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Compounding > Quiz 3 > Flashcards

Quiz 3 Flashcards

1
Q

Before <797> what was the range of error?

A

0.3-22%
average of 9%

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2
Q

What is included in <797> ?

A

combining
admixing
diluting
pooling
reconsituting
altering a drug/BDS to make a CSP
every where CSP compounded

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3
Q

What is not included in <797> ?

A

administration of CSPs
all radiopharmaceutical compounding
all HD compounding

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4
Q

segregated compounding area (SCA)

A

secondary engineering control (SEC) containing a primary engineering control (PEC)
room has unregulated air quality

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5
Q

What is the distance needed between the line of demarcation and the sink?

A

1 meter

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6
Q

Immediate Use

A

compounded outside of controlled environment
No PEC/Cleanroom suite/ SCA
administration begins within 4 hrs of start of compounding

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7
Q

Category 1 CSPs

A

may be prepared in PEC in SCA
Max BUD: 12 hr CRT; 24 hr refrigerated

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8
Q

Category 2 CSP

A

must be prepared in a cleanroom suite
all sterile ingredients, no sterilization/sterility testing
BUD: 4 days CRT; 10 days refrigerated; 45 days frozen

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9
Q

Category 3 CSP

A

must be prepared in cleanroom suite
BUD: 60 days CRT, 90 days Refrigerated, 180 days frozen

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10
Q

Quality assurance is a program while quality control is a ?

A

test

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11
Q

Written testing and demonstration of skills is required how often?

A

every 12 months

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12
Q

Finger Tip Test

A

assess hand hygiene
must be done once every 6 months

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13
Q

Media Fill Test

A

assesses compounding technique
must be completed once every six months

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14
Q

Indicators used to monitor environment control of clean rooms

A

room temperature
room humidity
room pressurization
room air changes per hour
air particle counts
microbial monitoring air and surfaces

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15
Q

How many ACPH in the ante room?

A

20 unless its HD then 30

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16
Q

How many ACPH in the sterile compounding room?

A

30

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17
Q

For positive pressure how many inches do you need in the water column?

A

0.02

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18
Q

In a ISO Class 5, what are the CFUs that require action for air and surface?

A

air- >1
surface- >3

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19
Q

In a ISO Class 7, what are the CFUs that require action for air and surface?

A

air- >10
surface - >5

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20
Q

In a ISO Class 8, what are the CFUs that require action for air and surface?

A

air- >100
surface- >50

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21
Q

ACPH

A

air changes per hour

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22
Q

administration

A

The direct and immediate use of a conventionally manufactured product or a CSP to a patient by injecting, infusing, or otherwise providing a sterile medication in its final form.

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23
Q

Ante room

A

An ISO Class 8 or cleaner room with fixed walls and doors where personnel hand hygiene, garbing procedures, and other activities that generate high particulate levels are performed. The ante-room is the transition room between the unclassified area of the facility and the buffer room.

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24
Q

aseptic technique

A

all procedures and preparations employed to create a sterile preparation

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25
Q

beyond use date

A

Either the date or hour and date after which a CSP must not be used or administration must not begin. The BUD is determined from the date/time that preparation of the CSP is initiated.

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26
Q

Biological safety cabinet (BSC)

A

HD compounding
negative pressure hood with vertical air flow

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27
Q

Buffer room

A

An ISO Class 7 or cleaner room with fixed walls and doors where PEC(s) that generate and maintain an ISO Class 5 environment are physically located. The buffer room may only be accessed through the ante- room

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28
Q

CAI

A

compounding Aseptic isolator

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29
Q

CSP

A

A preparation intended to be sterile that is created by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance.

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30
Q

Cleanroom

A

Controlled concentration of airborne particles within a room designed to minimize the introduction of particles. Temperature, humidity and air pressure are also controlled

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31
Q

Cleanroom suite

A

buffer room and ante room

32
Q

coring

A

taking a piece of the vial stopper into the vial upon needle insertion

33
Q

critical site

A

site of opening of a sterile product to the environment

34
Q

Designated person

A

one/more individuals assigned to be responsible and accountable for the performance and operation of the compounding facility and personnel in the preparation of CSPs

35
Q

Garb

A

protective coverings for compounders
donning- apply; doffing-remove

36
Q

line of demarcation

A

visible line on the floor that separates the clean and dirty sides of the ante room

37
Q

RABS

A

restricted access barrier system

38
Q

ACD

A

automated compounding device

39
Q

SOP

A

standard operating procedure

40
Q

Primary engineering controls (PECS)

A

iso 5 class air
Laminar airflow system/restricted access barrier system

41
Q

Secondary engineering controls must be kept at which temperature and humidity?

A

20 degrees celsius or less
60% or less humidity

42
Q

Minimum garbing requirements

A

low-lint garments with sleeves that fit snugly around wrists and enclosed at the neck
low lint disposable covers for shoes and head
face mask
sterile-powder free gloves

43
Q

medial fill

A

occurs every 6 months for category 1 & 2 compounding
occurs every 3 months for category 3 compounding
occurs annually if you oversee compounding but do not compound

44
Q

Sterile water is an example of a ?

A

cleaning agent

45
Q

PreEmpt is an example of a ?

A

disinfecting agent

46
Q

Peridox/Bleach is an example of a?

A

sporicidal agent

47
Q

Dedicated clean room cleaning tools

A

mop heads
ceiling and wall mops
floor mops

48
Q

stability

A

chemical properties of drug and compatibility of the container

49
Q

Category 1 compounding

A

compounded under the least controlled environmental conditions
may be prepared in SCA or clean room suite
BUD limits: 12 hrs CRT; 24 hrs fridge

50
Q

Category 2 compounding

A

must be prepared in a clean room suite
require more environmental controls and testing than category 1 CSPs
most pharmacies compound this

51
Q

Category 3 compounding

A

undergo sterility testing, supplemented by endotoxin testing when applicable
more requirements than Category 2 caps for personnel qualification, use of sterile garb, use of sporicidal disinfectants, frequency of environmental monitory, and stability determination

52
Q

Automation examples

A

IVX
TPN machine
repeater pump
robotic syringe compounder
electronic records

53
Q

Hazardous drugs are defined by one of the following

A
  1. carcinogenicity
  2. tetratogenicity/ developmental toxicity
  3. reproductive toxicity in humans
  4. organ toxicity at low doses in humans or animals
  5. genotoxicity
  6. new drugs that mimic existing hazardous drugs in structure/ toxicity
54
Q

Examples of non-antineoplastics

A

azathropine
carbamazepine
risperidone
spironolactone
oral contraceptives
estrogen

55
Q

Examples of drugs that may cause reproductive hazards

A

clonazepam
fluconazole
warfarin

56
Q

USP <800> sets standards for HD drug handling for patient and worker safety and environmental protection. What guidelines do they not have?

A

ones for manufacturers -> warehouses -> hospital
or for family members at homes

57
Q

Life cycle of HD

A

receipt
storage
compounding
dispensing
administration
disposal

58
Q

CPEC

A

containment primary engineering control
powder/vertical hood
class 2 bosc

59
Q

CSTD

A

closed system transfer device
supplemental
compounding should use, administration must use
protect workers

60
Q

What are some important sections of USP <800>

A

environmental quality and control
PPE
personnel training
receiving
storage
containment strategies
disposal
compounding
administering
deactivating, decontaminating, cleaning, and disinfecting
medical surveillance

61
Q

USP <800> facility considerations

A

receiving area
storage are
sterile compounding area
non-sterile compounding area

62
Q

Hazardous drugs must be unpacked in and with

A

in neutral/normal/negative pressure room
with chemo gloves worn

63
Q

Where are hazardous drugs stored

A

yellow, lidded bins
if refrigerated should be in a separate fridge

64
Q

Can nonantineoplastic HDs, reproductive risk only HDs, and final dosage forms of antineoplastic HDs be stored in non-HD inventory?

A

yes

65
Q

What is the hierarchy of containment strategies from most to least effective

A

elimination
substitution
engineering controls
administrative controls
PPE

66
Q

C-SEC

A

containment secondary engineering control
room with fixed walls separate from non HD compounding
negative pressure, vented to the outside, 30 air changes per hour

67
Q

Containment strategies work practices

A

identify HDs by bins/shelf stickers
buy in unit dose
dispense-no auto counting devices, designated tray and spatula
admin- PPE, crush in plastic sealable bag, 2 pair of chemo glove
transport-label as HD, secondary containment, no pneumatic transport for liquid/antineoplastics

68
Q

Assesment of Risk includes

A

drug
dosage form
risk of exposure
packaging
manipulation

69
Q

How often should you change gloves and gowns when compounding hazardous drugs?

A

gloves- every 30 minutes
gowns- every 2-3 hours

70
Q

chemical agent used for deactivation or decontamination

A

2% sterile bleach or peroxide
neutralized with sod thiosulfate, sterile IPA or sterile water

71
Q

chemical agent used for cleaning

A

detergent

72
Q

chemical agent used for disinfecting

A

sterile 70% IPA

73
Q

Personnel contempency for HDs is assessed every how many months?

A

12

74
Q

Yellow waste bags

A

non breakables/sharpers for outer chemo glovers, outer shoe covers and gown

75
Q

Yellow trace chemo waste bins

A

empty vials, syringes, tubing, bags and pads

76
Q

black waste bins

A

resource conservation and recovery act
for partially empty items

Compounding (6 decks)

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