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83 Cards in this Set

  • Front
  • Back
The 1938 federal Food, Drug and Cosmetic act did which of the following?

a) Prohibited fraudulent therapeutic claims
b) Allowed the FDA to inspect the manufacturing process for new drugs
c) Defined which drugs could be sold over-the-counter
d) Defined what a dietary supplement is and how it must be labeled
e) All of the answers are true
b) Allowed the FDA to inspect the manufacturing process for new drugs
A drug is defined as?

a) Any chemical sold in a Pharmacy
b) Any chemical substance used in the diagnosis and treatment of disease
c) Any chemical substance used in humans for therapeutic purposes
d) Any synthetic chemical substance used in the diagnosis and treatment of disease
e) None of the answers are correct
b) Any chemical substance used in the diagnosis and treatment of disease
The 1906 Food and Drug Act did which of the following?
a) Required safety testing for all new pharmaceuticals.
b) Required labels to be accurate and complete
c) Established the legal definition of a drug
d)Established the Bureau of Chemistry
e) None of the answers are correct
d) Established the Bureau of Chemistry
Pharmacodynamics is defined as?

a) What the body does to the drug
b) The role genetic variation plays in the mechanism of a drug’s action
c) Why you see adverse effects after drug administration
d) How absorption and excretion affect a drug’s mechanism of action
e) None of the answers are correct
e) None of the answers are correct
The Durham-Humphrey amendment did which of the following?

a) Prohibited fraudulent therapeutic claims
b) Allowed the FDA to inspect the manufacturing process for new drugs
c) Defined which drugs could be sold over-the-counter
d) Defined what a dietary supplement is and how it must be labeled
e) All of the answers are true
c) Defined which drugs could be sold over-the-counter
This is the basic & clinical applied science that concerns itself w/ the fate & actions of drugs in the body?
pharmacology
This is What body does to the drug, including absorption, distribution, biotransformation, excretion and the time course of action?
pharmacokinetics
This is What drug does to body, including its effects, mechanism of action and location of action?
pharmacodynamics
This is What role do genetic factors play in Pharmacokinetic and Pharmacodynamic actions?
pharmacogenomics
Adverse effects of chemical compounds is defined as?
toxicology
The working definition of a drug is any __________ substance used in diagnosis & _______________ of disease.
Chemical, treatment
The broad definition of a drug is any chemical substance that affects living processes in a _____________ or __________ manner?
Positive & negative
What did Dr Harvey Wiley do in 1883?
Responsible to prevent adulteration and misbranding of agriculture products.
a group of young men who volunteered to eat foods treated with measured amounts of chemical preservatives to measure safety?
Wiley & the poison squad
The Wiley Act is aka?
Federal pure food & drug act
This act prohibits misbranded or adulterated foods, drinks, or drugs?
Federal pure food & drug act
This act prohibits false claims on labels?
Federal pure food & drug act
This act requires registration & listing of addicting substances?
Federal pure food & drug act
What happened in connection to the FDA in 1911?
Supreme court ruled 1906 act did not prevent false therapeutic claims on labels
This amendment prohibited fraudulent therapeutic claims?
Sherley Amendment of 1912
What was important for the development of the FDC act of 1938?
Sulfanilamide elixir that is associated w/ 107 deaths
This act required safety testing?
Federal food, drug & cosmetic act of 1938
This act allowed factory inspections?
Federal food, drug & cosmetic act of 1938
This act made sure that labels are accurate & complete?
Federal food, drug & cosmetic act of 1938
This act removed requirement of Sherley Amendment?
Federal food, drug & cosmetic act of 1938
This amendment required the following statement: “ Caution: Federal law prohibits dispensing without prescription” on all labels?
Durham Humphrey Amendment of 1951
This amendment created over the counter designation for drugs that could be safely used w/o medical supervision?
Durham Humphrey Amendment of 1951
Under the Durham Humphrey Amendment, w/c drugs were considered prescription?
1) Drugs given by injection
2) Drugs that are hypnotics, narcotic or habit forming or derivatives of such
3) Drugs deemed because of toxicity, method of use or side effects, not safe unless administered by a licensed practitioner
4) Drugs limited to investigational use
Under the Durham Humphrey Amendment, w/c drugs were considered prescription?
1) Drugs given by injection
2) Drugs that are hypnotics, narcotic or habit forming or derivatives of such
3) Drugs deemed because of toxicity, method of use or side effects, not safe unless administered by a licensed practitioner
4) Drugs limited to investigational use
What was the Kefauver Harris Amendment? When was it established?
Required testing for both safety and effectiveness for new drugs and testing for those approved between 1938 and 1962. it was established in 1962
This act regulated labeling & therapeutic claims of dietary supplements?
Dietary Supplement Health and Education Act of 1994
T/F: part of the Dietary Supplement Health and Education Act of 1994 was that it required safety & effectiveness testing?
False, it was not required to do this for dietary supplements under this act
What was the pediatric rule that was passed in 1998?
FDA rule to require manufacturers of new and existent biological products to assess safety and efficacy in children
Where are the 3 places that drugs come from?
Natural substances made of plant or animal, semi-synthetic, & synthetic
Give examples of natural substances of drugs?
Morphine & Penicillin G
Give examples of semi-synthetic drugs?
Newer penicillins, insulin
Give examples of synthetic drugs?
Antidepresseants, antihypertensives
T/F: most drug designs were found by observing effects or another words, accidental?
True
What effects will drugs have on living processes?
Either positive or negative
What kinds of effects do we want from drugs on living processes?
Positive or beneficial effects that will produce desired outcome
What are some negative or harmful effects of drugs?
1) antihypertensives cause drowsiness, impotence 2) birth control pills cause headaches, depression, blood clots 3) antibiotics cause diarrhea, secondary yeast infections
Our understanding of drug mechanism is limited by our overall understanding of ______________ at the present moment?
Science
This defines how drugs work to produce their therapeutic actions & SE?
MOA
Which of the following is false about the MOA of a drug?
a) There is more than one mechanism of action for a drug
b) We don’t completely understand mechanism
c) Mechanisms usually correlate w/ the therapeutic time course
d) Mechanism may change as knowledge expands
c) Mechanisms DON’T correlate w/ therapeutic time course
T/F: therapeutic effects & SE of a drug may have different mechanisms?
True
A drug having more than one mechanism means that it can bind to several different __________ types?
receptor
Talk about the mechanism of aspirin of what we thought & what we know now?
Its mechanism was not understood until PG were discovered in the late 1970s. Back then it was thought that aspirin was a bradykinin antagonist but now we think it’s a cyclooxygenase inhibitor
Talk about the mechanism of morphine and what we knew then & what we know now?
It’s mechanism was not understood until receptor was discovered in late 1974. its action was not known but now we think it’s an agonist at opiate receptors
What is the goal of the thearpeutic use of drugs?
Some drugs can cure disease
Some drugs treat the symptoms
Some drugs are used as replacement therapy
All of the above is correct
d) All of the above is correct
The rational use of MOST drugs is to do what?
Although antibiotics can cure dz & we have drugs that are used for replacement therapy such as hormones, insulin, & L-DOPA, most of the drugs on the market are for the treatment of symptoms associated w/ a dz
How many prescription drugs are available on the market as of now?
Over 13,000
How often are new drugs approved?
Every 2-3 weeks
When visiting a doctor, how often is a patient given a Rx?
2/3 of all visits result in Rx
What is the cost of drugs to get to market?
Billions of dollars
How long does it take for a drug to be approved?
10-18 years
What is the patent life of a drug?
About 20 years unless the company markets a new therapeutic reason
What are the 3 steps in the approval process of new drugs?
Synthesis, screening, & behavioral testing
What happens in the synthesis process?
Synthesis: start out w/ some hypothesis about a receptor that might work in a certain way
What happens in the screening process?
Screening: test this by doing binding & function to different receptors and say for example u find a compound that binds only to kappa receptor of opioids but doesn’t bind to the other opioid receptor so we say this would be good for pain & won’t effect respiratory depression or nausea since it doesn’t bind those receptors. From here we go to behavioral testing
What happens in the behavioral testing?
Behavioral or physiological testing: test on animals to see how much pain tolerance they can stand for example so here u’re testing the screening above.
What is the IND for new drugs?
IND submitted to FDA: if the behavioral testing passes then u submit an investigational new drug application to be able to do very controlled testing in humans
In this phase of the drug testing, u give the drug to 1000’s of people around the country & u compare the new drug w/ a placebo & also a known controlled standard?
Phase 3
In this phase of drug testing u give the drug to a small group of healthy individuals to test for the safety of the drug?
Phase 1
In this phase u test for the efficacy of the drug?
Phase 2
What is the use of drugs for a person who is 65 yrs of age & either living independently, nursing home, or hospitalized? What about those who are over 65yr?
What happens after phase 3 of drug testing? How long does it take?
An NDA is submitted to the FDA w/c takes about 20-24 months to approve it or the drug company could be asked for additional testing
What happens in phase 4 drug testing?
This is the clinical testing where the company gives the drug to 10s -100s of thousands of people. This is where rare but serious SE effects can show up. This is also where the company can make the doctor aware of any off label use for the drug
Tell what happened in the cardiac arrhythmia suppression test (CAST)?
Since many patients suffer from PVC after an MI, a test was done to see if those PVCs could be prevented
What drugs were tested in the CAST?
Encainide, flecainide, & placebo
What was the hypotheis of CAST?
Suppression of PVCs after an MI would reduce the incidence of sudden death
After 10 month of CAST trial, what was the outcome?
89 patients died w/ 59 of them from arrhythmia (PVCs) but 43 of them were on the drugs while 16 were on placebo therefore discarded the trial
What is the generic for rezulin? What was it marketed for?
Troglitazone for DM
What was rezulin’s MOA? What was the problem w/ it?
It resensitizes body to insulin but 85 cases were shown to have liver failure & 56 were shown to have heart failure from it so it was removed in 2000
What is the generic name of avandia? What was the problem w/ it?
Rosiglitazone. It works by improving target cell response to insulin w/o increasing insulin secretion. It was shown to have increased incidence of MI in 43% & increase in CV death in 64% so there is a black box warning on its use
What were the COX-2 inhibitors used for & what were their benefit?
Used as analgesic & anti-inflammatory w/ a benefit to decrease stomach ulcers & bleeding events
When was vioxx approved?
In May 1999 while NDA was in Nov 1998 so it did not take the usual 20-24 months to be approved
Name the 3 COX-2 inhibitors mentioned in lecture?
Vioxx, celebrex, bextra
What is the vigor trial?
It was conducted in 1999 where vioxx & naproxen were compared for GI safety. In March 2000, it showed that there is an increased heart risk for those on vioxx
What was the cancer study done w/ vioxx & what was the outcome?
A study was done that showed the prevention of recurring colon polyps w/ a higher dose of vioxx given for 18 months. However it was found that 2x as many had increased incidence of MI, stroke, or blood clots compared to placebo. Therefore the drug was withdrawn from the market in Sept 2004
What is the concern w/ celebrex?
There is an adenoma prevention w/ celebrex but risk for heart problems was 2.5x higher for celebrex compared to placebo
How do fenfluramine, dexfenfluramine, & phentermine work?
They increase 5HT, NE, & DA
What happened w/ fen-phen?
Although this was not FDA approved, the combo of fenfluramine & phentermine were given together but in 1997, there were reports of valvular damage & pulmonary HTN d/t 2B receptor of 5HT. This caused dexfenfluramine & fenfluramine to be withdrawn from the market.
Give 3 examples of drugs that were manufactured for one thing but were found to be better for some other managment?
beta blockers for hypertension
Minoxidil for hair loss
Bimatoprost (Latisse) for eyelashes