15. Compounding I: Basics Flashcards
1
Q
Which USP chapter is related to non-sterile compounding?
A
USP 795
2
Q
Which USP chapter is related to sterile compounding?
A
USP 797
3
Q
Which USP chapter is related to hazardous compounding?
A
USP 800
4
Q
Non-sterile compounding is primarily used to ____ (3 examples)
A
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
5
Q
What type of non-sterile compounding: using compounding kit with step-by-step instructions
A
simple - requires simply following instructions
6
Q
What type of non-sterile compounding: mixing 2 topical creams when stability data for the mixture is not available
A
moderate - requires special calculations or procedures or making a preparation that has no established stability data
7
Q
What type of non-sterile compounding: transdermal dosage forms
A
complex - requires specialized training, equipment, facilities, or procedures
8
Q
Define CSPs
A
Compounded sterile products
IVs or other drugs that require sterile manipulation
9
Q
Define SVP
A
Small volume parenteral
IV bag or container containing ≤100mL
10
Q
Define LVP
A
Large volume parenteral
IV bag or container containing >100mL
11
Q
Define PPE
A
Personal protective equipment
Garb; “don” means to put on, “doff” means to take off
12
Q
Define PEC
A
Primary engineering control
Sterile hood that provides ISO 5 air for sterile compounding
13
Q
Define LAFW
A
Laminar airflow workbench
Type of sterile hood (PEC); parallel air streams flow in one direction
14
Q
Define C-PEC
A
Containment primary engineering control
Ventilated (negative pressure) chemo hood used for HDs
15
Q
Define BSC
A
Biological safety cabinet
Chemo hood (Class II or III for sterile HD), a type of C-PEC
16
Q
Define SEC
A
Secondary engineering control
ISO 7 “buffer room” where the sterile hood (PEC) is located
17
Q
Define C-SEC
A
Containment secondary engineering control
Ventilated (negative pressure) buffer room for HDs (room where C-PEC is located)
18
Q
Define SCA
A
Segregated compounding area
Designated space that contains an ISO 5 hood but is not part of cleanroom suite (air is not ISO-rated)
19
Q
Define C-SCA
A
Containment segregated compounding area
Ventilated (neg pressure) room used for HDs; not in a cleanroom suite (air is not ISO-rated)
20
Q
Define CAI
A
Compounding aseptic isolator
“Glovebox” for non-HDs, a closed-front sterile hood (PEC)
21
Q
Define CACI
A
Compounding Aseptic Containment Isolator
“Glovebox” for HDs, a type of closed-front C-PEC
22
Q
Define RABS
A
Restricted access barrier system
“Glovebox”/closed-front sterile hood (includes CAIs and CACIs)
23
Q
Define CSTD
A
Closed system transfer device
Device preventing escape of HD/vapors when transferring (e.g. from a vial to a syringe)
24
Q
Define CVE
A
Containment ventilated enclosure
Ventilated “powder hood” for non-sterile products (can be used for HDs if USP 800 standards are met)
25
The ISO sets the standards for air quality, which is determined by ____
the number and size of particles per volume of air
26
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
27
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
28
The buffer area (the SEC, which includes PECs) must be at least ISO ___
7
29
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
30
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
31
Smaller the ISO #, the (cleaner/dirtier) the air is
Cleaner
32
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
33
In vertical airflow biological safety cabinet (BSC) or C-PEC, the HEPA filter is at the (top/back) of the sterile hood
Top
34
In lamina airflow workbench (LAFW) or PEC, the HEPA filter is at the (top/back) of the sterile hood
back (horizontal airflow)
35
Compounding should be done in the cleanest air, which the air coming directly (into/out of) the HEPA filter
out of
36
The HEPA filter must be recertified by a speciality every ___ and any time a PEC has been moved
6 months
37
The air coming directly out of the HEPA filter is called ___
first air
38
Compound at least ___ inside the sterile hood to prevent exposing CSPs to dirtier ISO 7 airs from the SEC
6 inches
39
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
40
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)
41
The max BUD for a CSP made in a segregated compounding area (SCA) is __
12 hrs
42
___ 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)
43
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
44
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Abortifacients
Mifepristone, misoprostol
45
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antibiotics
Chloramphenicol
46
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Anticoagulants
Warfarin
47
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antifungals
Fluconazole, voriconazole
48
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antiretrovirals
Abacavir, entecavir, zidovudine
49
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Antivirals
Cidofovir, ganciclovir, valganciclovir
50
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Acne
Isotretinoin
51
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Arrythmias
Dronedarone
52
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Autoimmune conditions
Acitretin, azathioprine, leflunomide, fingolimod, teriflunomide
53
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: BPH
Dutasteride, finasteride
54
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Bisphosphonates
Pamidronate, zoledronic acid
55
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Chemoprotectant (Cardiac)
Dexrazoxane
56
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Depression
Paroxetine
57
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Diabetes
Exenatide, liraglutide
58
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Dyslipidemia
lomitapide
59
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Seizures/Epilepsy
Clobazam, clonazepam
carbamazepine, oxacarbazepine, eslicarbazepine, divalproex, fosphenytoin, phenytoin, topiramate, vigabatrin, zonisamide
60
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Gout
Colchicine
61
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: HF
Ivabradine, spironolactone
62
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Hepatitis
Ribavirin
63
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
64
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Hyperthyroidism
Methimazole, Propylthiouracil
65
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Insomnia
Temazepam, triazolam
66
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Iron overload
Deferiprone
67
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Migraine
Dihydroergotamine
68
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Parkinson Disease
Apomorphine,rasagiline
69
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Pulmonary Arterial Hypertension (PAH)
Ambrisentan, bosentan, macitentan, riociguat
70
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Schizophrenia
Ziprasidone
71
Hazardous Key Drugs on the Niosh List: Non-antineoplastic: Transplant
Cyclosporine, mycophenolate, tacrolimus, sirolimus
72
___ are a series of safety documents required by OSHA to be accessible to all employees working with hazardous materials
Safety data sheets (SDS)
73
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
74
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
75
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)
76
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
77
Adequate aseptic technique in hand hygiene, garbing, and gloving is demonstrated by passing the ____
gloved fingertip test
78
Adequate aseptic technique in sterile drug preparation is demonstrated by passing the ____
media-fill test
79
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
80
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
81
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
82
What is required to pass the media-fill test?
If the liquid stays clear after 14 days of incubation, the compounder passed the test
83
The SEC (buffer room) should be checked once daily and maintained at ___ºC or ___ºF or cooler
20ºC or 68ºF
84
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
85
Air sampling for contaminants, performed at least every ___
6 months
86
Surface sampling for contaminants, performed periodically; areas touched most frequently should be tested ___
at the end of the day (dirtiest state)
87
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
88
Humidity testing performed ___; should be maintained below __% because excess moisture can lead to bacterial growth
once daily (minimally)
60%
89
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
90
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.
91
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)
92
All areas and equipment used for handling HDs must be sanitized. What are the steps?
1. Deactivation and decontamination: 2% bleach (sodium hypochlorite) or peroxide (reduce HD toxicity and remove HD residue)
2. Cleaning: Germicidal detergent, such as Quat, Ammonium, Phenolics (removes dirt and microbial contamination)
3. Disinfection: sterile 70% isopropyl alcohol (inhibits or destroys microorganisms; required step in sterile compounding)
93
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
94
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
95
Which product is an example of a multi-purpose agent that combines deactivation and decontamination steps of sanitation?
Peridox RTU
96
Pharmacies involved in HD compounding should perform wipe sampling of all compounding surfaces initially and at least every ___
6 months
97
For eye exposure, flood affected eye at an eyewash fountain or with water or an isotonic eyewash for at least ____
15 minutes
98
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
99
An N95 respirator is sufficient for most HD compounding but does not provide adequate protection against ___
gases, vapors, or direct liquid splashes
100
____ should be consulted for guidance on spill clean-up procedures
Safety Data Sheets (SDS)
101
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
102
What kind of gloves should be used when handling hazardous drugs? (compounding or cleaning up a spill)
ASTM D6978 (chemotherapy)-rated gloves
103
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.
104
How many pairs of chemotherapy gloves are required when administering HDs?
two pairs
105
T/F: a chemotherapy gown is required when administering all HDs
False - only required for IV HDs, recommended for all others
106
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
107
What goes in yellow waste bins?
Trace HD waste: empty syringes, IV bags, used PPE including gowns, gloves, masks, and shoe covers
108
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
109
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
