Ch. 6: Handling Hazardous Drugs

Question 1

Hazardous drugs that require special handling to avoid toxicity to workers (Preg. X drugs, antineoplastics, 5-alpha reductase inh., hormones, transplant drugs, others)

Answer 1

All Pregnancy X drugs, many Category D’s and a few C’s, and paroxetine, MTX, misoprostol, mifeprostone (Mifeprex), ribavirin, valproic acid
Antineoplastics (daunorubicin)
5-alpha reductase inhibitors (dutasteride, finasteride)
Hormones (contraceptives, estradiol, testosterone)
Transplant drugs (myophenolate, tacrolimus, cyclosporine, everolimus, sirolimus)
Others: colchicine, dronedarone, fluconazole, spironolactone, risperidone, raloxifene, rasagiline, ziprasidone, ganciclovir

Question 2

When USP 800 will become federally forceable

Answer 2

July 2018

Question 3

Engineering Controls

Answer 3

Primary Engineering Control (CPEC) -Ventilated “hood”

Secondary Engineering Control (C-SEC)- the room where the hood is located

Question 4

NIOSH

Answer 4

Determines which drugs are hazardous

Question 5

USP 800

Answer 5

Sets standards on how to work safely with HDs

Question 6

ASHP

Answer 6

Provides detailed guidance for hospital pharmacists on implementing the USP standards

Question 7

Exception to HD separate room standard

Answer 7

Sterile and NS-HD drugs can be prepared n the same room if the room maintains ISO 7 air during NS compounding, Must be at least 1 meter apart. Particle generating activity, such as working with powders, cannot be performed when sterile compounding is being performed.

Question 8

PPE required in HD compounding

Answer 8

Head covers, hair covers, two pairs of shoe covers, gowns, and two pairs of chemotherapy gloves

Question 9

Acceptable C-PECs specific to Sterile HD compounding

Answer 9

Class II Biological Safety Cabinet (Class II BSC) or Compounding Aseptic Containment Isolator (CACI)

Question 10

C-PEC air type vs. anteroom and buffer room

Answer 10

C-PEC has ISO-5 air at 12 ACPH

Anteroom and Buffer room have ISO-7 air at 30 ACPH

Question 11

Closed System Transfer Devices (CSTDs)

Answer 11

Keep HDs contained within (inside) the device and block entry of environmental contaminants.
Recommended when compounding HDs and REQUIRED when administering antineoplastics

Question 12

Staff training for handling HDs must be completed and repeated:

Answer 12

Annually

Repeated when a new HD, a new piece of equipment, or some type of process that involves HDs is implemented

Question 13

Antineoplastics that require manipulation and all HD active pharmaceutical ingredients (i.e. progesterone) must be stored:

Answer 13

Stored separately from other non-HDs in an externally ventilated, negative-pressure room with at least 12 or more ACPH in order to prevent contamination and personnel exposure

Question 14

Refrigerated antineoplastics must be stored:

Answer 14

Stored in a dedicated refrigerator (for antineoplastics) in a negative pressure area with at least 12 ACPH (such as the buffer room)

Question 15

Administration of HDs must be done with:

Answer 15

Two pairs of chemotherapy gloves
Gowns are required when administering injectable antineoplastics and recommended when administering other HDs that are not in tablet of capsule form.
Single chemotherapy gloves are acceptable when administering intact tablets of capsules

Question 16

Trace antineoplastic waste (empty vials, empty syringes, empty IV bags, IV tubes, used gowns, used gloves, used pads) are thrown:

Answer 16

Into yellow containers (Trace Chemo Waste Bin)

Question 17

Bulk antineoplastic waste (unused or partially empty IV bags, syringes or vials) are thrown:

Answer 17

Into black containers (Bulk Chemo Waste Bin)

Question 18

Deactivation and Decontamination agents and purpose:

Answer 18

2% Sterile bleach (sodium hypochloride) or Peroxide

Inactivates and removes HD residue

Question 19

Cleaning agents and purpose

Answer 19

Germicidal detergent, such as Quat. Ammonium, Phenolics

Removes dirt and microbial contamination (organic and non-organic)

Question 20

Disinfection agents and purpose

Answer 20

70% sterile isopropyl alcohol (IPA)

Inhibits or destroys microorganisms; required step in sterile compounding

Question 21

Environmental Monitoring

Answer 21

Should be performed initially as a benchmark and least every 6 months

Question 22

When cleaning up a large HD spill, sanitizing the undertray of a C-PEC or when there is a known or suspected airborne exposure to powders or vapors, one must wear:

Answer 22

A full-face piece, chemical cartridge-type respirator or powdered air-purifying (PAPR)

Question 23

First air

Answer 23

Comes from the top of the C-PEC, so it is vertical first air

Cleanest air that is exiting the HEPA filter

Question 24

Size of syringe when handling HD

Answer 24

Smallest syringe, as long as it is not more than 75% full when filled with the solution

Question 25

When to dispose of PPE when leaving Sterile HD buffer room

Answer 25

Dispose of chemo gown and outer shoe cover into the yellow trace chemo waste bin before exiting the buffer room

Question 26

According to USP 800, ALL HDs must be compounded in a:

Answer 26

Negative pressure room

Question 27

Chemotherapy gloves must be changed:

Answer 27

Every 30 minutes or when torn, punctured, or contaminated

Question 28

How to handle receiving HD packages (garb and location of unpacking):

Answer 28

Must be handles with one pair of chemotherapy gloves when package is covered in plastic
When package is not covered in plastic, it must be handled with one pair of chemo gloves and an elastomeric half-mask with a multi-gas cartridge and P100-filter
Must be unpacked in a negative pressure area

Question 29

How to handle receiving HD packages (garb and location of unpacking):

Answer 29

Must be handles with one pair of chemotherapy gloves when package is covered in plastic
When package is not covered in plastic, it must be handled with one pair of chemo gloves and an elastomeric half-mask with a multi-gas cartridge and P100-filter
Must be unpacked in a neutral/negative pressure area; must not go into sterile or positive pressure areas

Question 30

According to USP 800, all HDs must be prepared with this amount and type of glove:

Answer 30

Two-pairs of chemotherapy powder-free gloves

Question 31

When should the C-PEC operate and under what circumstances?

Answer 31

It must operate continuously if it is supplying some or most of the negative pressure in the C-SEC

Question 32

Non-sterile HDs can be compounded in:

Answer 32

Containment ventilated enclosures (CVEs, powder hood) or in a class I biological safety cabinet; MUST be negative pressure

Question 33

How often should a chemo gown be changed?

Answer 33

Every 2 to 3 hours or immediately after a spill or splash