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NAPLEX 2023 > Chapter 15: Compounding I: Basics > Flashcards

Chapter 15: Compounding I: Basics Flashcards

1
Q

What is the PEC?

A

primary engineering control = the hood

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2
Q

What is the SEC?

A

secondary engineering control = the buffer room in which the hood sits

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3
Q

what does the C in C-SEC and C-PEC mean?

A

containment –> for handling hazardous drugs
contain the drug in a confinded space to protect the compounder

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4
Q

What is the CAI?

A

compounding aseptic isolator =
glovebox for non-HDs

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5
Q

What is the CACI?

A

compounding aseptic containment isolator = glovebox for HDs

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6
Q

What is the BSC?

A

biologic safety cabinet = chemo hood (Class II or III) for sterile HD, a type of C-PEC

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7
Q

Who sets the standards for compounding preparations, strength, quality and purity of human and animal drugs?

A

US Pharmacopeia (USP)

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8
Q

Which USP chapter is related to non-sterile compounding?

A

USP 795

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9
Q

Which USP chapter is related to sterile compounding?

A

USP 797

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10
Q

Which USP chapter is related to handling hazardous drugs?

A

USP 800

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11
Q

Who determines which drugs are hazardous?

A

The National Institute for Occupational Safety and Health (NIOSH)

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12
Q

Besides USP chapters, where else can pharmacists find detailed guidance on implementing USP standards?

A

American Society of Health-System Pharmacists (ASHP)

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13
Q

What particle size is counted in ISO 5?

A

If particles ≥ 0.5 microns

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14
Q

ISO rating for a PEC

A

ISO 5

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15
Q

ISO rating for a SEC

A

ISO 7

SEC = buffer room, contains the PEC (hood)

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16
Q

ISO rating for an anteroom with
1. SEC with positive pressure air
2. SEC with negative pressure air

A
  1. ISO 8
  2. ISO 7
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17
Q

What is the air directly from the HEPA filterin the hood called?

A

first air
this is the direct compounding area

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18
Q

How often must a HEPA filter be recertififed by a specialist?

A

every 6 months, anytime PEC is moved

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19
Q

SCA (segregated compounding area) has what type of air?

A

unclassified air

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20
Q

Compounds made in SCA (segregated compounding area) have a BUD of what?

A

12 hours - due to being made in unclassified air

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21
Q

What are the 4 characteristics that make a drug hazardous?

A
  • Carcinogenic
  • Teratogenic
  • Causes organ toxicity at low doses
  • Genotoxic (damages the DNA)
  • labeled by manufacturer for special handling
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22
Q

What must be included in a sterile compounding space?

A
  • anteroom
  • buffer area
  • primary engineering control (PEC) or a segregated compounding area (SCA)
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23
Q

What requirements must be met for a non-sterile HD to be prepared in a C-PEC inside a C-SEC?

A
  • The C-SEC must maintain ISO 7 air
  • There must be separate sterile and non-sterile C-PECs kept at least 1 meter apart
  • Particle-generating activity, such as working with powders, cannot be performed when any sterile compounding is being performed in the same C-SEC
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24
Q

C-PECs (containment primary engineering control) and C-SECs (containment secondary engineering control) must have ______

A

negative air pressure

protects compounder

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25
Q

In space where non-sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)

A

12

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26
Q

In space where sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)

A

30

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27
Q

What does it mean when air that has been contaminated with HDs must be externally exhausted?

A

The air is moved out of the space and cannot be recirculated and returned to the room

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28
Q

What is an alternative option to an external exhaust (for non-sterile HD compounding only)?

A

Redundant-HEPA filters

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29
Q

What is a class II biologic safety cabinet (BSC)

A

The chemo hood for sterile chemo drugs and other sterile HDs (aka a C-PEC)

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30
Q

The International Standards Organization (ISO) sets the standards for air quality, which is determined by the number and size of ___ per ___ of air

A

Particles per volume (the lower the particle count, the cleaner the air)

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31
Q

HEPA filters are >99.97% efficient in removing particles as small as ____ wide or larger, including bacteria, fungi, viruses, and dust

A

0.3 microns

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32
Q

In a ___ airflow biologic safety cabinet (BSC) or C-PEC, the HEPA filter is at the top of the sterile hood

A

Vertical

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33
Q

In a ____ airflow, or PEC, the HEPA filter is at the back of the sterile hood

A

Horizontal (laminar airflow workbench)

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34
Q

Running down the center of the anteroom is a large visible line called ____, which separates the room into clean and dirty sections

A

the line of demarcation

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35
Q

Air pressure inside the PEC and inside a non-hazardous SEC can both be ____ (positive or negative)

A

Positive

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36
Q

With hazardous compounding, the C-PEC and the C-SEC must have ____ pressure to keep the toxic air contained in the space (positive or negative)

A

Negative

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37
Q

Another name for and isolator PEC/glove box?

Where are they located?

A

compounding aseptic isolators (CAI) or compounding aseptic containment isolators (CACI)

Located in a segregated compounding area (SCA) or C-SCA for HD

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38
Q

The maximum beyond-use dates (BUD) for CSPs made in an isolator in a segregated compounding area (SCA) is _____

A

12 hours

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39
Q

If the anteroom is ISO 8, the air will be dirtier than inside the SEC. To keep the air from the anteroom out, the SEC will need to have _____ air pressure to push the air out of the SEC and into the anteroom

A

Positive

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40
Q

For sterile, non-hazardous preparation, ____ laminar airflow is used

A

Horizontal

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41
Q

For sterile hazardous preparation, ___ laminar airflow is used

A

Vertical

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42
Q

Adequate aseptic technique in hand hygiene, garbing and gloving is demonstrated by passing which test?

A

The gloved fingertip test

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43
Q

Adequate aseptic technique in sterile drug preparation is demonstrated by passing which test?

A

Media-fill test

44
Q

A passing score on the gloved fingertip test & media-fill test is required initially, then _ (if compounding low- and medium-risk compounded sterile products) and _ (if compounding high risk compounded sterile products)

A

Annually
Semi-annually

45
Q

How do you pass a gloved fingertip test?

A

3 consecutive gloved fingertip samples with zero colony-formulating units (CFUs) for both hands

46
Q

How do you pass a media-fill test?

A

The liquid must stay clear after 14 days of incubation

47
Q

How often must temperature be monitored in the SEC?

A

Once daily

48
Q

What should the temperature be kept at in the SEC?

A

20°C (68° F) or cooler

49
Q

How often must refrigerator and freezer temperature be monitored?

A

Daily

50
Q

What temperature should the refrigerator be kept at?

A

Between 2 - 8°C

51
Q

What temperature should the freezer be kept at?

A

Between -50 and -15°C

52
Q

Air sampling identifies contaminants in the air and should be performed at least every ____ by a person certified in air sampling or by a qualified compounding staff member

A

6 months

53
Q

What provides a good growth medium for surface sampling

A

Tryptic soy agar (TSA)

54
Q

____ and ____ are added to TSA in surface sampling to neutralize the effect of any disinfecting agents on the surfaces

A

Polysorbate 80 and lecithin

55
Q

When should surface sampling occur ?

A

At the end of the day when the surfaces are in the poorest state

56
Q

After surface sampling, the plates should have zero CFUs. Action must be taken if ___ CFUs are identified in the ISO 5 area, ___ CFUs in the ISO 7 area, and ___ CFUs in the ISO 8 area

A

> 3
5
100

57
Q

The air pressure testing confirms that there is the correct ____ between two spaces and ensures that the airflow is ____

A

Differential (difference in pressures)
Unidirectional

58
Q

How often should surface sampling be done?

A

periodically, goal is 0 CFUs

59
Q

How often should humidity be checked?

goal

A

daily (minimally)

< 60%

60
Q

Pressure gauges are installed in the cleanroom space and checked minimally ____

A

Once daily or with every work shift

61
Q

T or F: All PECs and C-PECs are kept running at all times to help keep the surfaces clean

A

True

62
Q

If there is a power outage, all compounding must stop and the PECs will need to be cleaned with ____ and then disinfected with ____ prior to the re-initiation of a compounding activity

A

A germicidal detergent
Sterile 70% isopropyl alcohol (IPA)

63
Q

If the power has been off, in addition to cleaning and disinfecting (or sanitation for C-PEC) the PEC or C-PEC must be on for at least ____ before compounding can begin

A

30 minutes

64
Q

T or F: You should use circular motions to clean the PEC

A

F - use slightly overlapping, unidirectional strokes

65
Q

Which direction is a PEC cleaned in?

A

From top to bottom, then back to front (cleanest areas are cleaned first)

66
Q

What is the order for sanitizing hazardous drug areas and equipment?

A
  1. Deactivation & Decontamination (2% bleach or peroxide)
  2. Cleaning (germicidal detergent - Quat, Ammonium, Phenolics)
  3. Disinfection (sterile 70% isopropyl alcohol)
67
Q

How can you prevent corrosion on stainless steel surfaces with bleach?

A

Neutralize it by wiping surfaces afterwards with sodium thiosulfate, sterile alcohol, sterile water or germicidal detergent

68
Q

What goes in the black waste bin?

A

Bulk hazardous drug waste (including containers with a clearly visible amount of an HD, supplies to administer HDs, or to clean up HD spills)

69
Q

What goes in the yellow waste bin?

A

For trace HD waste (empty syringes, IV bags, used PPE)

70
Q

What goes in the red waste bin?

A

Infectious waste (IV tubing and used culture dishes)

71
Q

What goes in the red sharps container?

A

Non-HD sharps, such as used syringes

72
Q

If no Assessment of Risk (AOR) is conducted for lower-risk HDs, the pharmacy must…

A

Follow the full USP 800 requirements

73
Q

USP 797 risk categories are based on the risk of …

A

Contamination of the sterile product

74
Q

When a drug or chemical is exposed in one’s eye, flood the affected eye at an eyewash fountain or with water or an isotonic eyewash for at least ____

A

15 minutes

75
Q

When HDs are unpacked and they are not contained in plastic, the staff member should wear ____

A

An elastomeric half-mask, with a multi-gas cartridge and P100-filter

76
Q

What must be included in a spill kit?

A

Protective gown, latex gloves, N95 respirator mask plus goggles with side shields
HD waste bag, chemo pads
HD spill report exposure form

77
Q

T or F: two pairs of gloves must be worn when administering HDs

A

True

78
Q

When is a closed-system transfer device (CSTD) recommended? When are they required?

A

When compounding HDs
When administering antineoplastics

79
Q

If manipulation (i.e. crushing tablets, opening capsules) is required for HDs, it should be done in ____ to contain any dust or particles

A

Plastic bag

80
Q

The outer chemotherapy gloves worn during compounding are discarded in ____ located inside the C-PEC or put in a sealable bag if discarded outside the C-PEC

A

Yellow trace chemo waste bin

81
Q

PPE for non-sterile HD compounding includes:

A

double gloves, gown, mask, disposable pad

82
Q

PPE for sterile HD compounding includes:

A

Head covers, face mask, & beard cover
Two pairs of shoe covers
A gown impermeable to liquids
Two pairs of ASTM D6978 (chemo)-rated gloves
A full-face piece respirator or a face shield with goggles when there is a risk for spills or splashes

83
Q

What is the order for garbing before sterile compounding?

A
  1. head cover
  2. shoe cover (x2 for HD)
  3. wash hand thoroughly - circular motion for 30 seconds
  4. garb gown
  5. enter buffer area
  6. put alcohol based cleaner on hands
  7. gloves (x2 for HD)
  8. apply alcohol to gloves
84
Q

How often must chemo gloves be changed?

A

Every 30 minutes or when torn, punctured or contaminated

85
Q

How often must chemo gowns be changed?

A

Every 2-3 hours or immediately after a spill or splash

86
Q

___ is a series of safety documents required by OSHA to be accessible to all employees who are working with hazardous materials

A

SDS

87
Q

Non-sterile compounding is primarily used to:

A
  • Change the formulation of a med
  • Avoid an excipient
  • Prepare a dose or formulation that is not commercially available
  • Add a flavor
88
Q

sterile compounding is primarily used to prepare:

A
  • Non-hazardous sterile IV drugs
  • Hazardous sterile IV drugs
  • Radiopharmaceuticals
  • Eyedrops
  • Irrigation
  • pulmonary inhalations (not nasal)
89
Q

Powders can cause air contamination and are best when used within a

A

Powder containment hood

90
Q

A hood that has ventilation, including HEPA filtered air, pressurized air (negative pressure to keep powder inside the hood) and exhaust systems

A

Ventilated Compounding Enclosure (VCE)

91
Q

Hazardous drugs must be stored separately from non-HD in an externally ventilated, negative-pressure room with at least ___ ACPH

A

12

92
Q

A small volume parenteral (SVP) is an IV container up to ___ mL & a large volume parenteral (LVP) is an IV container > __ mL

A

≤ 100
100

93
Q

The PECs in a non-HD cleanroom can be either:

A
  • CAI
  • Laminar Airflow Workbench
94
Q

A C-PEC can be either:

A
  • CACI
  • Biological safety cabinet (BSC)
95
Q

T/F: CAIs do not have an external vent, whereas CACIs do

A

True

96
Q

During the gloved fingertip test, the evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers over a surface which contains

A

Tryptic Soy Agar (TSA)

97
Q

The test container for the media-fill test contains

A

Tryptic soy broth (TSB)

98
Q

USP 795 risk categories are based on the …

A

complexity of the preparation

99
Q

USP 795 simple risk means

A

simply following instructions

100
Q

USP 795 moderate risk means

A

Compounding a preparation that has no established stability data, or a preparation with specialized calculations or procedures

101
Q

USP 795 complex risk means

A

specialized training, facilities, equipment or procedures are needed

102
Q

The gloves used in compounding & cleaning up spills are called

A

ASTM D6978-rated gloves

103
Q

How many gloves should be used for HD receiving and storage

A

single gloves

104
Q

____ should be worn for cleaning up large HD spills, sanitizing the undertray of a C-PEC or when there is known or suspected airborne exposure to powders or vapors

A

Powered air-purifying respirator (PAPR)

105
Q

What is the best material for a chemo gown

A

Polyethylene-coated polypropylene or other laminate material

NAPLEX 2023 (88 decks)

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