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Compounding Exam 2 > USP 800 > Flashcards

USP 800 Flashcards

1
Q

who determines which drugs are hazardous

A

NIOSH

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2
Q

who provides detailed guidance for hospital pharmacists on implementing USP standards

A

ASHP

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3
Q

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

A

OSHA

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4
Q

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

A

USP

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5
Q

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

A

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

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6
Q

**true or false

it is always required to follow USP 800 100%

name 3 scenarios

A

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

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7
Q

true or false

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

A

true

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8
Q

differentiate between the PEC used for nonhazardous drugs vs hazardous drugs

A

for hazardous – uses C-PEC
C = containment

BUT STILL ALWAYS ISO CLASS 5

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9
Q

Explain buffer and ante room for hazardous drugs

A

buffer room 7 (always) with NEGATIVE PRESSURE

ISO class 7 ante room

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10
Q

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

A

must be running at ALL TIMES

if power outage, everything must stop

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11
Q

*2 examples of C-PEC for hazardous drug compounding

A

CACI
class 2 BSC

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12
Q

**state what employees must wear for compounding HAZARDOUS drugs

A

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

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13
Q

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

A

respiratory protection

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

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14
Q

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

A

a plastic-backed preparation met

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15
Q

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

A

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

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16
Q

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

A

class II BSC OR CACIs (compounding aseptic containment isolator)

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17
Q

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

A

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

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18
Q

how often must chemo gowns be changed?

A

by manufacturer’s schedule

BUT if unknown…

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

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19
Q

how often should chemo gloves be changed

A

every 30 mins

20
Q

how many gowns for hazardous drugs

A

2

21
Q

t f

2 pairs chemo gloves are worn

A

true

22
Q

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

A

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

23
Q

3 scenarios in which gloves chould be changed for hd COMPOUNDING

A

-every 30 mins

-immediately when damaged or contaminated

-when operator exits C-PEC room

24
Q

coated gowns must be worn no longer than ______ during compounding

A

3 hours

25
Q

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

WHERE must they be removed

A

IN THR C-PEC

26
Q

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

A

CAN - ONLY luer-locking

CANT - no tuberculin syringes

27
Q

which is more stable - tuberculin syringe or luer lock

A

luer lock - needle actually snaps in

tuberculin needle might slip out

28
Q

important consideration when withdrawing HAZARDOUS solutions

A

create NEGATIVE PRESSURE

inject less air then you normally would back into the vial

29
Q

*** what is “CSTD

A

closed system vial transder devices (phaseal)

preparation technique – good bc no venting or exposure to outside environement

30
Q

***** order of cleaning

A

DDCD

deactivation
decontamination
cleaning
disinfection

31
Q

**DIFFERENTIATE between the steps of cleaning

A

deactivation - render the HD inert or inactive

decontamination - remove hazardous drug residues

32
Q

_______is the step of cleaning that removes organic and inorganic materials

A

cleaning

33
Q

explain the last step of cleaning

A

disinfection – destroying viable microorganisms

34
Q

3 things that can be used for deactivation

A

OXIDIZER

peroxide sodium hypochlorite

35
Q

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

A

deactivation and decontamination

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

36
Q

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

A

5mL

37
Q

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

A

1000mL

38
Q

true or false

PPE must be worn even during unpacking of HD

A

TRUE

39
Q

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

A

NEVER unpacked from external shipping containers areas of positive pressure

40
Q

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

A

black

41
Q

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

A

yello

42
Q

what goes in blue chemo trash***

A

all NON hazardous drugs

43
Q

true or false

chemo syringes and needles go in the red sharps container

A

FALSE

yellow

NO HAZARDOUS DRUGS IN RED

44
Q

what term defines HD as damaging to the developing fetus

A

teratogenic

45
Q

**approproate PPE must be made available to ALL

A

even just cashier or house keeper

46
Q
A

Compounding Exam 2 (9 decks)

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