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Misc. Pharm Exams > Compounding II > Flashcards

Compounding II Flashcards

1
Q

a complete absence of viable microorganisms and contaminants

A

sterility

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2
Q

methods and manipulations required to minimize contamination of sterile compounded formulations

A

aseptic technique

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3
Q

routes of administration for sterile preparation

A

IV, IM, SQ, IT, epidural, ID, ophthalmic, irrigations, intra-articular, pulmonary inhalations.

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4
Q

a device or zone that provides ISO class 5 air quality environment for sterile compounding

A

primary engineering controls (PECs)

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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

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6
Q

air quality in a PEC

A

ISO Class 5

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7
Q

air quality in a SEC

A

ISO Class 7

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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

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9
Q

BUD for immediate use CSP

A

administration within 4 hours following start of preparation

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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

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11
Q

category of CSPs prepared in a cleanroom suite with longer BUDs

A

category 2

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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

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13
Q

hour and date after which a CSP may not be used, stored, and transported

A

BUD

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14
Q

BUD at CRT for category 1 compounded in a SCA

A

<= 12 hours

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15
Q

BUD in refrigerator for category 1 compounded in a SCA

A

<= 24 hours

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16
Q

BUD at CRT for category 2
aseptically processed, no sterility testing, only sterile starting components

A

4 days

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17
Q

BUD in a refrigerator for category 2
aseptically processed, no sterility testing, only sterile starting components

A

10 days

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18
Q

BUD in a freezer for category 2
aseptically processed, no sterility testing, only sterile starting components

A

45 days

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19
Q

initial competency training must be done with what 2 tests

A

gloved fingertip and thumb test
media fill test

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20
Q

hand hygiene, garbing, and gloving must be requalified every

A

6 months for C1 & 2
3 months for C3

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21
Q

active air sampling is done every

A

6 months for C1 & 2
1 month for C3

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22
Q

surface sampling is done every

A

month for C1 & 2
week for C3

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23
Q

destruction of microorganisms

A

terminal sterilization

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24
Q

physical removal of organisms

A

filtration sterilization

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25
Q

this record must be kept for all CSPs from nonsterile ingredients or CSPs prepared for multiple patients

A

Master Formulation Record

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26
Q

record that must be kept for C1, 2, and 3 CSPs, or immediate use CSP for multiple patients

A

compounding record

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27
Q

when is bacterial endotoxin testing required

A

-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

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28
Q

small IV catheter placed into a smaller peripheral vein for short term use

A

peripheral VC

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29
Q

central line, IV catheter terminating at the superior vena cava where contents are more quickly inserted

A

central VC

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30
Q

advantages of PVC

A

convenient, easy to place, minimal AEs when placed

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31
Q

disadvantages of PVC

A

limitations on what can be infused, short term use

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32
Q

advantages of CVC

A

few limitations on what can be infused, can infuse higher volumes faster, long term

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33
Q

disadvantages of CVC

A

placement requires trained personnel and may require sedation, complications

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34
Q

examples of vesicants

A

-vasopressors (dopamine, epinephrine, norepinephrine)
-chemotherapeutic agents (doxorubicin, vincristine, vinblastine)
-calcium salts
-digoxin
-promethazine
-nafcillin

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35
Q

steps to manage extravasation

A
  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
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36
Q

filters are always needed with

A

ampules

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37
Q

which medications require filtration

A

amphotericin B, infliximab (remicade)

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38
Q

rapid drug administration in seconds to minutes

A

IV push

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39
Q

small volume infused over a specific amount of time

A

intermittent IV infusion

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40
Q

medication administered via secondary IV tubing connected to primary tubing

A

IV piggyback

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41
Q

BUD for a single dose container (vial, bag, etc.) once opened

A

immediate discard or 12 hours

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42
Q

BUD for a multi-dose container (bag, vial, etc) once opened

A

up to 28 days

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43
Q

critical points on a syringe

A

tip, plunger, plunger piston

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44
Q

critical point on an ampule

A

glass neck

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45
Q

critical point on a vial

A

rubber stopper unless to apply alcohol

46
Q

what factors affect the stability of CSPs

A

time in solution
temperature
light exposure
agitation

47
Q

type of incompatibility reaction that results in degradation of the drug

A

chemical

48
Q

type of incompatibility occurring between the container, diluent, or another drug

A

physical

49
Q

type of incompatibility that is mostly a problem with PVC containers, DEHP can leach into med, or drug moves into the container

A

container

50
Q

type of incompatibility that needs to be considered when compounding… some drugs incompatible with D5W and NS

A

diluent

51
Q

joining of infusion to minimize the number of lines, need to consider compatibility

A

y-site

52
Q

consider drugs mixed in the same container for this type of compatibility

A

admixture

53
Q

which 2 combinations are high risk incompatibilities

A

ceftriaxone + calcium
calcium + phosphate

54
Q

kcal content in proteins

A

4 kcal/gram

55
Q

kcal content in carbs

A

3.4 kcal/gram

56
Q

kcal content in lipids
10% emulsion?
20%?
30?

A

10% = 1.1 kcal/mL
20% = 2 kcal/mL
30% = 3 kcal/mL

57
Q

occurs when ILE administration exceeds the rate of hydrolysis, free fatty acid uptake, and clearance

A

fat overload syndrome

58
Q

contraindications to ILE

A

hypersensitivity to soybean, egg, or fish

59
Q

hepatic effects of long term PN that can progress to hepatic failure

A

PN associated liver disease (PNALD)

60
Q

PN combination of dextrose, AA, and lipids in 1 is called?
it is most stable if components are what %?

A

3-in-1 (TNA)
10% dext, 4% AA< 2% lipid

61
Q

creaming and cracking can occur with a TNA.. is this safe for administration?

A

creaming- yes, can make homogenous through inversion
cracking- no

62
Q

what needs to be considered when compounding TPN?

A

calcium phos precipitation
ion balancing
ingredient volumes
osmolarity limitations

63
Q

what influences calcium phos precipitation in TPN

A

dose/conc, Ca salts, pH/amino acid conc, order or Ca/phos addition, temperature, storage time

64
Q

recommended filter when administering TNAs, dextrose-AA admixtures, and ILE

A

1.2 micron filter

65
Q

standards for handling hazardous drugs to minimize risk of exposure to people

A

USP 800

66
Q

maintains a list of HDs used in healthcare settings (defines criteria & identifies drugs as hazardous)

A

NIOSH

67
Q

health risks associated with HDs include

A

fertility impairment
increases risk of cancer

68
Q

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

A

assessment of risk

69
Q

ventilated device to minimize worked and environmental HD exposure when directly handling HDs

A

containment primary engineering control (C-PEC)

70
Q

air quality in C-PEC

A

ISO 5

71
Q

types of C-PEC

A

containment ventilated enclosure
biological safety cabinet
compounding aseptic containment isolator

72
Q

powder containment hood with HEPA filtered air and negative air pressure for NONSTERILE compounding only, type of C-PEC

A

containment ventilated enclosure (CVE)

73
Q

vertical laminar airflow and negative air pressure for sterile compounding, must be class II or class III, type of C-PEC

A

biological safety cabinet (BSC)

74
Q

closed front C-PEC that can be located in a buffer room or a C-SCA

A

compounding aseptic containment isolator (CACI)

75
Q

room where C-PEC is placed, must be externally ventilated, physically separated, have appropriate air exchange, and have negative pressure, buffer room

A

containment secondary engineering control (C-SEC)

76
Q

air quality in a C-SEC

A

ISO 7

76
Q

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

A

closed system transfer devices

77
Q

when should closed system transfer devices be used

A

should be used for compounding when dosage form allows
MUST be used when administering antineoplastics when dosage form allows

78
Q

facility requirements for nonsterile HD

A

C-PEC (CVE, BSC, or CACI) and a C-SEC both externally vented

79
Q

facility requirements for sterile HD compounding

A

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
Q

how to store HDs

A

separate, externally vented, negative pressure room with 12 ACPH

81
Q

required PPE for compounding HDs

A

gown
head, hair, shoe covers
two pairs of gloves

82
Q

PPE required for administration of HDs for antineoplastics or injectables

A

antineoplastics- 2 pair of chemo gloves
injectable- above + chemo gown

83
Q

requirements for gloves when compounding HDs

A

wear 2 pairs that must be changed every 30 minutes or when damaged
where sterile outer gloves if sterile compounding

84
Q

requirements for gowns when compounding HDs

A

change every 2-3 hours or immediately after a spill or splash

85
Q

mask/eye/face protection requirements for HD compounding

A

goggles combined with face shields optimal
N95 respirator masks are sufficient
gas masks or a PAPR may be needed

86
Q

disposal container used for all trace neoplastic waste (empty vials, empty syringes, empty containers, used PPE, chemo pads)

A

yellow

87
Q

disposal container used for all bulk neoplastic waste (unused/partially used HD IV bags, syringes, and vials)

A

black

88
Q

written plan detailing the implementation of HD safety procedures, proper personnel training, competency assessment, and maintaining a list of all required HD documentation

A

hazard communication program

89
Q

SOP steps for a HD spill

A

-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
Q

what should be in a hazardous drug spill kit

A

gowns, gloves, N95 mask, goggles with side shields, HD waste bag, scoop & scraper, chemo pads, HD spill exposure form

91
Q

how often is environmental wipe sampling done for HD surfaces

A

every 6 months

92
Q

ingredients other than the API, non-active, functional ingredients that facilitate function of API

A

excipients

93
Q

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

A

chelating agents

94
Q

excipient added to inhibit free radicals produced by oxidation and maintain product stability

A

antioxidants

95
Q

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

A

buffer

96
Q

excipient added to increase drug solubility by using non-aqueous solvents

A

solubilizing agents

97
Q

excipient added to slow or prevent microbial growth

A

preservatives

98
Q

examples of chelating agents

A

edetate disodium
edetate calcium disodium
edetic acid

99
Q

examples of antioxidants

A

ascorbic acid, tocopherols, sodium ascorbate, sodium thiosulfate, etc.

100
Q

examples of buffers

A

sodium citrate + citric acid
sodium acetate + acetic acid
sodium bicarb + sodium carbonate

101
Q

examples of solubilizing agents

A

PEG, propylene glycol, glycerin, ethyl alcohol

102
Q

examples of preservatives

A

sodium benzoate, benzalkonium chloride, benzyl alcohol, propylene glycol, phenol, etc.

103
Q

what populations do you need to consider propylene glycol toxicity in? what complication is associated?

A

LBW infants
hepatic or kidney dysfunction
hyperosmolar metabolic acidosis

104
Q

what populations do you need to consider benzyl alcohol toxicity in?
what complication is associated?

A

neonates
gasping syndrome

105
Q

other sterile routes of administration are

A

pulmonary, irrigations, epidurals, intrathecal, ophthalmic

106
Q

which alternative sterile routes must be preservative free

A

epidural & intrathecal

107
Q

what considerations need to be made for pulmonary compounds

A

buffers, preservatives, tonicity adjusters, antioxidants, surfactants, viscosity inducing agents

108
Q

what considerations need to be made for irrigation compounds

A

tonicity, pH relative to site of administration

109
Q

what considerations need to be made for ophthalmic compounds

A

preservatives, tight control of pH, viscosity, and tonicity

Misc. Pharm Exams (5 decks)

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