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Compounding Exam 1 > Lecture 1 - Intro > Flashcards

Lecture 1 - Intro Flashcards

1
Q

define compounding

A

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

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2
Q

name 4 types of nonsterile compounding

A
  1. mixing 2 MANUFACTURED products
  2. diluting a liquid
  3. adding a flavor
  4. preparing solution, suspension, ointment, etc
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3
Q

true or false

adding water, syrup, or another vehicle to a highly concentrated digoxin solution is considered NONSTERILE compounding

A

true

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4
Q

if tablets cannot be swallowed, they are usually made into what dosage form and why?

A

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

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5
Q

true or false

turning tablets into a suspension is not considered nonsterile compounding

A

false - it is

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6
Q

is adding a flavor considered nonsterile compounding

A

yes

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7
Q

give an example of sterile compounding

A

IV admixtures

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8
Q

what is a general reason for compounding

A

to provide individualized patient care by meeting the specific needs of each patient

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9
Q

how is compounding useful for veterinary use

A

can make a solid dosage form into a gel to put on the animal’s paw and they can lick it off

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10
Q

true or false

adding flavor to a medication to make it more appealing to a child is considered nonsterile compounding

A

true

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11
Q

how many categories of compounding are there?

A

7

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12
Q

name what each of the 7 categories of compounding are**

A

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

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13
Q

each of the 7 categories of compounding is associated with….

A

specific training requirements for each

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14
Q

true or false

category 3 has higher risk levels than category 5

A

false - lower risk levels

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15
Q

1 liquid vial - transfering into IV bag

what is risk level?

give examples of other 2 risk levels as well

A

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

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16
Q

WHY is adding flavor to a manufactured product considered compounding?

A

because the BUD will change!!

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17
Q

is pyridostigmine suspension stored at room temp or fridge and what is BUD

A

35 days, room temp or fridge is fine

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18
Q

name 3 components of USP-NF

A

monographs

general chapters

general notices

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19
Q

between monographs, general chapters, and general notices all contained in USP-NF, which is used most of the time?
what is it used for?

A

monographs
used to understand the excipients and active ingredients.

includes a lot of things like the name, definition, packaging, labeling, and storage requirements,

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20
Q

what is contained in the “general chapters” of USP-NF

A

more detail on the test methods and procedures in the monographs

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21
Q

what is contained in the “general notices” portion of USP-NF

A

it’s like an appendix – provides definitions for terms used in the monographs

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22
Q

a prescription bottle is considered what type of container?

A

well closed container

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23
Q

what are the storage requirements for calcium citrate and what does this say about the stability of the ingredient

A

preserve in well-closed containers

the drug is probably pretty physically and chemically stable and won’t evaporate easily

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24
Q

USP chapters 795, 797, and 800

A

795 - nonsterile compounding

797 - sterile compounding

800 - hazardous drugs

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25
Q

chemotherapy tablets/IV would be under USP 795, 797, or 800?

A

800

even tho 1 nonsterile and 1 isn’t, still under 800 bc hazardous

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26
Q

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

A

plus/minus 10%

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27
Q

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

A

FALSE
it does. within 10%

anything from 450-550 is acceptable

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28
Q

USP 795 provides standards for compounding…..

A

quality NONSTERILE preparations

29
Q

as mentioned, according to USP 795 a variability of plus/minus 10% of labeled claim is acceptable

how long must it stay like this?

A

from the time prepared all the way through to its BUD

30
Q

***USP clarifies that nasal sprays and nasal irrigations are considered _______ preparations

sterile or nonsterile?

explain how this may be confusing

A

nonsterile

they can be prepared in nonsterile environments

however, many use sterile environments anyway to remove large particles

BUT STILL CONSIDERED NONSTERILE PREPARATIONS

31
Q

TRUE OR FALSE

USP 795 does not require gloves to be worn in nonsterile compounding

A

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

32
Q

explain how cleaning and sanitizing are different

name specific cleaning requirements

A

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

33
Q

true or false

in nonsterile compounding, cleaning is performed first, then sanitization

A

true

34
Q

legally, compounding a prescription must be ______. explain this

A

NECESSARY

it cannot be commercially available.

must be substantially different than any commercial products

35
Q

true or false

we are not legally allowed to compound for the physician’s office

A

TRUE

36
Q

true or false

it is never legally allowed to compound a product prior to receiving a prescription for it

A

false - you can in some circumstances (coming later)

only in limited quantity and based on prescription history of the pharmacy

37
Q

differentiate between compounding and manufacturing

A

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

38
Q

give 2 scenarios of when a patient would demonstrate a need for compounding

A
  1. pt not able to take commercially available drug
  2. the product they need is discontinued or in shortage
39
Q

true or false

it is required from the area of sterile preparations to be SEPARATE AND DISTINCT from nonsterile preparations

A

TRUE

40
Q

***name 3 different types of water and when they are allowed to be used for

A
  1. potable water (tap water) - ONLY for hand washing and equipment washing
  2. Purified water - only for nonsterile products (ie: to dilute something)
  3. Water for injection or bacteriostatic water for injection (for STERILE products)
41
Q

true or false

purified water can be used to dilute sterile preparations

A

FALSE - only nonsterile

water for injection or bacteriostatic water for injection are only ones that can be used for sterile preparations

42
Q

differentiate between water for injection and bacteriostatic water for injection

A

both are sterilized, but bacteriostatic water for injection additionally contains a preservative (benzyl alcohol)

43
Q

**true or false

tap water can be used to dilute a nonsterile product

A

FALSE - only purified water

tap water only used for hand and equipment washing

44
Q

equipment used for compounding should comply to _________ and should be of appropriate ___ and ____

A

USP standards (cannot just grab any measuring device from kitchen)

appropriate design and size

45
Q

it is most important to pick the proper size equipment when measuring what?

A

volume

46
Q

the equipment used in compounding should be made of surfaces that don’t what?

A

react/adsorb to pharmaceutical components or products

47
Q

name 3 basic compounding equipments

A

balance
volumetric apparatus
others (mortar and pestle/spatula, etc)

48
Q

name 2 pieces of equipment that can be used to levigate ointment

A

metal levigation spatula

flat plastic putty knife

49
Q

a graduated cylinder (cylindrical graduate) is calibrated in ___ units

A

metric

50
Q

minimum measurable volume of conical and cylindrical graduate****

A

20%

51
Q

a cylindrical graduate is used for what type of liquids**

A

nonviscous

ie - water, ethanol

52
Q

graduated medicinal droppers come in ___mL or ___mL graduates

A

1mL or 0.5mL

53
Q

do not use medicinal droppers to measure less than _____% of its capacity

A

20

54
Q

as mentioned, graduated cylinders are calculated in metric units

CONICAL graduates may be calibrated with what units?

A

metric and/or apothecaries’ unit

55
Q

are the errors larger for cylindrical or conical graduates?

A

conical - bc of the outward sloping sides

56
Q

conical graduates are advantegous with what kind of liquids?
give an example

A

viscous liquids

propylene glycol

57
Q

name 3 things easier to do in conical graduate rather than cylindrical

A

fill up without spilling
rinse out residues
clean and drain

58
Q

what is the measuring capacity of a 100mL graduate

A

20mL-100mL

59
Q

true or false

syrups should NOT be measured in a cylindrical graduate

A

TRUE

should be in conical

60
Q

the _____ the volume capacity of your equipment, the larger the error

A

smaller

61
Q

MVM (minimum volume measurable) of 50mL graduated cylinder

A

10mL

62
Q

name the 5 different types of stability

what are the main 3

A

chemical
physical
microbiological
therapeutic
toxicological

chemical, physical, and microbiological are the main 3

63
Q

name the type of stability

“appearance, palatability, uniformity, dissolution, and suspendability are retained”

A

physical

64
Q

name the type of stability

each active ingredient retains its integrity and labeled potency within the specified limits

A

chemical

65
Q

what is therapeutic stability

what is toxicological stability

A

therapeutic - therapeutic effect remains unchanged

toxicological - no significant increase in toxicity occurs

66
Q

what USP-NF chapter states the antimicrobial preservatives

A

USP 30 - NF 25

67
Q

****SHE WILL ASK:

which of the following are preservatives?

name 8 parts of words to look for in looking for a preservative

A

Cet
Cety
benz
paraben
cresol
Th(imersol) (thymol)
phenol
sorb(ate/ic)

68
Q
A

Compounding Exam 1 (9 decks)

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