17. Compounding III: Documentation + Preparation

Question 1

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

Answer 1

Master formulation record

Question 2

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

Answer 2

Compounding record (or log)

Question 3

What are the 3 completion steps

Answer 3

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

Question 4

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

Answer 4

Comminution

Question 5

Sieve number is based on ___

Answer 5

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

Question 6

3 Main methods of comminution

Answer 6

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)

Question 7

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

Answer 7

Solution

Question 8

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

Answer 8

Suspension

Question 9

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

Answer 9

Syrups

Question 10

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

Answer 10

Elixirs

Question 11

____ are plant or animal extracts dissolved in alcohol or hydroalcohol

Answer 11

Tinctures

Question 12

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

Answer 12

Spirits

Question 13

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

Answer 13

Precipitation/sedimentation

Question 14

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

Answer 14

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

Question 15

Continental (dry gum) method steps

Answer 15

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

Question 16

English (wet gum) method steps

Answer 16

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

Question 17

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

Answer 17

Magnesium stearate

Question 18

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

Answer 18

Sodium lauryl sulfate

Question 19

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

Answer 19

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

Question 20

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

Answer 20

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

Question 21

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

Answer 21

Glycerol and sorbitol

Question 22

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

Answer 22

Molded, compressed

Question 23

Ointments vs creams: oil to water content

Answer 23

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

Question 24

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

Answer 24

Ointment

Question 25

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

Answer 25

Lotions

Question 26

What is geometric dilution?

Answer 26

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

Question 27

Paddock Method to calculate density factor

Answer 27

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

Question 28

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

Answer 28

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

Question 29

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

Answer 29

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

Question 30

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

Answer 30

No later than 30 days Store at room temp

Question 31

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

Answer 31

True

Question 32

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

Answer 32

False - BUD can be extended if stability data is obtained

Question 33

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

Answer 33

30 days - topical, aqueous

Question 34

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

Answer 34

14 days, refrigerated - oral, aqueous

Question 35

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

Answer 35

180 days - non-aqueous

Question 36

BUD for example: Ciprofloxacin and dexamethasone in Versabase lotion

Answer 36

30 days - topic, aqueous

Question 37

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

Answer 37

180 days - non-aqueous

Question 38

BUD for unit-dose repackaging

Answer 38

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

Question 39

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

Answer 39

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

Question 40

pH of sterile products should be ___

Answer 40

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

Question 41

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

Answer 41

Non-PVC

Question 42

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

Answer 42

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

Question 43

Important things to note when sterile compounding with glass ampoules

Answer 43

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

Question 44

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

Answer 44

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

Question 45

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

Answer 45

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

Question 46

Explain terminal sterilization

Answer 46

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)

Question 47

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

Answer 47

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

Question 48

Label requirements of CSPs

Answer 48

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

Question 49

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

Answer 49

Gram-negative

Question 50

___ (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

Answer 50

Pyrogens

Question 51

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

Answer 51

Limulus amebocyte lysate (LAL)

Question 52

___-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

Answer 52

Low

Question 53

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

Answer 53

Medium

Question 54

Compounded parenteral nutrition is considered ___-risk sterile compounding

Answer 54

Medium - has many additives

Question 55

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)

Answer 55

Medium

Question 56

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

Answer 56

High

Question 57

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.

Answer 57

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

Question 58

BUD for Low-risk CSP: Room temp

Answer 58

48 hrs

Question 59

BUD for Low-risk CSP: Refrigerated

Answer 59

14 days

Question 60

BUD for Low-risk CSP: Frozen

Answer 60

45 days

Question 61

BUD for medium-risk CSP: Room temp

Answer 61

30 hrs

Question 62

BUD for medium-risk CSP: Refrigerated

Answer 62

9 days

Question 63

BUD for medium-risk CSP: Frozen

Answer 63

45 days

Question 64

BUD for high-risk CSP: Room temp

Answer 64

24 hrs

Question 65

BUD for high-risk CSP: Refrigerated

Answer 65

3 days

Question 66

BUD for high-risk CSP: Frozen

Answer 66

45 days

Question 67

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

Answer 67

True

Question 68

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

Answer 68

12 hours

Question 69

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

Answer 69

12 hours

Question 70

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

Answer 70

True

Question 71

BUD for Immediate-use CSP

Answer 71

1 hr

Question 72

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

Answer 72

False - BUD for immediate use CSP is 1 hr

Question 73

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

Answer 73

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

Question 74

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

Answer 74

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

Question 75

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 ____

Answer 75

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

Question 76

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

Answer 76

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

Question 77

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

Answer 77

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

Question 78

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

Answer 78

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

Question 79

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

Answer 79

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

Question 80

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

Answer 80

Osmolarity, tonicity

Question 81

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

Answer 81

out of Can cause RBCs to become shriveled and dysfunctional

Question 82

The highest osmolarity acceptable for peripheral IV administration is ___

Answer 82

~900 mOsmol/L

Question 83

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

Answer 83

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

Question 84

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

Answer 84

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

Question 85

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

Answer 85

Basic (more hydrogen ions)

Question 86

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

Answer 86

Acidic (less hydrogen ions)