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1. NAPLEX Prep > Compounding 1 > Flashcards

Compounding 1 Flashcards

1
Q

Who sets the standards for compounding?

A

USP

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2
Q

USP 795, 797, and 800 are considered the

A

minimal acceptable standards

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3
Q

Hospital pharmacists rely on the __________for guidance on implementing USP standards

A

American Society of Health-System Pharmacists (ASHP)

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4
Q

Non-Sterile compounding is used to:

A

1.) Prepare a dose or formulation that is not commercially available.
2.) Avoid an excipient.
3.) Add a flavor

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5
Q

Non sterile compounded preparations

A

PO, via tubs, rectally, vaginally, topically, nasally, in the ear

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6
Q

Simple non sterile compounding

A

Requires following instructions (using a compounding kit, etc.)

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7
Q

Moderate non sterile compounding

A

Involves specialized calculations or procedures or making a product with no established stability data

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8
Q

Complex non sterile compounding

A

Requires specialized training, equipment, facilities, or procedures
Example- transdermal

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9
Q

Non sterile compounding physical space requirements

A

Space should be specifically designed for non-sterile compounding.
Can be ambient (room) air, but must be separated from the dispensing part of the pharmacy.
Everything must be stored off the floor.
Two types of water needed

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10
Q

What is purified water used for in non sterile compounding?

A

Water-containing formulations, rinsing equipment and utensils

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11
Q

Which formulations require sterile compounding?

A

IV
IM
SC
Eye drops
Radiopharmaceuticals
Irrigations
Inhalations

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12
Q

Who sets the standards for air quality?

A

ISO

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13
Q

What is air quality determined by?

A

Particles per volume of air.
The lower the particle count, the cleaner the air

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14
Q

Air quality in critical areas for sterile compounding

A

ISO 5
(closest to exposed drug)

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15
Q

Particles are included in the air quality count if the are

A

0.5 microns or larger

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16
Q

Buffer area for sterile compounding

A

ISO 7

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17
Q

Anteroom for sterile compounding

A

ISO 8 if non hazardous
ISO 7 if hazardous

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18
Q

Particles in ISO 5 environment

A

3,520

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19
Q

Particles in ISO 6 environment

A

35,200

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20
Q

Particles in ISO 7 environment

A

352,000

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21
Q

Particles in ISO 8 environment

A

3,520,000

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22
Q

HEPA filters are ___________efficient at removing particles ______

A

> 99.97%
as small as 0.3 microns

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23
Q

Where is the HEPA filter in a vertical airflow BSC or CPEC?

A

At the top

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24
Q

Where is the HEPA filter in a laminar airflow workbench or PEC?

A

At the back
Horizontal airflow

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25
Q

Direct compounding area

A

Cleanest air where compounding is done.
The air is called first air

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26
Q

How often must a HEPA filter be recertified?

A

Every 6 months by a specialist and anytime the PEC has moved

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27
Q

Wipe the outside of materials with _________before putting into the PEC

A

70% isopropyl alcohol (ISA)

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28
Q

Physical space requirements for sterile compounding

A

Surfaces must be smooth and impervious to make the easy to clean and disinfect. Stainless steel is often used

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29
Q

Cleanroom suite

A

ISO 5 PECs (sterile hoods) inside of an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom

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30
Q

Segregated compounding area (SCA)

A

ISO 5 PEC is often an isolator/glovebox with a closed front. Located in a space with unclassified air.

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31
Q

The PEC is a device that provides

A

ISO 5 air
Sterile hood most common

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32
Q

Compounding aseptic isolator (CAI)

A

Closed front PEC that is often located in a segregated compounding area (SCA)

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33
Q

Minimal hygiene that must be performed when using a compounding aseptic isolator

A

Hand hygiene
Sterile, powder free gloves inside the CAI

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34
Q

Max BUD of a compound prepared in a segregated compounding area

A

12 hours

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35
Q

Who determines which drugs are HD?

A

NIOSH

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36
Q

HD are

A

Carcinogenic
Teratogenic
Genotoxic
Toxic to organs
Labeled by the manufacturer with special handling instructions

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37
Q

HD antibiotics

A

Chloramphenicol

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38
Q

HD anticoagulants

A

Warfarin

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39
Q

HD antifungals

A

Fluconazole
Voriconazole

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40
Q

HD antiretrovirals

A

Abacavir
Entecavir
Zidovudine

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41
Q

HD antivirals

A

Cidofovir
Ganciclovir
Valganciclovir

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42
Q

HD arrhythmias

A

Dronedarone

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43
Q

HD autoimmune

A

Acitretin, azathioprine, leflunomide
Fingolimod, teriflunomide

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44
Q

HD bisphosphonates

A

Pamidronate
Zoledronic acid

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45
Q

HD depression

A

Paroxdetine

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46
Q

HD diabetes

A

Exenatide
Liraglutide

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47
Q

HD dyslipidemia

A

Lomitapide

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48
Q

HD gout

A

Colchicine

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49
Q

HD hepatitis

A

Ribavirin

50
Q

HD insomnia

A

Temazepam
Triazolam

51
Q

HD migraine

A

DHE

52
Q

HD PD

A

Apomorphine
Rasagiline

53
Q

HD schizophrenia

A

Ziprasidone

54
Q

SDS

A

Required to be accessible to all employees working with HD. Includes safety information for PPE, first aid, and spill clean up

55
Q

Hazard communication plan

A

Designated individual creates
Must be written and include a confirmation in writing that all men and women of reproductive capability understand the risks associated with HD

56
Q

Lower risk activities according to USP 800

A

Counting and packaging tablets

57
Q

Assessment of Risk (AoR)

A

A pharmacy can conduct an assessment of risk for lower risk activities with HD.
SOPs must be developed with actions to limit staff exposure, such as:
-ASTM D6978-rated gloves

58
Q

Can you perform an AoR for a HD that requires manipulation?

A

No, any manipulation of the drug needs to follow full USP 800

59
Q

AoR documents must be reviewed

A

every 12 months

60
Q

Hoods and buffer rooms with HDs include the work

A

containment

61
Q

C-PECs for HD Compounding

A

Biological Safety Cabinets
Containment Ventilated Enclosures
Compounding Aseptic Containment Isolators

62
Q

Biological safety cabinets

A

Have vertical laminar airflow and negative pressure

63
Q

For sterile HD compounding, BSCs must be

A

Class II or III

64
Q

Containment Ventilated Enclosures

A

For non sterile HD compounding only

65
Q

Compounding aseptic containment isolators

A

Glovebox, located in SEC or C-SCA

66
Q

Non-sterile and sterile HD compounding in the same space

A

C-SEC must maintain ISO 7
Sterile and non-sterile C-PECs must be at least 1 meter apart

67
Q

What must have negative air pressure?

A

C-PECs
C-SECs
C-SCAs

68
Q

Air changes per hour

A

Number of times that the air is replaced in the room

69
Q

Non sterile HD ACPH

A

12 ACPH

70
Q

Sterile C-SEC ACPH

A

30 ACPH

71
Q

C-SCA ACPH

A

12 ACPH

72
Q

Alternative option to external exhaust in non-sterile HD compounding

A

Redundant HEPA filters
Only for non-sterile

73
Q

Storage of HD

A

Must be stored separately from non-HD drugs in a negative pressure room with at least 12 ACPH

74
Q

Gloved fingerprint test

A

Required initially and annually if compounding low and medium risk CSPs
Required semiannually if compounding high risk CSPs
Evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers on TSA

75
Q

Passing a gloved fingerprint test

A

Initially- requires 3 consecutive gloved fingerprint samples with 0 CFUs for both hands.
Ongoing- 1 sample with </= 3 CFUs

76
Q

Media fill test

A

Used to determine aseptic technique
Performed initially and annually
Tryptic soy broth (TSB) takes the place of the drug in the preparation.
Turbidity=contamination
Check after 14 days of incubation

77
Q

Temperature monitoring in the SEC

A

Must be checked once daily and maintained at 20 C or 68 F or cooler

78
Q

Temperature monitoring of the refrigerator

A

Checked at least daily
Refrigerator: 2-8 C

79
Q

Temperature monitoring of the freezer

A

Check at least once daily, twice if contains vaccines
No vaccines: -25 to -10 C
Vaccines: -50 to -15 C

80
Q

Air sampling

A

At least every 6 months by a person certified or a qualified compounding staff member

81
Q

Surface sampling

A

Test periodically at the end of the day
Tryptic Soy Agar (TSA) is a good growth medium.
Polysorbate 80 and lecithin are added to TSA to neutralize the effect of any disinfecting agents
Test anywhere exposed to staff- inside PECs and other work surfaces

82
Q

Passing surface sampling

A

0 CFUs preferred
>3 CFUs- action must be taken in ISO 5 area
>5 CFUs- action must be taken in ISO 7 area
> 100 CFUs- action must be taken in ISO 8 area

83
Q

Air pressure testing

A

Confirms there is a differential between the two spaces and that the airflow is unidirectional.
Must be check (minimum) of once daily or with every work shift

84
Q

What should you do if a PEC is turned off?

A

Clean with a germicidal detergent and then disinfect with sterile 70% IPA
If it is a C-PEC, sanitization is needed
Must be on for at least 30 minutes before compounding can begin

85
Q

Cleaning the PEC

A

Clean continuously
Lint-free sterile wipes are used
First clean with a germicidal detergent then disinfect with 70% IPA
Use overlapping, unidirectional strokes and replace used wipes often.
Clean top to bottom, back to front from the cleanest areas to the dirtiest.

86
Q

Cleaning counters and floors

A

Clean with germicidal cleaner and disinfect with 70% IPA daily

87
Q

How often to clean ISO 5 PECs

A

Before each shift
Every 30 min while working
Before and after each batch of CSPs
Whenever needed

88
Q

What should be cleaned monthly

A

Ceiling
Walls
Shelving
Chairs
Bins
Carts

89
Q

Sanitizing HD equipment

A

Deactivate
Decontaminate
Clean
Disinfect

90
Q

How often does sanitization occur with HD compounding

A

At least once daily

91
Q

Deactivation and decontamination agents

A

2% bleach (sodium hypochlorite)
Peroxide

92
Q

Cleaning agents

A

Germicidal detergent- Quat, Ammonium, Phenolics

93
Q

Disinfection agents

A

70% IPA

94
Q

When using sanitization agents,

A

Wetted wipes are preferred
Must wear appropriate PPE

95
Q

Agents that can be used for both deactivation and decontamination

A

Peridox
Bleach
Peroxide
If using bleach, must neutralize to prevent erosion

96
Q

Bulk HD waste

A

Black bin

97
Q

Trace HD waste

A

Yellow bin

98
Q

Red bin

A

Non hazardous sharps

99
Q

Where do syringes and needles go that were used with HD?

A

Yellow bin

100
Q

Surface sampling for HD

A

Wipe sampling must be done at least every 6 months to ensure hazardous residue is completely contained.

101
Q

Drug exposure

A

Get the drug or chemical off ASAP
- Immediately remove garb with drug on it
- Cleanse any affected skin
- If eye exposure, use eye wash for at least 15 min
- Obtain medical attention if needed

102
Q

HD exposure and spill management

A

Eye and face protection must be worn if at risk for spills or splashes
Face shields in combo with goggles is preferred

103
Q

Respiratory protection from HD

A

Elastomeric half-mask with a multiple gas cartridge and a P100 filter
N95 respirator is usually sufficient
If at risk for respiratory exposure wear:
-Fit tested respirator mask with attached gas canisters
-PAPR (powered air purifying respirator)

104
Q

Where to find information on HD spills?

A

SDS

105
Q

How to take care of HD spill

A

-Establish who, what, and when
-Place sign that says HD spill
-Spill kit

106
Q

Spill kit contents

A

-Protective gown, latex gloves, N95 mask, goggles
-HD waste bag, chemo pads
-HD spill report exposure form

107
Q

Procedure for cleaning up a HD spill

A

Put on heavy duty gloves over ASTM D6978 (chemo) rated hloves
-Put bulk waste in black bin

108
Q

PPE when admin HD

A

2 pairs of chemo gloves for all HD
Chemo gown is required for administering IV HD

109
Q

What must be used by nurses for HD admin?

A

Closed system transfer devices

110
Q

What are chemotherapy pins for?

A

Prevent HDs from aerosolizing

111
Q

Are CSTDs required for compounding HD?

A

No, recommended

112
Q

CSTDs have a build in valve that

A

equalizes air pressure

113
Q

If manipulation of oral HD is required,

A

Do in a plastic bag

114
Q

Outer chemo drugs worn in HD compounding should be put in

A

yellow bin or in a sealable bag if not in C-PEC

115
Q

Chemo gown and outer shoe covers should be

A

taken off before exiting the negative pressure room and plaecd in yellow bin

116
Q

Pneumatic tube systems _______be used to transfer liquid HDs or antineoplastics

A

CANNOT

117
Q

Garb for HD

A

Double chemo rated gloves
Single gloves could be used for receiving and storage
Non Sterile- double gloves, a gown, mask, and disposable pad to protect work surface
Sterile- Head cover, face mask, beard cover, 2 pairs of shoe covers, impermeable gown, 2 chemo gloves, full facepiece respirator or face shield with goggles

118
Q

Garbing for sterile compounding

A

Dirtiest to cleanest
1.) Hair covers and mask, then show covers while stepping over line of demarcation.
2.) Hand hygiene using soap and warm water, clean under nails, circular motions for 30 sec
3.) Don non-shedding gowns
4.) Enter buffer area (SEC)
5.) Apply alcohol based surgical hand scrub
6.) Don sterile powder free gloves
7.) Sanitize with 70% IPA

119
Q

What gowns are required for sterile HD?

A

disposable

120
Q

How often to change HD gowns

A

At least every 2-3h or immediately after spill

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