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Pharmacology - Exam 1 > Unit 1 > Flashcards

Unit 1 Flashcards

(70 cards)

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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
Schedule I
use forbidden except for research all drugs begin here - OTC, regular, controlled meds drugs that are too high potential for abuse
26
Schedules II-IV
ordered w/ script records kept for 2 yrs DEA sets quotas for amount made/sold
27
Schedule V
includes signature drugs no prescription necessary pharm keeps record of buyer, address, date for 2 yrs
28
Rx Forms
triplicate forms no longer required for Schedule II tamper resistant security Rx forms required in Cali for Schedule II and III
29
How are Schedules II-IV distinguished?
Usefulness vs potential for abuse
30
Schedule II
high potential for abuse (morphine, meth, amphetamines) Rx may not be refilled (30 days max)
31
Schedule III
abuse potential medium moderate to low physical dependence perhaps high psych dependence Rx - 6 mos or 5 refills
32
Schedule IV
lower potential for abuse may lead to limited physical or pysch dependence Rx - 6 mos or 5 refills
33
"Regular" legend drugs
state permission not likely to be abused
34
controlled subs
- Federal permission - registration # renewed yearly - records 2 years - abuse penalties greater
35
Food and Drug Admin
supervises and controls RESEARCH and MANUFACTURE of all drugs
36
Public Health Service
helps w/ some biologics inspects and licenses establishment examines and licenses products
37
Drug Enforcement Administration (DEA)
Est 1973 controls DISTRIBUTIONS and SALES of all drugs
38
Department of Commerce
Federal Trade Commission - controls misleading advertising for OTC products
39
who controls advertising for Rx products
FDA
40
Division of drug research and manufacture VS distribution and sale:
it separates drug enforcement from approval of new drugs
41
Drug Approval Process
avg drug: 12 yrs and $200 mil - lab tests and animal trials - human trials (phase I-III or IV)
42
Phase 1 - Human trials
healthy volunteers purity, bioavailability safety, toxicity efficacy and potency if subject is also a patient
43
Phase 2 - Human trials
test on relatively few individuals who need the drug therapy cont monitoring safety and toxicity add info on potency and efficacy
44
Phase 3 - Human trials
expanded clinical trials on pts who can benefit from the drug more data on usefulness provides info about more rare adverse effects
45
Phase 4 - Human trials
voluntary monitoring of drug thru the first yrs of its use company collects and monitors data on the product
46
Efficacy
MAX effect produced by a drug how effective it is at producing a desired pharmacologic response "intrinsic activity"
47
dose
about of drug or treatment given or taken at one time
48
effective dose
amount of drug necessary to produce a therapeutic effect (response)
49
toxic dose
amount of drug necessary to produce untoward effects or symptoms of poisoning
50
lethal dose
amount of a drug that will cause death
51
therapeutic dose
similar to effective dose
52
therapeutic index
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
bioavailability
percent of drug reaching the bloodstream in a form that has an effect (may be influence by factors such as route of admin)
54
half-life
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
additive
combined effect of 2 or more drugs (2+2=4)
56
antagonistic
2+2=1
57
synergistic
greater than the sum of their individual effects 2+2=6
58
potentiation
drug that has no effect by itself increases the effectiveness of a diff drug 0+2=3
59
affinity
how tightly a drugs binds to a receptor likelihood to bind to a receptor
60
Ratio between lethal dose and effective dose of medication is known as:
Therapeutic index
61
Law created in response to the thalidomide tragedy that occurred in Europe in the early 1969s
Kefauver-Harris Drug Amendments
62
Schedule 2 and 3 drugs have an equal potential for abuse
False
63
The prescription for a ______ may not be refilled and is limited to a 30 day supply
Schedule 2
64
If a drug is re-administered on the half-life, usually it will take ___ doses to reach a steady state
5
65
pharmacogenomics
genomic testing attempting to predict how an individual will respond to a drug based on their genetic makeup
66
specificity
binding of drug to a given receptor "dirty drug" binds more than one receptor and therefore can produce more than one response
67
characteristics of an ideal drug:
``` effective safe/selective predictability easy to admin cost effective few drug interactions ```
68
therapeutic window
amount of med // the amount that given an effect (effective dose) and the amount that gives more adverse effects than desired effects
69
short half-lives
leave the body quickly
70
long half-lives
leave the body slowly

Pharmacology - Exam 1 (3 decks)

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