Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmacology > Compounding > Flashcards

Compounding Flashcards

1
Q

Define brand name drug

A

drug that has a trade name and is protected by a patent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Define generic drug

A

bioequivalent version of a drug licensed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Define adminstration

A

giving drug to patient while patient is in office

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Define dispensing

A

providing drug to an owner to give to a patient that is under your care

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Define 503A compounding

A

traditional compounding performed by veterinarians and compounding pharmacies

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Define 503B compounding

A

compounding performed only by special outsourcing facilities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

If there is no specification of compounding which compounding is it?

A

503A

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Define compounding

A

manipulation of FDA approved drugs by a veterinarian or pharmacist upon the prescription of a veterinarian to meet the needs of an individual patient that is under his or her care

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

what can be used for compounding?

A

any FDA approved drug - trade-name and approved generic drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What does compounding bulk drug substances violate?

A

federal, food, drug, and cosmetic act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

who can compound

A

licensed veterinarian
pharmacist upon prescription of veterinarian

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

when can you compound

A

to meet needs to individual patient

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

who can you compound for?

A

patients with VCPR (typically cant be established online, email, or over phone)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

are compounded drugs a FDA approved medication?

A

no

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Is a compounded drug equivalent to a generic drug?

A

no

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

can you write a prescription for a compounded medication to make it more affordable?

A

NO - economics not sanctioned reason to choose compounded medications

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Is compounding a common thing to do?

A

Yes - FDA estimates 6.3 million prescriptions for compounded drugs each year

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

what is the benefit of buprenorphine ER?

A

allows us to provide long-lasting control w/o dispensing opioids

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

why is it important to regulate compounding?

A

can lead to many killed and sick

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

who regulates compounding?

A

FDA, state governments, state boards of pharmacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

who has the primary responsibility for day-to-day oversight of state-licensed pharmacies that compound drugs?

A

state board of pharmacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

what are the acts that the FDA uses to regulate compounding?

A

FDCA
AMDUCA
DQSA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What type of drug use is compounding considered?

A

extra label drug use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Appropriate to compound - as a vet, you mix two injectable drugs in your office to administer to a patient

A

yes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

Appropriate to compound - as a pharmacist, you prepare an oral paste or suspension from bulk substances so that you have it available to dispense when a vet sends you a prescription

A

NO - no bulk substances

26
Q

Appropriate to compound - as a veterinarian you add flavoring to a drug

A

yes

27
Q

Appropriate to compound - as a vet tech you compound a medication at a vets request

A

yes

28
Q

Appropriate to compound - as a vet in AZ, you prepare an oral paste or suspension from crushed tablet for a new patient thoroughly described to you by email

A

no - need audio and video communication

29
Q

Appropriate to compound - as a pharmacist with a prescription from a vet you prepare an oral paste or suspension from crushed tablets

A

yes

30
Q

Appropriate to compound - as a veterinarian, you cut scored tablets in half for a client with osteoarthritis

A

yes

31
Q

Appropriate to compound - as a veterinarian you write a prescription for a compound medication to make it more affordable

A

no

32
Q

why compound drugs?

A

-limited number of FDA approved drugs for the many species and conditions we treat
-make drugs easier to administer (conc., route, palatability)
-to make it easier to admin multiple medications

33
Q

Define extra label use

A

actual use or intended use of a drug in an animal in a manner that is not in accordance with approved labeling

34
Q

what is the GFI?

A

-guidance for industry
-FDA provides guidance that represents current thinking of FDA on various topics, non-binding

35
Q

what does GFI 256 adivse?

A

describes circumstances under which FDA does not intent to take enforcement action for violation of FDCA act for compounding animal drugs from bulk drug substances

36
Q

when was GFI 256 released

A

april 2023

37
Q

what is the primary product of focus of GFI 256?

A

-products being sold for administration
-secondary focus is need for documentation on patient-specific scripts

38
Q

when might veterinarians need bulk drug compounding?

A

-drug previously approved by FDA is no longer commercially available
-needed medication can’t be prepared from FDA approved drug

39
Q

what are the acceptable medical rationale for compounding?

A

-allergic to ingredient in approved product
-ingredient name is toxic to X species
-P require too many tablets of approved product
-P requires dose that would be a fraction of approved tablet and it is not scored to accomplish the fractioned dose
-patient cannot safely be pilled w/o approved capsule

40
Q

what are the unacceptable medical rationale for compounding?

A

-compounding drug is less expensive
-prefer compounded
-need half strength (approved product can make it work just less mLs)

41
Q

who inspects outsourcing facilities?

A

FDA

42
Q

what must the outsourcing facilities do?

A

-comply with cGMP requirements
-report adverse events
-provide FDA with certain information about products they compound

43
Q

what is cGMP?

A

-current good manufacturing practice
-main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals

44
Q

who enforces the cGMP

A

FDA

45
Q

what does adherence to the cGMP regulations assure?

A

-identity, strength, quality, and purity of drug products
-potency, sterility, stability

46
Q

who do you report adverse compounding events to?

A

FDA

47
Q

what is the USP convention?

A

-united states pharmacopeial convention
-develops and disseminates guidelines for medicines

48
Q

Is the USP a regulatory body?

A

NO

49
Q

define dispense

A

prescribing, administering, packaging, labeling, compounding, and security necessary to prepare and safeguard drug or device for delivery

50
Q

Who is required to carry product liability insurance and who is not?

A

drug manufacturers required to carry it
pharmacies not required to carry it

51
Q

what is the risk with veterinary compounding pharmacies?

A

some will openly manufacture and market illegally compounded drugs

52
Q

when could veterinarians be liable for veterinary malpractice with compounded drugs?

A

in the case of treatment failure

53
Q

what medication should not be administered transdermally? why?

A

antibiotics - likely lead to resistance and lack of efficacy due to low blood levels

54
Q

what type of drugs limit your liability?

A

FDA approved

55
Q

In the hierarchy for prescribing medication which are the best to prescribe?

A

FDA approved drugs

55
Q

Order these drugs in order of best to prescribe

  1. FDA approved human medication for that condition
    2.FDA approved vet medication for that species and condition
  2. compounded drug
  3. FDA approved vet medication for another species
A
  1. FDA approved vet medication for that species and condition
  2. FDA approved vet medication for another species
  3. FDA approved human medication for that condition
  4. compounded drug
55
Q

If there is not sufficient enough data for a compounded medications withdrawal interval and it was given to a food animal what must the veterinarian do?

A

ensure that the animal and its products never enter the food chain

56
Q

What can be concluded if a drug is an antibiotic available in a powder that has to be reconstituted in a viral or in an oral dispensing bottle prior to administration?

A

it should not be mixed with other drugs

56
Q

when do veterinarians use compounded drugs in food animals?

A

if there is ABSOLUTELY NOT OTHER CHOICE

56
Q

what should be the latest beyond use dating of a compounded product?

A

no later than 25% of the remaining time until the products expiration date

56
Q

What can be concluded if a drug is packaged in blister packs or with a moisture-proof barrier?

A

subject to loss of stability and potency if mixed with aqueous vehicles

56
Q

What can be concluded if a drug is packaged in light-protected or amber container?

A

prone to inactivation by light

Pharmacology (8 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions