What is the minimum ISO requirement for an anteroom that is attached to a positive-pressure buffer room?

ISO 8

The minimum air quality requirement in the anteroom would be ISO 8 if it opens into a positive-pressure buffer area. An ISO rating that has a number lower than 8 (e.g., ISO 7) would mean the air is even cleaner and would therefore also be acceptable, but is not required.

For a compounder to pass the media-fill test, how long must the sample remain free from turbidity?

14 days

Turbidity on or before day 14 indicates that contamination is present. If the liquid stays clear after 14 days of incubation, the compounder passed the test.

Which of the following areas requires at least 30 air changes per hour (ACPH)?

The buffer room used to prepare sterile hazardous drugs

How often should the pharmacist-in-charge perform a wipe sampling to determine the amount of hazardous drug residue in the class II biological safety cabinet?

Every 6 months

Which of the following practices help prevent contamination of compounded sterile products when working in a primary engineering control (PEC)? (Select ALL that apply.)

Keep needles and injection ports in the first air

Compound at least six inches inside the PEC

Do not block the HEPA filter with hands or supplies

A type of primary engineering control (PEC) which requires materials to be passed through a chamber into an enclosed working area that is accessed through glove ports is called a:

Compounding aseptic isolator

During a 12-hour work shift preparing intravenous chemotherapy (assuming no breaks), what is the minimum number of times that the gloves will need to be changed during the shift after donning the first pair?

23

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.

A pharmacy manager is taking an inventory of the sterile compounding area garbing supplies and finds some garb that should not be worn in the sterile compounding area. According to USP 797, all of the following items can be worn in the cleanroom EXCEPT:

Powdered gloves

The surfaces of the laminar airflow workbench should be disinfected with:

70% isopropyl alcohol

If a compounded sterile product is prepared in a compounding aseptic isolator that is located in a segregated compounding area, what is the maximum beyond-use date that can be assigned?

12 hours

The beyond-use date designated by USP for a sterile product compounded in a glove box located in an SCA is no more than 12 hours.

Which of the following is an acceptable alternative to an external exhaust when compounding non-sterile hazardous drugs?

Redundant HEPA filters

What is the name of the organization that determines which drugs are hazardous?

The National Institute for Occupational Safety and Health

A hospital pharmacy has the following layout for their sterile compounding area. What is the minimum ISO requirement for the ante room?

**Picture**

ISO 8

Use: Cyclophosphamide oral liquid is used in the treatment of many adult and pediatric malignancies.

Packaging: Package in tight, light-resistant containers.

Labeling: Keep out of the reach of children. Shake well. Store in a refrigerator. Discard after 56 days.

Stability: A beyond-use date of 56 days can be used for this preparation only when it is stored in a refrigerator. The reported stability study used the injection as the source of the drug.

Which of the following is a requirement for gloves while preparing this compound? (Select ALL that apply)

Gloves must be changed every 30 mins while compounding

Two pairs of ASTM-rated gloves are required

Gloves worn must be powder-free

Use: Cyclophosphamide oral liquid is used in the treatment of many adult and pediatric malignancies.

Packaging: Package in tight, light-resistant containers.

Labeling: Keep out of the reach of children. Shake well. Store in a refrigerator. Discard after 56 days.

Stability: A beyond-use date of 56 days can be used for this preparation only when it is stored in a refrigerator. The reported stability study used the injection as the source of the drug.

The workbench used to prepare this compound has which of the following characteristics? (Select ALL that apply)

Negative pressure airflow to protect the personnel compounding the product

Airflow is vented to the outside of the building

Use: Cyclophosphamide oral liquid is used in the treatment of many adult and pediatric malignancies.

Packaging: Package in tight, light-resistant containers.

Labeling: Keep out of the reach of children. Shake well. Store in a refrigerator. Discard after 56 days.

Stability: A beyond-use date of 56 days can be used for this preparation only when it is stored in a refrigerator. The reported stability study used the injection as the source of the drug.

If the space used to prepare this compound is also used to prepare sterile compounded products, what is the required air quality for the buffer room?

ISO 7

Where do the pharmacy personnel don garb for sterile compounding?

Anteroom

Handwashing, garbing, CSP labeling and other procedures that release a high amount of particulates are done in the anteroom.

A pharmacist intern will be reconstituting ifosfamide powder with sterile water for injection and further diluting it with normal saline. Two pairs of each of the following garb are required for this activity: (Select ALL that apply.)

Shoe covers

Chemotherapy gloves

(Ifosfamide is an intravenous chemotherapy drug. Healthcare workers must wear a head cover, a face mask, two pairs of shoe covers, a chemotherapy gown and two pairs of chemotherapy gloves when compounding sterile HDs.)

Carmustine vials must be stored at 2°C to 8°C (36°F to 46°F). Where can the carmustine vials be stored?

In a dedicated refrigerator that only contains antineoplastic drugs. The refrigerator is located in the negative pressure buffer room

A hospital pharmacy director is designing a new compounding cleanroom for preparing sterile and non-sterile hazardous drugs (HDs) within the same buffer room. Which of the following plans for containment primary engineering controls (C-PECs) is compliant with USP standards?

Two C-PECs, each dedicated for either sterile or non-sterile products, separated by at least 1 meter

Which of the following garb can be retained in the anteroom for reuse on the same shift when making non-hazardous compounded sterile products?

Gown

A drug wholesaler delivers a plastic tote containing chemotherapy drugs to the pharmacy. Upon opening the tote, the technician discovers that the drugs are not wrapped in plastic. What personal protective equipment should the technician wear when unpacking this tote?

An elastomeric half-mask with a multi-gas cartridge and P100-filter

Which of the following are acceptable reasons to compound a drug product for a patient? (Select ALL that apply.)

The patient needs a drug in a formulation that is not commercially available

There is currently a shortage of the commercially available product

The patient is allergic to preservatives, dyes or other inactive ingredients in the commercially available product

The patient needs a drug strength that is not commercially available

A technician will be cleaning underneath the work surface of a biological safety cabinet used for compounding chemotherapy. According to USP 800, which respirator is appropriate for this activity?

Powered air-purifying respirator

A pharmacist working in an Oncology Infusion Center is responsible for the sterile preparation of chemotherapy drugs. All of the following resources would be useful to educate the pharmacist regarding standard work practices EXCEPT:

USP Chapter 795

The pharmacy manager of a sterile compounding pharmacy wants to ensure that she is maintaining a clean environment. Which of the following is required to ensure a sterile environment? (Select ALL that apply.)

Air sampling

Surface sampling

Staff members must pass a gloved fingertip test

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?

The pharmacist must remove her makeup before entering the anteroom

The temperature range for refrigerators used to store drug products should remain between 2 and 8 ^oC. The freezer temperature should remain within the range of -25 to -10 ^oC when storing only compounded products. **Picture**

Reviewing the temperature log provided, the refrigerator temperature was out of range on Days 3 and 6. The freezer temperature was out of range on Days 4 and 6.

A pharmacy technician will prepare Zosyn 4.5 grams in 100 mL NS for a hospital patient. The supervising staff pharmacist is concerned because the technician is not following the hospital's policies and procedures for preparing sterile compounded preparations. Which of the following can be used to evaluate the technician's aseptic technique?

Media-fill test

During a 12-hour work shift preparing intravenous chemotherapy (assuming no breaks), what is the minimum number of gowns that will be needed for the entire shift assuming that no additional manufacturer information is available?

4

Gowns must be changed per the manufacturer’s schedule. If no information 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.

Which of the following is recommended when compounding to contain hazardous drugs and prevent spills?

Closed-system transfer devices (CSTDs)

After an eye exposure to a drug or chemical, what is the minimum number of minutes that the eye/s should be flushed out in the eyewash station?

15 mins

Which of the following drugs can a hospital pharmacist transport to a nurses' station through the pneumatic tube delivery system?

Finasteride

(Pneumatic tubes must not be used to transport any liquid HDs or any chemotherapy drugs because of the potential for breakage and contamination.)

A hazardous drug spill kit should contain each of the following items EXCEPT:

Brooms and dustpan to get spill waste into HD waste bag

Master Formulation Record
Atenolol 2 mg/mL oral suspension

Ingredients: Quantity Atenolol 100 mg5 tabletsGlycerin USP5 mLOra-Sweet sugar-freeqs ad 250 mL

Storage:
Keep refrigerated

At what temperature should the suspension be stored?

36 to 46^o Fahrenheit

The master formula record indicates that the suspension must be stored in the refrigerator, which should be 36 to 46^o Fahrenheit (2 to 8^o Celsius).

An oncology nurse accidentally drops a vial of reconstituted carmustine solution, resulting in a large spill on the floor. Which of the following products can be used to decontaminate the area?

Sodium hypochlorite (bleach)

A technician spills an oral rinse containing misoprostol while compounding. Which resource will provide the technician with detailed information on the steps required to manage the exposure?

The Safety Data Sheet (SDS)

The pharmacy technician will sanitize the class II biological safety cabinet used for preparing sterile hazardous drugs. Which of the following statements is correct?

Peroxide-containing agents can be used to both deactivate and decontaminate surfaces

Which of the following preparations require sterile compounding? (Select ALL that apply.)

Parenteral nutrition

Bladder irrigations

Radiopharmaceuticals

Eye drops

What is the most common source of contamination in a sterile compounding environment?

Compounding personnel

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 oral suspension. Which USP standards apply to both of these activities?

USP 800

A patient arrives at the pharmacy to pick up his medication. The technician notices that the patient's medication is Augmentin. Augmentin must be reconstituted before it is dispensed to the patient. What category of non-sterile compounding is this considered?

Simple

Simple compounding involves reconstituting (“manipulating”) a commercial product by adding one or more ingredients (such as water or alcohol), as directed by the manufacturer.

Home Medications
Crestor 20 mg PO daily
Cozaar 50 mg PO daily
Famotidine 20 mg PO BID
Prednisone 20 mg PO daily
Methotrexate 7.5 mg PO once weekly
Imitrex 50 mg PRN migraines

Which of the following medications requires healthcare staff to wear gloves during handling, administration and disposal?

Methotrexate

Which agent is used to clean sterile hoods and gloved hands during compounding?

70% isopropyl alcohol (IPA) is used to clean the sterile hood and is applied to gloved hands routinely during compounding; contamination from the compounding staff is the top source of contamination and this helps reduce the risk.