Drug Regulation

Question 1

Role of federal govt in regulation of prescription writing

Answer 1

Controls which drugs may be prescribed/sold to public through the FDA:

1) eval process for safety and efficacy of new drugs/dietary supplements
2) equivalency of brand vs generics
3) categorizing prescription vs non-prescription drugs (also controlled substances)

Question 2

Role of state govt in regulation of prescription writing

Answer 2

Controls who prescribes drugs through licensing processes (medical, dental)

Excludes controlled substances

Question 3

Role of local govt in regulation of prescription writing

Answer 3

may pass laws concerning drug use (e.g. medical marijuana - where things get tricky!)

Question 4

Describe Phase 1 (include: # and types of subjects, time involved, limitations)

Answer 4

Think: Is it safe?

Subjects: Healthy males 18-45 yo, <100 people

Time: 2-10 years

Limitations: the types of subjects; determines if animal/human response differ greatly

Question 5

Describe Phase 2 (include: # and types of subjects, time involved, limitations)

Answer 5

Think: Does it work in patients?

Subjects: select pt pool, 200-300, no other med problems

Time: 2 years

Limitations: compares to placebo/existing treatment; safety/efficacy evaluated, final dosing; may detect broader range of toxicities

Question 6

Describe Phase 3 (include: # and types of subjects, time involved, limitations)

Answer 6

Think: Does it work, double blind?

Subjects: 1000-6000 pts

Time: 3 years

Limitations: efficacy measured against established therapy; monitors adverse rxns after chronic use

Question 7

Describe Phase 4 (include: # and types of subjects, time involved, limitations)

Answer 7

Think: post-marketing surveillance (practitioners play a huge role in this phase)

Manufacturers submit reports of any adverse effects

FDA can revoke approval/restrict drug use based on any reported adverse effects

Question 8

Compare FDA regulation of prescriptions drugs vs dietary supplements

Answer 8

Not much— both must require evidence of safety. However, the extent of evidence differs.

Question 9

Contrast FDA regulation of prescriptions drugs vs dietary supplements

Answer 9

Prescriptions: require manufacturers to show proof of efficacy, safety before marketing — lots of steps to do this

Dietary Ss:

• can be sold to public without prior evidence of safety/efficacy
• Minimum requirement for a “history of use” that leads to reasonable expectation of safety

Question 10

Define pharmaceutical equivalence with regards to brand vs generic drugs

Answer 10

Drugs contain..

1) same active ingredient(s) in
2) same dosage formulation (e.g. capsule, tablet, solution) that
3) have same administration route and
4) are identical in strength/concentration

Question 11

Define bioequivalence with regards to brand vs generic drugs

Answer 11

Major equivalency test required by FDA

Drugs display comparable rate and extent of absorption from the drug and becomes available at action site (drug target)

Tmax and Cmax must be the same

Question 12

Define therapeutic equivalence with regards to brand vs generic drugs

Answer 12

Drugs that provide the same efficacy and safety (assuming same dose, individual, route of administration)

Requires expensive, time-consuming trials — therefore not required by FDA

Question 13

What is a dietary supplement?

Answer 13

A product intended to supplement the diet that contains a vitamin, mineral, amino acid or herb/botanical and is not represented in food

Remember that herbs processes are often unknown unlike the others

Question 14

What is a drug?

Answer 14

A known molecular entity defined as a therapeutic agent intended to diagnose, treat, cure or prevent disease

Question 15

Describe Pre-Clinical Testing (include: # and types of subjects, time involved, limitations)

Answer 15

Aka: Animal studies

Subjects: rodent and non-rodent species

Time: 5-8 years

Limitations: used to determine safe dose for humans and is highly predictive, but not reliable