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Module 3 > ADR > Flashcards

ADR Flashcards

1
Q

The science and activities relating to the detection,
assessment, understanding and prevention of adverse effects
and other medicine-related problems

A

Pharmacovigilance

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2
Q

Pharmacovigilance is aka

A

Post marketing surveillance

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3
Q

Monitor drugs already available in the marke

A

Post marketing surveillance

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4
Q

Show how the genetic makeup of an individual or population
affects drug response

A

Pharmacogenetic

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5
Q

Pharmacogenetic Show how the _______________ of an individual or population
affects drug response

A

genetic makeup

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6
Q

Show how the _______________ of an individual or population
affects drug response

A

Pharmacogenetic

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7
Q

analysis of genetic determinants of drug efficacy
and toxicity

A

Pharmacogenomics

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8
Q

Genome wide analysis of genetic determinants of drug efficacy
and toxicity

A

Pharmacogenomics

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9
Q

Study of the utilization and effects of drugs in large numbers of people

A

Pharmacoepidemiology

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10
Q

Adverse drug effects / reaction A noxious and unintended reaction which occurs
at _____________ doses in man for prophylaxis,
diagnosis, and therapy of disease

A

Therapeutic doses

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11
Q

A noxious and unintended reaction which occurs
at therapeutic doses in man for prophylaxis,
diagnosis, and therapy of disease

A

Adverse drug effects / reaction

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12
Q

Any adverse effect / injury associated with use of drugs in humans whether or not
considered to be drug-related

A

Adverse drug event

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13
Q

Any preventable event that may lead to
inappropriate drug use or patient harm

A

Medication error

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14
Q

Special care necessary for
safe and effective use of the
drug

A

Precautions

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15
Q

Strong advice; statement of
danger

A

Warning

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16
Q

A drug, procedure, or
surgery should not be used
because it may be harmful to a person

A

Contraindications

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17
Q

What are the risk factor for ADR

A

Age
Concurrent Medicines
Sex
Comorbidities
Duration of Therapy
Narrow Therapeutic Index
Ethnicities and
Genetics

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18
Q

Factors ( problems) for Concurrent Medicines

A

Drug adherence
Drug interaction

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19
Q

Problem for Age ADR

A

Pediatrics
Geriatrics

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20
Q

Problems : Sex ADR

A

Females are pront to QT prolonged elongation with anti- arrhythmic drugs

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21
Q

Problems: Comorbidities ADR

A

Liver- primary metabolism

Kidney - excretion

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22
Q

primary metabolism

A

Liver

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23
Q

Main site for excretion

A

Kidney

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24
Q

Problems: Duration of therapy ADR

A

Increase toxicity
TYPE C ADR (continuous)

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25
Q

Problems: Narrow Therapeutic index ADR

A

Increase toxicity

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26
Q

Problems: Erhnicity and genetics ADR

A

Asian: fast acetylators
Western : slow acetylators

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27
Q

FastEast
SloWest

A

Asian: fast acetylators
Western : slow acetylators

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28
Q

TITE meaning in therapeutic index

A

The bigger the better, and safer

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29
Q

Therapeutic index formula

A

TI= TD50/ ED50

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30
Q

< 37 weeks AOG

A

Premature

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31
Q

37-42 weeks AOG

A

Term

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32
Q

> 42 weeks AOG

A

Post-term

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33
Q

0-30 days

A

Neonate

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34
Q

0-1 year

A

Infant

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35
Q

1-3 years

A

Toddler

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36
Q

3-5 years

A

Pre-schooler

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37
Q

6-12 years

A

School age/ late childhood

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38
Q

13-17 years

A

Adolescent at

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39
Q

Severity of reaction

A

Mild
Modertae
Severe
Lethal

40
Q

Bothersome but requires no
change in therapy

A

Mild

41
Q

Change in therap

A

Moderate

42
Q

Life-threatening, cause
significant disability

A

Severe

43
Q

Directly or indirectly causes
death

A

Lethal

44
Q

Occurence of drug interaction

A

Established
probable
Suspected
Possible
Unlikely

45
Q

Well-proven clinically

A

Established

46
Q

Not proven clinically Very likely

A

Probable

47
Q

Some data,
Might

A

Suspected

48
Q

Limited data,
Could

A

Possible

49
Q

No evidence
Doubtful

A

Unlikey

50
Q

Types of AdDR

A

Type A, B, C, D, E, F

51
Q

Type A

A

Augmented

52
Q

type B

A

BIzarre

53
Q

Type C

A

Continuous

54
Q

Type D

A

Delayed

55
Q

Type E

A

End of use

56
Q

Type F

A

Failure of therapy

57
Q

Extension effects
* Side effects

A

Type A: Augmented

58
Q

Idiosyncratic

A

Type B Bizarre

59
Q

Type B
Hypersensitivity
* Type I -
* Type II -
* Type III –
* Type IV –

A

Type I - Anaphylactic
* Type II - Cytotoxic
* Type III – Immune complex
* Type IV – Delayed / cell-mediated

60
Q

Tolerance and tachyphylaxis
* Dependence
* Addiction
* Habituation

A

Type C continuous

61
Q

Carcinogenicity
* Teratogenicity

A

Type D delayed

62
Q

Type A: Augmented : __- related to MOA

A

Extension

63
Q

Type A: Augmented is it Pharmacologically
predictable

A

Yes

64
Q

Type A: Augmented is it Dose-Dependent

A

Yes

65
Q

Type A: Augmented INCIDENCE

A

More common

66
Q

Type A: Augmented: DETECTION

A

Early un clinical development

67
Q

Type A: Augmented: MORTALITY

A

Type III- Low

68
Q

Type A: Augmented MANAGEMENT

A

Dose reduction

69
Q

Type A: Augmented unintended or
secondary effects; not-so related

A

Sode effects

70
Q

Type B: Bizarre
due to genetics

A

Idiosyncratic

71
Q

Type B: Bizarre
MANAGEMENT

A

Change the drug/ discontinue

72
Q

Type B: Bizarre
Mortality

A

High

73
Q

Type B: Bizarre
DETECTION

A

Post Licensing
Phase 1-4

74
Q

Type B: Bizarre
Incidence

A

Uncommon

75
Q

Type B: Bizarre
DOSE DEPENDENT

A

No

76
Q

Type B: Bizarre PHARMACOLOGICALLY ACTIVE

A

No

77
Q

Type B: Bizarre
exaggerated
response by the immune system

A

Hypersensitivity

78
Q

Type A: Extension effect: exmaple of drugs

A

Sulfonylureas
CNS Depressant
Antidepressants
Anticoagulant
Antihypertensive
Furosemide
Nitroglycerin
Cytotoxic drugs
nSaids
Atropine
Steroids
Antihistamine

79
Q

Sulfonylureas are for

A

Hypoglycemia

80
Q

Sulfonylure causes the dx

A

Whipples triad

81
Q

Nitroglycerin effects

A

Flushing
Throbbing headache

82
Q

Moa of nitroglycerin ointment

A

Vasodilation

83
Q

Dose dependent CNS depressant effects

A

Tranquilizing →
Sedating → Hypnotic
→Anesthesia →
Respiratory depression
→Coma → Death

84
Q

Moa of Cytotoxin drugs

A

Kill

85
Q

Cytotoxin drugs

A

Alopecia
* Nausea and vomiting
* Myelosuppression

86
Q

Suppresion of bones

A

Myelosuppression

87
Q
A
88
Q
A
89
Q
A
90
Q
A
91
Q
A
92
Q
A
93
Q
A
94
Q
A
95
Q
A
96
Q
A
97
Q
A

Module 3 (5 decks)

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