ADR Exam 4

Question 1

What it is ADR?

Answer 1

any injury from medical intervention related to drug

Question 2

What are two things that make up adverse drug events?

Answer 2

Adverse drug reactions

Adverse drug events

Question 3

Which ADR classification is the biggest avoidable type?

Answer 3

Type A

Question 4

Predictable, Avoidable

Answer 4

Type A

Question 5

Unpredictable or idiosyncratic

Answer 5

Type B

Question 6

Long term effects, Rx accumulation

Answer 6

Type C

Question 7

Time distant effects, carcinogenesis, teratology

Answer 7

Type D

Question 8

What is primary direct effects?

Answer 8

known pharmacologic effects, in “normal” pt

Question 9

What is secondary indirect effects?

Answer 9

undesirable effects of medications

Question 10

mucosal erosion and ulceration

Answer 10

NSAIDS

Question 11

mucositis, systemic infections

Answer 11

Cancer Chemotherapy on GI mucosal cells

Question 12

xerostomia

Answer 12

anticholinergic drugs

Question 13

predisposition to MI

Answer 13

selective Cox-2 inhibitors (Rofecoxib)

Question 14

hepatotoxicity, liver failure

Answer 14

acetaminophen, ketoconazole

Question 15

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

Answer 15

> 4 gm/day

Question 16

What is responsible for hepatotoxic due to Acetaminophen?

Answer 16

NAPQI (metabolite) buildup

Question 17

What is the antidote for acetaminophen toxicity

Answer 17

N-acetylcysteine (NAC)

Question 18

What drugs are secreted through the kidneys?

Answer 18

Penicillin and Probencid

Question 19

What drugs can cause food interactions causing hypertensive crisis?

Answer 19

MAOI

Question 20

Grapefruit juice blocks which enzyme?

Answer 20

CYP3A4

Question 21

What is the most common pseudo-allergic reaction seen?

Answer 21

radiocontrast media (anaphylactic rxn)

Question 22

Intolerance can develop due to what?

Answer 22

tinnitus from small dose aspirin

Question 23

What are two common idiosyncratic reactions?

Answer 23

• codeine related toxicity

- G6PD deficiency hemolytic anemia due to primaquine

Question 24

What is a metabolite of codeine responsible for toxicity?

Answer 24

morphine

Question 25

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

Answer 25

CYP2D6

Question 26

Who is more likely to metabolize CYP2D6?

Answer 26

Ultra-rapid metabolizers

Question 27

Type B- hypersensitivity reactions can be classified into..

Answer 27

- immune mediated | - non- immune mediated

Question 28

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

Answer 28

Gell and Coombs | NOT addressing most ADRs

Question 29

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

Answer 29

two are more cell mediated and one is tissue mediated

Question 30

Type I hypersensitivity produces what?

Answer 30

IgE, histamine, and inflammatory mediators

Question 31

Type II hypersensitivity produces what?

Answer 31

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

Question 32

Type III hypersensitivity produces what?

Answer 32

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

Question 33

Type IV hypersensitivity produces what?

Answer 33

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

Question 34

How does pseudo-allergic reactions present?

Answer 34

like Type I w/o IgE

Question 35

Non immune induced reactions, produce what two big syndromes?

Answer 35

Steven Johnson Syndrome | Lupus-like syndrome

Question 36

What 4 drugs produce SJS?

Answer 36

Sulfonamides Abacavir Phenytoin Carbamazepine

Question 37

What 2 drugs produce Lupus like syndrome?

Answer 37

Hydralazine Procainamide (the SHIPS)

Question 38

Which gene should be tested before administrating Carbamazepine?

Answer 38

HLA-B*1502

Question 39

Which gene should be tested before administrating Abacavir, flucloxacllin?

Answer 39

HLA-B*5701

Question 40

Which gene should be tested before administrating Allopurinol?

Answer 40

HLA-B*5801

Question 41

What are non-immune DHRs?

Answer 41

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

Question 42

What are drug allergic reactions?

Answer 42

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

Question 43

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

Answer 43

Type I (mins to hrs) ( immediate hypersensitivity)

Question 44

Methyldopa and hemolytic anemia ADR are considered?

Answer 44

Type II (5-12hrs)

Question 45

PCN, CPH ADR are considered?

Answer 45

Type III (8- 10hrs)

Question 46

Topical drugs like antihistamines ADR are considered?

Answer 46

Type IV (2-7 days) (delayed)

Question 47

contact dermatitis (rash) is what type of reaction?

Answer 47

Type IV

Question 48

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

Answer 48

Type III

Question 49

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

Answer 49

Type II

Question 50

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

Answer 50

Type I

Question 51

Epinephrine should be given how?

Answer 51

IM or subQ NEVER IV

Question 52

When should systemic corticosteroids and bronchodilators be given?

Answer 52

short term

Question 53

If hypersensitivity reactions occur what should you do?

Answer 53

DISCONTINUE I, II, III, IV

Question 54

How do you manage pruritus, rash, and urticaria?

Answer 54

antihistamines

Question 55

Prerequisites for ADRs in DDX?

Answer 55

- polypharmacy - recognition that drugs remain in body weeks after therapy - clinical experience - Familiarity w/ relevant literature

Question 56

What are 3 things to look for when addressing casualty?

Answer 56

Onset, Duration, Offset

Question 57

What is the best way to treat causality?

Answer 57

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

Question 58

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

Answer 58

Phase IV (relying on clinician to report)

Question 59

Where are ADR reported by clinicians?

Answer 59

on the FDA MedWatch report

Question 60

What are some mechanisms of post-marketing safety issues?

Answer 60

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