ADR Exam 4 Flashcards

1
Q

What it is ADR?

A

any injury from medical intervention related to drug

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2
Q

What are two things that make up adverse drug events?

A

Adverse drug reactions

Adverse drug events

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3
Q

Which ADR classification is the biggest avoidable type?

A

Type A

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4
Q

Predictable, Avoidable

A

Type A

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5
Q

Unpredictable or idiosyncratic

A

Type B

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6
Q

Long term effects, Rx accumulation

A

Type C

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7
Q

Time distant effects, carcinogenesis, teratology

A

Type D

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8
Q

What is primary direct effects?

A

known pharmacologic effects, in “normal” pt

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9
Q

What is secondary indirect effects?

A

undesirable effects of medications

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10
Q

mucosal erosion and ulceration

A

NSAIDS

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11
Q

mucositis, systemic infections

A

Cancer Chemotherapy on GI mucosal cells

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12
Q

xerostomia

A

anticholinergic drugs

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13
Q

predisposition to MI

A

selective Cox-2 inhibitors (Rofecoxib)

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14
Q

hepatotoxicity, liver failure

A

acetaminophen, ketoconazole

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15
Q

Ingestion of how many grams of Acetaminophen is needed to cause toxicity?

A

> 4 gm/day

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16
Q

What is responsible for hepatotoxic due to Acetaminophen?

A

NAPQI (metabolite) buildup

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17
Q

What is the antidote for acetaminophen toxicity

A

N-acetylcysteine (NAC)

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18
Q

What drugs are secreted through the kidneys?

A

Penicillin and Probencid

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19
Q

What drugs can cause food interactions causing hypertensive crisis?

A

MAOI

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20
Q

Grapefruit juice blocks which enzyme?

A

CYP3A4

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21
Q

What is the most common pseudo-allergic reaction seen?

A

radiocontrast media (anaphylactic rxn)

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22
Q

Intolerance can develop due to what?

A

tinnitus from small dose aspirin

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23
Q

What are two common idiosyncratic reactions?

A
  • codeine related toxicity

- G6PD deficiency hemolytic anemia due to primaquine

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24
Q

What is a metabolite of codeine responsible for toxicity?

A

morphine

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25
Q

What enzyme should be screened for, before administrating codeine to anyone?

A

CYP2D6

26
Q

Who is more likely to metabolize CYP2D6?

A

Ultra-rapid metabolizers

27
Q

Type B- hypersensitivity reactions can be classified into..

A
  • immune mediated

- non- immune mediated

28
Q

Who is credited for classifying immune mediated reactions? BUT what is the problem with it?

A

Gell and Coombs

NOT addressing most ADRs

29
Q

What is the difference between I, II, III hypersensitivity reactions?

A

two are more cell mediated and one is tissue mediated

30
Q

Type I hypersensitivity produces what?

A

IgE, histamine, and inflammatory mediators

31
Q

Type II hypersensitivity produces what?

A

IgG or IgM, directed on cell surface, complement induced cell damage, lysis

32
Q

Type III hypersensitivity produces what?

A

drug deposited on capillary wall, initiates complement activation in tissues, causes inflammation

33
Q

Type IV hypersensitivity produces what?

A

delayed T cell response, cytokine release, macrophage activation, inflammatory response

34
Q

How does pseudo-allergic reactions present?

A

like Type I w/o IgE

35
Q

Non immune induced reactions, produce what two big syndromes?

A

Steven Johnson Syndrome

Lupus-like syndrome

36
Q

What 4 drugs produce SJS?

A

Sulfonamides
Abacavir
Phenytoin
Carbamazepine

37
Q

What 2 drugs produce Lupus like syndrome?

A

Hydralazine
Procainamide

(the SHIPS)

38
Q

Which gene should be tested before administrating Carbamazepine?

A

HLA-B*1502

39
Q

Which gene should be tested before administrating Abacavir, flucloxacllin?

A

HLA-B*5701

40
Q

Which gene should be tested before administrating Allopurinol?

A

HLA-B*5801

41
Q

What are non-immune DHRs?

A

If clinically resembles an allergy, but immun. process is not proven

42
Q

What are drug allergic reactions?

A

If definite immunological mechanism either IgE or T-cell is demonstrated.

43
Q

Beta lactam antibodies such as PCN and CPH ADR are considered?

A

Type I (mins to hrs) ( immediate hypersensitivity)

44
Q

Methyldopa and hemolytic anemia ADR are considered?

A

Type II (5-12hrs)

45
Q

PCN, CPH ADR are considered?

A

Type III (8- 10hrs)

46
Q

Topical drugs like antihistamines ADR are considered?

A

Type IV (2-7 days) (delayed)

47
Q

contact dermatitis (rash) is what type of reaction?

A

Type IV

48
Q

lymphadenopathy, fever, rash, glomerulonephritis, vasculitis is what type of reaction?

A

Type III

49
Q

hemolytic anemia, neutropenia, thrombocytopenia is what type of reaction?

A

Type II

50
Q

wheal and flare, cramping, allergic rhinitis, bronchospasm is what type of reaction?

A

Type I

51
Q

Epinephrine should be given how?

A

IM or subQ NEVER IV

52
Q

When should systemic corticosteroids and bronchodilators be given?

A

short term

53
Q

If hypersensitivity reactions occur what should you do?

A

DISCONTINUE I, II, III, IV

54
Q

How do you manage pruritus, rash, and urticaria?

A

antihistamines

55
Q

Prerequisites for ADRs in DDX?

A
  • polypharmacy
  • recognition that drugs remain in body weeks after therapy
  • clinical experience
  • Familiarity w/ relevant literature
56
Q

What are 3 things to look for when addressing casualty?

A

Onset, Duration, Offset

57
Q

What is the best way to treat causality?

A

De-challenge, monitor, re-challenge (in written of course)

58
Q

What phase is used to best measure ADR not seen during clinical trials?

A

Phase IV (relying on clinician to report)

59
Q

Where are ADR reported by clinicians?

A

on the FDA MedWatch report

60
Q

What are some mechanisms of post-marketing safety issues?

A
  • Scientific publications
  • Dear Doctor letters
  • Patient medication guides
  • Labeling changes (Black box)
  • Restricted use or distribution, or withdraw
  • Product withdrawal