USP 800

Question 1

who determines which drugs are hazardous

Answer 1

NIOSH

Question 2

who provides detailed guidance for hospital pharmacists on implementing USP standards

Answer 2

ASHP

Question 3

who mandates the availability of MSDSs (material saftey data sheets) for any hazardous drugs

Answer 3

OSHA

Question 4

who sets the standards on how to work safely with hazardous drugs

Answer 4

USP

Question 5

**NIOSH divides hazardous drugs into ____ tables and explain each table

Answer 5

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

Question 6

**true or false

it is always required to follow USP 800 100%

name 3 scenarios

Answer 6

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

Question 7

true or false

for hazardous, pure API’s we CANNOT do our own assessment and we must follow USP 800 100%

Answer 7

true

Question 8

differentiate between the PEC used for nonhazardous drugs vs hazardous drugs

Answer 8

for hazardous – uses C-PEC
C = containment

BUT STILL ALWAYS ISO CLASS 5

Question 9

Explain buffer and ante room for hazardous drugs

Answer 9

buffer room 7 (always) with NEGATIVE PRESSURE

ISO class 7 ante room

Question 10

important requirement for C-PEC for hazardous drug compounding**

Answer 10

must be running at ALL TIMES

if power outage, everything must stop

Question 11

*2 examples of C-PEC for hazardous drug compounding

Answer 11

CACI
class 2 BSC

Question 12

**state what employees must wear for compounding HAZARDOUS drugs

Answer 12

TWO pairs shoe covers
TWO gowns
TWO pairs of chemo gloves
hair covers

Question 13

***_____ is required when handling hazardous drugs outside of a C-PEC

Answer 13

respiratory protection

ie - NIOSH certified N95 respirator mask (for AIRBORNE PARTICLES ONLY — NOT gas, vapors, or splashes – use face shield and goggles)

Question 14

what must be placed on the work surface when preparing hazardous drugs????

Answer 14

a plastic-backed preparation met

Question 15

BEST scenario for haz drug separation between ante area and buffer room

Answer 15

ideally should be a physical barrier, but can do in a segragated area, BUT BUD very short

Question 16

BSC recommendation by USP 800 for hazardous drugs sterile compounding include WHAT 2 THINGS

Answer 16

class II BSC OR CACIs (compounding aseptic containment isolator)

Question 17

explain what the chemo gown must be like for preparing hazardous drugs***

Answer 17

must close in the BACK, have CLOSED CUFFS, have no seams or closures that can trap hazardous drug particles

Question 18

how often must chemo gowns be changed?

Answer 18

by manufacturer’s schedule

BUT if unknown…

every 2-3 hours OR immediately after a spill or splash

Question 19

how often should chemo gloves be changed

Answer 19

every 30 mins

Question 20

how many gowns for hazardous drugs

Answer 20

2

Question 21

t f

2 pairs chemo gloves are worn

Answer 21

true

Question 22

** after wiping down the final preparation of a hazardous drug, what is a very important consideration

Answer 22

OUTER GLOVES MUST BE CHANGED BEFORE LABLING OR REMOVING THE PRODUCT FROM THE BSC

Question 23

3 scenarios in which gloves chould be changed for hd COMPOUNDING

Answer 23

-every 30 mins

-immediately when damaged or contaminated

-when operator exits C-PEC room

Question 24

coated gowns must be worn no longer than ______ during compounding

Answer 24

3 hours

Question 25

as mentioned, after wiping down the final product and before labeling, our outer gloves should be removed WHERE must they be removed

Answer 25

IN THR C-PEC

Question 26

****what syringes can and can't be used for hazardous drug compounding

Answer 26

CAN - ONLY luer-locking CANT - no tuberculin syringes

Question 27

which is more stable - tuberculin syringe or luer lock

Answer 27

luer lock - needle actually snaps in tuberculin needle might slip out

Question 28

important consideration when withdrawing HAZARDOUS solutions

Answer 28

create NEGATIVE PRESSURE inject less air then you normally would back into the vial

Question 29

*** what is "CSTD

Answer 29

closed system vial transder devices (phaseal) preparation technique -- good bc no venting or exposure to outside environement

Question 30

***** order of cleaning

Answer 30

DDCD deactivation decontamination cleaning disinfection

Question 31

****DIFFERENTIATE between the steps of cleaning

Answer 31

deactivation - render the HD inert or inactive decontamination - remove hazardous drug residues

Question 32

_______is the step of cleaning that removes organic and inorganic materials

Answer 32

cleaning

Question 33

explain the last step of cleaning

Answer 33

disinfection -- destroying viable microorganisms

Question 34

3 things that can be used for deactivation

Answer 34

OXIDIZER peroxide sodium hypochlorite

Question 35

what 2 steps of cleaning can sodium hypochlorite be used for??? what is a very important consideration**

Answer 35

deactivation and decontamination sodium hypochlorite is CORROSIVE and must be neutralized with sodium thiosulfate 1%

Question 36

if a HD spill is greater than ____, it's best practive to call EMS

Answer 36

5mL

Question 37

chemotherapy spill kit includes supplys to absorb a spill of about ______

Answer 37

1000mL

Question 38

true or false PPE must be worn even during unpacking of HD

Answer 38

TRUE

Question 39

hazardous drugs must be received from the chicken company, where?

Answer 39

NEVER unpacked from external shipping containers areas of positive pressure

Question 40

***hazardous waste, spills, and bulk chemo goes in which color garbage

Answer 40

black

Question 41

**all sharps used to compound HD, empty IV, vials, CSDI's --- what color garbage?

Answer 41

yello

Question 42

what goes in blue chemo trash***

Answer 42

all NON hazardous drugs

Question 43

true or false chemo syringes and needles go in the red sharps container

Answer 43

FALSE yellow NO HAZARDOUS DRUGS IN RED

Question 44

what term defines HD as damaging to the developing fetus

Answer 44

teratogenic

Question 45

**approproate PPE must be made available to ALL

Answer 45

even just cashier or house keeper