Chapter 15: Compounding I: Basics Flashcards by Kristin Kattoula

Who sets the standards for compounding preparations, strength, quality and purity of human and animal drugs?

US Pharmacopeia (USP)

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Which USP chapter is related to non-sterile compounding?

USP 795

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Which USP chapter is related to sterile compounding?

USP 797

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Which USP chapter is related to handling hazardous drugs?

USP 800

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Who determines which drugs are hazardous?

The National Institute for Occupational Safety and Health (NIOSH)

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Besides USP chapters, where else can pharmacists find detailed guidance on implementing USP standards?

American Society of Health-System Pharmacists (ASHP)

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What are the 4 characteristics that make a drug hazardous?

Carcinogenic
Teratogenic
Causes organ toxicity at low doses
Genotoxic (damages the DNA)

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What must be included in a sterile compounding space?

anteroom
buffer area
primary engineering control (PEC) or a segregated compounding area (SCA)

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What requirements must be met for a non-sterile HD to be prepared in a C-PEC inside a C-SEC?

The C-SEC must maintain ISO 7 air
There must be separate sterile and non-sterile C-PECs kept at least 1 meter apart
Particle-generating activity, such as working with powders, cannot be performed when any sterile compounding is being performed in the same C-SEC

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C-PECs (containment primary engineering control) and C-SECs (containment secondary engineering control) must have ______

negative air pressure

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In space where non-sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)

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In space where sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)

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What does it mean when air that has been contaminated with HDs must be externally exhausted?

The air is moved out of the space and cannot be recirculated and returned to the room

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What is an alternative option to an external exhaust (for non-sterile HD compounding only)

Redundant-HEPA filters

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What is a primary engineering control (PEC)?

The sterile hood

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What is a secondary engineering control (SEC)?

The buffer room or sterile compounding room (the C-PEC is placed here)

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What is a class II biologic safety cabinet (BSC)

The chemo hood for sterile chemo drugs and other sterile HDs (aka a C-PEC)

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What is a Compounding Aseptic Containment Isolator (CACI)

The isolator glove box for HDs

CAI is for non-HD

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The International Standards Organization (ISO) sets the standards for air quality, which is determined by the number and size of ___ per ___ of air

Particles per volume (the lower the particle count, the cleaner the air)

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In critical areas that are closest to exposed sterile drugs and containers (i.e. inside the sterile hood) the air must be at least ISO __. Particles are included in this count if they are ____ in size or larger

0.5 microns

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The buffer area (or SEC) must be at least ISO __

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The anteroom (the room adjacent to the SEC, where hand washing and garbing occurs) must be at least ISO __ if it opens into a positive-pressure buffer area (non-HD sterile compounding) or at least ISO __ if it opens into a negative-pressure buffer area (HD sterile compounding)

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HEPA filters are >99.97% efficient in removing particles as small as ____ wide or larger, including bacteria, fungi, viruses, and dust

0.3 microns

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In a ___ airflow biologic safety cabinet (BSC) or C-PEC, the HEPA filter is at the top of the sterile hood

Vertical

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In a ____ airflow, or PEC, the HEPA filter is at the back of the sterile hood

Horizontal (laminar airflow workbench)

Compounding should be done in the cleanest air, which is the air coming directly out of the HEPA filter. This is called the _______

Direct compounding area (DCA)

The air from the HEPA filter is called the ____

First air

The HEPA filter must be recertified by a specialist every _ months & any time a PEC has been moved

Running down the center of the anteroom is a large visible line called ____, which separates the room into clean and dirty sections

the line of demarcation

Air pressure inside the PEC and inside a non-hazardous SEC can both be ____ (positive or negative)

Positive

With hazardous compounding, the C-PEC and the C-SEC must have ____ pressure to keep the toxic air contained in the space (positive or negative)

Negative

Another name for and isolator PEC/glove box? | Where are they located?

compounding aseptic isolators (CAI) or compounding aseptic containment isolators (CACI) Located in a segregated compounding area (SCA) or C-SCA for HD

The maximum beyond-use dates (BUD) for CSPs made in an isolator in a segregated compounding area (SCA) is _____

12 hours

If the anteroom is ISO 8, the air will be dirtier than inside the SEC. To keep the air from the anteroom out, the SEC will need to have _____ air pressure to push the air out of the SEC and into the anteroom

Positive

For sterile, non-hazardous preparation, ____ laminar airflow is used

Horizontal

For sterile hazardous preparation, ___ laminar airflow is used

Vertical

Adequate aseptic technique in hand hygiene, garbing and gloving is demonstrated by passing which test?

The gloved fingertip test

Adequate aseptic technique in sterile drug preparation is demonstrated by passing which test?

Media-fill test

A passing score on the gloved fingertip test & media-fill test is required initially, then ___ (if compounding low- and medium-risk compounded sterile products) and _____ (if compounding high-risk compounded sterile products)

Annually | Semi-annually

How do you pass a gloved fingertip test?

3 consecutive gloved fingertip samples with zero colony-formulating units (CFUs) for both hands

How do you pass a media-fill test?

The liquid must stay clear after 14 days of incubation

How often must temperature be monitored in the SEC?

Once daily

What should the temperature be kept at in the SEC?

20°C (68° F) or cooler

How often must refrigerator and freezer temperature be monitored?

Daily

What temperature should the refrigerator be kept at?

Between 2 - 8°C

What temperature should the freezer be kept at?

Between -50 and -15°C

Air sampling identifies contaminants in the air and should be performed at least every ____ by a person certified in air sampling or by a qualified compounding staff member

6 months

What provides a good growth medium for surface sampling

Tryptic soy agar (TSA)

____ and ____ are added to TSA in surface sampling to neutralize the effect of any disinfecting agents on the surfaces

Polysorbate 80 and lecithin

When should surface sampling occur ?

At the end of the day when the surfaces are in the poorest state

After surface sampling, the plates should have zero CFUs. Action must be taken if ___ CFUs are identified in the ISO 5 area, ___ CFUs in the ISO 7 area, and ___ CFUs in the ISO 8 area

>3 >5 >100

The air pressure testing confirms that there is the correct _____ between two spaces and ensures that the airflow is _____

Differential (difference in pressures) | Unidirectional

Pressure gauges are installed in the cleanroom space and checked minimally _____

Once daily or with every work shift

T or F: All PECs and C-PECs are kept running at all times to help keep the surfaces clean

True

If there is a power outage, all compounding must stop and the PECs will need to be cleaned with _____ and then disinfected with ____ prior to the re-initiation of a compounding activity

A germicidal detergent | Sterile 70% isopropyl alcohol (IPA)

If the power has been off, in addition to cleaning and disinfecting (or sanitation for C-PEC) the PEC or C-PEC must be on for at least ______ before compounding can begin

30 minutes

T or F: You should use circular motions to clean the PEC

F - use slightly overlapping, unidirectional strokes

Which direction is a PEC cleaned in?

From top to bottom, then back to front (cleanest areas are cleaned first)

What is the order for sanitizing hazardous drug areas and equipment?

1. Deactivation & Decontamination (2% bleach or peroxide) 2. Cleaning (germicidal detergent) 3. Disinfection (sterile 70% isopropyl alcohol)

How can you prevent corrosion on stainless steel surfaces with bleach?

Neutralize it by wiping surfaces afterwards with sodium thiosulfate, sterile alcohol, sterile water or germicidal detergent

What goes in the black waste bin?

Bulk hazardous drug waste (including containers with a clearly visible amount of an HD, supplies to administer HDs, or to clean up HD spills)

What goes in the yellow waste bin?

For trace HD waste (empty syringes, IV bags, used PPE)

What goes in the red waste bin?

Infectious waste (IV tubing and used culture dishes)

What goes in the red sharps container?

Non-HD sharps, such as used syringes

If no Assessment of Risk (AOR) is conducted for lower-risk HDs, the pharmacy must...

Follow the full USP 800 requirements

USP 797 risk categories are based on the risk of ...

Contamination of the sterile product

When a drug or chemical is exposed in one's eye, flood the affected eye at an eyewash fountain or with water or an isotonic eyewash for at least _____

15 minutes

When HDs are unpacked and they are not contained in plastic, the staff member should wear ____

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

What must be included in a spill kit?

Protective gown, latex gloves, N95 respirator mask plus goggles with side shields HD waste bag, chemo pads HD spill report exposure form

T or F: two pairs of gloves must be worn when administering HDs

True

When is a closed-system transfer device (CSTD) recommended? When are they required?

When compounding HDs | When administering antineoplastics

If manipulation (i.e. crushing tablets, opening capsules) is required for HDs, it should be done in _____ to contain any dust or particles

Plastic bag

The outer chemotherapy gloves worn during compounding are discarded in ______ located inside the C-PEC or put in a sealable bag if discarded outside the C-PEC

Yellow trace chemo waste bin

PPE for sterile HD compounding includes:

Head covers, face mask, & beard cover Two pairs of shoe covers A gown impermeable to liquids Two pairs of ASTM D6978 (chemo)-rated gloves A full-face piece respirator or a face shield with goggles when there is a risk for spills or splashes

What is the order for garbing before sterile compounding?

1. Head and facial hair covers and face masks 2. Shoe covers (2 if compounding HD) 3. Wash hands for 30 seconds from fingertips to elbows in circular motions 4. Gown 5. Enter buffer area (SEC) 6. Apply alcohol-based surgical hand scrub (Betadine or chlorhexidine) 7. Sterile, powder-free gloves (2 pairs of chemo-rated gloves for HDs). Tuck one pair under the cuffs of the gown and one pair over 8. Sanitize gloves with 70% IPA routinely during compounding

How often must chemo gloves be changed?

Every 30 minutes or when torn, punctured or contaminated

How often must chemo gowns be changed?

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

___ is a series of safety documents required by OSHA to be accessible to all employees who are working with hazardous materials

SDS

Non-sterile compounding is primarily used to:

- Change the formulation of a med - Avoid an excipient - Prepare a dose or formulation that is not commercially available - Add a flavor

sterile compounding is primarily used to prepare:

- Non-hazardous sterile IV drugs - Hazardous sterile IV drugs - Radiopharmaceuticals - Eyedrops - Irrigation

Powders can cause air contamination and are best when used within a

Powder containment hood

A hood that has ventilation, including HEPA filtered air, pressurized air (negative pressure to keep powder inside the hood) and exhaust systems

Ventilated Compounding Enclosure (VCE)

Hazardous drugs must be stored separately from non-HD in an externally ventilated, negative-pressure room with at least ___ ACPH

A small volume parenteral (SVP) is an IV container up to ___ mL & a large volume parenteral (LVP) is an IV container > __ mL

100 | 100

The PECs in a non-HD cleanroom can be either:

- CAI | - Laminar Airflow Workbench

A C-PEC can be either:

- CACI | - Biological safety cabinet (BSC)

T/F: CAIs do not have an external vent, whereas CACIs do

True

During the gloved fingertip test, the evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers over a surface which contains

Tryptic Soy Agar (TSA)

The test container for the media-fill test contains

Tryptic soy broth (TSB)

USP 795 risk categories are based on the ...

complexity of the preparation

USP 795 simple risk means

simply following instructions

USP 795 moderate risk means

Compounding a preparation that has no established stability data, or a preparation with specialized calculations or procedures

USP 795 complex risk means

specialized training, facilities, equipment or procedures are needed

The gloves used in compounding & cleaning up spills are called

ASTM D6978-rated gloves

How many gloves should be used for HD receiving and storage

single gloves

____ should be worn for cleaning up large HD spills, sanitizing the undertray of a C-PEC or when there is known or suspected airborne exposure to powders or vapors

Powered air-purifying respirator (PAPR)

What is the best material for a chemo gown

Polyethylene-coated polypropylene or other laminate material