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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
beyond use date
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.
26
Biological safety cabinet (BSC)
HD compounding negative pressure hood with vertical air flow
27
Buffer room
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
28
CAI
compounding Aseptic isolator
29
CSP
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.
30
Cleanroom
Controlled concentration of airborne particles within a room designed to minimize the introduction of particles. Temperature, humidity and air pressure are also controlled
31
Cleanroom suite
buffer room and ante room
32
coring
taking a piece of the vial stopper into the vial upon needle insertion
33
critical site
site of opening of a sterile product to the environment
34
Designated person
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
Garb
protective coverings for compounders donning- apply; doffing-remove
36
line of demarcation
visible line on the floor that separates the clean and dirty sides of the ante room
37
RABS
restricted access barrier system
38
ACD
automated compounding device
39
SOP
standard operating procedure
40
Primary engineering controls (PECS)
iso 5 class air Laminar airflow system/restricted access barrier system
41
Secondary engineering controls must be kept at which temperature and humidity?
20 degrees celsius or less 60% or less humidity
42
Minimum garbing requirements
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
medial fill
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
Sterile water is an example of a ?
cleaning agent
45
PreEmpt is an example of a ?
disinfecting agent
46
Peridox/Bleach is an example of a?
sporicidal agent
47
Dedicated clean room cleaning tools
mop heads ceiling and wall mops floor mops
48
stability
chemical properties of drug and compatibility of the container
49
Category 1 compounding
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
Category 2 compounding
must be prepared in a clean room suite require more environmental controls and testing than category 1 CSPs most pharmacies compound this
51
Category 3 compounding
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
Automation examples
IVX TPN machine repeater pump robotic syringe compounder electronic records
53
Hazardous drugs are defined by one of the following
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
Examples of non-antineoplastics
azathropine carbamazepine risperidone spironolactone oral contraceptives estrogen
55
Examples of drugs that may cause reproductive hazards
clonazepam fluconazole warfarin
56
USP <800> sets standards for HD drug handling for patient and worker safety and environmental protection. What guidelines do they not have?
ones for manufacturers -> warehouses -> hospital or for family members at homes
57
Life cycle of HD
receipt storage compounding dispensing administration disposal
58
CPEC
containment primary engineering control powder/vertical hood class 2 bosc
59
CSTD
closed system transfer device supplemental compounding should use, administration must use protect workers
60
What are some important sections of USP <800>
environmental quality and control PPE personnel training receiving storage containment strategies disposal compounding administering deactivating, decontaminating, cleaning, and disinfecting medical surveillance
61
USP <800> facility considerations
receiving area storage are sterile compounding area non-sterile compounding area
62
Hazardous drugs must be unpacked in and with
in neutral/normal/negative pressure room with chemo gloves worn
63
Where are hazardous drugs stored
yellow, lidded bins if refrigerated should be in a separate fridge
64
Can nonantineoplastic HDs, reproductive risk only HDs, and final dosage forms of antineoplastic HDs be stored in non-HD inventory?
yes
65
What is the hierarchy of containment strategies from most to least effective
elimination substitution engineering controls administrative controls PPE
66
C-SEC
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
Containment strategies work practices
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
Assesment of Risk includes
drug dosage form risk of exposure packaging manipulation
69
How often should you change gloves and gowns when compounding hazardous drugs?
gloves- every 30 minutes gowns- every 2-3 hours
70
chemical agent used for deactivation or decontamination
2% sterile bleach or peroxide neutralized with sod thiosulfate, sterile IPA or sterile water
71
chemical agent used for cleaning
detergent
72
chemical agent used for disinfecting
sterile 70% IPA
73
Personnel contempency for HDs is assessed every how many months?
12
74
Yellow waste bags
non breakables/sharpers for outer chemo glovers, outer shoe covers and gown
75
Yellow trace chemo waste bins
empty vials, syringes, tubing, bags and pads
76
black waste bins
resource conservation and recovery act for partially empty items

Compounding (6 decks)

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