Midterm Flashcards
3 different types of drug names
Chemical
Trade (brand)
Generic
Generic name starts with a
Lowercase letter
Before any drug is marketed it is given a ____ that becomes the “official” name for the drug
Generic name
Brand name starts with a
Upper case letter
acetaminophen is a trade name, what is an example of its generic name
Tylenol
FDA requires the active ingredient of the generic product to ____ at the same rate as the trade name product
Enter the bloodstream at the same rate
Generic name is generally ___ than brand name items
Cheaper
What does chemically equivalent mean
2 formulations of a drug meet the chemical and physical standards established by regulatory agencies
What does biologically equivalent mean
2 formulations of a drug produce similar concentrations of the drug in the blood and tissues
Therapeutically equivalent means
2 formulations of a drug have an equal therapeutic effect
For medications to be FDA approved it needs to be
Biologically equivalent and therapeutically equivalent
FDA determines?
Which drugs can be sold by prescriptions and OTC
Who regulates the labelling and advertising of prescription drugs
FDA
How long does it take for a new drug to be available on pharmacy shelves
12 years
Animal studies usually begin by measuring what?
Acute and chronic toxicity
Phase I clinical trials refers to small and then increasing doses administered to?
A limited number of healthy human volunteers
Phase I of clinical studies determines ?
Biologic effects
Metabolism
Safe dose range in humans
Toxic effects of the drigs
In phase II of clinical studies a larger group of humans are given the drug. What is reported by the FDA during this phase?
Adverse reactions
Phase 3 of clinical trials involves a large number of patients who have?
The condition for which the drug is indicated for
In phase III of clinical studies what must be demonstrated?
What is determined?
Safety and efficacy must be demonstrated
Dosage is determined
Phase 4 of clinical studies involves?
(Drug is now approved at this point)
Post marketing surveillance
-toxicity that occurs in pts taking the drug after it is released is recorded
Schedule II-IV drugs require a
Prescription
What schedule of drugs must be types or written in one or indelible ink
Schedule II
What schedule of drug prescriptions CANNOT be phoned to pharmacist
Schedule II
Schedule II prescriptions require what for refill
A new written prescription for refill
Schedule III-IV drugs may not be refilled more than how many times in what time frame?
May not be refilled more than 5 times in a 6 month period
Which schedule drug has the highest potential for abuse?
What are some examples
Schedule I
Ex. Herion. LSD. Hallucinogens
Examples of schedule II drugs
Oxycodone
Morphine
Amphetamine
Hydrocodone
Examples of schedule III drugs
Codeine mixtures (Tylenol 3)
Schedule V drugs do not need a prescription because
They can be purchased OTC
Package inserts should include what?
Chemical makeup of the drug
FDA approved indications for use
Warnings
Contraindications
Side effects
Drug interactions
Dose and administration
How supplied
What is the purpose of a black box warning
To draw attention to safety concerns associated with the drug
Orphan drugs are
Developed to treat rare medical conditions
(Funded by government assistance)
pc abbreviation means
After meals
ac abbreviation Means
Before meals
PO abbreviation means
By mouth / orally
ud abbreviation means
As directed
What part of the prescription includes prescribers name, address and phone #, patients name address age phone number and date of prescriptions
Heading
Body of prescriptions contains what
Rx symbol
Drug name / dose size / concentration
Directions to pt
Sig
Closing at the bottom of the prescription contains what
Prescribers sig
Refill instructions
Pharmokinetics is based off the principles of ADME which stands for
Absorption
Distribution
Metabolism
Excretion
Biologically active substance that can modify cellular function
Drug
What is potency
Amount of drug required to produce an effect
Efficacy is the
Maximum intensity of effect or response that can be produced by a drug
Will administering more of a drug increase the efficacy?
No
*increases the probability of an adverse rxn
Will administering more of a drug increase the efficacy?
No
*increases probability of an adverse rxn
Are efficacy and potency related?
No unrelated
The effects seen on cells organs and systems is the
Pharmacological effect
What is therapeutic effect
Desired effect of the drug
Unwanted effects of a drug is the
Adverse effect
Whether a drug will produce a pharmacological effect depends on the drug binding to its
Target
*concentration of the drug at the receptor site influences the drugs effect
Has affinity for a receptor
Combines with receptor
Produces an effect
Agonist
Counteracts action of agonist
Antagonist
What are the 3 types of antagonists
Competitive
Non competitive
Physiologic
Mechanisms of drug transfer
Passive transfer
Simple diffusion