Compounding Flashcards
A powder containment hood that has HEPA filtered air, negative air pressure, and an exhaust system is called a:
a. Compounding aseptic isolator
b. Buffered compounding box
c. Secondary engineering control
d. Laminar airflow workbench
e. Containment ventilated enclosure
e
-A powder containment hood is a box designed to contain powder while preparing a non-sterile compounded product. It doesn’t have ISO-rated air.
-A containment ventilated enclosure is a specific type of powder containment hood that has additional features, such as negative air pressure and an external exhaust, which makes it USP 800 compliant for compounding with non-sterile hazardous drug powders.
Carmustine vials must be stored at 2C to 8C (36F to 46F). Where can the carmustine vials be stored?
a. At room temp, on a dedicated shelf that only contains antineoplastic drugs. The shelf is located in a negative pressure segregated compounding area.
b. In a dedicated fridge that only contains hazardous drugs. The fridge is located in the anteroom.
c. In a dedicated fridge that only contains antineoplastic drugs. The fridge is located in the negative pressure buffer room.
d. In a dedicated freezer that only contains hazardous drugs. The freezer is located in the anteroom.
e. In a dedicated freezer that only contains hazardous drugs. The freezer is located in the negative pressure buffer room.
c
-Refrigerated antineoplastics must be stored in a dedicated fridge in a negative pressure area with at least 12 ACPH (e.g., storage room, buffer room, or containment segregated compounding area).
-The anteroom is a positive pressure room.
Another name for the buffer room is:
a. Anteroom
b. Segregated compounding area
c. Primary engineering control
d. Secondary engineering control
e. Direct compounding area
d
A pharmacy technician spilled cyclophosphamide solution on his gloves and gown while compounding. He feels the drug seeping under his gloves and his eye begin to burn. Which of the following should the technician do first?
a. Cleanse the skin with 2% sodium hydrochlorite
b. Remove the gloves and gown that have the drug on them
c. Flood the affected eye at an eyewash station for at least 5 minutes
d. Document the exposure in the employee’s record
e. Contact the hospital’s infection control team
b
-The first 10-15 seconds after an exposure are critical.
-The 1st priority is to get the drug off of the person ASAP.
-If the exposure involves a gown or gloves, the garb should be immediately removed and the skin washed with soap and water.
-For eye exposure, flood the affected eye/s at an eyewash station for at least 15 minutes.
-Once the exposure has been properly dealt with, the incident should be documented in the employee’s record.
Which organization publishes the List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings?
a. United States Pharmacopeia (USP)
b. National Institute for Occupational Safety and Health (NIOSH)
c. American Society of Health-System Pharmacists (ASHP)
d. Occupational Safety and Health Administration (OSHA)
e. United States Environmental Protection Agency (EPA)
b
A specialty oncology pharmacy has several rooms in the compounding suite. In one room, a technician is preparing a blinatumomab IV admixture for infusion. In another room, a technician is crushing mercaptopurine tablets to compound a 50 mg/mL PO suspension. Which USP standards apply to both of these activities?
a. USP 795
b. USP 797
c. USP 800
d. USP 1
e. USP 71
c
-USP 800 sets the standards for the safe handling of hazardous drugs.
-USP 800 applies to both non-sterile hazardous drugs (mercaptopurine PO solution) and sterile hazardous drugs (blinatumomab IV infusion).
After an eye exposure to a drug or chemical, what is the minimum # of minutes that the eye/s should be flushed out in the eyewash station?
a. 5
b. 10
c. 15
d. 20
e. 30
c
During a 12-hour work shift preparing IV chemo (assuming no breaks), what is the minimum # of times that the gloves will need to be changed during the shift after donning the 1st pair?
a. 23
b. 18
c. 11
d. 5
e. 3
a
While compounding hazardous drugs, gloves should be changed every 30 minutes and additional times if torn, punctured, or contaminated. After donning the initial pair, the gloves need to be changed 23 more times within the 12-hour shift.
The technician is cleaning the cleanroom suite prior to leaving for the day. Place the following in the correct order for cleaning and disinfection.
a. Clean the ceiling of the PEC
b. Clean the sides of the PEC, including the grill over the HEPA filter
c. Clean the counters and floors in the SEC
d. Clean the ante-area
e. Clean the work surface (bottom) of the PEC
a-b-e-c-d
What PPE should be worn when preparing tretinoin PO suspension in a containment primary engineering control located within a sterile C-SEC?
a. N95 respirator
b. 2 pairs of shoe covers
c. 2 pairs of ASTM D6978 (chemo-related) gloves
d. Disposable chemo gown
e. Earplugs/guards
b, c, d
-PPE needed when compounding in a BSC or CACI should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, and double gloving with sterile chemo-type gloves.
-An N95 respirator is only required when working outside of a control device (e.g., BSC/CACI)
After the pharmacy technician has finished preparing a tretinoin PO suspension, what color waste bin should the technician use to throw away the disposable mortar and pestle?
a. Red
b. Blue
c. Black
d. Yellow
e. Grey
d
-Black - bulk HD waste
> Any containers (drug vials, IV bags) that contain a clearly
visible amount of HD and any supplies that were used to
administer HDs or to clean up HD spills
-Yellow - trace HD waste
> Empty syringes, IV bags, used PPE, including gowns, gloves,
and shoe covers
> The mortar and pestle that was used to compound the PO
suspension would contain trace amounts of tretinoin,
indicating that it should be disposed of in a yellow waste
container
-Red - infectious waste, including IV tubing an used culture dishes
What is an appropriate method to efficiently count all the capsules needed to prepare a tretinoin suspension?
a. Use an automated pill counting machine
b. Use a dedicated tray and spatula
c. Count the capsules aloud
d. Use a robotic dispensing system
e. Use an automated pouch packing machine
b
-When equipment is “dedicated” for use with HDs, it’s not used to handle non-hazardous drugs
-HD tabs and caps can’t be put into automated counting or packaging machines because they can leave powder residue and contaminate other drugs
Master Formulation Record
Tretinoin 10 mg/mL PO Suspension
Ingredients & Quantity:
-Tretinoin, 10 mg capsules - 1 g
-Butylated hydroxyanisole - 0.02 g
-Edetate disodium dehydrate - 0.1 g
-Soybean oil, qs ad - 100 mL
Storage: Stable for 30 days at room temp
Auxiliary Labels: Shake well; protect from light
If today is January 1, 2022, what beyond-use-date should be written on the label of the tretinoin PO suspension?
a. July 1, 2022
b. January 15, 2022
c. January 31, 2022
d. February 15, 2022
e. January 4, 2022
c
Master Formulation Record
Tretinoin 10 mg/mL PO Suspension
Ingredients & Quantity:
-Tretinoin, 10 mg capsules - 1 g
-Butylated hydroxyanisole - 0.02 g
-Edetate disodium dehydrate - 0.1 g
-Soybean oil, qs ad - 100 mL
Storage: Stable for 30 days at room temp
Auxiliary Labels: Shake well; protect from light
In addition to the auxiliary labels listed in the master formula, what other auxiliary label should be added to the bottle of tretinoin PO suspension?
a. “Contains Peanut Oil”
b. “Chemo - Dispose of Properly”
c. “Take on Empty Stomach”
d. “May Cause Discoloration of the Urine”
e. “Keep in the Refrigerator”
b
What ISO air rating is required for a compounding aseptic isolator?
a. 4
b. 5
c. 6
d. 7
e. 8
b
-Primary engineering control (PEC, called the sterile hood, or isolator, if using a glove box): ISO 5
-Secondary engineering control (SEC, called the buffer room or buffer area) and Anteroom, if it opens into a negative pressure SEC (same ISO # as the SEC): ISO 7
-Anteroom, if it opens into a positive pressure SEC: ISO 8
Which compounding area can have unclassified (I.e., room) air?
a. Anteroom
b. Buffer room
c. Containment aseptic isolator
d. Segregated compounding area
e. Containment secondary engineering control
d
A segregated compounding area (SCA) is a designated area in the pharmacy, such as a corner in the regular pharmacy space, where an isolator (glove box) is located. The air in the SCA is unclassified with no minimum ISO air requirements.
Which of the following is used for disinfection while performing sanitization?
a. Sodium hypochlorite
b. Peroxide
c. Ammonia
d. 70% isopropyl alcohol
e. Sodium thiosulfate
d
Sanitization process:
1. Deactivation and decontamination - 2% bleach (sodium hypochlorite) or peroxide) –> reduces HD toxicity, then removes HD residues
2. Cleaning - germicidal detergent, such as Quat, Ammonium, Phenolics –> removes dirt and microbial contamination
3. Disinfection - sterile 70% isopropyl alcohol (IPA) –> inhibits or destroys microorganisms (required step in sterile compounding)
A nurse will be administering an PO chemo drug through the pt’s feeding tube. The nurse will need to crush the tablet at the pt’s bedside. What precaution must the nurse take when crushing the tablet?
a. Wear a reusable chemo gown
b. Use a chemo pin
c. Wear one pair of sterile, powdered gloves
d. Use a plastic bag to crush the tablet
e. Wear one pair of shoe covers
d
What temp range should be maintained for refrigerators and freezers?
Fridge: 2-8 celsius
Freezer: -25 to -10 celsius; if freezer also contains vaccines, the temp should be maintained at -50 to -15 celsius
Laminar airflow in a sterile compounding hood describes airflow that is:
a. Bidirectional
b. Unidirectional
c. Turbulent
d. Recirculated
e. Ionized
b
What is the purpose of using a closed-system transfer device (CSTD)?
a. Reduces waste from hazardous drug compounding
b. Saves pharmacy costs associated with hazardous drug compounding
c. Increases the speed of drug delivery to various nursing units in the hospital
d. Protects staff from hazardous drug fumes and particles
e. Provides adequate mixing of a chemo drug with the diluent
d
A CSTD is a drug transfer device that prevents the escape of hazardous drug fumes and particles that could endanger personnel during manipulation, such as compounding or drug administration.
What is the most common source of contamination in a sterile compounding environment?
a. Compounding personnel
b. Defective HEPA filters
c. Inadequate room air pressurization
d. Lack of an external exhaust
e. Excessive humidity
a
Most contamination to compounded sterile products comes from the compounding staff, largely from inadequate hand hygiene and garbing.
Rank the following steps of garbing for sterile compounding in the correct order.
a. Don gloves
b. Clean hands with an alcohol-based surgical hand scrub
c. Perform hand hygiene with soap and water
d. Don shoe covers, hair covers, and face mask
e. Don gown
d - c - e - b - a
Which of the following can be used to prepare hazardous drugs?
a. Class II biological safety cabinet
b. Horizontal laminar airflow workbench
c. Compounding aseptic isolator
d. Compounding aseptic containment isolator
e. Positive-pressure airflow workbench
a, d