Compounding 1: Basics Flashcards
compounded drugs
for individual patient based on prescription
cannot be commercially available
U.S. Pharmacopeia (USP)
standards for compounding
chapters 795, 797, 800 set minimum acceptable standards
USP 795
non-sterile compounding
USP 797
sterile compounding
USP 800
hazardous drugs
American Society of Health-System Pharmacists
ASHP
how to implement USP into hospital
reasons for non-sterile compounding
dose or formulation not commercial available
avoid excipient
add flavor
administration routes for non-sterile
mouth, tube, rectally, vaginally, topically, nasally, in ear
USP 795 simple
following instructions
USP 795 moderate
specialized calculations or procedures
OR no established stability data
USP 795 complex
needs specialized training, equipment, facilities, procedures (transdermal form)
non-sterile compounding physical space
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
types of sterile compounding
IV
IM
SC
eye drops
irrigations
inhalation (not nasal)
CSP
compounded sterile products
SVP
small volume parenteral
100 mL or less
LVP
large volume parenteral
>100 mL
PPE
personal protective equipment
don = put on; doff = take off
PEC
primary engineering control
sterile hood that give ISO 5 air for compounding
LAFW
laminar airflow workbench
sterile hood (PEC) type; parallel air streams flow in one direction
C-PEC
containment primary engineering control
negative pressure chemo hood for HDs
BSC
biological safety cabinet
chemo hood (Class II or III for sterile HD)
type of C-PEC
SEC
secondary engineering control
negative pressure buffer room for HDs
where C-PEC is located
SCA
segregated compounding area
space with ISO 5 hood but not part of cleanroom suite (air is not ISO-rated)
CAI
compounding aseptic isolator
“glovebox” for non-HDs
closed-front sterile hood (PEC)
CACI
compounding aseptic containment isolator
“glovebox” for HDs
type of closed-front C-PEC
RABS
restricted access barrier system
“glovebox”/closed-front sterile hood (CAIs and CACIs)
CSTD
closed system transfer device
device preventing escape of HD/vapors when transferring
CVE
containment ventilated enclosure
ventilated “powder hood” for non-sterile products
can be used for HD is USP 800 met
International Standards Organization
sets air quality standards by particles per voume of air
lower count = cleaner
particles 0.5 microns or bigger count
air quality for USP 797
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
HEPA filters
> 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)
ISO air quality inside of PEC
wipe off materials with 70% ISA
tear packages along tear line
compound inside the hood 6”
air presure
positive for non-HD
negative in C-PEC and C-SEC for HD
CAI air flow
often inside SCA
practice hand hygiene
use sterile powder-free gloves inside CAI
line of demarcation
in anteroom to show clean from dirty side
apply shoe covers one at a time while stepping over the line
SCA
unclassified air
max BUD for 12 hours
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare settings
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
SDS
safety data sheets
previously MSDS
for those working with hazardous materials
hazard communication program
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
lower-risk HD activities
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
USP 800 physical space basics
hoods/buffer rooms for HDs include containment (C-PEC)
C-PECs for HDs
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
non-sterile and sterile HD in same space
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
negative air pressure
required in C-PECs, C-SECs, and C-SCAs
HD air changes
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
HD external exhaust
required for air with HDs
cannot be recirculated
alternative: use redundant HEA filters (has multiple HEPA filters in a series)
HD storage
store separately from non-HD
negative-pressure room of >=12 ACPH
compounding staff training/testing
hand hygiene, garbing, gloving - pass gloved fingertip test
gloved fingertip test
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
media-fill test
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
temperature monitoring
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
air sampling
do at least every 6 months by certified person or qualified compounding staff member
surface sampling
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
air pressure testing
confirms differential between two spaces
ensures airflow is unidirectional
check pressure gauge at least daily or preferably with every work shift
humidity testing
check at least daily
keeping sterile compounding area clean
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
HD cleaning
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
black waste bin
Bulk HD waste: containers with visible amount of HD, supplies used to administer/clean spills of HD
yellow waste bin
trace HD waste
empty syringes, IV bags, used PPE
red waste bin
non-HD sharps
drug exposure
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
HD exposure and spill management
eye and face protection if risk of HD spills/splashes
face shields with goggles preferable for HD
respiratory protection HD
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)
HD spilled
SDS should be consulted on clean-up procedures
HD spill kit contents
gown
latex gloves
N95 respirator plus goggles
HD waste bag
chemo pads
HD spill report exposure form
HD procedure to cleaning up spill
put heavy duty gloves over ASTM D6978 (chemotherapy) - rated gloves
put in bulk HD waste (black bin)
administering HD
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
HD disposal
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
transporting HD
pneumatic tube cannot be used to transport liquid HD or any antineoplastics bc risk of breakage/contamination
garb for HD drugs
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
garbing for sterile compounding
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
