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NAPLEX Review > Compounding I: Basics > Flashcards

Compounding I: Basics Flashcards

1
Q

What sets the standards for compounding preparations?

A

US Pharmacopia (USP)

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2
Q

What are the USP 795, 797, and 800 chapters on?

A

795 – Non-sterile compounding
797 – Sterile compounding
800 – Hazardous drugs

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3
Q

What does the National Institute for Occupational Safety and Health (NIOSH) determine?

A

Which drugs are hazardous

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4
Q

What is the NIOSH list of hazardous drugs called?

A

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

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5
Q

What are safety data sheets (SDS)?

A

Series of safety documents required by the occupational safety and health administration (OSHA) to be accessible to all employees who are working with hazardous materials

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6
Q

True or false – the dose and formulation of a compounded medication can NOT be commercially available for a pharmacist to compound it

A

True – if it can be bought, then buy it

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7
Q

What is non-sterile compounding primarily used for?

A 
Change formulation (from tablet to liquid)
Avoid an excipient
Prepare a dose or formulation that is not commercially available
Add a flavor
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8
Q

Sterile products that are injected into the blood must be free of what?

A

Microorganisms and other contaminants

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9
Q

Sterile compounding is primarily used to prepare what?

A 
Non hazardous sterile IV drugs
Hazardous sterile IV drugs
Radiopharmaceuticals
Eyedrops
Irrigations
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10
Q

What characteristics make a drug hazardous?

A

Carcinogenic
Teratogenic
Causes organ toxicity
Genotoxic (damages DNA)

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11
Q

What type of air pressure is required in a room where hazardous drugs are being compounded?

A

Negative

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12
Q

Where to store hazardous drugs?

A

Away from non-hazardous drugs

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13
Q

In a room where hazardous drugs are compounded, how many air changes per hour (ACPH) are needed?

A

Non sterile HD: 12 or more

Sterile HD: 30 or more

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14
Q

What medications are antineoplastic

A

chemo drugs

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15
Q

What does primary engineering control (PEC) mean?

A

Sterile hood

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16
Q

What does secondary engineering control (SEC) mean?

A

Buffer room

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17
Q

What is the compounding aseptic isolator (CAI)?

A

A hood that is completely closed in and has gloves and sleeves to put your hands in

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18
Q

What is considered a small volume parenteral? Large volume parenteral?

A

Small: 100 ml or less
Large: over 100 ml

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19
Q

What is the ISO rating and number of particles allowed for the following area
Primary engineering control (sterile hood, isolator, glove box)

A

ISO - 5

Particles/m3 - 3520

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20
Q

What is the ISO rating and number of particles allowed for the following area
Non pharmacy spaces

A

ISO - 6

Particles/m3 - 35,200

21
Q

What is the ISO rating and number of particles allowed for the following area
Secondary engineering control (buffer room, anteroom if it opens into a negative pressure buffer room)

A

ISO - 7

Particles/m3 - 352,000

22
Q

What is the ISO rating and number of particles allowed for the following area
Anteroom if it opens into a positive pressure buffer room

A

ISO - 8

Particles/m3 - 3,520,000

23
Q

What does HEPA filter stand for? How efficient are they at removing particles 0.3 microns or larger?

A

High-efficiency particulate air

>99.97% efficient

24
Q

Does air flow vertically or horizontally in a laminar airflow workbench?

A

verticle (Up)

25
Q

How often does a HEPA filter need to be recertified by a specialist?

A

Every 6 months

26
Q

What type of air has an ISO rating of 9?

A

Room air

27
Q

What does the line of demarcation separate?

A

Clean and dirty sections of the anteroom

28
Q

How long is the beyond use date for something that was prepared in non-sterile conditions (for code, emergency, etc)

A

1 hour

29
Q

If a clean room is being used to compound hazardous drugs, should it have positive or negative pressure?

A

Negative (keeps all hazardous particles in the room)

30
Q

What types of hoods can be used in non-HD and HD cleanrooms?

A

non-HD: Compounding aseptic isolator (CAI) and laminar airflow workbench (LAFW)
HD: Compounding aseptic containment isolator (CACI) and biological safety cabinet (BSC)

31
Q

What is a segregated compounding area (SCA)? When is it used? BUD for medications made here

A

Option when cleanroom is not available
Does not have buffer area or anteroom
Usually in satellite pharmacies
Max BUD is 12 hours

32
Q

True or false:

Closed front hoods do not need to be placed inside an SEC

A

True b/c they are closed off to outside air

Includes Compounding aseptic isolator (CAI) and compounding aseptic containment isolator (CAIC) (both are “glove boxes”

33
Q

Which closed front PECs are used for hazardous materials? non hazardous?

A

Hazardous: Compounding aseptic CONTAINMENT isolator (CAIC) - contains hazardous drugs
Non-hazardous: Compounding aseptic isolator (CAI)

34
Q

How often is a fingertip test required?

A

Initially (when training for the first time) then annually if compounding low and medium-risk CSPs and semi annually if compounding high-risk CSPs

35
Q

How long must the liquid in a media fill test bag stay clear for a person to pass?

A

14 days

36
Q

How often does temp need to be monitored in the SEC? What should it be?

A

Daily

20C (68F) or cooler

37
Q

How often should the refrigerator and freezer be monitored? What if it contains vaccines?

A

Daily

twice daily if contains vaccines

38
Q

How often should the air, surfaces, air pressure, and humidity be tested in the compounding area of a pharmacy?

A

Air: Every 6 months
Surfaces: periodically
Air pressure: each shift (preferably) or daily (minimally)
Humidity: daily

39
Q

What should be done in a sterile compounding room if the power goes out?

A 
Stop compounding (air isn't being removed, filtered, etc)
Clean with germicidal detergent then disinfected with sterile 70% isopropyl alcohol (IPA)
40
Q

How to clean an area that was used to compound a hazardous drug?

A

Deactivate and decontaminate (bleach or peroxide)
Cleaning (germicidal detergent)
Disinfection (isopropyl alcohol)

41
Q

When compounding hazardous drugs, what do the black, yellow, and red bins contain?

A

Black: Bulk hazardous waste
Yellow: trace hazardous waste (including HD sharps)
Red: sharps - NOT FOR HAZARDOUS WASTE

42
Q

What must be done every time there is a HD spill in the hood?

A

Decontamination with bleach or peroxide

43
Q

When a HD is unpacked and it is not contained in plastic, what should the HCP wear?

A

Elastomeric half-mask with a multi-gas cartridge and P100-filter

44
Q

What does an N95 mask not protect against?

A

Gasses

45
Q

Where should you look for information on how to clean up a HD spill?

A

Safety data sheet (SDS)

46
Q

Can you use a pneumatic tube to transport HD?

A

Cannot be used for any liquid or antineoplastic (cancer) drugs

47
Q

When are double ASTM D6978 gloves required?

A

When cleaning up HD spills

48
Q

Order for garbing up

A 
Head and facial covers
Shoe covers
Wash hands
Gown
Gloves
Sanitize gloves with alcohol regularly
49
Q

What is required when garbing up for compounding HD that is not required for non-HD drugs?

A 
Respirator
Face mask
Head AND hair coverings
Eye/face protection
Chemo gown
Chemo gloves
Two pairs of shoe covers

NAPLEX Review (79 decks)

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