Compounding I: Basics Flashcards
1
Q
USP 795
A
Non-sterile compounding
2
Q
USP 797
A
Sterile compounding
3
Q
USP 800
A
Handling hazardous drugs (both sterile & non-sterile)
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)
5
Q
Simple non-sterile compounding
A
requires (simply) following instructions
6
Q
Moderate non-sterile compounding
A
involves specialized calculations or procedures, or making a preparation that has no established stability data
7
Q
Complex non-sterile compounding
A
requires specialized training, equipment, facilities, or procedures
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.
9
Q
What type of water is used for hand & equipment washing (non-sterile compounding)?
A
Potable (drinkable, such as from the tap)
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)
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
12
Q
SVP
A
Small Volume Parenteral: IV bag or container containing 100 mL or less
13
Q
LVP
A
Large Volume Parenteral: IV bag or container containing more than 100 mL
14
Q
PEC
A
Primary Engineering Control: sterile hood that provides ISO 5 air for sterile compounding
15
Q
LAFW
A
Laminar Airflow Workbench: type of sterile hood (PEC); parallel air streams flow in one direction
16
Q
C-PEC
A
Containment Primary Engineering Control; ventilated (negative pressure) chemo hood used for HDs
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)
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)
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
20
Q
CSTD
A
Closed System Transfer Device: device preventing escape of HD/vapors when transferring (e.g. from a vial to a syringe)
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)
22
Q
ISO rating of PECs
A
5
23
Q
Particles are included in the ISO count if they are ________ or larger
A
0.5 microns
24
Q
ISO rating of SEC (aka the buffer area or buffer room)
A
7
25
ISO rating of an anteroom if it opens into a negative pressure SEC
7
26
ISO rating of an anteroom if it opens into a positive pressure SEC
8
27
HEPA filters are ______ efficient in removing particles as small as _________ wide or larger.
HEPA filters are > 99.97% efficient in removing particles as small as 0.3 microns wide or larger.
28
The HEPA filter must be recertified by a specialist every ___________.
every 6 months & anytime a PEC has been moved
29
Wipe off the outside of all materials (e.g. vials, syringes) with ______________ before bringing them into the PEC
70% isopropyl alcohol (IPA)
30
Compound at least __________ inside the sterile hood.
six inches
31
garb required when compounding in a CAI
depends on the manufacturer's instructions but minimally hand hygiene must be performed & sterile, powder-free gloves used inside the CAI
32
How are shoe covers applied in the ante room?
Shoe covers must be applied one at a time while stepping over the demarcation line.
33
maximum BUD for a CSP made in an SCA
12 hours
34
________ determines which drugs are hazardous.
National Institute for Occupational Safety and Health (NIOSH)
35
A drug is considered hazardous if it is...
carcinogenic, teratogenic, genotoxic, toxic to organs at low doses, or labeled by the manufacturer with special handling instructions
36
T/F: Prior to handling HDs, only women of reproductive capability must confirm in writing that they understand the risks associated with handling HDs.
FALSE.
Prior to handling HDs, men and women of reproductive capability must confirm in writing that they understand the risks associated with handling HDs.
37
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.
Assessment of Risk (AoR)
38
As part of an AoR, SOPs must be developed, which include actions to limit staff exposure, such as...
- 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
Biologic safety cabinets (BSCs) have ___________ laminar airflow & ___________ air pressure.
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
For sterile hazardous compounding, the BSC must be Class ___.
Class II (most common) or Class III
41
If there are separate sterile and non-sterile C-PECs in the same C-SEC, they must be kept at least _________ apart.
1 meter
42
In space where non-sterile HDs are compounding, there must be at least ____ ACPH.
12
43
In space where sterile HDs are compounding, there must be at least ____ ACPH.
30
44
In a C-SCA, there must be at least ____ ACPH.
12
45
An alternative option to an external exhaust (for NON-STERILE HD compounding only) is to use _______________ filters.
redundant HEPA filters
46
Hazardous drugs must be stored separately from non-HDs in an externally ventilated, negative-pressure room with at least ____ ACPH.
12
47
Adequate aseptic technique in hand hygiene, garbing, and gloving is demonstrated by passing the _____________.
gloved fingertip test
48
Adequate aseptic technique in sterile drug preparation is demonstrated by passing the _____________.
media-fill test
49
A passing score on the gloved fingertip test is required initially then _________.
every 6 months if making category 1 or 2 CSPs (per USP 797 update)
50
In a GFT, the evaluator collects a gloved sample from ____________ by rolling the pads of the fingers and thumb over a surface which contains _________________.
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
Passing initial gloved fingertip test requires...
three consecutive gloved fingertip samples, taken after garbing, with 0 CFUs for both hands
52
Ongoing gloved fingertip competency requires...
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
The media fill test must be performed initially during training and _________.
every 6 months if making category 1 & 2 CSPs (per USP 797 update)
54
What takes place of the drug in the preparation during a media fill test & what indicates contamination is present?
tryptic soy broth (TSB)
turbidity (cloudiness) -> contamination is present
55
how to pass a media fill test
liquid stays clear after 14 days of incubation
56
The temperature of the SEC should be checked _____ daily and be maintained at __________.
daily and maintained at 20 C (68 F), or cooler
57
The refrigerator and freezer temps should be monitored how often?
daily unless they contain vaccines, which require twice daily monitoring
58
refrigerator temperature
2-8 degrees C
59
freezer temperature
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
Air sampling for contaminants must be performed how often?
every 6 months
61
Surface sampling for contaminants should be performed periodically; Areas touched most frequently (e.g. inside the PEC, door handles) should be tested when?
at the end of the day (dirtiest state)
62
How often is air pressure testing performed?
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
How often is humidity testing performed?
once daily; should be maintained below 60% because excess moisture can lead to bacterial growth
64
All PECs and C-PECs are preferable kept running at all times. If there is a power outage, compounding must stop and...
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
If the power has been off, the PEC or C-PEC must be on for at least __________ before compounding can begin.
30 minutes
66
PECs are cleaned in what direction?
top to bottom, back to front (cleanest areas cleaned first, dirtiest areas cleaned last)
67
For all sterile work, what is cleaned DAILY?
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
For HDs, what is cleaned DAILY?
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
What is cleaned MONTHLY?
ceiling, walls, shelving, chairs, bins, carts
70
ISO 5 PECs, all types, are cleaned how often?
- before each shift
- every 30 minutes while working
- before & after each batch of CSPs
- whenever needed, including after spills
71
All areas & equipment used for handling HDs must be ______________, which includes deactivating, decontaminating, & cleaning at least ______________.
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
What can be used for both deactivation & decontamination?
bleach or peroxide
*to prevent corrosion from bleach on stainless steel, neutralize the bleach
73
Pharmacies involved in HD compounding should perform wipe sampling of all compounding surfaces initially & at least _______________ to ensure that hazardous residue is contained.
every 6 monthsFor
74
For an eye exposure, flood the affected ate at an eyewash fountain or with water or an isotonic eyewash for at least ____ minutes.
15
75
When HDs are unpacked & they are not contained in plastic, the staff member should wear an ______________.
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
What type of mask is sufficient for most HD compounding?
N95 respirator
but does not provide adequate protection against gases, vapors, or direct liquid splashes
77
When there is a risk of respiratory exposure from HDs, one of the following "masks" should be worn:
- a fit-tested respiratory mask with attached gas canisters (a "gas mask")
- a powered air-purifying respirator (PAPR)
78
spill kit contents
- 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
appropriate PPE for administering HDs
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
What devices must be used by nurses for drug administration if available for the formulation being used?
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
The outer chemotherapy gloves worn during compounding are discarded in a _________ waste bin located inside the C-PEC.
Yellow trace chemotherapy
82
The chemotherapy gown and outer shoe covers must be taken off before exiting the negative-pressure area & thrown away in the ____________ waste bi
Yellow trace chemotherapy
83
What is the black waste bin for?
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
What goes in the yellow waste bin?
Trace HD waste: empty syringes, IV bags, used PPE, including gowns, gloves, masks, & shoe covers
85
What is the red waste bin used for?
- 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
Can pneumatic tube systems be used for HDs?
Pneumatic tube systems cannot be used to transport any LIQUID HDs or any antineoplastics because of the potential for breakage and contamination.
87
How many & what type of gloves are required when HD compounding or cleaning up spills? And during HD receiving & storage?
- Double ASTM D6978 (chemotherapy)-rated gloves when compounding or cleaning up spills
- Single gloves can be used for HD receiving and storage.
88
For non-sterile HD drugs, if a BSC or CACI is not available then what PPE should be used?
- 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
PPE for sterile HD compounding includes:
- 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
When should coats, sweaters, makeup, & visible jewelry be removed?
Before entering the ante-area
91
Order of garbing for sterile compounding
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
How often should chemotherapy gown be changed?
Per manufacturer's schedule, or if unknown, every 2-3 hours or immediately after a spill or splash
93
How often should chemotherapy gloves by changed?
Must be changed every 30 minutes or when torn, punctured, or contaminated
