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Pharmacology - Exam 1 > Unit 1 > Flashcards

Unit 1 Flashcards

1
Q

pharmacology

A

study of drugs and their interactions w/ living orgs

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2
Q

pharmacotherapeutics “clinical pharmacology”

A

drugs used to prevent disorders and/or diagnosis and treat disease

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3
Q

pharmacodynamics

A

mechanism of action and observable effects, both biochem and physiological

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4
Q

pharmacokinetics

A

movement of drugs through the body

what the body does to the drug

  • absorption
  • distribution
  • metabolism or biotransformation
  • excretion
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5
Q

toxicology

A

study of harmful effects

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6
Q

drug

A

chem agent other than food that is capable of interacting w/ living orgs to produce biological effects

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7
Q

therapeutic effect

A

effect for which the drug is administered

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8
Q

side effect

A

any effect other than the one for which the drug is administered

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9
Q

untoward effect

A

a side effect regarded as harmful or very unpleasant to the individual

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10
Q

potency

A

AMOUNT of drug necessary to produce a given pharmacologic effect

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11
Q

placebo

A

an inactive substance given

“control”

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12
Q

double blind experiment

A

neither patient nor investigator knows who has received the placebo

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13
Q

crossover study

A

order of drug administration randomized, i.e. some patients get control med first, others get the test substance first

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14
Q

cardinal rule #1

A

all drugs are potential poison

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15
Q

cardinal rule #2

A

all drugs have more than one effect - all have multiple effects

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16
Q

cardinal rule #3

A

drugs do not cure a disease

  • they relieve the symptoms
  • exceptions - antibiotics, chemo?
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17
Q

drugs laws

A

no legislation until 20th century

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18
Q

Pure Food and Drug Act (1906)

A

improved labeling

-too many loopholes - drugs did not have to be safe or effective

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19
Q

Another “Incident” (1937)

A

Elixir of Sulfanilamide

-107 deaths (antifreeze mixture)

considered “mislabeling” - implied alcohol

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20
Q

Federal Food, Drug, and Cosmetic Act (1938)

A

safety insured - tests required before petitioning FDA for approval to market drugs

  • quality and purity of origin assured
  • labeling improved - use, dosage
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21
Q

Durham-Humphrey Amendment (1952)

A

Distinguishes Rx vs. OTC

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22
Q

Kefauver-Harris Drug Amendments (1962)

A

Drug must be effective and safe

Thalidomide - did not work and caused birth defects

drug usefulness must outweigh dangers

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23
Q

Drug Abuse Prevention and Control Act (1970)

A

applies to all dependence causing drugs

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24
Q

Schedule of Controlled Drugs

A

I - most strict
V - least strict

based upon - med usefulness and potential abuse

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25
Q

Schedule I

A

use forbidden except for research

all drugs begin here - OTC, regular, controlled meds

drugs that are too high potential for abuse

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26
Q

Schedules II-IV

A

ordered w/ script

records kept for 2 yrs

DEA sets quotas for amount made/sold

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27
Q

Schedule V

A

includes signature drugs

no prescription necessary

pharm keeps record of buyer, address, date for 2 yrs

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28
Q

Rx Forms

A

triplicate forms no longer required for Schedule II

tamper resistant security Rx forms required in Cali for Schedule II and III

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29
Q

How are Schedules II-IV distinguished?

A

Usefulness vs potential for abuse

30
Q

Schedule II

A

high potential for abuse (morphine, meth, amphetamines)

Rx may not be refilled (30 days max)

31
Q

Schedule III

A

abuse potential medium

moderate to low physical dependence

perhaps high psych dependence

Rx - 6 mos or 5 refills

32
Q

Schedule IV

A

lower potential for abuse

may lead to limited physical or pysch dependence

Rx - 6 mos or 5 refills

33
Q

“Regular” legend drugs

A

state permission

not likely to be abused

34
Q

controlled subs

A
  • Federal permission
  • registration # renewed yearly
  • records 2 years
  • abuse penalties greater
35
Q

Food and Drug Admin

A

supervises and controls RESEARCH and MANUFACTURE of all drugs

36
Q

Public Health Service

A

helps w/ some biologics

inspects and licenses establishment

examines and licenses products

37
Q

Drug Enforcement Administration (DEA)

A

Est 1973

controls DISTRIBUTIONS and SALES of all drugs

38
Q

Department of Commerce

A

Federal Trade Commission - controls misleading advertising for OTC products

39
Q

who controls advertising for Rx products

A

FDA

40
Q

Division of drug research and manufacture VS distribution and sale:

A

it separates drug enforcement from approval of new drugs

41
Q

Drug Approval Process

A

avg drug: 12 yrs and $200 mil

  • lab tests and animal trials
  • human trials (phase I-III or IV)
42
Q

Phase 1 - Human trials

A

healthy volunteers

purity, bioavailability safety, toxicity

efficacy and potency if subject is also a patient

43
Q

Phase 2 - Human trials

A

test on relatively few individuals who need the drug therapy

cont monitoring safety and toxicity

add info on potency and efficacy

44
Q

Phase 3 - Human trials

A

expanded clinical trials on pts who can benefit from the drug

more data on usefulness

provides info about more rare adverse effects

45
Q

Phase 4 - Human trials

A

voluntary monitoring of drug thru the first yrs of its use

company collects and monitors data on the product

46
Q

Efficacy

A

MAX effect produced by a drug

how effective it is at producing a desired pharmacologic response

“intrinsic activity”

47
Q

dose

A

about of drug or treatment given or taken at one time

48
Q

effective dose

A

amount of drug necessary to produce a therapeutic effect (response)

49
Q

toxic dose

A

amount of drug necessary to produce untoward effects or symptoms of poisoning

50
Q

lethal dose

A

amount of a drug that will cause death

51
Q

therapeutic dose

A

similar to effective dose

52
Q

therapeutic index

A

lethal dose^50 / effective dose ^50

can only be calculated in animals

indicates relative margin of safety

desire a high number

T.I. = 16mg/4mg = 4

53
Q

bioavailability

A

percent of drug reaching the bloodstream in a form that has an effect

(may be influence by factors such as route of admin)

54
Q

half-life

A

time required to eliminate 1/2 the amount of a given drug from the body that was present at the beginning of the timed period

diff for all drugs

~5 half-lives drugs will reach steady state

55
Q

additive

A

combined effect of 2 or more drugs (2+2=4)

56
Q

antagonistic

A

2+2=1

57
Q

synergistic

A

greater than the sum of their individual effects 2+2=6

58
Q

potentiation

A

drug that has no effect by itself increases the effectiveness of a diff drug

0+2=3

59
Q

affinity

A

how tightly a drugs binds to a receptor

likelihood to bind to a receptor

60
Q

Ratio between lethal dose and effective dose of medication is known as:

A

Therapeutic index

61
Q

Law created in response to the thalidomide tragedy that occurred in Europe in the early 1969s

A

Kefauver-Harris Drug Amendments

62
Q

Schedule 2 and 3 drugs have an equal potential for abuse

A

False

63
Q

The prescription for a ______ may not be refilled and is limited to a 30 day supply

A

Schedule 2

64
Q

If a drug is re-administered on the half-life, usually it will take ___ doses to reach a steady state

A

5

65
Q

pharmacogenomics

A

genomic testing attempting to predict how an individual will respond to a drug based on their genetic makeup

66
Q

specificity

A

binding of drug to a given receptor

“dirty drug” binds more than one receptor and therefore can produce more than one response

67
Q

characteristics of an ideal drug:

A 
effective
safe/selective
predictability
easy to admin
cost effective
few drug interactions
68
Q

therapeutic window

A

amount of med // the amount that given an effect (effective dose) and the amount that gives more adverse effects than desired effects

69
Q

short half-lives

A

leave the body quickly

70
Q

long half-lives

A

leave the body slowly

Pharmacology - Exam 1 (3 decks)

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