a physical barrier, but can do in a segragated area, BUT BUD very short
BSC recommendation by USP 800 for hazardous drugs sterile compounding include WHAT 2 THINGS
class II BSC OR CACIs (compounding aseptic containment isolator)
explain what the chemo gown must be like for preparing hazardous drugs***
must close in the BACK, have CLOSED CUFFS, have no seams or closures that can trap hazardous drug particles
how often must chemo gowns be changed?
by manufacturer’s schedule
BUT if unknown…
every 2-3 hours OR immediately after a spill or splash
how often should chemo gloves be changed
every 30 mins
how many gowns for hazardous drugs
2
t f
2 pairs chemo gloves are worn
true
** after wiping down the final preparation of a hazardous drug, what is a very important consideration
OUTER GLOVES MUST BE CHANGED BEFORE LABLING OR REMOVING THE PRODUCT FROM THE BSC
3 scenarios in which gloves chould be changed for hd COMPOUNDING
-every 30 mins
-immediately when damaged or contaminated
-when operator exits C-PEC room
coated gowns must be worn no longer than ______ during compounding
3 hours
as mentioned, after wiping down the final product and before labeling, our outer gloves should be removed
WHERE must they be removed
IN THR C-PEC
**what syringes can and can’t be used for hazardous drug compounding
CAN - ONLY luer-locking
CANT - no tuberculin syringes
which is more stable - tuberculin syringe or luer lock
luer lock - needle actually snaps in
tuberculin needle might slip out
important consideration when withdrawing HAZARDOUS solutions
create NEGATIVE PRESSURE
inject less air then you normally would back into the vial
*** what is “CSTD
closed system vial transder devices (phaseal)
preparation technique – good bc no venting or exposure to outside environement
***** order of cleaning
DDCD
deactivation
decontamination
cleaning
disinfection
**DIFFERENTIATE between the steps of cleaning
deactivation - render the HD inert or inactive
decontamination - remove hazardous drug residues
_______is the step of cleaning that removes organic and inorganic materials
cleaning
explain the last step of cleaning
disinfection – destroying viable microorganisms
3 things that can be used for deactivation
OXIDIZER
peroxide sodium hypochlorite
what 2 steps of cleaning can sodium hypochlorite be used for??? what is a very important consideration**
deactivation and decontamination
sodium hypochlorite is CORROSIVE and must be neutralized with sodium thiosulfate 1%
if a HD spill is greater than ____, it’s best practive to call EMS
5mL
chemotherapy spill kit includes supplys to absorb a spill of about ______
1000mL
true or false
PPE must be worn even during unpacking of HD
TRUE
hazardous drugs must be received from the chicken company, where?
NEVER unpacked from external shipping containers areas of positive pressure
***hazardous waste, spills, and bulk chemo goes in which color garbage
black
**all sharps used to compound HD, empty IV, vials, CSDI’s — what color garbage?
yello
what goes in blue chemo trash***
all NON hazardous drugs
true or false
chemo syringes and needles go in the red sharps container
FALSE
yellow
NO HAZARDOUS DRUGS IN RED
what term defines HD as damaging to the developing fetus
teratogenic
**approproate PPE must be made available to ALL
even just cashier or house keeper
