Lecture 1

Question 1

what is the new drug that just came out that is the same thing as mounjaro? what is it used for

Answer 1

zepbound
used for weight loss

Question 2

explain what happened when eliliy made PROZAC and what they did as the patent was about to run out

Answer 2

when eliliy first made prozac (fluoxetine) is became extremely popular.

when the patent almost ran out, elilily made a new brand name of fluoxetine called SARAFEM but with a new indication – for PMDD (premenstrual dysphoric disorder–mood changes)

Question 3

as mentioned, when the patent for prozac was about to run out, eliliy created a new brand name (sarafem) for the exact same drug but with a new indication (PMDD)
how did they discover this new indication?

Answer 3

when running the trials for prozac

Question 4

what does medicalization mean

Answer 4

making a social issue a medical issue and making treatment for it (ie: mental health)

Question 5

what is the primary focus of conducting animal studies ?

Answer 5

determine safety

Question 6

are pharmaceutical companies allowed to promote their products for an off label use?

Answer 6

NO – used to be allowed

Question 7

the entire process of creating a drug and then marketing it costs approximately how much

Answer 7

2-3 billion dollars

Question 8

true or false

animals can always be tested for the efficacy of drugs

Answer 8

false

Question 9

is testing on animals considered a clinical study?

Answer 9

no – preclinical

Question 10

when is an SNDA submitted?

Answer 10

ex: for a preexisting drug with a new indication

Question 11

LEGALLY, what are the 2 criteria for approval of an NDA

Answer 11

safety and efficacy

Question 12

GENERALLY (not legally) what are the requirements for an approval of a drug

Answer 12

safety
efficacy
economics
quality

economics and quality is more so the concern of insurers and not the FDA (who is concerned with safety and efficacy)

Question 13

how long does the FDA have to review an NDA?

Answer 13

180 days (6 months)

Question 14

true or false

the FDA does not perform clinical trials

Answer 14

TRUE – they just review the data

Question 15

after an NDA is approved, what happens next?

Answer 15

phase IV – postmarketing surveillance

Question 16

what is the purpose of phase IV

Answer 16

postmarketing surveillance — assess the long term safety

Question 17

how many “centers” does the FDA have? which is relevant to drugs?

Answer 17

9 centers
CDER is relevant to drugs – centers for drug evaluation and research

Question 18

dietary supplements can also be called

Answer 18

nutraceuticals

Question 19

true or false

dietary supplements/neutracueticals have to go through clinical trials

Answer 19

false – they do not. they are regulated by the FDA as food and not drugs

Question 20

what does RCT stand for

Answer 20

randomized controlled trials

Question 21

when patients are prescribed a medication for obesity, what are they likely to have to go through?

Answer 21

PA’s or step therapy

Question 22

phase 4 of clinical trials and ____ share a common purpose. explain

Answer 22

phase 4 and medwatch have a common purpose — safety of the drug in long term use

Question 23

who is the “sponsor” of the drug

Answer 23

the manufacturer

Question 24

true or false

phase 4 of clinical trials could be run by sponsors and it is entirely optional

Answer 24

false – mandatory for sponsors to conduct them

Question 25

true or false medwatch is run by the FDA and is not mandatory

Answer 25

true

Question 26

who runs medwatch?

Answer 26

the FDA

Question 27

Explain how medwatch works

Answer 27

collects aggregate data -- from health care professionals, patients, consumers, etc. uncovers patterns of issues in long term administration of drugs

Question 28

who is the #1 source of submissions on medwatch?

Answer 28

pharmacists

Question 29

what does ISMP stand for? is it a federal or private organization?

Answer 29

institute of safe medicine practices. a PRIVATE organization

Question 30

which phase could be considered "real world clinical trials"

Answer 30

phase 4

Question 31

phase 4 uses _____ of real patients (how many)

Answer 31

MILLIONS

Question 32

can phase 4 be considered RCT's? (randomized clinical trials)

Answer 32

NO. RCTS are lab run

Question 33

what are 3 official resources to see the status of a drug product? (if it's FDA approved or not)

Answer 33

1. Drugs@FDA 2. orange book/purple book 3. NDC (national drug code)

Question 34

drugs@FDA is designed for what population?

Answer 34

consumers

Question 35

what does orange book contain?

Answer 35

approved drug products with TE evaluations (TE=therapeutic equivalence) basically just brand names with their TE equivalents (generics)

Question 36

if a product has a TE equivalence code, it is a _____

Answer 36

generic

Question 37

explain the different classes of generics

Answer 37

A rated and B rated generics A rated are "good" generics -- no clinical concerns or issues B rated aren't necessarily "bad" generics -- they just aren't considered therapeutically equivalent due to bioequivalence issues

Question 38

true or false in the pharmacy, we cannot substitute a brand name for a B rated generic, but we can for A rated.

Answer 38

false -- pharmacist can use B generic, just more risks involved. in times of shortage this is done more often

Question 39

why is the issue of obesity controversial

Answer 39

a lot of people think they are obese and need medication when they clinically are not all based on BMI