Exam I Flashcards
What is the technical definition of a drug?
any substance that produces a change in function in a living organism
What is toxicology?
study of adverse effects of chemical, physical or biological agents on living organisms and ecosystem
What is the generic name of Tylenol?
Acetaminophen
What is the chemical name of Tylenol?
N-acetyl-p-aminophenol
Therapeutic effect
intended physiological effect of the drug
Indication
medical conditions or diseases for which the drug is meant to be used
Contraindication
conditions for which the drug should NOT be used
Caution
conditions or types of patients that warrant closer observation for specific side effects
Side effect
unintended effects other than therapeutic effect
Adverse effect
a side effect that is negative
Toxic effect/toxicity
adverse effect of a drug resulting in drug poisoning
Interaction
Drugs, supplements or foods that may alter the effect of the drug, and should not be given at the same time
Site of action
where the drug exerts its effect
Mechanism of action
how a drug produces its effects
Agonists
drugs that bind to a specific receptor and produce an action
Antagonists
drugs that bind to specific receptors, prohibiting an effect
Competitive antagonism
when both agonist and antagonist drugs bind to the same receptor and re administered together
What is an example of competitive antagonism?
treating drug overdose
What is the drug action determined by?
dose and frequency
What is the ceiling effect?
maximal response reached
What is Effective Dose 50 (ED50)?
dose necessary to produce half of the maximum response
What is ED50 used for?
to compare potency of drugs
Minimum dose
smallest amount of a drug that will produce a therapeutic effect
Maximum dose
largest amount of a drug that will produce a desired effect WITHOUT toxicity
Loading Dose
initial high dose used to quickly elevate blood levels of the drug
Maintenance dose
dose required to keep the drug blood levels steady in order to maintain desired effect
What was the first attempt to protect consumors?
1906 Pure Food and Drug Act
1938 Federal Food, Drug and Cosmetic Act
authorized the FDA to demand evidence of safety for new drugs, issue standars for food, and conduct factory inspections
1951 FD&C Durham-Humphrey Amendment
defined drugs that could only be purchased with the prescription from a licensed practitioner
1958 FD&C Food Additives Amendment
approval of new food additives was required & safety determined by manufacturer before they could be marketed
What are exceptions to the food additives amendment?
- substances classified as “generally recognized as safe”
- substances previously approved for use in other food
1960 FD&C Color Additives Amendment
all colors must be approved
1962 FD&C Kefauver-Harris Amendment
required the use of standard labeling listing adverse reactions and contraindications
-also required to prove their drugs’ safety and effectiveness
1970 Comprehensive Drug Abuse Prevent and Control Act
regulate dispensing of drugs that have the potential for abuse
==>5 schedules
1994 Dietary Supplements Health & Edu Act
FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market
1996 Food Quality Protection Act
- reinvestigated pesticide tolerance levels
- developed stricter pesticide safety standards
What are the 2 requirements every drug must fulfill prior to FDA approval?
- efficacy
2. safety
Tegretol
- carbamazepine
- causes craniofacial and fingernail deformities
Diethylstilbestrol
- synthetic estrogen
- causes vaginal tumors and genital malformations in offspring