Drug Regulation

Question 1

What role does the federal government play in drug regulation?

Answer 1

They control what drugs can be prescribed or directly sold to the public. The organization that oversees this is the food and drug administration (FDA)

Question 2

What does the FDA regulate?

Answer 2

1. Evaluation process for determining safety and efficacy of new drugs prior to public availability. and removal of dietary supplements deemed unsafe after availability
2. Equivalency of brand vs. generic
3. Placement of drug in prescription vs. nonprescription and controlled substances

Question 3

What is the role of the state government in drug regulation?

Answer 3

They control who may prescribe drugs through licensing This does not include controlled substances in which a prescriber must register with the DEA

Question 4

What is the role of the local government in drug regulation?

Answer 4

may pass laws that concern drug use in their jurisdiction

Question 5

Prescription drugs:

Evaluated?
Prescription Only?
Abuse potential?

Answer 5

Yes
Yes
Very Low

Question 6

Controlled Substances:

Evaluated?
Prescription Only?
Abuse potential?

Answer 6

Yes

Yes

Yes

Question 7

Over-the-Counter

Evaluated?
Prescription Only?
Abuse potential?

Answer 7

Yes

No

No

Question 8

Dietary Supplements

Evaluated?
Prescription Only?
Abuse potential?

Answer 8

No

No

No

Question 9

What did the Food, Drug, and Cosmetic Act of 1938 do?

Answer 9

Requires for new drugs and drugs since 1938 manufacturers must demonstrate proof of efficacy and safety prior to release to the public

Question 10

Describe animal studies

Answer 10

Attempts to determine safe dosage range for humans. Highly predicitive but not totally reliable

Question 11

After what successful study is the Investigational New Drug Application submitted? Does the application have to be specific for a particular indication?

Answer 11

After successful animal studies

Yes

Question 12

Describe Phase I

Answer 12

Testing the pharmokinetics. Is it safe? Using less than 100 healthy male volunteers

Question 13

Describe: Phase II.

Answer 13

Does it work in patients?
Select patient pool of 200-300 with no other medical problems.
Safety and Efficacy evaluated

Comparison of placebo or existing treatment

Question 14

Describe: Phase III

Answer 14

Does it work, double blinded?

1000-6000 patients

Question 15

What is a accelerated or conditional approval?

Answer 15

Approval for drugs with the greatest potential benefit for serious, life-threatening disease

Question 16

When is a NDA approved?

Answer 16

After positive results from phase III

Question 17

What is the abbreviated New Drug Application?

Answer 17

Application for generic drugs to skip clinical trials. Only approved if bioequivalence standards are met

Question 18

Describe: Phase IV

Answer 18

Post-marketing surveillance where manufacturers are required to submit reports to the FDA about adverse effects of their drugs. Used to study groups omitted in clinical trials practitioners must play active role in reporting adverse reactions

Question 19

Name some similarities of generic and brand name drugs

Answer 19

1. Same active ingredient
2. exact same dosage, intended use, therapeutic effects, SIDE EFFECTS, ROA, risk, safety, and efficacy
   3, Pharmacologically the same

Question 20

Are generic drugs cheaper because they are inferior to the brand name?

Answer 20

No. they didn’t have to pay for clinical trials

Question 21

Most generic brands are bioequivalents and have a mean bioavailability variation of less than what percent?

Answer 21

4%

Question 22

What two drugs is it advised to use one or the other formulation?

Answer 22

1. Levothyroxine

2. Anti-epipleptic drugs

Question 23

What is a pharmaceutical alternative?

Answer 23

same therapeutic moiety but different salts or esters, different dosage forms, or strengths

Question 24

Name four dietary supplements.

Answer 24

Vitamins
Botanicals/ Herbs
Amino acids
Minerals

Question 25

What is the Dietary Supplement Health and Education Act of 1994 (DSHEA)

Answer 25

Products intended to SUPPLEMENT THE DIET to be TAKEN BY MOUTH that CONTAINS ONE OR MORE DIETARY INGREDIENTS

Question 26

Which of the four dietary supplements has a molecular entity imparting pharmacologic activity is known?

Answer 26

Vitamins
Amino Acids
Minerals

Question 27

Which of the four dietary supplements does not have a molecular entity imparting pharmacologic activity that is known?

Answer 27

Herbal medications

Question 28

What are the regulations on dietary supplements before ‘94?

After 94?

Who is the burden of evidence on to prove a dietary supplement is unsafe?

Answer 28

Not required to be reviewed by FDA for safety before marketing

After must provide reasonable evidence, but manufacturer does not have to probide the FDA with evidence of safety and effectiveness

FDA

Question 29

Does a health claim on a dietary supplement require evaluation by FDA?

Answer 29

Yes

Question 30

Does a structure/function claim on a dietary supplement require evaluation by FDA?

Answer 30

No, but the label must contain a disclaimer

Question 31

Does the law require identification of active principle or data regarding bioavailability, pharmacokinetics, or potential interactions

Answer 31

No, not even on prescription or OTC

Question 32

What does the Good Manufacturing Practice do?

Who enforces it?

When was it implemented?

Answer 32

Rules that describe conditions under which dietary supplements must be prepared, packed, and stored

FDA

2011