Lecture 1 Flashcards
what is the new drug that just came out that is the same thing as mounjaro? what is it used for
zepbound
used for weight loss
explain what happened when eliliy made PROZAC and what they did as the patent was about to run out
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)
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?
when running the trials for prozac
what does medicalization mean
making a social issue a medical issue and making treatment for it (ie: mental health)
what is the primary focus of conducting animal studies ?
determine safety
are pharmaceutical companies allowed to promote their products for an off label use?
NO – used to be allowed
the entire process of creating a drug and then marketing it costs approximately how much
2-3 billion dollars
true or false
animals can always be tested for the efficacy of drugs
false
is testing on animals considered a clinical study?
no – preclinical
when is an SNDA submitted?
ex: for a preexisting drug with a new indication
LEGALLY, what are the 2 criteria for approval of an NDA
safety and efficacy
GENERALLY (not legally) what are the requirements for an approval of a drug
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)
how long does the FDA have to review an NDA?
180 days (6 months)
true or false
the FDA does not perform clinical trials
TRUE – they just review the data
after an NDA is approved, what happens next?
phase IV – postmarketing surveillance
what is the purpose of phase IV
postmarketing surveillance — assess the long term safety
how many “centers” does the FDA have? which is relevant to drugs?
9 centers
CDER is relevant to drugs – centers for drug evaluation and research
dietary supplements can also be called
nutraceuticals
true or false
dietary supplements/neutracueticals have to go through clinical trials
false – they do not. they are regulated by the FDA as food and not drugs
what does RCT stand for
randomized controlled trials
when patients are prescribed a medication for obesity, what are they likely to have to go through?
PA’s or step therapy
phase 4 of clinical trials and ____ share a common purpose. explain
phase 4 and medwatch have a common purpose — safety of the drug in long term use
who is the “sponsor” of the drug
the manufacturer
true or false
phase 4 of clinical trials could be run by sponsors and it is entirely optional
false – mandatory for sponsors to conduct them
true or false
medwatch is run by the FDA and is not mandatory
true
who runs medwatch?
the FDA
Explain how medwatch works
collects aggregate data – from health care professionals, patients, consumers, etc. uncovers patterns of issues in long term administration of drugs
who is the #1 source of submissions on medwatch?
pharmacists
what does ISMP stand for? is it a federal or private organization?
institute of safe medicine practices. a PRIVATE organization
which phase could be considered “real world clinical trials”
phase 4
phase 4 uses _____ of real patients (how many)
MILLIONS
can phase 4 be considered RCT’s? (randomized clinical trials)
NO.
RCTS are lab run
what are 3 official resources to see the status of a drug product? (if it’s FDA approved or not)
- Drugs@FDA
- orange book/purple book
- NDC (national drug code)
drugs@FDA is designed for what population?
consumers
what does orange book contain?
approved drug products with TE evaluations (TE=therapeutic equivalence) basically just brand names with their TE equivalents (generics)
if a product has a TE equivalence code, it is a _____
generic
explain the different classes of generics
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
true or false
in the pharmacy, we cannot substitute a brand name for a B rated generic, but we can for A rated.
false – pharmacist can use B generic, just more risks involved. in times of shortage this is done more often
why is the issue of obesity controversial
a lot of people think they are obese and need medication when they clinically are not
all based on BMI
