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Exam 1 Flashcards

to not fail this exam PLZ (84 cards)

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1
Q

What indicators are not automatically provided on the prescription label blanks and must be manually filled in?

A

Rx:, Qty:, Refills:, BUD:

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2
Q

The quantity part of label must contain _____.

A

units

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3
Q

T or F: storage conditions and compound info can be typed onto the label or provided by auxillary label.

A

true (one or the other, not both)

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4
Q

How many decimal places should scale weights have in the compounding log?

A

3

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5
Q

T or F: trailing zeros are not allowed, even in scale readings.

A

F

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6
Q

What characteristics must be included in the compound notes if using a formulation record?

A

indicate the title of document used (exactly) and if there were any differences, problems with effect on outcome . analysis and possible solutions for future

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7
Q

What characteristics must be included in the compound notes if not using a formulation record?

A

must document all steps in making the compound in PAST TENSE. include calculations, weigh/measure/count ingredients, description of steps in making - how, where, what equipment, packaging and preparation for dispensing

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8
Q

What is the pharmacy compounding triad?

A

The relationship between the patient, prescriber, and pharmacist. It tailors to the individual patient needs.

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9
Q

Patient-friendly definition of compounding:

A

A prescription for a patient given by a practitioner, that the pharmacist specially makes for that patient. A compound is a preparation of a drug that is in a form not commercially available, this can be is the form of packaging, device, form, or ingredient (active or filler).

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10
Q

Who has authority to regulate compounding?

A

State boards of pharmacy

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11
Q

Who has authority to regulate manufacturing?

A

FDA

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12
Q

What are the 3 components of simple compounding in USP 795?

A

USP-NF monograph (tf is this), directions from manufacturer, known stability

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13
Q

What are the 3 components of moderate compounding in USP 795?

A

special calculations, special calibration of equipment, unknown stability

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14
Q

What are the 4 components of complex compounding in USP 795?

A

Special training, special environment, special equipment, special procedures

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15
Q

define hazardous drug in terms of USP 800

A

NIOSH (Nat’l Institute of Occupational Safety and Health)
antineoplastic, carcinogenic, teratogenic, reproductive toxicity, organ toxicity @ low doses, genotoxic
- use PPE and education to reduce risk of exposure
- designate person for oversight

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16
Q

What are the facility and equipment requirements of USP 800 hazardous compounding?

A
  • drugs should be kept in a separate room with fixed walls
  • separate area: facility/equipment/handling
  • ventilation: negative pressure, air changes per hour
  • contaminant ventilated enclosure (powder hood)
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17
Q

USP 800 is all about safety and protection of ______

A

COMPOUNDER

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18
Q

compounder responsibilities include:

A

Be proficient and prepare compounds:
- Of acceptable strength quality, and purity

  • In accordance with prescription order
  • With appropriate packaging or label
  • In compliance with state and/or federal laws and regulations
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19
Q

Who are the 3 primary regulators in compounding?

A

USP-NF
FDA
State Board of Pharmacy

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20
Q

FDA in compounding vs. state board of pharmacy

A

FDA does not have jurisdiction in enforcing state compounding laws.
FDA required to ensure that medicinal products and preparations are safe/effective.
Will become involved when compounding pharmacy violates NDA, adulteration, or misbranding.
May create own laws, but generally follow USP-NF regulations

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21
Q

USP-NF ______ are one way to ensure quality and benefit of a compounded preparation. Stability in monograph and BUD is assumed to be identical to compound made using it.

A

monographs

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22
Q

What is quality control?

A 
product based (detection)
- daily operational monitoring to ensure appropriate control of compounding procedures
(high quality raw materials, SOP followed, product testing, documentation)
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23
Q

What is quality assurance?

A 
PROCESS based (prevention)
- examining the planned and systemic activities implemented within a compounding pharmacy
(SOPs, training, documentation, verification, random testing)
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24
Q

oxidation, separation, cracking, photolysis, microbial/fungal contamination/growth are examples of ______

A

stability failures

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25
Drug, Quality and Security Act of 2013
only applies to humans, provides do not compound list
26
Compounding Policy Priorities Plan of 2018
Solidifies FDA's partnership with state regulatory authorities
27
503A = ______ pharmacy
traditional
28
503B = ________ facility
outsourcing
29
What are the 4 characteristics of a 503A pharmacy?
- patient specific Rx's - cannot dispense for office use - cannot compound large batches (can do limited quantities) - pharmacists provide internal quality testing
30
what are the 4 characteristics of a 503B facility?
- with or without Rxs to be sold to healthcare facilities for office use only - compound large batches - follow CGMP (every process validated before brought to market) - independent quality department must be in place
31
What are the 9 legally req. components of a compound prescription label?
Date Rx filled Rx number Patient’s name Directions for usage Prescribers name* Pharmacy name and address Exact name of each API and dosage of drug dispensed BUD Pharmacist’s Name
32
Pharmaceutical elegance:
Outward appearance of the prescription drug package is often the only tangible basis for the patient’s judgement of a pharmacist’s care and skill
33
Beyond Use Date (BUD):
Date after which a compound should NOT be used because of stability or potency is unknown Formulation records for compounds may have stability information based on studies If stability information is unavailable, follow USP-NF <795> recommendations
34
Best by or use by dates:
FOR FOOD. | based on guarantee of flavor or texture
35
Expiration date:
for medication | set by manufacturer, calculated based on amount of active drug present.
36
What are some ways to increase stability of compounds?
- reduce water content - refrigerate (for formulations subject to hydrolysis) - use buffers for pH stability (5-6) - use of antioxidants to prevent oxidation - chelating agents to form complex with trace metals (prevents oxidation)
37
What are 5 causes of instability from USP 1191?
1. Physical (retains original physical properties) 2. Chemical (retains chemical integrity and labeled potency) 3. Microbial (retains sterility or resistance to microbial growth) 4. Therapeutic (retains therapeutic effect) 5. Toxicological (has no significant increase in toxicity)
38
What would the BUD be for a non-aqueous formulation like a capsule or tablet?
Whichever is earlier: | 6 months or earliest expiration of any API
39
What would the BUD be for a topical or mucosal preparation containing water (ointment, dermal, semisolid)?
30 days
40
What would the BUD be for an oral formulation containing water (solution/suspension)?
14 days under refrigeration
41
mortar vs. pestle
bowl shaped thingy = mortar stick shaped thingy = pestle (im rolling my eyes right now)
42
electronic mortar and pestle
pretty self explanatory. a faster and more clean way to triturate and mix
43
comminution:
particle size reduction
44
sifting:
if particles are small but clumped together
45
triturate:
grind in mortar with pestle to create a smaller particle size
46
pulverize:
trituration of large pieces or tablets
47
ointment mill
used to REDUCE PARTICLE SIZE and increase pharmaceutical elegance
48
What is "washing"?
used to transfer liquids from one utensil to another to ensure all drug is captured (suspensions/thick liquids) - 2 to 4 washes of 1 to 4 mL each, not exceeding final volume
49
ointment slab and paper
slab is same as pill tile, made of porcelain or glass. provides a non-absorbant surface to mix preparations like oint/creams. some have a rough area for reducing particle size through comminution. paper should be self explanatory
50
Spatulation:
mixing on a slab or paper with a spatula in a side to side manner w/ enough pressure to see surface through the compound. - reduces particle size, form of comminution.
51
Geometric dilution is a method that is used with powders and semisolids to accomplish what?
even mixing of 2 or more substances
52
How do you do geometric dilution?
- take smallest amount (A) and mix with equal amount of larger ingredient (B) - take (A/B) mixture and mix in equal amount of (B) - repeat until all mixed evenly - if you have 3 or more ingredients, do this for each ingredient
53
Levigation:
trituration w/ use of liquid to suspend/separate particles to evenly disperse - liquid must be miscible with vehicle or base - drug cannot be soluble in this liquid.
54
Group 1 levigating agents that should be used with water soluble drugs include:
mineral oil, castor oil, olive oil
55
Group 2 levigating agents that should be used with oil soluble drugs include:
water, glycerin, alcohol, propylene glycol, polyethylene glycol 400
56
solution:
liquid preparations containing one or more drug substances (APIs) molecularly dispersed in a suitable solvent or a mixture of mutually miscible solvents. (Drug dissolved)
57
pros/cons of solutions
- easier to swallow than tablets for certain patients - dose adjustments - any route of administration cons -- - taste, bioavailability, stability, transport
58
What are the goals of drug disposal?
- keep drugs out of environment - avoid accidental poisonings - avoid drug diversion
59
ways to dispose of tabs, caps, troches, sublingual films
remove personal info, mix with cat litter or coffee grounds, place in sealed container in trash.
60
ways to dispose of liquids
remove personal info, mix with absorbable material like cat litter, paper, or oatmeal, place in sealed container in trash
61
ways to dispose of patches
remove personal info, fold in half (sticky sides together), put back in envelope and fold, place in trash
62
exceptions to disposal methods listed:
- narcotics- flush to prevent misuse or diversion | inc. fentanyl patches.
63
what flavor can be used to mask bitter or metallic flavors?
marshmallow/mint
64
What is a physiological flavoring technique?
anesthetics or refrigeration
65
What is a chemical method of flavoring?
prodrug, complexes
66
What is a physical method of flavoring?
use of insoluble form, emulsions, effervescent liquids, viscous syrups
67
T or F: Oil flavors are measured in mL.
F (must be measured in DROPS)
68
How do you add an oil based flavor to an aqueous preparation?
dissolve flavor in small amount of glycerin, alcohol, sorbitol, or propylene glycol before adding to preparation.
69
Is aspartame heat stable?
No
70
T or F: Large amounts of sweetener will only make your preparation sweeter.
F: many sweeteners are bitter at high concentrations.
71
Newborns require (more/less) flavor in their preparations due to (more/less) taste experience
LESS/LESS
72
Pediatric patients are (more/less) sensitive to taste and prefer (sweet/bitter) tastes like ______
MORE sweet raspberry, bubblegum, marshmallow, berry, citrus, vanilla
73
Adults are more tolerant of _______ flavors
tart, bitter | (for bitter drugs, you can use coffee, chocolate, maple, butterscotch, cherry, anise, grapefruit, or mint)
74
Elderly have a (decreased/increased) sense of smell and (decreased/increased) sense of taste. Because of this, we should use _____ flavor.
decreased decreased more
75
What are 2 pieces of equipment used to protect from powders?
Powder containment hood | PPE
76
2 Methods of making dry powder capsules:
hand punching | machine
77
Pros/cons of capsules
Pros: Easier to swallow Covers taste for bitter medications ER formulations Can easily change dose Cons: Size limitation Bioavailability
78
soft gels
not compounded, but are commercially available. | flavors and sweeteners can be added. API is dissolved or suspended in a liquid vehicle
79
T or F: Sizes of capsules (00-5) go from small to large
F -- 00 is huge, 5 is tiny
80
What are hard shell capsules made of?
typically gelatin, sometimes starch (hydroxypropylmethylcellulose)
81
What's in a capsule?
drug (API), filler (lactose, methylcellulose, etc.), other excipients (help flow, pH change, modify release rate)
82
How can you create a rapid release capsule?
``` hydrophilic excipients (quick dissolve) pierce holes in capsule ```
83
How can you create a delayed release capsule?
coat capsule
84
How to create a slow release capsule?
hydroxypropyl methylcellulose products (Methocel A, E, F, K)

Compounding (1 decks)

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