Lecture 1 - Intro Flashcards
define compounding
preparation, mixing, assembling, packaging, or labeling of drug or device as a result of practitioner’s prescription order or initiative based on pharmacist/patient/prescriber relationship
name 4 types of nonsterile compounding
- mixing 2 MANUFACTURED products
- diluting a liquid
- adding a flavor
- preparing solution, suspension, ointment, etc
true or false
adding water, syrup, or another vehicle to a highly concentrated digoxin solution is considered NONSTERILE compounding
true
if tablets cannot be swallowed, they are usually made into what dosage form and why?
SUSPENSION
tablets contain magnesium stearate as a lubricant, which is poorly water soluble. will never be able to make a total homogenous solution, so we make suspension
true or false
turning tablets into a suspension is not considered nonsterile compounding
false - it is
is adding a flavor considered nonsterile compounding
yes
give an example of sterile compounding
IV admixtures
what is a general reason for compounding
to provide individualized patient care by meeting the specific needs of each patient
how is compounding useful for veterinary use
can make a solid dosage form into a gel to put on the animal’s paw and they can lick it off
true or false
adding flavor to a medication to make it more appealing to a child is considered nonsterile compounding
true
how many categories of compounding are there?
7
name what each of the 7 categories of compounding are**
category 1 – nonsterile simple: mixing 2 commercial products (no calcs)
2 - nonsterile but complex. bulk drug or calcs required
3 - sterile - risk level 1 (low levels)
4 - sterile - risk level 2 (medium levels)
5 - sterile - ridk level 3 - high levels
6 - radiopharmaceuticals
7 - veterinary
each of the 7 categories of compounding is associated with….
specific training requirements for each
true or false
category 3 has higher risk levels than category 5
false - lower risk levels
1 liquid vial - transfering into IV bag
what is risk level?
give examples of other 2 risk levels as well
LOW - not high risk of contamination
probably category 3 (risk level 1)
if multiple vials, may be medium risk
high risk may be making TPN products (total parenteral nutrition) or complicated manipulations are involved
WHY is adding flavor to a manufactured product considered compounding?
because the BUD will change!!
is pyridostigmine suspension stored at room temp or fridge and what is BUD
35 days, room temp or fridge is fine
name 3 components of USP-NF
monographs
general chapters
general notices
between monographs, general chapters, and general notices all contained in USP-NF, which is used most of the time?
what is it used for?
monographs
used to understand the excipients and active ingredients.
includes a lot of things like the name, definition, packaging, labeling, and storage requirements,
what is contained in the “general chapters” of USP-NF
more detail on the test methods and procedures in the monographs
what is contained in the “general notices” portion of USP-NF
it’s like an appendix – provides definitions for terms used in the monographs
a prescription bottle is considered what type of container?
well closed container
what are the storage requirements for calcium citrate and what does this say about the stability of the ingredient
preserve in well-closed containers
the drug is probably pretty physically and chemically stable and won’t evaporate easily
USP chapters 795, 797, and 800
795 - nonsterile compounding
797 - sterile compounding
800 - hazardous drugs
chemotherapy tablets/IV would be under USP 795, 797, or 800?
800
even tho 1 nonsterile and 1 isn’t, still under 800 bc hazardous
in 2019, there were notable changes made to USP 795.
one of these is that the ***acceptability variability in strength is within ________% of the labeled strength
plus/minus 10%
true or false**
if a product is labeled to have 500mg of API and it really has 460mg, it does not meet acceptable variability strength according to USP 795
FALSE
it does. within 10%
anything from 450-550 is acceptable
USP 795 provides standards for compounding…..
quality NONSTERILE preparations
as mentioned, according to USP 795 a variability of plus/minus 10% of labeled claim is acceptable
how long must it stay like this?
from the time prepared all the way through to its BUD
***USP clarifies that nasal sprays and nasal irrigations are considered _______ preparations
sterile or nonsterile?
explain how this may be confusing
nonsterile
they can be prepared in nonsterile environments
however, many use sterile environments anyway to remove large particles
BUT STILL CONSIDERED NONSTERILE PREPARATIONS
TRUE OR FALSE
USP 795 does not require gloves to be worn in nonsterile compounding
FALSE - does require
didn’t used to be this way - it was a recent major change in 2019
they also must document additional garbing requirements and how much they changed
explain how cleaning and sanitizing are different
name specific cleaning requirements
TWO DIFFERENT STEPS
cleaning comes 1st, then sanitization
cleaning - wipe table to remove dust and particles. NO DETERGENTS OR SOAPS. use LEAD GRADE DETERGENT. regular soap and detergents leave residues
sanitization - 70% isopropyl alcohol
true or false
in nonsterile compounding, cleaning is performed first, then sanitization
true
legally, compounding a prescription must be ______. explain this
NECESSARY
it cannot be commercially available.
must be substantially different than any commercial products
true or false
we are not legally allowed to compound for the physician’s office
TRUE
true or false
it is never legally allowed to compound a product prior to receiving a prescription for it
false - you can in some circumstances (coming later)
only in limited quantity and based on prescription history of the pharmacy
differentiate between compounding and manufacturing
compounding - done by licensed pharmacist to meet unique needs of individual pt when commercial products dont
manufacturing - production/preparation/processing of drug or device by extraction from natural origin, or independently through chemical or biochemical synthesis
give 2 scenarios of when a patient would demonstrate a need for compounding
- pt not able to take commercially available drug
- the product they need is discontinued or in shortage
true or false
it is required from the area of sterile preparations to be SEPARATE AND DISTINCT from nonsterile preparations
TRUE
***name 3 different types of water and when they are allowed to be used for
- potable water (tap water) - ONLY for hand washing and equipment washing
- Purified water - only for nonsterile products (ie: to dilute something)
- Water for injection or bacteriostatic water for injection (for STERILE products)
true or false
purified water can be used to dilute sterile preparations
FALSE - only nonsterile
water for injection or bacteriostatic water for injection are only ones that can be used for sterile preparations
differentiate between water for injection and bacteriostatic water for injection
both are sterilized, but bacteriostatic water for injection additionally contains a preservative (benzyl alcohol)
**true or false
tap water can be used to dilute a nonsterile product
FALSE - only purified water
tap water only used for hand and equipment washing
equipment used for compounding should comply to _________ and should be of appropriate ___ and ____
USP standards (cannot just grab any measuring device from kitchen)
appropriate design and size
it is most important to pick the proper size equipment when measuring what?
volume
the equipment used in compounding should be made of surfaces that don’t what?
react/adsorb to pharmaceutical components or products
name 3 basic compounding equipments
balance
volumetric apparatus
others (mortar and pestle/spatula, etc)
name 2 pieces of equipment that can be used to levigate ointment
metal levigation spatula
flat plastic putty knife
a graduated cylinder (cylindrical graduate) is calibrated in ___ units
metric
minimum measurable volume of conical and cylindrical graduate****
20%
a cylindrical graduate is used for what type of liquids**
nonviscous
ie - water, ethanol
graduated medicinal droppers come in ___mL or ___mL graduates
1mL or 0.5mL
do not use medicinal droppers to measure less than _____% of its capacity
20
as mentioned, graduated cylinders are calculated in metric units
CONICAL graduates may be calibrated with what units?
metric and/or apothecaries’ unit
are the errors larger for cylindrical or conical graduates?
conical - bc of the outward sloping sides
conical graduates are advantegous with what kind of liquids?
give an example
viscous liquids
propylene glycol
name 3 things easier to do in conical graduate rather than cylindrical
fill up without spilling
rinse out residues
clean and drain
what is the measuring capacity of a 100mL graduate
20mL-100mL
true or false
syrups should NOT be measured in a cylindrical graduate
TRUE
should be in conical
the _____ the volume capacity of your equipment, the larger the error
smaller
MVM (minimum volume measurable) of 50mL graduated cylinder
10mL
name the 5 different types of stability
what are the main 3
chemical
physical
microbiological
therapeutic
toxicological
chemical, physical, and microbiological are the main 3
name the type of stability
“appearance, palatability, uniformity, dissolution, and suspendability are retained”
physical
name the type of stability
each active ingredient retains its integrity and labeled potency within the specified limits
chemical
what is therapeutic stability
what is toxicological stability
therapeutic - therapeutic effect remains unchanged
toxicological - no significant increase in toxicity occurs
what USP-NF chapter states the antimicrobial preservatives
USP 30 - NF 25
****SHE WILL ASK:
which of the following are preservatives?
name 8 parts of words to look for in looking for a preservative
Cet
Cety
benz
paraben
cresol
Th(imersol) (thymol)
phenol
sorb(ate/ic)
