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Compounding & Hazardous Drugs_NAPLEX > Compounding I: Basics > Flashcards

Compounding I: Basics Flashcards

1
Q

USP 795

A

Non-sterile compounding

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2
Q

USP 797

A

Sterile compounding

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3
Q

USP 800

A

Handling hazardous drugs (both sterile & non-sterile)

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4
Q

Non-sterile preparations include those administered by…

A

mouth, via tube, rectally, vaginally, topically, nasally, or in the ear (except if the eardrum is perforated)

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5
Q

Simple non-sterile compounding

A

requires (simply) following instructions

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6
Q

Moderate non-sterile compounding

A

involves specialized calculations or procedures, or making a preparation that has no established stability data

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7
Q

Complex non-sterile compounding

A

requires specialized training, equipment, facilities, or procedures

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8
Q

Non-sterile compounding can be performed in ______ air but must be separated from the ____________ of the pharmacy.

A

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

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9
Q

What type of water is used for hand & equipment washing (non-sterile compounding)?

A

Potable (drinkable, such as from the tap)

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10
Q

What type of water is used for use in water-containing formulations & for rinsing equipment & utensils (non-sterile compounding)?

A

Purified (e.g., distilled)

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11
Q

Sterile compounding is used to prepare…

A

injections (including IV, IM, SQ), eye drops, irrigations (liquid “washes” that go into a body cavity), & pulmonary inhalations

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12
Q

SVP

A

Small Volume Parenteral: IV bag or container containing 100 mL or less

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13
Q

LVP

A

Large Volume Parenteral: IV bag or container containing more than 100 mL

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14
Q

PEC

A

Primary Engineering Control: sterile hood that provides ISO 5 air for sterile compounding

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15
Q

LAFW

A

Laminar Airflow Workbench: type of sterile hood (PEC); parallel air streams flow in one direction

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16
Q

C-PEC

A

Containment Primary Engineering Control; ventilated (negative pressure) chemo hood used for HDs

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17
Q

SEC & C-SEC

A

Secondary Engineering Control - ISO 7 “buffer room” where the sterile hood (PEC) is located

Containment Secondary Engineering Control - ventilated (negative pressure) room for HDs (room where C-PEC is located)

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18
Q

SCA

A

Segregated Compounding Area; designated space that contains an ISO 5 hood but is not part of a cleanroom suite (air is not ISO-rated)

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19
Q

CAI/CACI

A

Compounding Aseptic Isolator: “glovebox” for non-HDs, a closed-front sterile hood (PEC)

Compounding Aseptic Containment Isolator: “glovebox” for HDs, a type of closed-front C-PEC

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20
Q

CSTD

A

Closed System Transfer Device: device preventing escape of HD/vapors when transferring (e.g. from a vial to a syringe)

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21
Q

CVE

A

Containment Ventilated Enclosure: ventilated “powder hood” for non-sterile products (can be used for HDs if USP 800 standards are met)

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22
Q

ISO rating of PECs

A

5

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23
Q

Particles are included in the ISO count if they are ________ or larger

A

0.5 microns

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24
Q

ISO rating of SEC (aka the buffer area or buffer room)

A

7

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25
Q

ISO rating of an anteroom if it opens into a negative pressure SEC

A

7

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26
Q

ISO rating of an anteroom if it opens into a positive pressure SEC

A

8

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27
Q

HEPA filters are ______ efficient in removing particles as small as _________ wide or larger.

A

HEPA filters are > 99.97% efficient in removing particles as small as 0.3 microns wide or larger.

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28
Q

The HEPA filter must be recertified by a specialist every ___________.

A

every 6 months & anytime a PEC has been moved

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29
Q

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

A

70% isopropyl alcohol (IPA)

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30
Q

Compound at least __________ inside the sterile hood.

A

six inches

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31
Q

garb required when compounding in a CAI

A

depends on the manufacturer’s instructions but minimally hand hygiene must be performed & sterile, powder-free gloves used inside the CAI

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32
Q

How are shoe covers applied in the ante room?

A

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

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33
Q

maximum BUD for a CSP made in an SCA

A

12 hours

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34
Q

________ determines which drugs are hazardous.

A

National Institute for Occupational Safety and Health (NIOSH)

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35
Q

A drug is considered hazardous if it is…

A

carcinogenic, teratogenic, genotoxic, toxic to organs at low doses, or labeled by the manufacturer with special handling instructions

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36
Q

T/F: Prior to handling HDs, only women of reproductive capability must confirm in writing that they understand the risks associated with handling HDs.

A

FALSE.

Prior to handling HDs, men and women of reproductive capability must confirm in writing that they understand the risks associated with handling HDs.

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37
Q

A pharmacy can conduct an ________________ for drugs with lower risk to avoid having to follow all USP 800 requirements for drugs that will be dispensed without manipulation.

A

Assessment of Risk (AoR)

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38
Q

As part of an AoR, SOPs must be developed, which include actions to limit staff exposure, such as…

A
  • putting HDs in distinctive shelf bins to alert staff
  • wearing ASTM D6978-rated gloves when counting or packaging drugs
  • dedicating a counting tray and spatula for counting HDs and decontaminating after
  • placing prepared HD containers into a sealable plastic bag
39
Q

Biologic safety cabinets (BSCs) have ___________ laminar airflow & ___________ air pressure.

A

Biologic safety cabinets (BSCs) have vertical laminar airflow & negative air pressure, which protects the worker from being exposed to the HD they are working with.

40
Q

For sterile hazardous compounding, the BSC must be Class ___.

A

Class II (most common) or Class III

41
Q

If there are separate sterile and non-sterile C-PECs in the same C-SEC, they must be kept at least _________ apart.

A

1 meter

42
Q

In space where non-sterile HDs are compounding, there must be at least ____ ACPH.

A

12

43
Q

In space where sterile HDs are compounding, there must be at least ____ ACPH.

A

30

44
Q

In a C-SCA, there must be at least ____ ACPH.

A

12

45
Q

An alternative option to an external exhaust (for NON-STERILE HD compounding only) is to use _______________ filters.

A

redundant HEPA filters

46
Q

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

A

12

47
Q

Adequate aseptic technique in hand hygiene, garbing, and gloving is demonstrated by passing the _____________.

A

gloved fingertip test

48
Q

Adequate aseptic technique in sterile drug preparation is demonstrated by passing the _____________.

A

media-fill test

49
Q

A passing score on the gloved fingertip test is required initially then _________.

A

every 6 months if making category 1 or 2 CSPs (per USP 797 update)

50
Q

In a GFT, the evaluator collects a gloved sample from ____________ by rolling the pads of the fingers and thumb over a surface which contains _________________.

A

In a GFT, the evaluator collects a gloved sample from each hand by rolling the pads of the fingers and thumb over a surface which contains tryptic soy agar (TSA).

51
Q

Passing initial gloved fingertip test requires…

A

three consecutive gloved fingertip samples, taken after garbing, with 0 CFUs for both hands

52
Q

Ongoing gloved fingertip competency requires…

A

at least one sample taken from each hand immediately after completion of the media-fill test with a foal of less than or equal to 3 CFUs total for both hands

53
Q

The media fill test must be performed initially during training and _________.

A

every 6 months if making category 1 & 2 CSPs (per USP 797 update)

54
Q

What takes place of the drug in the preparation during a media fill test & what indicates contamination is present?

A

tryptic soy broth (TSB)

turbidity (cloudiness) -> contamination is present

55
Q

how to pass a media fill test

A

liquid stays clear after 14 days of incubation

56
Q

The temperature of the SEC should be checked _____ daily and be maintained at __________.

A

daily and maintained at 20 C (68 F), or cooler

57
Q

The refrigerator and freezer temps should be monitored how often?

A

daily unless they contain vaccines, which require twice daily monitoring

58
Q

refrigerator temperature

A

2-8 degrees C

59
Q

freezer temperature

A

If the freezer contains only CSPs (no vaccines): between -25 and -10 degrees C according to USP 797

If the freezer also contains vaccines: between -50 and -15 degrees C per CDC guidance

60
Q

Air sampling for contaminants must be performed how often?

A

every 6 months

61
Q

Surface sampling for contaminants should be performed periodically; Areas touched most frequently (e.g. inside the PEC, door handles) should be tested when?

A

at the end of the day (dirtiest state)

62
Q

How often is air pressure testing performed?

A

once daily (minimally) or with every work shift to confirm the correct differential (difference in pressures) between two spaces & ensure that the airflow is unidirectional

63
Q

How often is humidity testing performed?

A

once daily; should be maintained below 60% because excess moisture can lead to bacterial growth

64
Q

All PECs and C-PECs are preferable kept running at all times. If there is a power outage, compounding must stop and…

A

The PECs will need to be cleaned with a germicidal detergent & then disinfected with sterile 70% IPA before re-initiating compounding activity.

If the PEC is a C-PEC, sanitization will be needed.

65
Q

If the power has been off, the PEC or C-PEC must be on for at least __________ before compounding can begin.

A

30 minutes

66
Q

PECs are cleaned in what direction?

A

top to bottom, back to front (cleanest areas cleaned first, dirtiest areas cleaned last)

67
Q

For all sterile work, what is cleaned DAILY?

A

Before entering the cleanroom, wipe the outside container of all supplies.

Clean with germicidal cleaner & disinfect with sterile 70% IPA, every day: counters & floors

68
Q

For HDs, what is cleaned DAILY?

A

Always sanitize the work area at the end of a shift: Deactivate, Decontaminate, Clean, Disinfect.

Leaving HD residue for the next shift is NOT acceptable & is likely a justification for termination.

69
Q

What is cleaned MONTHLY?

A

ceiling, walls, shelving, chairs, bins, carts

70
Q

ISO 5 PECs, all types, are cleaned how often?

A
  • before each shift
  • every 30 minutes while working
  • before & after each batch of CSPs
  • whenever needed, including after spills
71
Q

All areas & equipment used for handling HDs must be ______________, which includes deactivating, decontaminating, & cleaning at least ______________.

A

All areas & equipment used for handling HDs must be sanitized, which includes deactivating, decontaminating, & cleaning at least once daily.

STERILE compounding areas & equipment must be disinfected as a final step (with sterile 70% IPA)

72
Q

What can be used for both deactivation & decontamination?

A

bleach or peroxide

*to prevent corrosion from bleach on stainless steel, neutralize the bleach

73
Q

Pharmacies involved in HD compounding should perform wipe sampling of all compounding surfaces initially & at least _______________ to ensure that hazardous residue is contained.

A

every 6 monthsFor

74
Q

For an eye exposure, flood the affected ate at an eyewash fountain or with water or an isotonic eyewash for at least ____ minutes.

A

15

75
Q

When HDs are unpacked & they are not contained in plastic, the staff member should wear an ______________.

A

elastomeric half-mask, with a multi-gas cartridge & P100-filter… until assessment of the packaging integrity ensures that no breakage or spillage occurred during transport

76
Q

What type of mask is sufficient for most HD compounding?

A

N95 respirator

but does not provide adequate protection against gases, vapors, or direct liquid splashes

77
Q

When there is a risk of respiratory exposure from HDs, one of the following “masks” should be worn:

A
  • a fit-tested respiratory mask with attached gas canisters (a “gas mask”)
  • a powered air-purifying respirator (PAPR)
78
Q

spill kit contents

A
  • protective gown, latex gloves (minimally), N95 respiratory mask plus goggles with side shields
  • HD waste bag, scoop & scraper to get spill waste into waste bag, chemo pads
  • HD spill report exposure form
79
Q

appropriate PPE for administering HDs

A

two pairs of chemotherapy gloves required for administering all HDs
- a chemotherapy gown is required for administering IV HDs & recommended when administering others (e.g. oral)

80
Q

What devices must be used by nurses for drug administration if available for the formulation being used?

A

Closed-system transfer devices (CSTDs) = vial transfer devices
- Chemotherapy pins are used to prevent HDs from aerosolizing by reducing air pressure with venting
- CSTDs should be used to transfer drugs whenever possible to keep the HDs contained within the device
- CSTDs are recommended when compounding HDs & required for administering antineoplastics
- Have a built-in valve that equalizes the air pressure

81
Q

The outer chemotherapy gloves worn during compounding are discarded in a _________ waste bin located inside the C-PEC.

A

Yellow trace chemotherapy

82
Q

The chemotherapy gown and outer shoe covers must be taken off before exiting the negative-pressure area & thrown away in the ____________ waste bi

A

Yellow trace chemotherapy

83
Q

What is the black waste bin for?

A

Black is for bulk HD waste: any containers (drug vials, IV bags) that contain a clearly visible amount of HD & any supplies that were used to administer HDs or to clean up HD spills

84
Q

What goes in the yellow waste bin?

A

Trace HD waste: empty syringes, IV bags, used PPE, including gowns, gloves, masks, & shoe covers

85
Q

What is the red waste bin used for?

A
  • The red waste bin is for infectious waste, including IV tubing & used culture dishes
  • The red sharps container is only for NON-HAZARDOUS sharps, such as used syringes. The used syringes from preparing HDs go into the yellow bin.
86
Q

Can pneumatic tube systems be used for HDs?

A

Pneumatic tube systems cannot be used to transport any LIQUID HDs or any antineoplastics because of the potential for breakage and contamination.

87
Q

How many & what type of gloves are required when HD compounding or cleaning up spills? And during HD receiving & storage?

A
  • Double ASTM D6978 (chemotherapy)-rated gloves when compounding or cleaning up spills
  • Single gloves can be used for HD receiving and storage.
88
Q

For non-sterile HD drugs, if a BSC or CACI is not available then what PPE should be used?

A
  • Double gloves, a gown, a mask, & a disposable pad to protect the work surface
  • But remember for activities like placing intact tablets or capsules into unit-dose or multidose containers on an occasional basis poses relatively low risk so a single pair of gloves may be adequate but need an AoR
89
Q

PPE for sterile HD compounding includes:

A
  • Head covers, a face mask & beard cover
  • Two pairs of shoe covers
  • A gown impermeable to liquids
  • Two pairs of ASTM D6978 (chemotherapy)-rated gloves
  • A full-facepiece respiratory or a face shield with goggles when there is a risk for spills or splashes
90
Q

When should coats, sweaters, makeup, & visible jewelry be removed?

A

Before entering the ante-area

91
Q

Order of garbing for sterile compounding

A

Dirtiest to cleanest: head and facial hair covers and face masks, then shoe covers while stepping over line of demarcation (remember a second pair of shoe covers is needed for compounding HDs), then perform hand hygiene then don non-shedding gown (disposable required for HD compounding & preferred for non-HD compounding) then apply an alcohol-based surgical hand scrub then don sterile, powder-free gloves (for HD compounding, two pairs of ASTM D6978 (chemo)-rated gloves)

92
Q

How often should chemotherapy gown be changed?

A

Per manufacturer’s schedule, or if unknown, every 2-3 hours or immediately after a spill or splash

93
Q

How often should chemotherapy gloves by changed?

A

Must be changed every 30 minutes or when torn, punctured, or contaminated

Compounding & Hazardous Drugs_NAPLEX (6 decks)

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