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NAPLEX 2024 > 17. Compounding III: Documentation + Preparation > Flashcards

17. Compounding III: Documentation + Preparation Flashcards

1
Q

____ is the recipe that is followed to compound a preparation (what you SHOULD do)

A

Master formulation record

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2
Q

____ is the log book of all products made at the pharmacy (what you DID)

A

Compounding record (or log)

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3
Q

What are the 3 completion steps

A
  1. Package product and apply container label and any needed auxiliary labels. A duplicate container label can be placed on the compounding record.
  2. Perform QC: validate the weight, check the product for mixing, adequacy, color, clarity, odor, consistency, and pH. Enter measurements and observations in compounding record.
    3.Counsel the patient and if any subsequent ADRs are reported, add them to the compounding record
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4
Q

____ means to reduce particle size by grinding, crushing, milling, vibrating, or other processes (manual or mechanical)

A

Comminution

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5
Q

Sieve number is based on ___

A

the number of holes per inch (sieve #100 = 100 openings/inch)

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6
Q

3 Main methods of comminution

A
  1. Trituration (commonly a/w grinding tabs with mortar and pestle but can describe liquids)
  2. Levigation (triturating powder with mortar and pestle with a little liquid) or spatulation (similar to levigation but on an ointment slab with spatula instead of motar+pestle)
  3. Pulverization by intervention (used for crystalline powders that will not crush easily – crystals dissolved with solvent and mixed until solvent evaporates, when it recrystallizes = smaller particles)
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7
Q

___ is a solute dissolved in a solvent (such as NaCl dissolved in water)

A

Solution

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8
Q

___ is a solid dispersed in a liquid. It is a two-phase heterogeneous (not uniform) mixture.

A

Suspension

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9
Q

___ are oral solutions with sucrose, other sugars, or artificial sugars

A

Syrups

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10
Q

____ are sweet hydroalcoholic solutions used for drugs that would be insoluble in a purely aqueous formulation.

A

Elixirs

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11
Q

____ are plant or animal extracts dissolved in alcohol or hydroalcohol

A

Tinctures

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12
Q

___ are alcohols or hydroacohols of volatile (easily vaporizes), aromatic compounds such as camphor.

A

Spirits

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13
Q

____ is when the dispersed phase settles (clumps) together. Happens with suspensions and emulsions, less commonly with solutions.

A

Precipitation/sedimentation

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14
Q

Emulsions can be made by either the Continental or English gum method. Explain it.

A

Mixing oil, water, and an emulsifier (gum) in a 4:2:1 ratio

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15
Q

Continental (dry gum) method steps

A
  1. Levigate gum with oil
  2. add water all at once
  3. Triturate (shake or mortar+pestle)
  4. add other ingredients and homogenize
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16
Q

English (wet gum) method steps

A
  1. Triturate gum with water
  2. Slowly add oil
  3. add other ingredients and homogenize
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17
Q

____ is an example of a glidant/lubricant to improve the flowability of a powder

A

Magnesium stearate

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18
Q

___ is an example of a surfactant to neutralize the static charge and keep the powder from floating away

A

Sodium lauryl sulfate

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19
Q

If melting ingredients (for any formulation), melt the ingredient with the (highest/lowest) melting point prior to adding the ingredients with (highest/lowest) melting points

A

Highest first, then lower
Prevents exposing substances with low melting points to higher temps than necessary

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20
Q

A ___ mixture means that the combination of ingredients will melt at a lower temperature than either of the individual component’s melting temperatures

A

Eutectic
Can be an issue because it can burn or create a sticky mess

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21
Q

___ and ___ are used as plasticizers to make capsules less brittle and more flexible

A

Glycerol and sorbitol

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22
Q

___ tablets are most common tablet type made in compounding vs ____ tablets are more common in manufacturing

A

Molded, compressed

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23
Q

Ointments vs creams: oil to water content

A

Ointment 80-100% oil, 0-20% water
Creams 50/50, usualy water >20% and up to 50% oil

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24
Q

Which has the most amount of oil: ointment, creams, lotion

A

Ointment

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25
Q

Which has the most amount of water: ointment, creams, lotion

A

Lotions

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26
Q

What is geometric dilution?

A

You mix a small amount of drug and diluent, and then another equal amount of ingredients, repeat until completed (ensures homogenous mixture)

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27
Q

Paddock Method to calculate density factor

A

Density factor = B / (A-C+B)
A-weight of suppository blank
B-weight of medication per suppository
C-weight of medicated suppository

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28
Q

BUD for Nonsterile: Nonaqeuous Formulation (e.g. a drug in petrolatum)

A

No later than 6 months (180 days)
Store at room temp

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29
Q

BUD for Nonsterile: Water-containing oral formulations (such as an oral suspension)

A

No later than 14 days when stored at controlled cold temperatures
Store in refrigerator

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30
Q

BUD for Nonsterile: Water-containing topical/dermal and mucosal liquid and semisolid formulation (such as cream or lotion)

A

No later than 30 days
Store at room temp

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31
Q

T/F: If any ingredient expires before the BUD, use the earlier expiration date

A

True

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32
Q

T/F: BUD should be kept the same for standardization even if stability data is obtained to determine longer stability

A

False - BUD can be extended if stability data is obtained

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33
Q

BUD for example: Metronidazole topical solution prepared with propylene glycol and distilled water

A

30 days - topical, aqueous

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34
Q

BUD for example: APAP, diphenhydramine and hydroxyzine oral suspension prepared in lemon syrup (citric acid, purified water, lemon flavoring)

A

14 days, refrigerated - oral, aqueous

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35
Q

BUD for example: Topical preparation of zinc oxide in white petrolatum

A

180 days - non-aqueous

36
Q

BUD for example: Ciprofloxacin and dexamethasone in Versabase lotion

A

30 days - topic, aqueous

37
Q

BUD for example: morphine powder with stevia sweetener in a PEG lozenge

A

180 days - non-aqueous

38
Q

BUD for unit-dose repackaging

A

Manufacturer’s expiration date or 6 months from repackaging date (whichever is earlier)

39
Q

Most sterile preparations, including IV and ophthalmic products, should be (hypertonic/isotonic/hypotonic) to human blood and contain similar osmolarity of ____ mOsm/L

A

isotonic, ~285 mOsm/L
Osmolarity = # particles in solution

40
Q

pH of sterile products should be ___

A

close to neutral (pH 7)
Blood is slightly alkaline at pH 7.35-7.45

41
Q

___ bags should be used for IV meds that have leaching or sorption issues

A

Non-PVC

42
Q

T/F: For sterile compounding, items should be placed in a line one in front of another

A

False - should be side by side, no closer than 6 inches from the back of the hood.
Nothing should be between sterile object and the HEPA filter in a horizontal hood or above a sterile object in a vertical airflow hood

43
Q

Important things to note when sterile compounding with glass ampoules

A

Snap neck away from you
Use filter needed and then change needle before injecting into IV bag

44
Q

When sterile compounding, you should inject air into the vial to draw up medicine except when it is a ____

A

hazardous drug - positive pressure can cause HD to spray out around the needing (contaminating workspace and endangering personnel)
Use negative-pressure technique instead

45
Q

Explain negative-pressure technique when drawing up medication from a vial

A

Pull plunger back to fill syringe with air equal to the volume of drug to be removed
Insert needle, invert vial, and pull on plunger (creates vacuum that pulls drug out of vial and into syringe)
Do in small increments, pausing to allow air to move into the vial until desired volume of drug has been drawn up

46
Q

Explain terminal sterilization

A

Required for CSPs that are compounding with any non-sterile ingredients
Methods include
1) steam sterilization (with an autoclave)
2) Dry-heat sterilization (depryrogenation)
3) Gas sterilization and ionizing radiation
Note: do NOT use heat on heat-sensitive drugs (e.g. proteins like hormones and insulin)

47
Q

Heat-sensitive CSPs (e.g. hormones, insulins, and other proteins) cannot be sterilized with heat. How do we sterilize?

A

Filtration using a 0.22 micron filter (will remove anything larger than 0.22 microns, including bacteria, viruses, yeast, and fungi
Bubble-point test must be performed to test filter integrity

48
Q

Label requirements of CSPs

A

Names + amounts of conc of ingredients
Total volume
BUD
Route of administration
Storage requirements
Other info for safe use
Special labels for hazardous preparations, special handling, high-alert meds, etc

49
Q

Endotoxins from gram-(negative/positive) bacteria are more potent and represent a serious threat to patient safety

A

Gram-negative

50
Q

___ (bacterial endotoxins) can come from using equipment washed with tap water. To avoid, glassware and utensils should be rinsed with sterile water and depyrogenated using steam sterilization with an autoclave

A

Pyrogens

51
Q

Certain CSPs must be tested for endotoxins. The reagent for bacterial endotoxins test (BET) is called ____

A

Limulus amebocyte lysate (LAL)

52
Q

___-risk sterile compounding uses 1 to 3 components (including diluent) that are supplied as sterile from the manufacturer, no more than 2 entries into any 1 sterile container or device

A

Low

53
Q

___-risk sterile compounding uses >3 components OR multiple doses of a sterile product withdrawn from the same vial to make batch of drugs

A

Medium

54
Q

Compounded parenteral nutrition is considered ___-risk sterile compounding

A

Medium - has many additives

55
Q

Making a batch of drugs is considered ___-risk compounding (ex. preparing 10 IV bags of cefazolin in 50mL D5W for 10 surgeries schedules that day)

A

Medium

56
Q

___-risk sterile compounding uses non-sterile ingredients and/or equipment

A

High

57
Q

Certain high-risk CSPs and CSPs intended for use beyond the recommended BUD require sterility testing. Sterility testing should use either __ or ____ and include bacterial endotoxin (pyrogen) testing prior to use.

A

tryptic soy broth (TSB) or fluid thioglycollate medium (FTM)

58
Q

BUD for Low-risk CSP: Room temp

A

48 hrs

59
Q

BUD for Low-risk CSP: Refrigerated

A

14 days

60
Q

BUD for Low-risk CSP: Frozen

A

45 days

61
Q

BUD for medium-risk CSP: Room temp

A

30 hrs

62
Q

BUD for medium-risk CSP: Refrigerated

A

9 days

63
Q

BUD for medium-risk CSP: Frozen

A

45 days

64
Q

BUD for high-risk CSP: Room temp

A

24 hrs

65
Q

BUD for high-risk CSP: Refrigerated

A

3 days

66
Q

BUD for high-risk CSP: Frozen

A

45 days

67
Q

T/F: BUD for frozen CSPs for low, medium, and high risk is the same

A

True

68
Q

BUD for Low-risk CSP prepared in an ISO 5 PEC or C-PEC in an SCA or C-SCA (not in a clean room): Room temp

A

12 hours

69
Q

BUD for Low-risk CSP prepared in an ISO 5 PEC or C-PEC in an SCA or C-SCA (not in a clean room): Refrigerated

A

12 hours

70
Q

T/F: BUD for Low-risk CSP prepared in an ISO 5 PEC or C-PEC in an SCA or C-SCA (not in a clean room) is the same regardless of room temp or refrigerated

A

True

71
Q

BUD for Immediate-use CSP

A

1 hr

72
Q

T/F: Immediate-use CSP can be stored in the refrigerator or freezer to be used later

A

False - BUD for immediate use CSP is 1 hr

73
Q

T/F: Low-risk CSP prepared in an ISO 5 PEC or C-PEC in an SCA or C-SCA (not in a clean room) can be frozen to be used later

A

False - only 12hrs at room temp or refrigerated, not frozen

74
Q

T/F: single-dose containers can be used 1 hour from the time of puncture or opening regardless of inside or outside an ISO 5 environment

A

False
1 hr from the time of puncture or opening if outside an ISO 5 environment
up to 6 hours from the time of puncture or opening if inside ISO 5 environment

75
Q

Single-dose containers can be used 1 hour (outside ISO 5 environment) or up to 6 hours (inside ISO 5 environment) from the time of puncture or opening. The only exception is ____

A

ampoules - any unused contents cannot be stored, must be discarded

76
Q

BUD of multi-dose containers (MDC) regardless of inside or outside an ISO 5 environment is ___

A

up to 28 days from the time of puncture or opening, unless otherwise specified by manufacturer

77
Q

Microbial growth is observed in an intrathecal injection and the manufacturer declares a recall. What kind of recall would this be?

A

Class I recall - a situation in which there is a reasonable probability that the use or exposure will cause serious adverse health consequences or death

78
Q

In 2010 and 2015, ketorolac injections were recalled due to the possibility of particles in the vials. What kind of recall would this be?

A

Class II recall - a situation in which use or exposure can cause temporary or reversible adverse health consequences or where the probability or harm is remote

79
Q

The coloring on tablets may have been applied inconsistently and the manufacturer declares a recall. What kind of recall would this be?

A

Class III recall - a situation in which use or exposure is not likely to cause adverse health consequences

80
Q

___ includes all solutes and ___ includes only the solutes that do NOT cross the vasculature (biological membrane)

A

Osmolarity, tonicity

81
Q

When hypertonic saline is administered, water will move (into/out of) RBCs

A

out of
Can cause RBCs to become shriveled and dysfunctional

82
Q

The highest osmolarity acceptable for peripheral IV administration is ___

A

~900 mOsmol/L

83
Q

Solutions with higher osmolarity should be administered via (central/peripheral) line to avoid phlebitis (damage to veins)

A

central line - delivers IV meds and fluids into larger blood volume = faster dilution

84
Q

When hypotonic saline is administered, water will move (into/out of) RBCs

A

into
Can cause hemolysis (RBCs will burst) - can be fatal

85
Q

When pH rises, blood becomes more (acidic/basic)

A

Basic (more hydrogen ions)

86
Q

When pH falls, blood becomes more (acidic/basic)

A

Acidic (less hydrogen ions)

NAPLEX 2024 (74 decks)

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