15. Compounding I: Basics Flashcards
Which USP chapter is related to non-sterile compounding?
USP 795
Which USP chapter is related to sterile compounding?
USP 797
Which USP chapter is related to hazardous compounding?
USP 800
Non-sterile compounding is primarily used to ____ (3 examples)
Prepare dose or formulation that is not commercially available (solid tablet to liquid for NPO, preparing 10% ointment when only 5% and 15% is available)
Avoid an excipient (e.g. gluten or red dye)
Add flavor (e.g. cherry-flavored antiviral suspension for a child
What type of non-sterile compounding: using compounding kit with step-by-step instructions
simple - requires simply following instructions
What type of non-sterile compounding: mixing 2 topical creams when stability data for the mixture is not available
moderate - requires special calculations or procedures or making a preparation that has no established stability data
What type of non-sterile compounding: transdermal dosage forms
complex - requires specialized training, equipment, facilities, or procedures
Define CSPs
Compounded sterile products
IVs or other drugs that require sterile manipulation
Define SVP
Small volume parenteral
IV bag or container containing ≤100mL
Define LVP
Large volume parenteral
IV bag or container containing >100mL
Define PPE
Personal protective equipment
Garb; “don” means to put on, “doff” means to take off
Define PEC
Primary engineering control
Sterile hood that provides ISO 5 air for sterile compounding
Define LAFW
Laminar airflow workbench
Type of sterile hood (PEC); parallel air streams flow in one direction
Define C-PEC
Containment primary engineering control
Ventilated (negative pressure) chemo hood used for HDs
Define BSC
Biological safety cabinet
Chemo hood (Class II or III for sterile HD), a type of C-PEC
Define SEC
Secondary engineering control
ISO 7 “buffer room” where the sterile hood (PEC) is located
Define C-SEC
Containment secondary engineering control
Ventilated (negative pressure) buffer room for HDs (room where C-PEC is located)
Define SCA
Segregated compounding area
Designated space that contains an ISO 5 hood but is not part of cleanroom suite (air is not ISO-rated)
Define C-SCA
Containment segregated compounding area
Ventilated (neg pressure) room used for HDs; not in a cleanroom suite (air is not ISO-rated)
Define CAI
Compounding aseptic isolator
“Glovebox” for non-HDs, a closed-front sterile hood (PEC)
Define CACI
Compounding Aseptic Containment Isolator
“Glovebox” for HDs, a type of closed-front C-PEC
Define RABS
Restricted access barrier system
“Glovebox”/closed-front sterile hood (includes CAIs and CACIs)
Define CSTD
Closed system transfer device
Device preventing escape of HD/vapors when transferring (e.g. from a vial to a syringe)
Define CVE
Containment ventilated enclosure
Ventilated “powder hood” for non-sterile products (can be used for HDs if USP 800 standards are met)
The ISO sets the standards for air quality, which is determined by ____
the number and size of particles per volume of air
In critical areas that are closest to exposed sterile drugs and containers (i.e. inside the sterile hood (PEC)), the air quality must be at least ISO ___
5
ISO 5 means there are no more than ___ particles per cubic meter. Particles are included in this count if they are ___ microns (µm) or larger.
3520, 0.5 microns
The buffer area (the SEC, which includes PECs) must be at least ISO ___
7
The anteroom (room adjacent to the SEC, where hand washing and garbing occurs) must be at least ISO ___ if it opens into a positive-pressure buffer area (non-HD sterile compounding)
8
The anteroom (room adjacent to the SEC, where hand washing and garbing occurs) must be at least ISO ___ if it opens into a negative-pressure buffer area (HD sterile compounding)
7
Smaller the ISO #, the (cleaner/dirtier) the air is
Cleaner
HEPA filteres are >___% efficient in removing particles as small as __ microns wide or larger, including bacteria, viruses, fungi, and dust
99.97%, 0.3 microns
In vertical airflow biological safety cabinet (BSC) or C-PEC, the HEPA filter is at the (top/back) of the sterile hood
Top
In lamina airflow workbench (LAFW) or PEC, the HEPA filter is at the (top/back) of the sterile hood
back (horizontal airflow)
Compounding should be done in the cleanest air, which the air coming directly (into/out of) the HEPA filter
out of
The HEPA filter must be recertified by a speciality every ___ and any time a PEC has been moved
6 months
The air coming directly out of the HEPA filter is called ___
first air
Compound at least ___ inside the sterile hood to prevent exposing CSPs to dirtier ISO 7 airs from the SEC
6 inches
For non-HD compounding, air pressure inside PEC and SEC are (positive/negative)
Positive - since the air will not cause toxicity if it moves into adjacent spaces
For HD compounding, air pressure inside PEC and SEC are (positive/negative)
Negative - to contain and exhaust the toxic air in the space (protects compounding staff)
The max BUD for a CSP made in a segregated compounding area (SCA) is __
12 hrs
___ is a designated area with unclassified air and does not have a buffer area or ante room, only to be used for certain (low-risk) CSPs
Segregated compounding area (SCA)
What makes a drug considered to be hazardous?
Carcinogenic
Teratogenic (cause congenital disabilities) or has reproductive toxicity
Genotoxic
Toxic to organs at low doses
Labeled by manufacturer with special handling instructions
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Abortifacients
Mifepristone, misoprostol
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antibiotics
Chloramphenicol
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Anticoagulants
Warfarin
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antifungals
Fluconazole, voriconazole
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antiretrovirals
Abacavir, entecavir, zidovudine
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antivirals
Cidofovir, ganciclovir, valganciclovir
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Acne
Isotretinoin
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Arrythmias
Dronedarone
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Autoimmune conditions
Acitretin, azathioprine, leflunomide, fingolimod, teriflunomide
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: BPH
Dutasteride, finasteride
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Bisphosphonates
Pamidronate, zoledronic acid
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Chemoprotectant (Cardiac)
Dexrazoxane
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Depression
Paroxetine
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Diabetes
Exenatide, liraglutide
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Dyslipidemia
lomitapide
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Seizures/Epilepsy
Clobazam, clonazepam
carbamazepine, oxacarbazepine, eslicarbazepine, divalproex, fosphenytoin, phenytoin, topiramate, vigabatrin, zonisamide
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Gout
Colchicine
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: HF
Ivabradine, spironolactone
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Hepatitis
Ribavirin
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Hromonal Agents
Androgens (e.g. testosterone)
Estrogens (e.g. estradiol)
Oxytocin, dinoprostone
Progesterones (e.g. medroxyprogesterone)
SERD/SERMs (e.g. fulvestrant, tamoxifen)
Ulipristal
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Hyperthyroidism
Methimazole, Propylthiouracil
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Insomnia
Temazepam, triazolam
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Iron overload
Deferiprone
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Migraine
Dihydroergotamine
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Parkinson Disease
Apomorphine,rasagiline
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Pulmonary Arterial Hypertension (PAH)
Ambrisentan, bosentan, macitentan, riociguat
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Schizophrenia
Ziprasidone
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Transplant
Cyclosporine, mycophenolate, tacrolimus, sirolimus
___ are a series of safety documents required by OSHA to be accessible to all employees working with hazardous materials
Safety data sheets (SDS)
Pharmacies must maintain a list of all hazardous drugs stocked. The list must be reviewed every ___ or whenever a new drug or dosage form is stocked or used.
12 months
T/F: Prior to handling any HDs, both men and women with reproductive capability must confirm in writing that they understand the risks a/w handling HDs
True
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 w/o manipulation
Assessment of Risk (AoR)
T/F: If AoR is conducted, full USP 800 requirements do not have to be followed for tasks like using powder to prepare a solution or cutting tablets in half
False - if any manipulation of the low-risk hazardous drug is required (e.g. using powder to prepare a solution ,cutting tablets in half, adding a vial of HD to a large volume fluid), USP 800 requirements must be followed
Adequate aseptic technique in hand hygiene, garbing, and gloving is demonstrated by passing the ____
gloved fingertip test
Adequate aseptic technique in sterile drug preparation is demonstrated by passing the ____
media-fill test
How often do you need to pass the gloved finger test and media-fill test?
Initially then annually if compounding only low- and medium-risk CSPs OR semi-annually if compounding high-risk CSPs
What is required to pass the initial gloved finger test?
3 consecutive gloved fingertip samples, taken after garbing, with 0 colony-forming units (CFUs) for both hands
What is required to pass the annual/semi-annual gloved finger tests?
At least 1 sample taken from each hand immediately after completion of media-fill test, with a goal of ≤3 CFUs total for both hands
What is required to pass the media-fill test?
If the liquid stays clear after 14 days of incubation, the compounder passed the test
The SEC (buffer room) should be checked once daily and maintained at ___ºC or ___ºF or cooler
20ºC or 68ºF
The refrigerator and freezer should be monitored daily (or twice daily if it containes vaccines).
Refrigerator temperature between ___ to ____ ºC
Freezer temperature between ___ to ___ºC if no vaccines
Freezer temperature between ___ to ___ºC if yes vaccines
2 to 8ºC
-25 to -10ºC
-50 to -15ºC
Air sampling for contaminants, performed at least every ___
6 months
Surface sampling for contaminants, performed periodically; areas touched most frequently should be tested ___
at the end of the day (dirtiest state)
Air pressure testing, performed ___ to confirmed the correct differential between two spaces and ensure that the airflow is unidirectional
once daily (minimally) or with every work shift
Humidity testing performed ___; should be maintained below __% because excess moisture can lead to bacterial growth
once daily (minimally)
60%
PECs and C-PECs should be running at all times. If there is a power outage, PECs will need to be cleaned with _____ and then disinfected with ____. (C-PECs sanitation more complicated)
Afterwards, they must be turned on for at least ___ before compounding can begin
Germicidal detergent
Sterile 70% isopropyl alcohol (IPA)
30 mins
T/F: You should spray inside the PEC and use circular motions when cleaning
False - you should never spray inside the PEC. Use slightly overlapping, unidirectional strokes.
What order should PECs be cleaned? (top/bottom/front/back)
Top to bottom
Back to front
(Cleanest will be cleaned first, dirtiest will be cleaned last)
All areas and equipment used for handling HDs must be sanitized. What are the steps?
- Deactivation and decontamination: 2% bleach (sodium hypochlorite) or peroxide (reduce HD toxicity and remove HD residue)
- Cleaning: Germicidal detergent, such as Quat, Ammonium, Phenolics (removes dirt and microbial contamination)
- Disinfection: sterile 70% isopropyl alcohol (inhibits or destroys microorganisms; required step in sterile compounding)
T/F: Using a spray bottle to spray onto HD handled surfaces and equipment directly is preferred for more thorough sanitation
False - wetted wipes should be used instead because the spray can cause HD residue to aerosolize and spread to other areas
Bleach can cause corrosion on stainless steel surfaces (includes surfaces of C-PECs). To prevent corrosion, how should you neutralize bleach?
Wipe afterwards with sodium thiosulfate, sterile alcohol, sterile water, or a germicidal detergent
Which product is an example of a multi-purpose agent that combines deactivation and decontamination steps of sanitation?
Peridox RTU
Pharmacies involved in HD compounding should perform wipe sampling of all compounding surfaces initially and at least every ___
6 months
For eye exposure, flood affected eye at an eyewash fountain or with water or an isotonic eyewash for at least ____
15 minutes
When HDs are unpacked and they are not contained in plastic, the staff member should wear ____, until assessment of the packaging integrity ensures that no breakage or spillage occurred during transport
an elastomeric half-mask with a multi-gas cartridge and P100-filter
An N95 respirator is sufficient for most HD compounding but does not provide adequate protection against ___
gases, vapors, or direct liquid splashes
____ should be consulted for guidance on spill clean-up procedures
Safety Data Sheets (SDS)
What is typically in a spill kit?
Protective gown, latex gloves (minimally), N95 respirator mask plus goggles with side shields
HD waste bag, scoop and scraper to get spill waste into waste bag, chemo pads to absorb HD liquid
HD spill report exposure form to document HD exposure
What kind of gloves should be used when handling hazardous drugs? (compounding or cleaning up a spill)
ASTM D6978 (chemotherapy)-rated gloves
T/F: When there is a hazardous spill, powders and broken glass should be broomed immediately
False - never use a brush to clean up broken glass or powder that is contaminated with HDs. Brushes can cause particles to become airborne.
How many pairs of chemotherapy gloves are required when administering HDs?
two pairs
T/F: a chemotherapy gown is required when administering all HDs
False - only required for IV HDs, recommended for all others
What goes in black waste bins?
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 administer HDs or to clean up HD spills
What goes in yellow waste bins?
Trace HD waste: empty syringes, IV bags, used PPE including gowns, gloves, masks, and shoe covers
What goes in red waste bins?
Used for infectious waste, including IV tubing and used culture dishes.
Red sharps container only used for non-hazardous sharps, such as used syringes.
Used syringes from preparing HDs goes into YELLOW
What should staff wear for PPE when sterile HD compounding?
Head covers, face mask, beard covers (if applicable)
2 pairs of shoe covers
a gown impermeable to liquids
2 pairs of ASTM D6978 (chemotherapy)-rated gloves
full-facepiece respirator or a face shield with goggles when there is a risk for spills or splashes
