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CPHT > DRUG APPROVAL PROCESS > Flashcards

DRUG APPROVAL PROCESS Flashcards

1
Q

Who approves new drugs for human use?

A

FDA

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2
Q

Compounds are consider as _____and _____.

A
  • DRUGS - prozac, loft
  • BIOLOGICS - comes from a natural source such as proteins or sugar from human or animals
    - Humira, vaccines
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3
Q

Animal trials to determine if it is safe and effective

A

Preclinical Testing

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4
Q

Investigational New Drug (IND) applications filed w/ FDA

-Once application is approved, human trials begin to determine if it is safe and effective

A

Clinical Testing

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5
Q

application submitted for naturally sourced compounds seeking FDA approvals

A

Biologic License Application (BLA)

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6
Q

a drug compound undergoing clinical testing in humans

A

Investigational drugs

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7
Q

First time given to human subjects
Goal - focus on safety and minimal adverse effects
SUBJECTS - health volunteers, don’t have the disease, less than 100 subjects

A

Phase 1

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8
Q
  • generic name instead of alphanumeric format
    • Goal : Effective dose, drug delivery method, dosing internals, continue safety evaluation
      SUBJECTS - ppl who has the disease, 50-300, if phase 1 is proven to be safe.
A

Phase 2

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9
Q
  • Goal - establish acceptable uses of the drug, monitor safety and efficacy
    • SUBJECTS - 3000 subjects w/ condition
    • Documentation - dosages, timing of administration, adverse effects, and outcomes
    • If approved, drug companies can manufacture and sell the product.
      • Market brand name along w/ its generic.
A

Phase 3

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10
Q
  • FDA still monitors the safety and efficacy data after the drugs goes to market.
    Requires to report adverse effect after drugs goes to market.
A

Phase 4 (Postmarketing Testing)

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11
Q

committee or board

- Purpose is to review/approve research w/ human subjects
- Approve documents: protocols, consent forms, brochures
A

Institutional Review Board (IRB)

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12
Q

makes ethical decisions to protect the health and welfare of research volunteers

- Free of bias and conflict of interest
- Represent diverse opinions and point of view
A

Composition of the IRB

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13
Q
  • 5 or more ppl of different professions
    • Diverse
    • Consideration of race, gender, and cultural backgrounds
    • At least one scientist
    • At least one non-specialist
    • At least one person NOT affiliated w/ the institution
A

RULES OF IRB

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14
Q
  • person who wants to conduct the study, name listed on all paperwork
    Responsible and accountable for study implementation
A

Principal investigator

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15
Q

may be an individual, pharmaceutical company, device manufacturer, governmental agency, academic institution or other.
- Provides funding to support the research

A

Drug Sponsor

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16
Q

Makes and provides the study drug

A

Pharmaceutical Manufacturer

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17
Q

consists of specially trained pharmacists and technicians

- Help investigators accomplish goals
- Maintain compliance w/ standards and regulations
A

Investigations Drug Services (IDS)

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18
Q

Cause or potential to cause serious adverse events

A

Drug Recalls

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19
Q

Who does drug recalls?

A

drug companies

20
Q

Usually voluntary unless request/require from FDA (TRUE OR FALSE)

A

True

21
Q

Class __Recall
most severe
Likely to cause serious adverse events or death

A

Class I Recall

22
Q

Class __Recall
Likely to cause temporary but reversible side effects
- Most common

A

Class II Recall

23
Q

Class __Recall
(least severe) : Unlikely to cause adverse effects
- - Usually from packaging issues or labeling mix up, not from a problem w/ the actual meds

A

Class III Recall

24
Q
  • Drug withdrawals are permanent
    • Cannot return to market w/o FDA approval
    • Drug is harmful, not due to manufacturing issues
    • Drug is unapproved
A

Market Withdrawals

25
Q
  • New drug -comes under protected brand name, brand name is patent product, exclusive rights for 20 yrs
    (T OR F)
A

True

26
Q

Generic is given in the place of brand name med

A

generic substitution

27
Q

identical in active ingredients, strength, dosage form, and route of admin

A

Pharmaceutical equivalence

28
Q

identical in active ingredients, strength, dosage form, and route of admin AND absorb and release the same in the body

A

Therapeutic equivalence - Bioequivalent

29
Q
  • generic meds that looks identical to the brand

- Repackaged brand name products - relabeled as generic, markets as generic

A

Authorized Generics

30
Q
  • Same active ingredients, extended - release version
    • Different dosage form
      Different strength
A

Pharmacologic Alternatives

31
Q 
- Different active ingredients, diff drug
Similar product : same drug class, different drug class that’s used to treat same condition
A

Therapeutic Alternative

32
Q

Does Therapeutic Alternatives = Therapeutic Equivalence?

A

no

33
Q

Substituting Alternatives Required the pharmacist to contact the prescriber for a change. (T or F)

A

True

34
Q

between pharmacist and prescriber

- Pharmacist can automatically substitute w/ alternatives

A

Collaborative Agreements

35
Q

Nationally recognized code set that’s transmitted w/ a pharmacy claim to the insurance or third party provider.

A

DISPENSE AS WRITTEN CODES

36
Q

DAW

A

DISPENSE AS WRITTEN CODES

Also known as product selection codes

37
Q

Common DAW Codes

A

DAW 0, 1, 2, 7

38
Q

(default code) : no product selection preferred, okay to substitute

A

DAW 0

39
Q

substitution NOT allowed, prescriber request, state law dictates specific wording

 - "Brand medically necessary"
 - "Do not substitute"
 - "Dispense as written"
 - "Brand only"
A

DAW 1

40
Q

substitution is allowed, patient requested BRAND, may be more expensive

A

DAW 2

41
Q

substitution NOT allowed, Brand name drug mandated by state law+

A

DAW 7

42
Q

pharmacist decides the brand-name is to be dispensed, product available from multiple sources

A

DAW 3

43
Q

generic is NOT in stock, based on pharmacy’s buying habits not due to product availability in the market

A

DAW 4

44
Q

brand is dispensed as the generic, substitution allowed by prescriber

A

DAW 5

45
Q

override is required by insurance, rarely used

A

DAW 6

46
Q

substitution allowed by prescriber, generic drug is not available in the marketplace/manufacturer

A

DAW 8

47
Q

Other, reserved and not in use

A

DAW 9

CPHT (11 decks)

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