Compounding Flashcards
Who sets the standards for compounding preparations?
U.S. Pharmacopeia (USP)
USP 795 pertains to ____
Non-sterile compounding
USP 797 pertains to _____
Sterile compounding
USP 800 pertains to _____
Handling Hazardous Drugs
Sterile HDs consist of:
IV drugs, eye drops
Non-sterile HDs consist of
orals, topicals, nasals
Who determines which drugs are hazardous?
National Institue for Occupational Safety and Health (NIOSH)
What do hospital pharmacists rely on for detailed guidance on implementing USP standards?
American Society of Health-System Pharmacists (ASHP)
What provides drug-specific safety information including PPE, first aid procedures, and spill clean-up?
SDS (Safety Data Sheet)
What are the four primary reasons non-sterile compounding is used for?
- change the formulation of a medication
- avoid excipient due to intolerance
- prepare a dose or formulation that’s not commercially available
- add flavor
What are the four characteristics that could make a drug hazardous
- carcinogenic
- teratogentic
- organ toxicity at low doses
- genotoxic (damages DNA)
Prior to handling HDs what must men and women of reproductive capability do?
confirm in writing that they understand the risks associated with handling HDs
Key HDs: abortifacient
misoprostol
Key HDs: antibiotics
chloramphenicol
telavancin
Key HDs: anticoagulants
warfarin
Key HDs: antifungals
fluconazole
Key HDs: antiretrovials
abacavir, entecavir, nevirapine, zidovudine
Key HDs: antivirals
cidofovir, ganciclovir, valganciclovir
Key HDs: acne
isotretinoin
Key HDs: arrhythmias
dronedarone
Key HDs: BPH
finasteride, dutasteride
Key HDs: depression
paroxetine
Key HDs: diabetes
exenatide
Key HDs: gout
cochicine
Key HDs: heart failure
ivabradine, spironolactone
Non-sterile compounding should not take place in sterile space unless:
it’s a non-sterile HD
what is a powder containment hood?
Not an ISO-rate air hood
simply a box to prevent powder from contaminating the air
what is a VCE
a ventilated compounding enclosure
a powder containment hood with ventilation
what types of water are needed for non-sterile compounding
Potable - for hand and equipment washing
Purified - for use in formulations and rinsing equipment
What spaces are required in a sterile compounding area?
- anteroom
- buffer area
- primary engineering control (PEC) or segregated compounding area (SCA)
What does the C in C-PEC and C-SEC stand for?
containment!
these rooms are required for compounding HDs
how far apart must sterile and non-sterile C-PECs be if non-sterile HDs are going to be compounded within a C-PEC
1 meter
C-PECS and C-SECs must have _____ air pressure
negative
negative air flow means
air is flowing into the hood and away from the person compounding
what is the minimum ACPH for non-sterile HD storage?
12 air changes per hour
what is the minimum ACPH for sterile HD space?
30 ACPH
when can a redundant HEPA filter be used?
non-sterile HD only
what size counts as a LVP (large volume parenteral)
IV container > 100 mL
Which is “cleaner” ISO 5 or ISO 7
ISO 5! means fewer particles of smaller size per volume of air
what ISO class must critical areas (sterile hood) in sterile compounding be?
ISO class 5 or better
what iso class must the buffer area be?
7
what iso class must the anterooom be?
8 if opens to a postive-pressure buffer area
7 if opens into a negative-pressure buffer area
HEPA filters are >99.99% efficient in removing particles as small as ___ microns
0.3
where is the HEPA filter in a vertical flow hood?
top!
where is the HEPA filter in a horizontal flow hood?
back!
how often must a HEPA filter be recertified?
every 6 months or anytime a PEC has been moved
where must the injection port of a vial and syringe be kept while compounding in a PEC?
first air!
how far inside the hood must compounding be completed in
6 inches
what is the line that runs down the center of an anteroom called?
line of demarcation
what is the BUD for a compound prepared stat in suboptimal conditions?
1 hour
when must air pressure be negative?
hazardous compounding, otherwise, positive is fine.
what is a CAI?
Compounding aseptic isolator
“glove boxes”
what is the max BUD for CSPs made in an isolator?
12 hours
What goes in what? (PECs and SECs)
PECs go in SECs (hoods go in rooms)
how long must liquid stay clear after a media-fill test before the compounded passes?
14 days
how long are plates from a gloved fingerprint test incubated?
2-3 days
