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Naplex 2023 > Compounding 1: Basics > Flashcards

Compounding 1: Basics Flashcards

1
Q

compounded drugs

A

for individual patient based on prescription
cannot be commercially available

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2
Q

U.S. Pharmacopeia (USP)

A

standards for compounding
chapters 795, 797, 800 set minimum acceptable standards

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3
Q

USP 795

A

non-sterile compounding

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4
Q

USP 797

A

sterile compounding

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5
Q

USP 800

A

hazardous drugs

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6
Q

American Society of Health-System Pharmacists

A

ASHP
how to implement USP into hospital

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7
Q

reasons for non-sterile compounding

A

dose or formulation not commercial available
avoid excipient
add flavor

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8
Q

administration routes for non-sterile

A

mouth, tube, rectally, vaginally, topically, nasally, in ear

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9
Q

USP 795 simple

A

following instructions

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10
Q

USP 795 moderate

A

specialized calculations or procedures
OR no established stability data

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11
Q

USP 795 complex

A

needs specialized training, equipment, facilities, procedures (transdermal form)

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12
Q

non-sterile compounding physical space

A

specifically designated
can be in room air but separated from dispensing area
needs potable water for hand/equipment washing and purified for water-containing formulation and rinsing equipment/utensils
single-use towels for sanitary drying hands

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13
Q

types of sterile compounding

A

IV
IM
SC
eye drops
irrigations
inhalation (not nasal)

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14
Q

CSP

A

compounded sterile products

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15
Q

SVP

A

small volume parenteral
100 mL or less

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16
Q

LVP

A

large volume parenteral
>100 mL

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17
Q

PPE

A

personal protective equipment
don = put on; doff = take off

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18
Q

PEC

A

primary engineering control
sterile hood that give ISO 5 air for compounding

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19
Q

LAFW

A

laminar airflow workbench
sterile hood (PEC) type; parallel air streams flow in one direction

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20
Q

C-PEC

A

containment primary engineering control
negative pressure chemo hood for HDs

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21
Q

BSC

A

biological safety cabinet
chemo hood (Class II or III for sterile HD)
type of C-PEC

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22
Q

SEC

A

secondary engineering control
negative pressure buffer room for HDs
where C-PEC is located

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23
Q

SCA

A

segregated compounding area
space with ISO 5 hood but not part of cleanroom suite (air is not ISO-rated)

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24
Q

CAI

A

compounding aseptic isolator
“glovebox” for non-HDs
closed-front sterile hood (PEC)

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25
Q

CACI

A

compounding aseptic containment isolator
“glovebox” for HDs
type of closed-front C-PEC

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26
Q

RABS

A

restricted access barrier system
“glovebox”/closed-front sterile hood (CAIs and CACIs)

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27
Q

CSTD

A

closed system transfer device
device preventing escape of HD/vapors when transferring

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28
Q

CVE

A

containment ventilated enclosure
ventilated “powder hood” for non-sterile products
can be used for HD is USP 800 met

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29
Q

International Standards Organization

A

sets air quality standards by particles per voume of air
lower count = cleaner
particles 0.5 microns or bigger count

30
Q

air quality for USP 797

A

inside hood must be ISO 5 or better
buffer area (SEC where PEC is located) must be ISO 7 or better
anteroom (adjacent to SEC - hand washing/garbing) must be ISO 8 or better if open into positive-pressure buffer area or ISO 7 or better if opens into negative-pressure buffer area

31
Q

HEPA filters

A

> 99.97% efficient in removing particles as small as 0.3 microns
in vertical airflow BSC/C-PEC, HEPA at top
in laminar airflow workbench (LAWF) or PEC, HEPA at back - horizontal airflow
direct compounding area (DCA) should be done where air is coming directly out of HEPA filter (first air)

32
Q

ISO air quality inside of PEC

A

wipe off materials with 70% ISA
tear packages along tear line
compound inside the hood 6”

33
Q

air presure

A

positive for non-HD
negative in C-PEC and C-SEC for HD

34
Q

CAI air flow

A

often inside SCA
practice hand hygiene
use sterile powder-free gloves inside CAI

35
Q

line of demarcation

A

in anteroom to show clean from dirty side
apply shoe covers one at a time while stepping over the line

36
Q

SCA

A

unclassified air
max BUD for 12 hours

37
Q

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare settings

A

carcinogenic, teratogenic, genotoxic, toxic to orans, labeled by manufacturer with special handling instructions
Mifepristone, Misoprostol
Chloramphenicol
Warfarin
Fluconazole, Voriconazole
Abacavir, Entecavir, Zidovudine
Cidofovir, Ganciclovir, Valganciclovir
Isotretinoin
Dronedarone
Acitretin, Azathioprine, Leflunomide
Fingolimod, Teriflunomide
Dutasteride, Finasteride
Pamidronate, Zoledronic Acid
Dexrazoxane
Paroxetine
Exenatide, Liraglutide
Lomitapide
Clobazam, Clonazepam
Carbamazepine, Oxcarbazepine, Eslicarbazepine, Divalproex, Fosphenytoin, Phenytoin, Topiramate, Vigabatrin, Zonisamide
Colchicine
Ivabradine, Spironolactone
Ribavirin
Androgens
Estrogens
Oxytocin, Dinoprostone
Progesterone
SERD/SERMs fulvestrant, tamoxifen
ulipristal
methimazole, PTU
temazepam, triazolam
deferipone
dihydroergotamine
apomorphine, rasagaline
ambrisentan, bosentan, macitentan, riociguat
ziprasidone
cyclosporine, myocphenolate, tacrolimus, sirolimus

38
Q

SDS

A

safety data sheets
previously MSDS
for those working with hazardous materials

39
Q

hazard communication program

A

must have designated individual for creating SOPs on worker safety (includes wearing ASTM D6978-rated gloves with counting or packing)
includes written plan with details of HD safety
men and women with reproductive ability must confirm in writing they understand the risks of handling HDs

40
Q

lower-risk HD activities

A

counting and packaging tablets
can do an Assessment of Risk for lower risk drugs to avoid following all USP 800 if not being manipulated - if no AoR, follow USP 800; review AoR every 12 months

41
Q

USP 800 physical space basics

A

hoods/buffer rooms for HDs include containment (C-PEC)

42
Q

C-PECs for HDs

A

BSCs have vertical laminar airflow and negative air pressure
for sterile HDs - must be BSC Class II (most common) or III
CVEs: for non-sterile only; powder containment, negative air pressure
CACIs: closed-front C-PECs that are often in C-SCA

43
Q

non-sterile and sterile HD in same space

A

preferable to separate non-sterile and sterile
can make non-sterile HDs in C-PEC if: C-SEC has ISO 7 or better, separate sterile and non-sterile C-PECs >=1 m apart

44
Q

negative air pressure

A

required in C-PECs, C-SECs, and C-SCAs

45
Q

HD air changes

A

ACPH = air changes per hour
non-sterile HD must have >= 12 ACPH
sterile C-SEC must have >=30 ACPH
C-SCA must have >= 12 ACPH

46
Q

HD external exhaust

A

required for air with HDs
cannot be recirculated
alternative: use redundant HEA filters (has multiple HEPA filters in a series)

47
Q

HD storage

A

store separately from non-HD
negative-pressure room of >=12 ACPH

48
Q

compounding staff training/testing

A

hand hygiene, garbing, gloving - pass gloved fingertip test

49
Q

gloved fingertip test

A

required initially and annually (if low-medium risk CSPs) or semi-annually (if high-risk CSPs)
collect gloved sample from each hand with tryptic soy agar (TSA)
incubate for 2-3 days
look for colony-forming units (CFUs)
pass: initially need 3 consecutive gloved fingertip samples with zero CFUs for both hands
ongoing: at least 1 sample from each hand with goal <=3 CFUs for total

50
Q

media-fill test

A

if compounder is preparing CSP in aseptic manner
perform initially and at least annual for low-medium risk
tryptic soy broth used instead of drug
turbidity means contamination
pass: after 14 days, stays clear

51
Q

temperature monitoring

A

document
SEC (buffer room) check once daily and kept <=20 C/68 F
refrigerator and freezer checked daily
refrigerator: 2-8 C
freezer w CSPs no vaccines: -25 to -10 C
freezer w CSPs + vaccines: -50 to -15 C

52
Q

air sampling

A

do at least every 6 months by certified person or qualified compounding staff member

53
Q

surface sampling

A

periodically test: at least every 6 months for HD
tryptic soy agar with polysorbate 80 and lecithin added to neutralize disinfecting agent
perform at end of day
all regularly exposed surfaces (inside PECs, work surfaces) should be tested
results should indicate 0 CFUs
take action if >3 CFUs for ISO 5, >5 CFUs in ISO 7, and >100 CFUs in ISO 8 area

54
Q

air pressure testing

A

confirms differential between two spaces
ensures airflow is unidirectional
check pressure gauge at least daily or preferably with every work shift

55
Q

humidity testing

A

check at least daily

56
Q

keeping sterile compounding area clean

A

preferably PECs and C-PECs running at all times
if power outage - stop compounding; clean PECs with germicidal agent and disinfect with sterile 70% ISA
if CPEC - sanitation needed if power turned out
run PEC/C-PEC for at least 30 minutes before compounding if power turned off
lint-free wipes used to clean PEC
clean with germicidal agent then disinfect with 70% IPA
use slight overlapping, unidirectional strokes
replace used wipes often
clean top to bottom, back to front (cleanest areas
cleaned first)
sterile work: clean counters and floors with germicidal and sterile 70% IPA every day
HD: sanitize work area at end of shift
monthly: clean ceiling, walls, shelving, chairs, bins, carts

57
Q

HD cleaning

A

sanitize by deactivating, decontaminating, cleaning at least daily
sterile must be disinfected
use wetted wipes for sanitizing agent
wear appropriate PPE
deactivation and decontamination: use bleach or peroxide
neutralize bleach afterwards

58
Q

black waste bin

A

Bulk HD waste: containers with visible amount of HD, supplies used to administer/clean spills of HD

59
Q

yellow waste bin

A

trace HD waste
empty syringes, IV bags, used PPE

60
Q

red waste bin

A

non-HD sharps

61
Q

drug exposure

A

1) remove garb that has drug on it
2) cleanse affected skin with soap and water
3) eye exposure: flood with water or isotonic eyewash for >=15 min
4) obtain medical attention when warranted

62
Q

HD exposure and spill management

A

eye and face protection if risk of HD spills/splashes
face shields with goggles preferable for HD

63
Q

respiratory protection HD

A

when HDs unpacked and not contained inplastic: wear elastromeric half-mask with multi-gas cartridge and P100-filter until confirmed no breakage or spillage during transport
N95 respirator for most HD compounding
if risk of respiratory exposure: fit-tested respirator mask with gas canisters or powered air-purifying respiratory (PAPR)

64
Q

HD spilled

A

SDS should be consulted on clean-up procedures

65
Q

HD spill kit contents

A

gown
latex gloves
N95 respirator plus goggles
HD waste bag
chemo pads
HD spill report exposure form

66
Q

HD procedure to cleaning up spill

A

put heavy duty gloves over ASTM D6978 (chemotherapy) - rated gloves
put in bulk HD waste (black bin)

67
Q

administering HD

A

two pairs of chemotherapy gloves required
gown required if IV HDs
closed-system drug transfer devices (CSTDs) must be used by nurses for administration
chemo pins used to prevent HDs from aerosolizing
CSTDs used to transfer whenever possible to keep HDs in device - reduce leaks/spills from reconstituting dried powders into solutions
CSTDs recommended when compounding HD and required for administering antineoplastics
CSTDs have build-in valve that equalizes air pressure
manipulate (crushing tablets) in plastic bag

68
Q

HD disposal

A

outer chemo gloves go to yellow waste bin inside C-PEC or put in sealable bag if outside C-PEC
chemo gown and outer shoe covers taken off before leaving negative-pressure area and go in yellow waste bin
put trace antineoplastic waste (empty vials, empty syringes, empty IV bags, IV tubes, used gloves, used gowns, used pads) go in yellow waste bin
bulk antineoplastic waste (unused/partially empty IV bags, syringes, and vials) - black waste bin

69
Q

transporting HD

A

pneumatic tube cannot be used to transport liquid HD or any antineoplastics bc risk of breakage/contamination

70
Q

garb for HD drugs

A

double ATM D6978 (chemotherapy) - rated gloves when compounding or cleaning up spills; single gloves for receiving/storage
non-sterile HD: if BSC or CACi not available: use double gloves, gown, mask, disposable pad for work surface
sterile HD: head covers, face mask, beard covers, two pairs shoe covers, liquid-impermeable gown, two pair chemo gloves
full-facepiece respirator or face shield with goggles

71
Q

garbing for sterile compounding

A

remove coat, sweater, makeup, jewelry before going to ante-area; no artificial nails
done garb in ante-area dirtiest to cleanest
head/facial hair covers and face masks
then shoe covers where stepping over line of demarcation (second pair of shoe covers for HDs)
wash hands with soap and water, clean under fingernails, wash fingertips to elbows in circulation motion for 30 seconds
non-shedding gown (disposable required for HD and preferred for non-HD)
enter buffer area (SEC)
use alcohol-based surgical hand scrub (chlorhexidine or povidone-iodine if allergic)
put on sterile, powder-free gloves (2 pairs ASTM D6978 chemo gloves required for HD compounding)
sanitize gloves with 70% IPA routinely during compounding or if touch non-sterile surface
use all this garb with isolator/glove box unless manufacturer documents not required
if not visibly soiled, gown can be kept on clean side of anteroom and re-worn for later in shift

Naplex 2023 (21 decks)

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