Hazardous Drugs

Question 1

NIOSH Alert

Answer 1

List of hazardous drugs and tear out sheets available in Spanish

Question 2

Cytotoxic drug parenteral lab

Answer 2

Put plastic backed baker with plastic side down in the hood
Must use Luer-locking syringes
Never recap an needle or remove it from the syringe
Never take other used materials directly out of the hood
Never reuse anything

Question 3

USP 800

Answer 3

Hazardous drug compounding

Question 4

USP 800 chapters

Answer 4

1. Introduction and scope
2. List of hazardous drugs
3. Types of exposure
4. Responsibilities of personnel handling HDs
5. Facilities and engineering controls
   5.1 Receipt
   5.2 Storage

Question 5

People not included in USP 800

Answer 5

Manufacturers, Wholesale personnel, researchers, family

Question 6

Must have in hazardous drug list

Answer 6

Type of HD
Dosage form
Risk of exposure
Packaging
Manipulation

Question 7

Types of exposure

Answer 7

Dermal (do not absorb)
Mucosal absorption
Inhalation
Injection
Ingestion

Question 8

Designated areas required for HDs

Answer 8

Receipt and unpacking
Storage
Non-sterile compounding
Sterile compounding

Question 9

HD unpacking area

Answer 9

Needs neutral and negative pressure

Question 10

HD storage

Answer 10

Must be stored in manner to prevent spillage/breakage
HDs requiring manipulation stored separately

Question 11

HD Compounding primary engineering controls

Answer 11

The hood
Restricted access barrier system
Must be externally vented
Must follow USP 795, 797
Should be closed system drug-transfer device

Question 12

HD compounding secondary engineering controls

Answer 12

The room
Must be externally vented
Must be physically separated
Must be negative pressure
Must have eyewash station available

Question 13

PhaSeal

Answer 13

Encapsulate the hazardous drug to limit need for additional garbing
Completely closed needle safe system for preparation, administration and waste handling

Question 14

Features to prevent leakage

Answer 14

Dry connections
Pressure equalization

Question 15

Chemo dispensing pin

Answer 15

Prevent leaks
Replaces the needle during the reconstitution process

Question 16

Construction of the dispensing pin

Answer 16

A vented spike needle
Filter should remain at the top during the reconstitution process

Question 17

Non-sterile HD compounding

Answer 17

Must follow USP <795>
Regulations for
—cutting, crushing
—externally vented or redundant HEPA
—containment ventilated enclosure

Question 18

Environmental quality and control

Answer 18

Should sample routinely=initially and then every 6 months

Question 19

PPE

Answer 19

Must define the use of PPE for handling HDs
—receipt
—storage
—transport
—etc.

Question 20

Hazard communication program

Answer 20

All containers must be labeled
Entities must have an SDS for each chemical
SDSs must be readily accessible
Personnel must be provided information and training before job
Personnel of reproductive capability must confirm that they understand the risks of handling HDS

Question 21

Personnel training

Answer 21

Must be trained based on their job functions
Must be assessed every 12 months
Must be trained on new HDs and equipment
Must document competencies

Question 22

Transport

Answer 22

Must not transport liquid HDs via pneumatic tubes

Question 23

HD disposal

Answer 23

No drugs can go down the drain
Must be labeled based on category

Question 24

HD dispensing

Answer 24

Antineoplastics must not be placed in automated counting/packaging machines

Question 25

HD compounding

Answer 25

Should use a CSTD for sterile compounding
Must follow 797 and 795
Chemo mat should be used
Must dedicate equipment to HDs

Question 26

Administration

Answer 26

Must use CSTDs or protective medical devices and techniques
Must pre-prime IV tubing with non-HD solution
Must wear PPE
Must avoid manipulation (splitting, crushing, opening capsules)

Question 27

HD Spills

Answer 27

Deactivation
Decontamination
Cleaning
Disinfecting

Question 28

Spill control

Answer 28

Must have proper training for spill management
Must have spill kits readily available
Must dispose of materials as hazardous materials
Must address size of spills

Question 29

SOPs for HDs

Answer 29

Must review SOPs every 12 months

Question 30

Medical surveillance

Answer 30

Plan should be consistent with HRs plan
Identify people with HD exposure
Must quantify handling risk
Medical assessment on hire and routinely
Develop exit interview assessment strategy

Question 31

What makes waste hazardous?

Answer 31

Ignitability
Corrosively
Reactivity
Toxicity
Or specifically listed as hazardous

Question 32

Pharmaceutical waste

Answer 32

Expired drugs
Patient discarded medications
Waste materials containing excess drugs
Waste materials with chemo drug residue
Open containers of drugs that can’t be used
Containers that held acute hazardous waste
Drugs that are discarded
Contaminated material (spill kits, clothes, etc)

Question 33

P-listed disposal

Answer 33

Triple rinsed
Bottle is no longer hazardous
The rinsate is managed as hazardous waste

Question 34

U-listed containers are empty when

Answer 34

All contents are removed that can be removed through normal means
No more than 3% by weight remains

Question 35

Use non PVC IV sets

Answer 35

Reduce the adverse effects on the environment and public health when incinerated

Question 36

Ignitability

Answer 36

Aqueous solutions with more than 24% alcohol and flash point <140 F
Rubbing alcohol
Topical

Question 37

Corrosivity

Answer 37

PH 2 or less or 12.5 or more

Question 38

Incinerator types

Answer 38

Municipal
Medical waste
Hazardous waste

Question 39

Storage accumulation

Answer 39

Provides a storage area for hazard waste while it awaits shipping
Maximum storage time 90 or 180 days