Compounding II Flashcards
1
Q
a complete absence of viable microorganisms and contaminants
A
sterility
2
Q
methods and manipulations required to minimize contamination of sterile compounded formulations
A
aseptic technique
3
Q
routes of administration for sterile preparation
A
IV, IM, SQ, IT, epidural, ID, ophthalmic, irrigations, intra-articular, pulmonary inhalations.
4
Q
a device or zone that provides ISO class 5 air quality environment for sterile compounding
A
primary engineering controls (PECs)
5
Q
an area where the PEC is placed, it incorporates specific design and operational parameters required to minimize risk of contamination within the compounding area
A
secondary engineering controls
6
Q
air quality in a PEC
A
ISO Class 5
7
Q
air quality in a SEC
A
ISO Class 7
8
Q
category for a CSP compounded in normal room air, aseptic technique and processes are followed, standards of practice are in place
cannot involve more than 3 different sterile products
A
immediate use
9
Q
BUD for immediate use CSP
A
administration within 4 hours following start of preparation
10
Q
category for CSP prepared in ISO 5 or better PEC that may be placed in an unclassified SCA and have shorter BUDs
A
category 1
11
Q
category of CSPs prepared in a cleanroom suite with longer BUDs
A
category 2
12
Q
category of CSPs that undergo sterility testing, supplemented with endotoxin testing when applicable, and have more requirements than category 2, still done in a cleanroom with a PEC
A
category 3
13
Q
hour and date after which a CSP may not be used, stored, and transported
A
BUD
14
Q
BUD at CRT for category 1 compounded in a SCA
A
<= 12 hours
15
Q
BUD in refrigerator for category 1 compounded in a SCA
A
<= 24 hours
16
Q
BUD at CRT for category 2
aseptically processed, no sterility testing, only sterile starting components
A
4 days
17
Q
BUD in a refrigerator for category 2
aseptically processed, no sterility testing, only sterile starting components
A
10 days
18
Q
BUD in a freezer for category 2
aseptically processed, no sterility testing, only sterile starting components
A
45 days
19
Q
initial competency training must be done with what 2 tests
A
gloved fingertip and thumb test
media fill test
20
Q
hand hygiene, garbing, and gloving must be requalified every
A
6 months for C1 & 2
3 months for C3
21
Q
active air sampling is done every
A
6 months for C1 & 2
1 month for C3
22
Q
surface sampling is done every
A
month for C1 & 2
week for C3
23
Q
destruction of microorganisms
A
terminal sterilization
24
Q
physical removal of organisms
A
filtration sterilization
25
this record must be kept for all CSPs from nonsterile ingredients or CSPs prepared for multiple patients
Master Formulation Record
26
record that must be kept for C1, 2, and 3 CSPs, or immediate use CSP for multiple patients
compounding record
27
when is bacterial endotoxin testing required
-C2 injectable CSP compounded from 1 or more nonsterile components and assigned a BUD that requires sterility testing
-C3 injectable CSP compounded from one or more nonsterile components
28
small IV catheter placed into a smaller peripheral vein for short term use
peripheral VC
29
central line, IV catheter terminating at the superior vena cava where contents are more quickly inserted
central VC
30
advantages of PVC
convenient, easy to place, minimal AEs when placed
31
disadvantages of PVC
limitations on what can be infused, short term use
32
advantages of CVC
few limitations on what can be infused, can infuse higher volumes faster, long term
33
disadvantages of CVC
placement requires trained personnel and may require sedation, complications
34
examples of vesicants
-vasopressors (dopamine, epinephrine, norepinephrine)
-chemotherapeutic agents (doxorubicin, vincristine, vinblastine)
-calcium salts
-digoxin
-promethazine
-nafcillin
35
steps to manage extravasation
1. stop administration
2. disconnect iv tubing
3. aspirate residual drug
4. administer drug specific antidote
5. elevate limb with site
6. local warming/cooling
36
filters are always needed with
ampules
37
which medications require filtration
amphotericin B, infliximab (remicade)
38
rapid drug administration in seconds to minutes
IV push
39
small volume infused over a specific amount of time
intermittent IV infusion
40
medication administered via secondary IV tubing connected to primary tubing
IV piggyback
41
BUD for a single dose container (vial, bag, etc.) once opened
immediate discard or 12 hours
42
BUD for a multi-dose container (bag, vial, etc) once opened
up to 28 days
43
critical points on a syringe
tip, plunger, plunger piston
44
critical point on an ampule
glass neck
45
critical point on a vial
rubber stopper unless to apply alcohol
46
what factors affect the stability of CSPs
time in solution
temperature
light exposure
agitation
47
type of incompatibility reaction that results in degradation of the drug
chemical
48
type of incompatibility occurring between the container, diluent, or another drug
physical
49
type of incompatibility that is mostly a problem with PVC containers, DEHP can leach into med, or drug moves into the container
container
50
type of incompatibility that needs to be considered when compounding... some drugs incompatible with D5W and NS
diluent
51
joining of infusion to minimize the number of lines, need to consider compatibility
y-site
52
consider drugs mixed in the same container for this type of compatibility
admixture
53
which 2 combinations are high risk incompatibilities
ceftriaxone + calcium
calcium + phosphate
54
kcal content in proteins
4 kcal/gram
55
kcal content in carbs
3.4 kcal/gram
56
kcal content in lipids
10% emulsion?
20%?
30?
10% = 1.1 kcal/mL
20% = 2 kcal/mL
30% = 3 kcal/mL
57
occurs when ILE administration exceeds the rate of hydrolysis, free fatty acid uptake, and clearance
fat overload syndrome
58
contraindications to ILE
hypersensitivity to soybean, egg, or fish
59
hepatic effects of long term PN that can progress to hepatic failure
PN associated liver disease (PNALD)
60
PN combination of dextrose, AA, and lipids in 1 is called?
it is most stable if components are what %?
3-in-1 (TNA)
10% dext, 4% AA< 2% lipid
61
creaming and cracking can occur with a TNA.. is this safe for administration?
creaming- yes, can make homogenous through inversion
cracking- no
62
what needs to be considered when compounding TPN?
calcium phos precipitation
ion balancing
ingredient volumes
osmolarity limitations
63
what influences calcium phos precipitation in TPN
dose/conc, Ca salts, pH/amino acid conc, order or Ca/phos addition, temperature, storage time
64
recommended filter when administering TNAs, dextrose-AA admixtures, and ILE
1.2 micron filter
65
standards for handling hazardous drugs to minimize risk of exposure to people
USP 800
66
maintains a list of HDs used in healthcare settings (defines criteria & identifies drugs as hazardous)
NIOSH
67
health risks associated with HDs include
fertility impairment
increases risk of cancer
68
performed to avoid having to follow USP 800 for low-risk HDs dispensed without manipulation, which is for low-risk activities such as counting and prepacking
assessment of risk
69
ventilated device to minimize worked and environmental HD exposure when directly handling HDs
containment primary engineering control (C-PEC)
70
air quality in C-PEC
ISO 5
71
types of C-PEC
containment ventilated enclosure
biological safety cabinet
compounding aseptic containment isolator
72
powder containment hood with HEPA filtered air and negative air pressure for NONSTERILE compounding only, type of C-PEC
containment ventilated enclosure (CVE)
73
vertical laminar airflow and negative air pressure for sterile compounding, must be class II or class III, type of C-PEC
biological safety cabinet (BSC)
74
closed front C-PEC that can be located in a buffer room or a C-SCA
compounding aseptic containment isolator (CACI)
75
room where C-PEC is placed, must be externally ventilated, physically separated, have appropriate air exchange, and have negative pressure, buffer room
containment secondary engineering control (C-SEC)
76
air quality in a C-SEC
ISO 7
76
drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapor concentrations outside the system
closed system transfer devices
77
when should closed system transfer devices be used
should be used for compounding when dosage form allows
MUST be used when administering antineoplastics when dosage form allows
78
facility requirements for nonsterile HD
C-PEC (CVE, BSC, or CACI) and a C-SEC both externally vented
79
facility requirements for sterile HD compounding
ISO 7 buffer room with ISO 7 anteroom with a C-PEC (BSC or CACI) and a C-SEC both externally vented
or
unclassified C-SCA with a C-PEC and a S-SEC
80
how to store HDs
separate, externally vented, negative pressure room with 12 ACPH
81
required PPE for compounding HDs
gown
head, hair, shoe covers
two pairs of gloves
82
PPE required for administration of HDs for antineoplastics or injectables
antineoplastics- 2 pair of chemo gloves
injectable- above + chemo gown
83
requirements for gloves when compounding HDs
wear 2 pairs that must be changed every 30 minutes or when damaged
where sterile outer gloves if sterile compounding
84
requirements for gowns when compounding HDs
change every 2-3 hours or immediately after a spill or splash
85
mask/eye/face protection requirements for HD compounding
goggles combined with face shields optimal
N95 respirator masks are sufficient
gas masks or a PAPR may be needed
86
disposal container used for all trace neoplastic waste (empty vials, empty syringes, empty containers, used PPE, chemo pads)
yellow
87
disposal container used for all bulk neoplastic waste (unused/partially used HD IV bags, syringes, and vials)
black
88
written plan detailing the implementation of HD safety procedures, proper personnel training, competency assessment, and maintaining a list of all required HD documentation
hazard communication program
89
SOP steps for a HD spill
-open spill kit, don PPE
-clean large spills and broken glass
-cover liquid with spill pad
-decontaminate surfaces where spill
-put hazard waste in bag and seal
-doff PPE & perform hand hygiene
-decontaminate respirator PRN
-replace spill kit
90
what should be in a hazardous drug spill kit
gowns, gloves, N95 mask, goggles with side shields, HD waste bag, scoop & scraper, chemo pads, HD spill exposure form
91
how often is environmental wipe sampling done for HD surfaces
every 6 months
92
ingredients other than the API, non-active, functional ingredients that facilitate function of API
excipients
93
excipient added to chelate metal ions that have unshared electrons in the outer shell
inactivates the metals that catalyze oxidative degradation of drug molecules
can prevent oxidation and hydrolysis
chelating agents
94
excipient added to inhibit free radicals produced by oxidation and maintain product stability
antioxidants
95
excipient added that consists of a weak base + salt of weak base or a weak acid + salt of weak acid so that the drug solubility/stability may achieve a certain pH
buffer
96
excipient added to increase drug solubility by using non-aqueous solvents
solubilizing agents
97
excipient added to slow or prevent microbial growth
preservatives
98
examples of chelating agents
edetate disodium
edetate calcium disodium
edetic acid
99
examples of antioxidants
ascorbic acid, tocopherols, sodium ascorbate, sodium thiosulfate, etc.
100
examples of buffers
sodium citrate + citric acid
sodium acetate + acetic acid
sodium bicarb + sodium carbonate
101
examples of solubilizing agents
PEG, propylene glycol, glycerin, ethyl alcohol
102
examples of preservatives
sodium benzoate, benzalkonium chloride, benzyl alcohol, propylene glycol, phenol, etc.
103
what populations do you need to consider propylene glycol toxicity in? what complication is associated?
LBW infants
hepatic or kidney dysfunction
hyperosmolar metabolic acidosis
104
what populations do you need to consider benzyl alcohol toxicity in?
what complication is associated?
neonates
gasping syndrome
105
other sterile routes of administration are
pulmonary, irrigations, epidurals, intrathecal, ophthalmic
106
which alternative sterile routes must be preservative free
epidural & intrathecal
107
what considerations need to be made for pulmonary compounds
buffers, preservatives, tonicity adjusters, antioxidants, surfactants, viscosity inducing agents
108
what considerations need to be made for irrigation compounds
tonicity, pH relative to site of administration
109
what considerations need to be made for ophthalmic compounds
preservatives, tight control of pH, viscosity, and tonicity
