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A - NAPLEX > Chapter 15: Compounding I: Basics > Flashcards

Chapter 15: Compounding I: Basics Flashcards

1
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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2
Q

Which USP chapter is related to non-sterile compounding?

A

USP 795

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3
Q

Which USP chapter is related to sterile compounding?

A

USP 797

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4
Q

Which USP chapter is related to handling hazardous drugs?

A

USP 800

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5
Q

Who determines which drugs are hazardous?

A

The National Institute for Occupational Safety and Health (NIOSH)

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6
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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7
Q

What are the 4 characteristics that make a drug hazardous?

A
  • Carcinogenic
  • Teratogenic
  • Causes organ toxicity at low doses
  • Genotoxic (damages the DNA)
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8
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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9
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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10
Q

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

A

negative air pressure

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11
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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12
Q

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

A

30

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13
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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14
Q

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

A

Redundant-HEPA filters

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15
Q

What is a primary engineering control (PEC)?

A

The sterile hood

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16
Q

What is a secondary engineering control (SEC)?

A

The buffer room or sterile compounding room (the C-PEC is placed here)

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17
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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18
Q

What is a Compounding Aseptic Containment Isolator (CACI)

A

The isolator glove box for HDs

CAI is for non-HD

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19
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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20
Q

In critical areas that are closest to exposed sterile drugs and containers (i.e. inside the sterile hood) the air must be at least ISO __. Particles are included in this count if they are ____ in size or larger

A

5

0.5 microns

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21
Q

The buffer area (or SEC) must be at least ISO __

A

7

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22
Q

The anteroom (the room adjacent to the SEC, where hand washing and garbing occurs) must be at least ISO __ if it opens into a positive-pressure buffer area (non-HD sterile compounding) or at least ISO __ if it opens into a negative-pressure buffer area (HD sterile compounding)

A

8

7

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23
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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24
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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25
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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26
Q

Compounding should be done in the cleanest air, which is the air coming directly out of the HEPA filter. This is called the _______

A

Direct compounding area (DCA)

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27
Q

The air from the HEPA filter is called the ____

A

First air

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28
Q

The HEPA filter must be recertified by a specialist every _ months & any time a PEC has been moved

A

6

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29
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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30
Q

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

A

Positive

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31
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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32
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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33
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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34
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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35
Q

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

A

Horizontal

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36
Q

For sterile hazardous preparation, ___ laminar airflow is used

A

Vertical

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37
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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38
Q

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

A

Media-fill test

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39
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

40
Q

How do you pass a gloved fingertip test?

A

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

41
Q

How do you pass a media-fill test?

A

The liquid must stay clear after 14 days of incubation

42
Q

How often must temperature be monitored in the SEC?

A

Once daily

43
Q

What should the temperature be kept at in the SEC?

A

20°C (68° F) or cooler

44
Q

How often must refrigerator and freezer temperature be monitored?

A

Daily

45
Q

What temperature should the refrigerator be kept at?

A

Between 2 - 8°C

46
Q

What temperature should the freezer be kept at?

A

Between -50 and -15°C

47
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

48
Q

What provides a good growth medium for surface sampling

A

Tryptic soy agar (TSA)

49
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

50
Q

When should surface sampling occur ?

A

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

51
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

52
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

53
Q

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

A

Once daily or with every work shift

54
Q

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

A

True

55
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)

56
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

57
Q

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

A

F - use slightly overlapping, unidirectional strokes

58
Q

Which direction is a PEC cleaned in?

A

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

59
Q

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

A
  1. Deactivation & Decontamination (2% bleach or peroxide)
  2. Cleaning (germicidal detergent)
  3. Disinfection (sterile 70% isopropyl alcohol)
60
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

61
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)

62
Q

What goes in the yellow waste bin?

A

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

63
Q

What goes in the red waste bin?

A

Infectious waste (IV tubing and used culture dishes)

64
Q

What goes in the red sharps container?

A

Non-HD sharps, such as used syringes

65
Q

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

A

Follow the full USP 800 requirements

66
Q

USP 797 risk categories are based on the risk of …

A

Contamination of the sterile product

67
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

68
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

69
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

70
Q

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

A

True

71
Q

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

A

When compounding HDs

When administering antineoplastics

72
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

73
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

74
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

75
Q

What is the order for garbing before sterile compounding?

A
  1. Head and facial hair covers and face masks
  2. Shoe covers (2 if compounding HD)
  3. Wash hands for 30 seconds from fingertips to elbows in circular motions
  4. Gown
  5. Enter buffer area (SEC)
  6. Apply alcohol-based surgical hand scrub (Betadine or chlorhexidine)
  7. Sterile, powder-free gloves (2 pairs of chemo-rated gloves for HDs). Tuck one pair under the cuffs of the gown and one pair over
  8. Sanitize gloves with 70% IPA routinely during compounding
76
Q

How often must chemo gloves be changed?

A

Every 30 minutes or when torn, punctured or contaminated

77
Q

How often must chemo gowns be changed?

A

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

78
Q

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

A

SDS

79
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
80
Q

sterile compounding is primarily used to prepare:

A
  • Non-hazardous sterile IV drugs
  • Hazardous sterile IV drugs
  • Radiopharmaceuticals
  • Eyedrops
  • Irrigation
81
Q

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

A

Powder containment hood

82
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)

83
Q

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

A

12

84
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

85
Q

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

A
  • CAI

- Laminar Airflow Workbench

86
Q

A C-PEC can be either:

A
  • CACI

- Biological safety cabinet (BSC)

87
Q

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

A

True

88
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)

89
Q

The test container for the media-fill test contains

A

Tryptic soy broth (TSB)

90
Q

USP 795 risk categories are based on the …

A

complexity of the preparation

91
Q

USP 795 simple risk means

A

simply following instructions

92
Q

USP 795 moderate risk means

A

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

93
Q

USP 795 complex risk means

A

specialized training, facilities, equipment or procedures are needed

94
Q

The gloves used in compounding & cleaning up spills are called

A

ASTM D6978-rated gloves

95
Q

How many gloves should be used for HD receiving and storage

A

single gloves

96
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)

97
Q

What is the best material for a chemo gown

A

Polyethylene-coated polypropylene or other laminate material

A - NAPLEX (83 decks)

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