USP 800 - Block 4

Question 1

Define hazardous drugs?

Answer 1

Drugs that can cause adverse health effects if health care workers are exposed to these products

Question 2

USP 800 requires individual institutions to maintain ___?

Answer 2

List of HDs

Question 3

What are the categories of NIOSH list?

Answer 3

1. Antineoplastic HD
2. Non-antineoplastic HD
3. Reproductive Risks

Question 4

How often are NIOSH lists reviewed?

Answer 4

Annually

Question 5

A hospital must follow USP 800 containment strategies for:

Answer 5

1. All hazardous drug APIs
2. Antineoplastics that require further manipulation

Question 6

AOR must document the following considerations (at a minimum)

Answer 6

1. Type of HD
2. Dosage forms
3. Risk of exposure
4. Packging
5. Manipulation

Question 7

How do you order HDs?

Answer 7

Establish with the suppliers that HD “should be recieved from the supplier in impervious palstic segregate them from other drugs to allow safety durign transfer”

Question 8

How should hospitals recieve HDs?

Answer 8

1. Must have a designated area for receipt and unpacking HD
2. PPE
3. API Removed in a neutral or negative pressure area
4. HD removed from external shipping contain outside sterile compounding
5. Inform police about damged packages

Question 9

How do you stock HD?

Answer 9

1. A sign designating the entrance to this hazardous drug handling area must be clearly visible
2. This area must be away from a break room or area where food/drink are consumed
3. Access to this designated receiving area must be restricted to authorized personnel
4. Stored to prevent spilling or brekaing

Question 10

Where should antineoplastics be stored?

Answer 10

• Separately from non-hazards
• Externally ventilated
• Negative pressure room with at least 12 air pressure changes per hr (ACPH) same goes for refrigerated

Question 11

Hands must be washed with soap and water after ___?

Answer 11

Removing gloves

Question 12

What is the purpose of PPE?

Answer 12

To provide employees protection from hazardous aerosols and drug residue during preparation of products
* GLoves and gowns

Question 13

Glove guidelines?

Answer 13

1. ASTM-tested chemo gloves
2. Powder free
3. No defects
4. 2 pairs (inner worn under gown cuff and outer over)
5. Changed every 30 min
6. Discard inside C-PEC

Question 14

Gown guidelines?

Answer 14

1. Worn when handling HD
2. Protection from spills and waste
3. Disposable
4. Polyethylene-coated polypropylene or other laminate materials
5. Must close in back
6. No seams or closure
7. Cloth material or other absorbent materials are not appropriate wear to handle HDs

Question 15

Respirtory protection fo HD?

Answer 15

1. Unpacking HD that are not contained in plastic should wear an elastomeric half-mask whith a multigas cartridge and P100 filter

Question 16

When shoudl PAPR be worn?

Answer 16

1. HD spill
2. Exposure underneath work surfce of a C-PEC
3. Airborne exposure

Question 17

What is a Closed System Transfer Devices (CSTDs)?

Answer 17

1. Closed System Transfer Devices (CSTDs)
2. prohibits the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside of the system
3. Limit the potential for generating aersols during compounding

Question 18

Work practices that must be followed when using CSTD?

Answer 18

1. Provides supplemental control for compoudning shall be used inside a C-PEC
2. Used when compounding HDs when dosage form allows
3. Used when adminsitering HDs when the dosage form allows

Question 19

What are the safety practices using negative pressure technique?

Answer 19

1. Perform all manipulation of HDs in C-PEC
2. Observe proper material handling practices before introducing any item into ISO Clss 5 C-PEC
3. Swab the vital septum with sterile 70% IPA and allow to dry
4. Perform manipulations in the direct compounding areas that is not obstructive of HEPA filter
5. Use a syringe that is 25% larger than the total dose
6. Carefully attach the needle and syringe being careful to avoid touch contamination of either critical site
7. Draw up the amount of air that is equal to the total dose to be drawn up
8. Insert the needle into the septum being mindful of the first air coming down from the top of the C-PEC

Question 20

Cleanup procedure for HD?

Answer 20

1. Use wet ipes with appropriate solution
2. Don’t us spray bottles to avoid spreading HD

Question 21

What is the purpose for deactivation?

Answer 21

Transform the HD int less HD agents using chemical, heat, UV light

Question 22

What is the purpose of decontamination?

Answer 22

Removal of HD residue on exposed surfaces

Question 23

What is the purpose of cleaning?

Answer 23

Removal of soil from surfaces/objects

Question 24

What is the purpose for disinfection?

Answer 24

Inhibits or destroys microbes

Question 25

What are is the cleaning process?

Answer 25

1. Deactivation
2. Decontamination
3. Cleaning
4. Disinfection

Question 26

What is the disposal plan for trace HD waste?

Answer 26

1. Containers/tubing with <3% by weight of HD remaining
2. All disposable supplies involved in compounding or cleaning
3. PPE used in compounding

Question 27

What is the disposal plan for bulk HD waste?

Answer 27

1. Containers/tubing w/ >3% by weight of HD remaining
2. Significantly contaminated supplies and PPE used in compounding, cleaning, etc
3. Materials used in cleaning up spills

Question 28

What is unintended xposure?

Answer 28

Personnel who are potentially exposed to a HD or who have direct skin or eye contact require immediate evaluation