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
During a 12-hour work shift preparing IV chemo (assuming no breaks), what is the minimum # of gowns that will be needed for the entire shift assuming that no additional manufacturer info is available?
a. 1
b. 2
c. 3
d. 4
e. 5
d
Gowns must be changed per the manufacturer’s schedule. If no info is provided, gowns should be changed every 2-3 hours and immediately after a spill or splash. Since the shift is 12 hours, and the gown must be changed at least every 3 hours, a minimum of 4 gowns will be needed during the shift.
Master Formulation Record
Herceptin (Trastuzumab) IV Admixture
Ingredients - Quantity:
-Herceptin lyophilized powder, multidose vial - 420 mg
-Bacteriostatic Water for Injection, USP - 20 mL
-0.9% Sodium Chloride Injection, USP - 250 mL
Storage: The solution of Herceptin for infusion diluted in polyvinylchloride or polyethylene bags containing 0.9% NaCl Injection, USP, should be stored at 2C-8C (36F-46F) for no more than 24 hours prior to use. Don’t freeze.
Quality control procedure: Visually inspect for any abnormal particulate matter or color.
The technician has finished preparing all the Herceptin IV admixtures and will be leaving the compounding area. The compounding area has a buffer room and an anteroom. Where and when should the technician throw away his garb?
a. The garb should be thrown away in the bulk chemo waste bin before leaving the buffer.
b. The chemo gown and outer shoe covers should be thrown away in the bulk chemo waste bin before leaving the buffer room.
c. Both pairs of chemo gloves should be thrown away in the trace chemo waste bin before leaving the anteroom.
d. The chemo gown and outer shoe covers should be thrown away in the trace chemo waste bin before leaving the buffer room.
e. All the garb should be thrown away in the bulk chemo waste bin before leaving the anteroom.
d
-The outer chemo gloves worn during compounding are discarded in a yellow trace chemo waste bin located insidde the C-PEC.
-The chemo gown and outer shoe covers must be taken off before exiting the buffer room and in the yellow trace chemo waste bin.
-The rest of the garb is removed when leaving the anteroom.
A technician will be cleaning underneath the work surface of a biological safety cabinet used for compounding chemo. According to USP 800, which respirator is appropriate for this activity?
a. N90 respirator
b. N95 respirator
c. Surgical face mask
d. Powered air-purifying respirator
e. Elastomeric half-mask
d
An N95 respirator is sufficient for most hazardous drug compounding. Additional respiratory protection is needed in situations with direct hazardous drug exposure, such as cleaning underneath the work surface of a C-PEC. When there’s risk of respiratory exposure, either a respirator mask with an attached gas canister or a powered air-purifying respirator (PAPR) should be worn.
A pharmacist will be checking a batch of IV admixtures inside of the buffer room. The director of pharmacy notices that the pharmacist is wearing makeup. What is the most appropriate action for the director of pharmacy to take?
a. Skin foundation is acceptable to wear, but eye makeup must be removed.
b. Since the pharmacist isn’t preparing the IV admixtures herself, it’s acceptable to wear makeup.
c. The pharmacist must remove her makeup before entering the anteroom.
d. It’s acceptable for the pharmacist to wear makeup as long as she wears a face mask.
e. It’s acceptable for the pharmacist to wear makeup as long as she stays 10 feet away from the hood.
c
Which approach is NOT acceptable for delivering chemo infusions to the pt’s bedside?
a. Delivery to the nurse by a technician
b. Delivery to the nurse by a pharmacist intern
c. Delivery through the pneumatic tube system
d. Delivery by a pharmacist
e. The nurse picking up the infusion at the pharmacy
c
Pneumatic tube systems can’t be used to transport any liquid hazardous drugs or any antineoplastics because of the potential for breakage and contamination.
A pharmacist intern will be reconstituting ifosfamide powder with sterile water for injection and further diluting it with normal saline. 2 pairs of each of the following garb are required for this activity:
a. Shoe covers
b. Chemo gowns
c. Head covers
d. Chemo gloves
e. Face masks
a, d
A technician spills a PO rinse containing misoprostol while compounding. Which resource will provide the technician with detailed info on the steps required to manage the exposure?
a. The Compounding Log
b. USP 797
c. The SDS
d. The NIOSH List
e. The Orange Book
c
What color waste bin should be used for disposal of a partial vial of ifosfamide remaining after preparation of the admixture?
a. Red
b. Blue
c. Black
d. Yellow
e. White
c
Bulk antineoplastic waste includes unused or partially empty IV bags, syringes, or vials.
The technician will be using a syringe and needle to withdraw a ifosfamide solution from the vial. This compounding activity should be performed in the cleanest air, which is:
a. The first air that’s coming out from the back of the horizontal laminar airflow hood
b. The first air that’s coming out from the top of the vertical airflow biological safety cabinet
c. The first air that’s flowing into the biological safety cabinet from the buffer room
d. The first air that’s within the first 6 inches from the front of the laminar airflow hood
e. The first air that’s recycled through the redundant HEPA filters of the biological safety cabinet
b
Vertical airflow biological safety cabinets are used to compound hazardous sterile drugs. The HEPA filter is located at the top of a BSC, which is where the direct compounding area containing the cleanest air (or first air) is located.
A dr ordered 1200 mg/m2/day of ifosfamide for a pt with a BSA of 1.6 m2. How much of the solution should the technician withdraw from the vial and what syringe size should be used of a ifosfamide IV solution with a concentration of 3 g/60 mL?
a. Use a 35 mL syringe to withdraw 24 mL of solution
b. Use a 30 mL syringe to withdraw 24 mL of solution
c. Use a 5 mL syringe to withdraw 3.8 mL of solution
d. Use a 50 mL syringe to withdraw 38.4 mL of solution
e. Use a 60 mL syringe to withdraw 3.8 mL of solution
d
Ifosfamide is prepared in a biological safety cabinet with an ISO 7 buffer room and anteroom.
Ingredients - Quantity:
-Ifosfamide IV solution - 3 g/60 mL
-D5W - 100 mL
What is the risk level of this preparation?
a. Low risk
b. Medium risk
c. High risk
d. Low risk with 12-hr BUD
e. Immediate use
a
-Low risk - uses 1-3 components (including the diluent) that are supplied as sterile from the manufacturer
-Medium risk - more than 3 sterile components are needed (including the diluent)
Which testing parameter is compliant with USP 797 for a hospital compounding low- and medium-risk sterile products?
a. Air sampling weekly
b. Surface sampling daily
c. Air pressure monthly
d. Gloved fingertip testing every 6 months
e. Temperature daily
e
-Air sampling - at least every 6 months
-Surface sampling - periodically
-Air pressure - each shift (preferably) or daily (minimum)
-Humidity - daily
-Gloved fingertip testing - annually
Which of the following drugs would be eligible for an Assessment of Risk?
a. MTX tabs that are split in half
b. Hydroxyurea powder used to prepare a PO solution
c. Carboplatin IV solution that’s added to a bag of normal saline
d. Intact tamoxifen tabs which are packed into unit-dose packages
e. Carmustine powder whish is reconstituted with dehydrated alcohol
d
-A pharmacy can conduct an AoR that permits modification of the USP 800 requirements for HDs with lower risk by developing a plan to limit staff exposure.
-Activities that don’t require manipulation, such as counting and packaging, can be covered under an AoR.
-If manipulation is required, the full USP 800 requirements must be followed.
The pharmacist-in-charge performs wipe sampling of the surfaces inside the class II biological safety cabinet every 6 months. What is the pharmacist checking for?
a. Hazardous drug residue
b. Bacterial endotoxins
c. Proper aseptic technique of the compounding staff
d. Contamination of the compounding staff’s hands
e. Sodium hypochlorite residue
a
Wipe sampling of all compounding surfaces should be performed initially and at least every 6 months to ensure hazardous residue is contained. If contamination is present, the source must be identified, and a plan implemented to contain it.
Which of the following drugs would be found on the NIOSH list?
a. Bleomycin
b. Nystatin
c. Tacrolimus
d. Medroxyprogesterone
e. Isotretinoin
a, c, d, e
The pharmacist intern is reconstituting a 1 g vial of ceftazidime with 10 mL of sterile water for injection. The reconstituted solution will be added to a bag of normal saline for IV administration. The primary engineering control used to compound this IV admixture should have:
a. Positive pressure air
b. Unclassified air
c. At least ISO 5 air quality
d. At least ISO 7 air quality
e. Horizontal laminar airflow
a, c, e
Which of the following is an acceptable alternative to an external exhaust when compounding non-sterile hazardous drugs?
a. Redundant HEPA filters
b. An internal exhaust
c. Charcoal filters
d. Ionization of the contaminant air
e. Recirculating air vents
a
A hazardous drug spill kit should contain each of the following items EXCEPT:
a. Protective gown and latex gloves
b. N95 respirator mask plus goggles with side shields
c. Chemo pads to absorb hazardous liquid
d. Hazardous drug spill report exposure form to document exposure
e. Broom and dustpan to get spill waste into HD waste bag
e
Which of the following garb can be retained in the anteroom for reuse on the same shift when making non-hazardous compounded sterile products?
a. Shoe covers
b. Hair cover
c. Gloves
d. Gown
e. Face mask
d
The hospital routinely prepares antibiotic IV admixtures and total parenteral nutrition with only sterile ingredients. How often do the compounding pharmacy technicians need to pass the media-fill test to evaluate their aseptic technique?
a. Every 14 days
b. Twice a year
c. Yearly
d. Every other year
e. Quarterly
c
Non-sterile compounding that requires specialized training, facilities, equipment, or procedures is considered what category of compounding?
a. Simple
b. Moderate
c. Complex
d. Low-risk
e. Medium-risk
c
Compounding transdermal patches or ER tablets are examples of complex compounding.
What is the max recommended temp (in degrees Celsius) inside the secondary engineering control (SEC)?
a. 15
b. 20
c. 18
d. 30
e. 45
b
The pharmacist is compounding cyclophosphamide PO suspension. What type of gloves should the technician wear?
a. Gloves are optional for oral preparations
b. One pair of sterile gloves
c. One pair of ASTM-rated gloves
d. Two pairs of ASTM-rated gloves
e. Two pairs of powdered sterile gloves
d
According to USP 800, two pairs of ASTM-rated (chemo) gloves should be worn when manipulating all hazardous drugs.
Which environmental parameter is matched correctly with its minimum monitoring frequency?
a. Air sampling; weekly
b. Air pressure; daily
c. Surface sampling; daily
d. Air pressure; weekly
e. Air sampling; annually
b
-Air sampling - at least every 6 months
-Surface sampling - periodically
-Air pressure - each shift (preferably) or daily (minimum)
-Humidity - daily
-Gloved fingertip testing - annually
Which of the following statements are correct regarding the operation of a horizontal laminar airflow workbench?
a. If power is interrupted, the hood can be used immediately for compounding.
b. The hood must be operating continuously during compounding activity.
c. The hood can be turned off for a max of 8 hours.
d. If the hood is turned off, it must be on for at least 30 minutes before it can be used for compounding.
e. The hood must be turned off any time it’s not being used for compounding activity.
b, d
A pharmacy only prepares low-risk and medium-risk CSPs. If today’s date is January 22, 2022, which of the following personnel needs to perform the gloved fingertip test within the next month?
Date of Last Gloved Fingertip Test:
Angie - July 30, 2021
Jennifer - August 15, 2021
Karen - February 10, 2021
Pamela - March 20, 2021
Stephanie - December 1, 2021
a. Angie
b. Jennifer
c. Karen
d. Pamela
e. Stephanie
c
The gloved fingertip test is required at initial training and then annually for personnel who compound low- and medium-risk CSPs.
A pharmacy only prepares low-risk and medium-risk CSPs. If today’s date is January 22, 2022, which of the following personnel needs to perform the gloved fingertip test within the next month?
Date of Last Gloved Fingertip Test:
Angie - July 30, 2021
Jennifer - August 15, 2021
Karen - February 10, 2021
Pamela - March 20, 2021
Stephanie - December 1, 2021
a. Angie
b. Jennifer
c. Karen
d. Pamela
e. Stephanie
c
The gloved fingertip test is required at initial training and then annually for personnel who compound low- and medium-risk CSPs.
A drug wholesaler delivers a plastic tote containing chemo drugs to the pharmacy. Upon opening the tote, the technician discovers that the drugs aren’t wrapped in plastic. What PPE should the technician wear when unpacking this tote?
a. Two pairs of shoe covers
b. N95 respirator
c. Goggles
d. Surgical face mask
e. Elastomeric half-mask with a multi-gas cartridge and P100-filter
e
Should be used when unpacking HDs not wrapped in plastic until an assessment of the packaging ensures that no breakage or spillage occurred during transport.
USP requires periodic testing of the surfaces involved in sterile compounding. Which of the following statement/s concerning testing is/are accurate?
a. Testing should occur at the end of the day
b. Surfaces regularly exposed to staff should be tested
c. At least one surface sample must be taken from each 5, 7, and 8 area
d. Action must be taken if any colony-forming units (CFUs) are identified
e. Tryptic soy agar (TSA) is used as the growth medium
a, b, c, e
Action must be taken once > CFUs are identified in the ISO 5 area, > 5 CFUs in the ISO 7 area, or > 100 CFUs in an ISO 8 area
