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Mpje Study Guide > Agencies And Purposes Of Agencies > Flashcards

Agencies And Purposes Of Agencies Flashcards

1
Q

Which act created the FDA

A

1906 Pure Food and Drug Act

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2
Q

Main Purpose of the FDA

A

Consumer protection in regard to food and drugs

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3
Q

FDA protects public health by ensuring the safety and efficacy of what 5 things

A
  1. Drugs (vet and human)
  2. Biologic medications
  3. Medical Devices
  4. Cosmetics
  5. Food supply (supplements fall under this)
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4
Q

Purpose of Center for Drug Evaluation and Research (CDER)

A

Ensure safe and effective drugs are available to patients without risk (think phases)

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5
Q

In phase 1 trials who is treated

A

1st time for use in humans. - younger healthy volunteers who may not have the sickness the drug is used to treat

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6
Q

How many people are used in a phase one trial?

A

A few dozen to no more than 100

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7
Q

What percent of drugs pass through phase 1?

A

70% move to phase 2

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8
Q

What info is gathered during phase 1

A

Pharmacokinetics (absorption distribution metabolism and elimination)
Ultimately finding out effects on humans

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9
Q

First phase where drug efficacy is tested

A

Phase 2

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10
Q

Who gets the medication in Phase 2

A

Patients who have the disease

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11
Q

How many people in a phase 2 trial

A

100s of patients but less than 1000

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12
Q

Explain the phase 2 trial

A

Randomized controlled trials with a control group getting placebo or standard of care

Side effects and tolerability are observed

Monitored for safety and efficacy

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13
Q

How many people in a phase 3 trial

A

Up to 3000

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14
Q

Where are phase 3 trials conducted

A

Across the country or across the world (multi centered)

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15
Q

What is the last phase prior to being released to the general public for sale

A

Phase 3

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16
Q

What specific things are found in phase 3?

A
  1. Specific dosing
  2. Specific indication
  3. Package insert and labeling for the drug
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17
Q

When is phase 4 conducted?

A

Post marketing

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18
Q

Who still monitors safety and efficacy during phase 4?

A

FDA and CDER

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19
Q

How many patients in phase 4?

A

Tens of thousands or possibly more

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20
Q

In which phase can long term use data be obtained

A

Phase 4

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21
Q

I’m which pase are rare side effects usually identified

A

Phase 4

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22
Q

What application needs to be filled out prior to giving a new drug to patients and prior to phase 1 trials

A

Investigation new drug application (IND)

23
Q

What application need to be completed prior to selling a drug to the public?

A

New Drug Application (NDA)

24
Q

What information is in a new drug application (NDA)

A

Clinical trial information that the FDA can review prior to approval for sale

25
Q

What application is submitted to the FDA for approval of a generic drug?

A

Abbreviated New Drug Application (ANDA)

26
Q

What is the only thing that needs to be proven in an Abbreviated New Drug Application

A

Bio equivalence

27
Q

What is it called when the FDA approves medications to be sold without a prescription?

A

Over the Counter Approval

28
Q

2 characteristics of a P drug

A
  1. Novel treatment or has advantages over existing treatments
  2. Will receive special attention and be approved more quickly
    Think P stands for priority
29
Q

2 characteristics of S drugs

A
  1. Similar molecule to already approved drug (Me too drug)
  2. Not in a hurry to approve
    Think S for standard
30
Q

What is right to try legislation?

A

Allows patients with life threatening diseases to get medications that have made it through phase 1 but have not finished phase 2 or 3 the be approved for sale.

31
Q

What is responsible for biologic medication approval?

A

Center forBiologics Evaluation and Research CBER (FDA controlled)

Similar to CDER but for biologics

32
Q

What application is needed for biologics?

A

Biologic License Application (BLA)(similar to NDA but for biologics)

33
Q

What does Medwatch do?

A

A way for patients consumers and health care professionals to report serious adverse reactions

34
Q

What 4 things are reported under Medwatch?

A
  1. Medications
  2. Biologics
  3. Devices
  4. Dietary Supplements
35
Q

What form is used by patients and non health care workers to report a Medwatch event?

A

3500B

36
Q

What form is used by health care professionals to report to Medwatch?

A

3500

37
Q

Is it mandatory to report to Medwatch?

A

No

38
Q

Which class of recall is the most urgent

A

Class 1

39
Q

What are the risks of a class 1 recall

A

Immediate danger, death, or serious injury ( very rare)

40
Q

What are the actions needed from the pharmacy on a class 1 drug recall?

A

1.Action needs to be taken asap
2. Quarantine drugs
3. Contact patients

41
Q

What are the risks with a class 2 drug recall?

A
  1. No immediate danger
  2. Risk of injury is possible but unlikely
  3. Reversible with cessation of the product
42
Q

Which class of recall does not pose an immediate threat that most likely just does not meet fda regulations but is not harmful?

A

Class 3 drug recall

43
Q

What amendment mandated the orange book?

A

Hatch-Waxman amendment

44
Q

What is the orange book used for?

A

Identifies which medications can be substituted

45
Q

Why would an ab rating have a number after it ie AB1 and AB2

A

Same drug strength and dosage form, but not bio equivalent ie diltiaZem

46
Q

In the orange book what does AA mean?

A

No bioequivalence problems in conventional dosage forms

47
Q

What is the equivalence rating for an aerosolized solution in the orange book?

A

AN

48
Q

What is the equivalence rating for oil solutions in the orange book?

A

AO

49
Q

What is the equivalence rating for an aqueous solution in the orange book?

A

AP

50
Q

What is the equivalence rating for topical products in the orange book?

A

AT

51
Q

What does it mean in the orange book if it starts with a B

A

The two agents cannot be substituted for one another (not therapeutically equivalent)

52
Q

The purple book and the orange book are the same except what two things does the purple book contain that the orange book does not?

A
  1. It has Biologics
  2. Identifies biosimilars
53
Q

What does the Biologics Control Act of 1902 do?

A

Ensures safety and purity of 1. Vaccines, 2. Serums

Mpje Study Guide (5 decks)

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