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303 MEDIMAGE > 8. Adverse reactions to medicines including contrast media > Flashcards

8. Adverse reactions to medicines including contrast media Flashcards

1
Q

what is an adverse event or experience

A

untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment

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2
Q

what is an adverse drug reaction

A

in the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic doses may not be established and all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reaction

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3
Q

what is an unexpected adverse drug reaction

A

an adverse reaction the nature or severity of which is not consistent with the applicable product info

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4
Q

what does the term severe indicate

A

describes the intensity of a specific event, the event itself may be of relatively minor medical significance

eg severe headache

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5
Q

what does the term serious indicate

A

not the same as severe, which is based on patient even outcome or action criteria usually associated with events that pose a threat to a patients life or functioning

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6
Q

a serious adverse event/experience or reaction is any untoward medical occurrence that at any dose is what 6 things

A

results in death
life threatening
requires hospitalization/prolonged hospitalisation
results in persistent/significant disability
is a congenital anomaly/birth defect
is medically important event/reaction

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7
Q

what are mild severity graded adverse events in regard to how bad the symptoms are, how it is observed and what intervention is indicated

A

symptomatic/mild symptoms

clinical/diagnostic observation only

intervention not indicated

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8
Q

what are moderate severity graded adverse events in regard to what intervention is indicated and what activities are limited

A

minimal, local or non invasive intervention indicated

limiting age dependent daily living

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9
Q

what are severe/medically significant but not immediately life threatening severity graded adverse events in regard to outcomes

A

hospitalisation or prolongation of hospitalisation, disabling

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10
Q

what are the 5 common terminology criteria for adverse events severity grades

A
  1. mild
  2. moderate
  3. severe or medically significant but not immediately life threatening
  4. life threatening consequences
  5. death
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11
Q

how are adverse reactions graded in NZ

A

by letters A-I with A being the least severe and I being error causing death

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12
Q

what is category A adverse reaction

A

circumstances or events that have the capacity to cause error

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13
Q

what is category B adverse reaction

A

error occurred but error did not reach the patient

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14
Q

what is category C adverse reaction

A

error occurred that reached the patient but did not cause patient harm

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15
Q

what is category D adverse reaction

A

error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm

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16
Q

the ADR mechanism involve what 2 things

A

interaction with receptor/enzymes (pharmacological?)

alteration of structural proteins, DNA or lipids (chemical)

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17
Q

what are type 1 or A adverse reactions

A

predictable dose dependent based on the known pharmacology of the drug

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18
Q

what are type 2 or B adverse reactions

A

not predictable, no clear dose dependency and not due to the known pharmacology of drug

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19
Q

type 1 or A adverse reactions happen due to what

A

due to the known pharmacology of the drug and are therefore dose dependent and predictable

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20
Q

what are 3 example situations of type 1/A adverse reaction causes

A

take too much drug (eg wrong dose/freq/duration)

take 2+ drugs with overlapping pharmacology

take 2+ drugs that have metabolic interaction

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21
Q

what do 2 or more drugs compete for in terms of absorption

A

reduced uptake, decreased effect

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22
Q

what do 2 or more drugs compete for in terms of metabolism in terms of clearance, inhibition, bioactivation, enzymes

A

reduced clearance = increased plasma conc
inhibition of one pathway = greater clearance via bioactivation = incr toxicity
induction of enzymes = decr plasma conc

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23
Q

what do 2 or more drugs compete for in terms of distribution

A

competition for uptake transporters or protein binding = increased plasma conc

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24
Q

what do 2 or more drugs compete for in terms of excretion

A

competition for efflux transporters = decreased elimination = increased plasma conc

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25
Q

what is a perpertrator drug and victim drug

A

perpetrator drug can inhibit the enzyme that metabolizes victim drug

this increases drug conc of victim drug

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26
Q

what happens when drug A induces the enzyme responsible for the metabolism of Drug B

A

plasma conc of drug B is less than expected = less activity = therapeutic failure

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27
Q

what is polypharmacy

A

taking several medicines at the same time (4 or 5+)

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28
Q

what is hyperpolypharmacy

A

10 or more medicines

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29
Q

what does lack of metabolism lead to

A

enhanced plasma conc and exaggerated pharmacological responses

enhanced toxicity due to lack of detoxification pathway

30
Q

is hypersensitivity conc dependent

A

no clear dose and conc dependency

31
Q

anaphylaxis has what effect on peripheral resistance and BP

A

drop in peripheral resistance leads to drop in blood pressure

32
Q

what is anaphylactoid reactions or hypersensitivity and what does it involve, does it involve IgE

A

involve release of mediators such as histamine and may/may not involve specific IgE

33
Q

what are chemotoxic organ specific ADRs what 6 things is it associated with

A

assocaited with ionicity, iodine conc, viscosity, osmolality, dose and injection rate

34
Q

what 2 things can vasovagal ADRs manifest as

A

bradycardia and hypotension

35
Q

what is hypersensitivity

A

reproducible symptoms or signs initiated by exposure to a defined stimulus at a dose tolerated by normal people

36
Q

what is an allergy

A

hypersensitivity reaction initiated by specific immunological mechanisms

37
Q

what are the 2 ways that allergies are mediated by

A

antibody or cell mediated

38
Q

what is anaphylaxis

A

severe life threatening generalized or systemic hypersensitivity reaction involving IgE mediated release of mediators from tissue mast cells and peripheral basophils

39
Q

what is anaphylactoid

A

immediate systemic reactions not involving an IgE immune response

40
Q

what do immediate reactions involve for hypersensitivity in terms of immune system

A

involve histamine and tryptase release from basophils and mast cells

41
Q

does hypersensitivity involve IgE antibodies

A

no

42
Q

when is hypersensitivity likely to be a true allergic reaction

A

the more serious and severe the reaction the more likely it is a true allergic reaction

43
Q

are hypersentivity ADR more likely to be anaphylactoid or anaphylactic

A

anaphylactoid

44
Q

anaphylactoid reactions tend to be what related and what are the characteristics and prevalence

A

tends to be more conc related, unpredictable and happens in more people

45
Q

what test can be done to confirm CM hypersensitivity in terms of whether it involves cell mediated hypersensitivity

A

skin test can confirm with CD4+ T cell infiltrates

46
Q

what are the 5 acute kidney injury

A 
stage 1 = risk
stage 2 = injury
stage 3 = failure
loss of kidney function
end stage kidney disease
47
Q

what is loss of kidney function defined as

A

complete loss of kidney function >4wks

48
Q

what is end stage kidney disease defined as

A

complete loss of kidney function >3months

49
Q

what is the SCr and GFR changes in stage 1 acute kidney injury /risk

A

increase SCr by 1.5 and GFR decreases more than 25%

50
Q

what is the SCr and GFR changes in stage 2 acute kidney injury /injury

A

increase SCr x 2 and GFR decreases more than 50%

51
Q

what is the SCr and GFR changes in stage 3 acute kidney injury /failure

A

increase SCr x 3 and GFR decreases more than 75%

52
Q

how does kidney function rely on blood vessels

A

relies on blood vessels around glomerulus

under pressure, liquid is forved out and with that liquid goes unboudn endogenous metabolites and drugs

53
Q

how is osmolality and viscosity a risk factor for CI AKI

A

high osmolality unacceptable risk

CM not reabsorbed so gets conc in tubules leading to increases of osmolality and viscosity and increases water reabsorption

increased viscosity decreases flow rate and increases exposure of distal nephron

CM isnt getting reabsorbed so the conc gets greater of CM as water is resorbed and this pulls water back in to the tubes and ruins renal flow and urinary output

54
Q

how is volume administered a risk factor for CI AKI

A

ideally CM volume <3 x eGFR

55
Q

how is intra arterial administration a risk factor for CI AKI

A

larger volume of CM administered and the potential for renal emoblisation

56
Q

the risk of CM induced AKI is greatest with people of what GFR

A

greatest in those with estimated GFR less <30mL/min/1.73m^2

57
Q

several medications are contradicted with ICM because why

A

may crystalize and form precipitates

58
Q

caution should be exercised when using ICM in patients medicated with what drugs

name 3 examples

what levels need to be assessed before using CT CM in these patients

A

medicated with known nephrotoxic drugs

ACE inhibitors, metformin, NSAIDs

creatinine level need to be assessed

59
Q

what is hypervolaemia

A

lose alot of blood and reduced blood volume so kidneys dont get alot of liquid to do its normal function

60
Q

how do you mitigate the risk of kidney failure in hypervolemia

2 ways

A

encourage oral hydration or can stop taking ACE inhibitors so your BP may go up but preserves kidney function which is the greater good

61
Q

ICM has what effects in CM drug interactions

A

ICM have some anti-coagulant effects so potentiate effects of some medications like heparin, warfarin and aspirin

62
Q

B blockers do what to the risk and severity of anaphylactoid reactions

A

increase risk

63
Q

calcium channel blockers can do what to the effects of ICM

A

potentiate antihypertensive effects of ICM

64
Q

diuretics can do what to nephrotoxicity

A

increase risk

65
Q

free Gd3+ is toxic why

A

as it inhibits Ca2+ at calcium channels

will accumulate in carious tissues such as brain

66
Q

what happens when Gd ions inhibits Calcium channels

A

interferes with muscle contraction and can interfere with force of cardiac contraction

67
Q

is the reaction profile of Gd CM dependent on ionicity, viscosity and osmolality of ICM

A

no

68
Q

is gadolinium CM considered nephrotoxic and why

A

no

it is similar to serum and so tissues remain isotonic

69
Q

what ADR is related to Gd based CM

A

nephrogenic systemic fibrosis

70
Q

Gd CM induced NSF involves what mechanism

A

involves Gd dependent release of cytokines, stimulation of skin macrophages or blood monocytes and subsequent activation of fibroblasts with deposition of collagen

71
Q

what is a physical effect of Gd CM NSF

A

thickening and hardening of skin associated with pain, muscle weakness, bone pain, joint contractures

303 MEDIMAGE (14 decks)

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