RxPrep Compounding I

compounded drug

A traditional ________ is prepared for an individual patient based on a prescription.

true

True or False: A compounded drug's dose or formulation cannot be commercially available as a manufactured product.

U.S. Pharmacopeia

What does USP stand for?

USP

organization that sets the standards for preparation, strength, quality, and purity of human and animal drugs, including manufactured and compounded drugs

795

What USP chapter involves non-sterile compounding?

797

What USP chapter involves sterile compounding?

800

What USP chapter involves hazardous drugs?

minimum acceptable standards

USP 795, 797, and 800 are considered to be ________ for compounding by the FDA, the state boards of pharmacy, and the Joint Commission.

non-sterile

(Non-sterile/Sterile) compounding involves orals, topicals, and nasals.

sterile

(Non-sterile/Sterile) compounding involves IV drugs and eye drops.

pharmacopeia

A(n) ________ is a list of medicinal drugs, with preparation instructions.

American Society of Health-System Pharmacists

What does ASHP stand for?

ASHP

pharmacists rely on this organization for detailed guidance on implementing USP standards

non-sterile compounding

primarily used to prepare a dose or formulation that's not commercially available, avoid an excipient, or add a flavor

intranasal, oral, otic (not inhalation)

topical

rectal, vaginal

via tube

What 7 routes of administration are used for non-sterile preparations?

false

True or False: The non-sterile compounding area does not have to be specifically designated for non-sterile compounding.

true

True or False: Non-sterile compounding can be performed in ambient (room) air, but must be separated from the dispensing part of the pharmacy.

false (all components, equipment, and containers should be stored off the floor)

True or False: Non-hazardous components of non-sterile compounding may be stored on the floor.

potable, purified

What 2 types of water must be available for non-sterile compounding?

potable

(Potable/Purified) water is used in non-sterile compounding for hand and equipment washing.

potable

(Potable/Purified) water is drinkable, such as from the tap.

purified

(Potable/Purified) water is used in non-sterile compounding for use in water-containing formulations, and for rinsing equipment and utensils.

single-use towels

What is a sanitary method of drying hands?

eye drops, inhalations,

injections,

irrigations

Sterile compounding is used to prepare what 4 formulations?

compounded sterile product

What does CSP stand for?

CSP

IVs or other drugs that require sterile manipulation

small volume parenteral

What does SVP stand for?

SVP

IV bag or container containing ≤100 mL

large volume parenteral

What does LVP stand for?

LVP

IV bag or container containing >100 mL

personal protective equipment

What does PPE stand for?

PPE

garb (e.g., gown, gloves, mask)

don

(Doff/Don) means to put on PPE.

doff

(Doff/Don) means to take off PPE.

primary engineering control

What does PEC stand for?

PEC

sterile hood that provides ISO 5 air for sterile compounding

laminar airflow workbench

What does LAFW stand for?

LAFW

type of sterile hood (PEC); open-front PEC where air flows out in parallel lines from the HEPA filter, typically from the back of the hood

containment primary engineering control

What does C-PEC stand for?

C-PEC

ventilated (negative pressure) chemo hood used for hazardous drugs

biological safety cabinet

What does BSC stand for?

BSC

chemo hood (class II or III for sterile hazardous drugs), a type of C-PEC

secondary engineering control

What does SEC stand for?

SEC

ISO 7 "buffer room" where the sterile hood (PEC) is located

containment secondary engineering control

What does C-SEC stand for?

C-SEC

ventilated (negative pressure) buffer room for hazardous drugs (room where the C-PEC is located)

segregated compounding area

What does SCA stand for?

SCA

designated space that contains an ISO 5 sterile hood, often an isolator (glovebox) with a closed front, but isn't part of a cleanroom suite (air isn't ISO-rated)

containment segregated compounding area

What does C-SCA stand for?

C-SCA

ventilated (negative pressure) room used for hazardous drugs; not in a cleanroom suite (air isn't ISO-rated)

compounding aseptic isolator

What does CAI stand for?

CAI

"glovebox" for non-hazardous drugs, a closed-front sterile hood (PEC)

compounding aseptic containment isolator

What does CACI stand for?

CACI

"glovebox" for hazardous drugs, a type of closed-front C-PEC

restricted access barrier system

What does RABS stand for?

RABS

"glovebox"/closed-front sterile hood (includes CAIs and CACIs)

closed system transfer device

What does CSTD stand for?

CSTD

device preventing escape of hazardous drugs/vapors when transferring (e.g., from a vial to a syringe)

containment ventilated enclosure

What does CVE stand for?

CVE

ventilated "powder hood" for non-sterile products (can be used for hazardous drugs if USP 800 standards are met)

International Standards Organization

What does ISO stand for?

ISO

organization that sets the standards for air quality in sterile compounding

particles; volume

ISO determines air quality by the number and size of ________ per ________ of air.

lower

The (higher/lower) the particle count per volume of air, the cleaner the air.

5

In critical areas that are closest to exposed sterile drugs and containers (i.e., inside the sterile hood), the air quality must be at least ISO ________.

0.5

Particles are included in the ISO count if they're ________ microns or larger.

7

The buffer area (the SEC, which contains PECs) must be at least ISO ________.

8; 7

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, or at least ISO ________ if it opens into a negative-pressure buffer area.

3,520

ISO 5 allows ________ particles/m^3.

35,200

ISO 6 allows ________ particles/m^3.

352,000

ISO 7 allows ________ particles/m^3.

3,520,000

ISO 8 allows ________ particles/m^3.

high-efficiency particulate air

What does HEPA stand for?

>99.97; 0.3

HEPA filters are ________% efficient in removing particles as small as ________ microns wide or larger, including bacteria, viruses, fungi, and dust.

vertical

In a (horizontal/vertical) airflow BSC or C-PEC, the HEPA filter is at the top of the sterile hood.

horizontal

In a (horizontal/vertical) airflow BSC or C-PEC, the HEPA filter is at the back of the sterile hood.

horizontal

A (horizontal/vertical) airflow BSC or C-PEC is also called a LAFW.

direct compounding area

What does DCA stand for?

DCA

area in the PEC where compounding occurs

first air

air coming directly out of the HEPA filter

6 months

The HEPA filter must be recertified by a specialist every ________ and anytime a PEC has been moved.

5

The PEC provides ISO ________ air quality for sterile compounding.

70% isopropyl alcohol

Wipe off the outside of all materials (e.g., vials, syringes) with ________ before bringing them into the PEC.

6

Compounding should be completed at least ________ inches inside the sterile hood to prevent exposing CSPs to dirtier ISO 7 air from the SEC.

positive

For non-hazardous compounding, the air pressure inside the PEC and SEC are both (negative/positive) since the air won't cause toxicity if it moves into adjacent spaces.

negative

With hazardous compounding, the C-PEC and C-SEC must both have (negative/positive) pressure to contain and exhaust the toxic air in the space.

stainless steel

What type of material is often used for sterile compounding equipment?

cleanroom suite

1 or more sterile hoods (ISO 5 PECs) inside an ISO 7 buffer room (SEC) that's entered through an adjacent anteroom

sterile hood

In a pharmacy, the most common way to achieve ISO 5 air is by using a(n) ________.

SCA

A CAI is often located in a(n) ________.

hand hygiene, sterile/powder-free gloves

What are the 2 minimum requirements for sterile compounding with a CAI?

anteroom

Where does garbing occur for sterile compounding?

line of demarcation

separates the anteroom into clean and dirty sections

shoe covers

________ must be applied one at a time while stepping over the demarcation line.

12 hours

The maximum BUD for a CSP made in an SCA is ________.

beyond-use date

What does BUD stand for?

PECs

A horizontal laminar airflow workbench and compounding aseptic isolator are examples of ________.

positive air pressure

________ in the PEC and SEC protects the CSPs from contamination.

hazardous drugs

can cause toxicity to the healthcare workers who handle them in any manner, including unloading the drugs in the receiving dock, stocking the shelves, preparing the drugs in the pharmacy, administering the drugs to a patient, and obtaining/cleaning up body fluids that contain residues

reduce exposure

Hazardous drugs require workspaces, equipment, and devices that are designed to ________.