compounding I: basics Flashcards
U.S Pharmacopeia
sets the standard for compounding preperations.
795 for non-sterile
797 for sterile
+800 if it is hazard..
non-sterile compounding
- prepare a dose or formulation taht is not commercially available: such as
—> Changing a solid tab to liquid
—> compounding an ointment 10% when only 5% and 15% available - avoid an excipient (ex. dye, gluten)
- add a flavor to med
non-sterile prep admin include: by mouth, via tube, rectally, vaginally, topically, nasally or in the ear
USP 795 divides non-sterile compounding into three categories based on complexity
- simple: following instructions (kits, w/ step by step)
- moderate: specialized calculations or procedures, or making a preparation that no established stability data. (ex. mixing two topical creams when stability data for mixture is not available)
- complex: requires specialized training, equipment, facilities or procedures (ex. transdermal dosage forms)
specifically designated for non-sterile compounding
- separate location
- performed in ambient air (room air)
- separated from the dispensing part of pharm
- all components, equipment should be stored off the floor
two types of water:
- portable (drinkable)
- purified (distilled) for water-containing formulations and for rinsingequipment..
sterile compounding used to prep:
- IV
- IM and subq
- radio pharm
- eye drops
- irrigation
- pulmonary inhalation (not include nasal inhalation)
CSPs
compounding sterile products
SVP
small volume parenteral
<100ml
LVP
large volume parenteral
>100ml
PPI
personal protective equipment
“don”- put on
“doff”- take off
PEC
primary engineering control
LAFW
Laminar Airflow Workbench
C-PEC
containment Primary engineering control
BSC
biologic safety cabinet
SEC
secondary engineering control
C-SEC
containment secondary engineering control
SCA
segregated compounding area
C-SCA
containment segregated compounding area
CAI
compounding aseptic isolator
CACI
compounding aseptic containment isolator
RABS
restricted access barrier system
CSTD
closed system transfer device
CVE
containment ventilated enclosure
air quality
particles per volume of air, lower particle= cleaner air
critical areas, closet to exposed sterile drugs
ISO 5
particles in the count 0.5 microns or larger
buffer area
anteroom (garbing)
buffer ISO 7- the SEC contains PEC
anteroom- at least ISO 8 if it opens into positive-pressure room, but at least ISO7 if negative pressure room
ISO 5
ISO 6
ISO 7
ISO 8
3,520
35,200
352,000
3,520,000
high efficiency article air filters
HEPA are >99.97% efficient at removing particle as small as 0.3
must be recertified every 6 month
vertical flow
HEPA filter at at the top of the sterile hood
laminar flow
HEPA filter at the back- horizontal flow
direct compounding and first air
- PEC provides ISO 5 air quality for sterile compounds. air coming directly out of HEPA is first air
- do not obstruct first air
- do not block airflow
to prevent contamination, injection port of the villa and syringe needle must be kept in the first air
Prevent contamination of air in PEC
- wipe off outsides of all material w/ 70% isopropyl alcohol before bring into PEC
- open packages along designed tear lines
- compound 6” inside the sterile hood
- move waste outside shortly after it is created
non-hazardous compounding
pressure inside PEC and SEC is positive
hazardous
PEC (C-PEC) and SEC (C-SEC) is negative pressure
types of sterile compounding area
- cleanroom suite: one or more ISO-5 PECs (sterile hoods) inside an ISO 7 buffer room that is entered through an adjacent anteroom
- segregated sterile compounding area (SCA) w/ ISO 5-PEC: sterile hood often an isolated (glovebox) w/ closed front. -unclassified air
NIOSH general categories of hazardous meds
- carcinogenic
- teratogenic
- genotoxic
- toxic to organs at low doses
- labeled by the manufacturer w/ special handling instructions
Key hazardous drugs on NIOSH list
abortifacient
Mifepristone, misoprostol
Key hazardous drugs on NIOSH list
antiretrovirals
antiviral
abacivr, entecavir, zidovudine
cidofovir, ganciclovir, valganciclovir
Key hazardous drugs on NIOSH list
antibiotics
antifungal
anticoagulants
chloramphenicol
fluconazole, voriconazole
warfarin
Key hazardous drugs on NIOSH list
acne
arrhythmias
isotretinoin
dronedarone
Key hazardous drugs on NIOSH list
autoimmune condition
acitretin, azathioprine, leflunomide
fingolimod, teriflunomide
Key hazardous drugs on NIOSH list
benign prostatic hyperplasia (BPH)
biphosphate
dutasteride, finasteride
pamidronate, zoledronic acid
Key hazardous drugs on NIOSH list
chemoprotectant (cardiac)
depression
diabetes
dexrazoxane
paroxetine
exenatide, liraglutide
Key hazardous drugs on NIOSH list
dyslipidemia
seizure/epilepsy
lomitapide
clobazam, clonazepam
carbamazepine, oxcarbamazepine, eslicarbazepine, divalproex, fosphenytoin, phenytoin, topiramate, vigabatrin, zonisamide
Key hazardous drugs on NIOSH list
gout
HF
Hepatitis
colchicine
ivabradine, spironolactone
ribavarin
Key hazardous drugs on NIOSH list
hormonal agents
androgens
estrogens
oxytocin, dinoprostone
progesterones
SERD/SERMs
ulipristal
Key hazardous drugs on NIOSH list
hyperthyroid
insomnia
methimazole, propylthiouracil
temazepam, triazolam
Key hazardous drugs on NIOSH list
iron overload
migraine
Parkinson
deferiprone
dihydroergotamine
apomorphine, rasagiline
Key hazardous drugs on NIOSH list
pulmonary arterial hypertension
schizophrenia
transplant
ambrisentan, bosentan, macitentan, riociguat
ziprasidone
cyclosporine, mycophenolate, tacrolimus, sirolimus
as part of assessment of risk (AoR), standard operating procedures (SOPs) must be developed:
- putting HDs in distinctive shelf bins to alert staff
- wearing ASTM D6978 rated gloves when counting or packaging drugs
- dedicating a counting tray and spatial for HDs and decontaminating both after use
- placing prepared HD containers into a sealable plastic bag
AoR doc reviewed every 12 months or whenever a new drug or dosage form is stocked or used
HD hoods and buffer room include word containment
C-PEC
C-SEC
C-SCA
CACI
C-PEC is located inside C-SEC or C-SCA
type of C-PEC for HD
BSCs
biological safety cabinets have vertical laminar airflow and negative air pressure
for sterile hazardous drugs
type of C-PEC for HD
CVEs
containment ventilated enclosures are powder containment hood w/ HEPA filter air and negative air pressure
used for non-sterile compounding only
type of C-PEC for HD
CACIs
are closed-front C-PECs (gloveboxes) located in buffer room (SEC) but are often located in C-SCA
external vent, negative air pressure
it is perferred that non-sterile and sterile compounding space separate, an exception can be made to prepare a non-sterile hazardous drug in a C-PEC inside a C-SEC if these requirements are met
- C-SEC must maintain ISO 7
- separate sterile and non-sterile C-PEC in same C-SEC y at least 1 meter apart
- particle-generating activity (powders) can not be performed at the same time
- occasional non-sterile HD compounding can be completed C-PEC but it must be properly decontaminated, cleaned, and disinfected before using again with sterile HDs
negative pressure
C-PECs, C-SECs, and C-SCAs
air changes
non-sterile HD (C-SEC) 12ACPH
sterile C-SEC 30 ACPH
C-SCA 12 ACPH
ACPH- air changes per hour
hazardous drug storage
stored separately from non-hazardous drugs, negative pressure 12 ACPH
temp monitoring
SEC buffer room- once daily, kept at 20 C or 68F or cooler
refrigerator and freezer monitor daily unless they contain vax which is twice daily monitoring
refrigerator: 2 to 8C
freezer: -25 to -10C- w/vax -50 to-15 per CDC
air sampling
every 6 months
Keep PEC running
running at all times,
if there is a power outage, all compounding must stop, and PEC cleaned w/ germicidal detergent and then disinfected w/ sterile 70% isopropyl alcohol
must be on for least 30min before compounding
deactivation and decontamination
2%bleach (sodium hypochlorite) or peroxide
cleaning
germicadal detergetn such as
Quat, ammonium, phenolics (removes dirt and microbial contamination)
Disinfection
sterile 70% isopropyl alcohol (PA)
inhibits or destroys microorganism; required in sterile compounding
black waste bin
black is for bulk HD waste: any containers (drug vials, IV bags) that contain a clearly visible amount of HD and any supplies that were used to admin HDs or to clean HD spills
Yellow waste bin
trace HD waste: empty syringes, IV bags, used PPE, including gowns, gloves, masks, and shoes
red sharps contain is only for non-hazardous sharps
disposal hazard
- outer chemotherapy gloves worn during compounding is discarded in yellow waste bin inside C-PEC. or put in a sealable bag if discarding outside
- chemo gown and outer shoe covering ist take off before exiting the negative-pressure area and thrown in yellow bin
garb for HD
general
Nonsterile HD
- double ASTM D6978 (chemotherapy) rated golves when compounding or cleaning up spills
- single gloves can be used for HD receiving and storage
- double gloves, gown, a mask and
- disposable pad to protect the work surface
garb for HD
sterile HD
- head covers, face mask, and beard covers if applicable
- two pairs of shoe covers
- gown impermeable to liquid
- two pairs of ASTM D6978 gloves
- full-facepiece respirator or a face shield w/ googles
garbing for sterile
-remove coat, rings, watches, etc. no make up
- don head and facial coverings, facemask and then shoe covers (2nd pair are needed for HD)
- perform hand hygiene w/ sopa and warm water
–> clean under fingernails, fingertips to elbow, circular motion for 30 seconds
–> Dry hands
-don nonshedding gown and disposable gown
- enter buffer area (SEC)
–> apply an alcohol-based surgical hand scrub
–> don sterile, powder-free gloves, two pairs of chemo for HD
–> stanize gloves w/ 70% IPA
garbing for HD
- N95
- fae shield w/googles or respirator
- gloves must be changed every 30min or when torn, punctured or contaminated
- gloves powder free
- for non-sterile HD, glove one pair is ok
- glove two pairs must be to admin drug
- gown changed every 2-3 hrs or immediately after spill
- two pairs of shoe covering
Admin HD
- two pairs of chemo drugs
- ## gown required when IV HD
test to ensure pharmacists and techs are performing sterile compounds safely good and properly
- gloved fingerprint test
- media-fill test (tryptic soy broth)
