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316 Pharmacology > Exam 1: Intro to Pharm + Gov regulations > Flashcards

Exam 1: Intro to Pharm + Gov regulations Flashcards

1
Q

Pharmacology can be described as

A

Study of drugs/chemicals that alter functions in living organisms

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2
Q

Drugs are chemicals that are introduced into the body to effect physiological processes by

A

replacing
increasing
depressing
interfering

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3
Q

How do drugs replace

A

Replace or act as a substitute for missing chemicals

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4
Q

How do drugs increase a physiological process

A

Increase or stimulate cellular activity

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5
Q

How do drugs depress physiological process

A

Depress or slow cellular activity

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6
Q

How do drugs interfere with physiological processes?

A

Interfere with the function of foreign cells

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7
Q

Properties of an ideal drug

A

Efficacy
Safety
Selectivity

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8
Q

An effective drug is a drug that

A

does something useful

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9
Q

A safe drug is one that

A

Does no produce harmful effects

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10
Q

Is there such thing as an absolute safe drug?

A

NO, there is not such thing because all drugs have the potential to cause injury

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11
Q

How can the relative safety of a drug be increased?

A

By proper drug selection, dosage, and monitoring

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12
Q

A truly selective drug is

A

one that elicits only the desired response and not undesired or adverse effects

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13
Q

Is there such thing as a truly selective drug?

A

No there is no such thing as a truly selective drug because all drugs cause effects other than the intended therapeutic effect

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14
Q

Principle 1 of drug action

A

Drugs modify existing functions within the body, they do not create new functions

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15
Q

Principle 2 of drug action

A

No drug has a single action

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16
Q

Principle 3 of drug action

A

Drug effects are determined by the drugs interaction with the body

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17
Q

1906 pure food and drug act

A

Required listing of ingredients to prevent the marketing of adulterated drugs

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18
Q

1938 federal pure food, drug, and cosmetic act

A

-Mandated testing for drug toxicity
-provided means to recall drugs
Established procedures for introduction of new drugs, FDA enforced

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19
Q

1951 Durham-Humphrey Amendement

A

Defined two categories of medications (prescription and over-the-counter)

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20
Q

Criteria for a drug to be OTC

A
  • Acceptable margin of safety (therapeutic index)
  • Little potential for abuse
  • recognized and treated with minimal or no intervention by HCP
  • Benefits>risks
  • Deemed safe and effective without a prescription
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21
Q

Problems with OTC medications

A
  • May mask signs and symptoms of other disease
  • may interact with prescription drugs
  • may be taken in greater than the recommended dose—> Toxicity
  • may not report use of OTC
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22
Q

OTC drugs account for

A

60% of all doses; 40% of Americans take at least 1 OTC drug every 2 days

23
Q

1962 Harris-Kefauver Amendments

A

-Tightened control over quality of drugs
-Efficacy and safety required to be established
Required that all drugs between 1932-1962 undergo testing for effectiveness

24
Q

Harris - Kefauver Amendments (1962) was in response to

A

Thalidomide tragedy

25
Q

Preclinical trials

A
  • chemicals tested on laboratory animals
  • Determine valur on living tissues
  • Evaluate adverse effects
  • —-Toxicity
  • —-Teratogenicity
  • —-Safety margins
  • —- has to have LD50 to get accepted
26
Q

Reasons medications are discarded at the end of preclinical trials

A
  • Lack of therapeutic activity
  • Toxicity to living animals creating too high a risk for drug development
  • High incidence of teratogenic effects
  • Safety margins too small for use in clinical setting
27
Q

1970 controlled substance act

A

-Controlled substances were divided into five classes on basis of their therapeutic use, safety, and potential for abuse

28
Q

Class 1 drug schedule

A

Abuse potential - Highest
Physical dependency- High
Psychologic dependency- High

29
Q

Examples of class 1 drug

A

Heroin, LSD, marijuana

30
Q

Class 2 drug schedule

A

Abuse potential - high
Physical dependency - high
Psychologic dependency - high

31
Q

Examples of class 2 drugs

A

Morphine, cocaine, methamphetamine

32
Q

Class 3 drug schedule

A

Abuse potential - Moderate
Physical dependency - moderate
Psychologic dependency - High

33
Q

Examples of class 3 drug schedule

A

Codeine, hydrocodone with aspirin or Tylenol, some barbiturates

34
Q

Class 4 drug schedule

A

Abuse potential - lower
Physical Dependency - lower
Psychologic dependency - lower

35
Q

Examples of class 4 drug schedule

A

Dextropropoxyphene, pentazocine, diazepam, alprazolam

36
Q

Class 5 drug schedule

A

Abuse potential - lowest
Physical Dependency - lowest
Psychologic dependency - lowest

37
Q

Examples of class 5 drugs

A

OTC cough medicines with codeine, diphenoxylate

38
Q

1983 orphan drug act

A

law passed to facilitate the development of drugs for rare diseases, orphan drugs

39
Q

A rare disease is defined as

A

one that affects fewer than 200,000 people in the US

40
Q

Examples of rare diseases

A

Huntington’s disease
Amyotrophic Lateral Sclerosis (ALS)
Tourette syndrome
Muscular dystrophy

41
Q

Teratogenesis

A

Induction of developmental defects in the somatic tissues of a fetus

42
Q

Mutagenesis

A

induction of changes in genetic material

43
Q

what category is usually given to pregnant women

A

Category A-C

44
Q

Pregnancy and lactation labeling rule

A
  • PLR format
  • help assess benefit vs. risk
  • remove pregnancy letter
  • label be updated
45
Q

Drugs interact with intended site and

A

affect ALL cellular receptors with which they are compatible

46
Q

Adverse drug reactions

A

response to a medicine that is noxious, unintended, and undesired side effect that occurs at normal frug doses

47
Q

patients older than 60 account for nearly

A

50% of all ADRs

48
Q

fetal ADR % is

A

5%

49
Q

Black box warnings

A

Strongest warning FDA can place on drug label

50
Q

Drug interaction

A

altered or modified effect of drugs as a result of interaction with

  • 2 or more drugs
  • nutrients
  • herbal preparations
51
Q

Drug interactions can be

A

intended & desired

Unintended & undesired

52
Q

effect can vary by

A
  • Intensification of effects
  • reduction of effects
  • creation of unique response
53
Q

Generic drugs

A

Name of medication containing chemical

54
Q

Off label use of a drug

A

use of a drug for an indication that is unapproved by the FDA

316 Pharmacology (19 decks)

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