17. Compounding III: Documentation + Preparation Flashcards
____ is the recipe that is followed to compound a preparation (what you SHOULD do)
Master formulation record
____ is the log book of all products made at the pharmacy (what you DID)
Compounding record (or log)
What are the 3 completion steps
- Package product and apply container label and any needed auxiliary labels. A duplicate container label can be placed on the compounding record.
- 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
____ means to reduce particle size by grinding, crushing, milling, vibrating, or other processes (manual or mechanical)
Comminution
Sieve number is based on ___
the number of holes per inch (sieve #100 = 100 openings/inch)
3 Main methods of comminution
- Trituration (commonly a/w grinding tabs with mortar and pestle but can describe liquids)
- 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)
- 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)
___ is a solute dissolved in a solvent (such as NaCl dissolved in water)
Solution
___ is a solid dispersed in a liquid. It is a two-phase heterogeneous (not uniform) mixture.
Suspension
___ are oral solutions with sucrose, other sugars, or artificial sugars
Syrups
____ are sweet hydroalcoholic solutions used for drugs that would be insoluble in a purely aqueous formulation.
Elixirs
____ are plant or animal extracts dissolved in alcohol or hydroalcohol
Tinctures
___ are alcohols or hydroacohols of volatile (easily vaporizes), aromatic compounds such as camphor.
Spirits
____ is when the dispersed phase settles (clumps) together. Happens with suspensions and emulsions, less commonly with solutions.
Precipitation/sedimentation
Emulsions can be made by either the Continental or English gum method. Explain it.
Mixing oil, water, and an emulsifier (gum) in a 4:2:1 ratio
Continental (dry gum) method steps
- Levigate gum with oil
- add water all at once
- Triturate (shake or mortar+pestle)
- add other ingredients and homogenize
English (wet gum) method steps
- Triturate gum with water
- Slowly add oil
- add other ingredients and homogenize
____ is an example of a glidant/lubricant to improve the flowability of a powder
Magnesium stearate
___ is an example of a surfactant to neutralize the static charge and keep the powder from floating away
Sodium lauryl sulfate
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
Highest first, then lower
Prevents exposing substances with low melting points to higher temps than necessary
A ___ mixture means that the combination of ingredients will melt at a lower temperature than either of the individual component’s melting temperatures
Eutectic
Can be an issue because it can burn or create a sticky mess
___ and ___ are used as plasticizers to make capsules less brittle and more flexible
Glycerol and sorbitol
___ tablets are most common tablet type made in compounding vs ____ tablets are more common in manufacturing
Molded, compressed
Ointments vs creams: oil to water content
Ointment 80-100% oil, 0-20% water
Creams 50/50, usualy water >20% and up to 50% oil
Which has the most amount of oil: ointment, creams, lotion
Ointment
Which has the most amount of water: ointment, creams, lotion
Lotions
What is geometric dilution?
You mix a small amount of drug and diluent, and then another equal amount of ingredients, repeat until completed (ensures homogenous mixture)
Paddock Method to calculate density factor
Density factor = B / (A-C+B)
A-weight of suppository blank
B-weight of medication per suppository
C-weight of medicated suppository
BUD for Nonsterile: Nonaqeuous Formulation (e.g. a drug in petrolatum)
No later than 6 months (180 days)
Store at room temp
BUD for Nonsterile: Water-containing oral formulations (such as an oral suspension)
No later than 14 days when stored at controlled cold temperatures
Store in refrigerator
BUD for Nonsterile: Water-containing topical/dermal and mucosal liquid and semisolid formulation (such as cream or lotion)
No later than 30 days
Store at room temp
T/F: If any ingredient expires before the BUD, use the earlier expiration date
True
T/F: BUD should be kept the same for standardization even if stability data is obtained to determine longer stability
False - BUD can be extended if stability data is obtained
BUD for example: Metronidazole topical solution prepared with propylene glycol and distilled water
30 days - topical, aqueous
BUD for example: APAP, diphenhydramine and hydroxyzine oral suspension prepared in lemon syrup (citric acid, purified water, lemon flavoring)
14 days, refrigerated - oral, aqueous
BUD for example: Topical preparation of zinc oxide in white petrolatum
180 days - non-aqueous
BUD for example: Ciprofloxacin and dexamethasone in Versabase lotion
30 days - topic, aqueous
BUD for example: morphine powder with stevia sweetener in a PEG lozenge
180 days - non-aqueous
BUD for unit-dose repackaging
Manufacturer’s expiration date or 6 months from repackaging date (whichever is earlier)
Most sterile preparations, including IV and ophthalmic products, should be (hypertonic/isotonic/hypotonic) to human blood and contain similar osmolarity of ____ mOsm/L
isotonic, ~285 mOsm/L
Osmolarity = # particles in solution
pH of sterile products should be ___
close to neutral (pH 7)
Blood is slightly alkaline at pH 7.35-7.45
___ bags should be used for IV meds that have leaching or sorption issues
Non-PVC
T/F: For sterile compounding, items should be placed in a line one in front of another
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
Important things to note when sterile compounding with glass ampoules
Snap neck away from you
Use filter needed and then change needle before injecting into IV bag
When sterile compounding, you should inject air into the vial to draw up medicine except when it is a ____
hazardous drug - positive pressure can cause HD to spray out around the needing (contaminating workspace and endangering personnel)
Use negative-pressure technique instead
Explain negative-pressure technique when drawing up medication from a vial
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
Explain terminal sterilization
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)
Heat-sensitive CSPs (e.g. hormones, insulins, and other proteins) cannot be sterilized with heat. How do we sterilize?
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
Label requirements of CSPs
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
Endotoxins from gram-(negative/positive) bacteria are more potent and represent a serious threat to patient safety
Gram-negative
___ (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
Pyrogens
Certain CSPs must be tested for endotoxins. The reagent for bacterial endotoxins test (BET) is called ____
Limulus amebocyte lysate (LAL)
___-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
Low
___-risk sterile compounding uses >3 components OR multiple doses of a sterile product withdrawn from the same vial to make batch of drugs
Medium
Compounded parenteral nutrition is considered ___-risk sterile compounding
Medium - has many additives
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)
Medium
___-risk sterile compounding uses non-sterile ingredients and/or equipment
High
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.
tryptic soy broth (TSB) or fluid thioglycollate medium (FTM)
BUD for Low-risk CSP: Room temp
48 hrs
BUD for Low-risk CSP: Refrigerated
14 days
BUD for Low-risk CSP: Frozen
45 days
BUD for medium-risk CSP: Room temp
30 hrs
BUD for medium-risk CSP: Refrigerated
9 days
BUD for medium-risk CSP: Frozen
45 days
BUD for high-risk CSP: Room temp
24 hrs
BUD for high-risk CSP: Refrigerated
3 days
BUD for high-risk CSP: Frozen
45 days
T/F: BUD for frozen CSPs for low, medium, and high risk is the same
True
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
12 hours
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
12 hours
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
True
BUD for Immediate-use CSP
1 hr
T/F: Immediate-use CSP can be stored in the refrigerator or freezer to be used later
False - BUD for immediate use CSP is 1 hr
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
False - only 12hrs at room temp or refrigerated, not frozen
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
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
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 ____
ampoules - any unused contents cannot be stored, must be discarded
BUD of multi-dose containers (MDC) regardless of inside or outside an ISO 5 environment is ___
up to 28 days from the time of puncture or opening, unless otherwise specified by manufacturer
Microbial growth is observed in an intrathecal injection and the manufacturer declares a recall. What kind of recall would this be?
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
In 2010 and 2015, ketorolac injections were recalled due to the possibility of particles in the vials. What kind of recall would this be?
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
The coloring on tablets may have been applied inconsistently and the manufacturer declares a recall. What kind of recall would this be?
Class III recall - a situation in which use or exposure is not likely to cause adverse health consequences
___ includes all solutes and ___ includes only the solutes that do NOT cross the vasculature (biological membrane)
Osmolarity, tonicity
When hypertonic saline is administered, water will move (into/out of) RBCs
out of
Can cause RBCs to become shriveled and dysfunctional
The highest osmolarity acceptable for peripheral IV administration is ___
~900 mOsmol/L
Solutions with higher osmolarity should be administered via (central/peripheral) line to avoid phlebitis (damage to veins)
central line - delivers IV meds and fluids into larger blood volume = faster dilution
When hypotonic saline is administered, water will move (into/out of) RBCs
into
Can cause hemolysis (RBCs will burst) - can be fatal
When pH rises, blood becomes more (acidic/basic)
Basic (more hydrogen ions)
When pH falls, blood becomes more (acidic/basic)
Acidic (less hydrogen ions)
