Compounding I: Basics

Question 1

What sets the standards for compounding preparations?

Answer 1

US Pharmacopia (USP)

Question 2

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

Answer 2

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

Question 3

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

Answer 3

Which drugs are hazardous

Question 4

What is the NIOSH list of hazardous drugs called?

Answer 4

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

Question 5

What are safety data sheets (SDS)?

Answer 5

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

Question 6

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

Answer 6

True – if it can be bought, then buy it

Question 7

What is non-sterile compounding primarily used for?

Answer 7

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

Question 8

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

Answer 8

Microorganisms and other contaminants

Question 9

Sterile compounding is primarily used to prepare what?

Answer 9

Non hazardous sterile IV drugs
Hazardous sterile IV drugs
Radiopharmaceuticals
Eyedrops
Irrigations

Question 10

What characteristics make a drug hazardous?

Answer 10

Carcinogenic
Teratogenic
Causes organ toxicity
Genotoxic (damages DNA)

Question 11

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

Answer 11

Negative

Question 12

Where to store hazardous drugs?

Answer 12

Away from non-hazardous drugs

Question 13

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

Answer 13

Non sterile HD: 12 or more

Sterile HD: 30 or more

Question 14

What medications are antineoplastic

Answer 14

chemo drugs

Question 15

What does primary engineering control (PEC) mean?

Answer 15

Sterile hood

Question 16

What does secondary engineering control (SEC) mean?

Answer 16

Buffer room

Question 17

What is the compounding aseptic isolator (CAI)?

Answer 17

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

Question 18

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

Answer 18

Small: 100 ml or less
Large: over 100 ml

Question 19

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

Answer 19

ISO - 5

Particles/m3 - 3520

Question 20

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

Answer 20

ISO - 6

Particles/m3 - 35,200

Question 21

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)

Answer 21

ISO - 7

Particles/m3 - 352,000

Question 22

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

Answer 22

ISO - 8

Particles/m3 - 3,520,000

Question 23

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

Answer 23

High-efficiency particulate air

>99.97% efficient

Question 24

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

Answer 24

verticle (Up)

Question 25

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

Answer 25

Every 6 months

Question 26

What type of air has an ISO rating of 9?

Answer 26

Room air

Question 27

What does the line of demarcation separate?

Answer 27

Clean and dirty sections of the anteroom

Question 28

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

Answer 28

1 hour

Question 29

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

Answer 29

Negative (keeps all hazardous particles in the room)

Question 30

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

Answer 30

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

Question 31

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

Answer 31

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

Question 32

True or false: | Closed front hoods do not need to be placed inside an SEC

Answer 32

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"

Question 33

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

Answer 33

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

Question 34

How often is a fingertip test required?

Answer 34

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

Question 35

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

Answer 35

14 days

Question 36

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

Answer 36

Daily | 20C (68F) or cooler

Question 37

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

Answer 37

Daily | twice daily if contains vaccines

Question 38

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

Answer 38

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

Question 39

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

Answer 39

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

Question 40

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

Answer 40

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

Question 41

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

Answer 41

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

Question 42

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

Answer 42

Decontamination with bleach or peroxide

Question 43

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

Answer 43

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

Question 44

What does an N95 mask not protect against?

Answer 44

Gasses

Question 45

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

Answer 45

Safety data sheet (SDS)

Question 46

Can you use a pneumatic tube to transport HD?

Answer 46

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

Question 47

When are double ASTM D6978 gloves required?

Answer 47

When cleaning up HD spills

Question 48

Order for garbing up

Answer 48

``` Head and facial covers Shoe covers Wash hands Gown Gloves Sanitize gloves with alcohol regularly ```

Question 49

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

Answer 49

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