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PCL201 > Lec 16 - Adverse Drug Reactions > Flashcards

Lec 16 - Adverse Drug Reactions Flashcards

1
Q

what is an adverse drug reaction

A

un intended halful event attributed to use of med

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2
Q

contrast ADR vs Undesirable/Unwanted (side) effect vs toxicity

A

ADR is harm attributed to the med

A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome.

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3
Q

t/f: ADR is always toxic

A

false

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4
Q

t/f: not all drugs have unintended effects

A

false

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5
Q

why are drugs with small TI more dangerous?

A

theres a smaller window in which they can be used safely

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6
Q

explain what it means to say “ the ADR timeline is diverse”

A

can happen at anytime during treatement, after stopping, only at certain conc, only with other drugs

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7
Q

what was the ADR associated with thalidomide?

A

morning sickness medicine that caused limb abnormalities in babies

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8
Q

what is Vioxx? what was the ADR associated with it? valdecoxib?

A

a cox 2 inhibitor (analgesis, anti inflam) for rhematoid, adr = high rate of myocard infarction for those on nsaids. valdecoxib -> severse skin reactions

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9
Q

t/f: there is a spectrum for ADRs

A

yes

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10
Q

what are mild ADRs? how do you change drug therapy?

A

diestic probs, headaches, fatigue, malaise. no change required

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11
Q

what are mod ADRs? how do you change drug therapy?

A

rashes, tremor, visual disturbances, urinary difficulty, mood swings: no change

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12
Q

what are severe and lethal ADRs? changes in drug therapy?

A

arrythmia, allergies, organ failure
discontinue, hospitalize

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13
Q

what percentage of ADRs are preventable?

A

30 -50%

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14
Q

why are ADRs relevant to public health?

A

leading cause of morbitity, longer stays in hospital higher cost

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15
Q

what is the relationship between polypharmacy and ADRs?

A

the more drugs you take, the higher chance of adrs

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16
Q

what are risk factors for ADRs?

A

polypharm, history, impared renal and hepatic function, age, gender, genetic predisposition

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17
Q

how can impaired renal and hepatic function lead to ADR?

A

not enough excretion so too high blood conc

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18
Q

how does age impact ADR? is it an independent risk factor?

A

no, but associated w other factors like elimination, concurrent dieases, physiology alterations

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19
Q

how does genetic predisposition impact ADRs

A

certain snp, cant metabolise, high plasma levels

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20
Q

what are drug related mechanisms of ADRs

A

physiochemical, pk, formulation, dose, admin rate, admin route, interactions

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21
Q

what are patient related mechanisms of ADRs

A

genetics, physiology, pathology

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22
Q

what are type A ADR classifications. severity?

A

dose related. these are predictable, morest common, have low mortality, and have predictable pharm effects. severity is proportional to the dose

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23
Q

how do you treat dose related ADRs

A

dose adjustment

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24
Q

t/f: dose related adrs are uncommon

A

false

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25
Q

what kind of effects do dose related adrs have

A

same as the phar, effects… just slightly more.

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26
Q

examples of type A adrs

A

opiates: resp depression
propranolol: bracycardia

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27
Q

what does it mean to say that impaired elimination in patient facilitates type a adr

A

impaired elim, cant get rid of drug, more in plasma, adr

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28
Q

t/f: a drug causes a single specific response

A

false

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29
Q

how can drug effects be mediated in dose related adrs

A

it could be due to:
- same receptors in the same tissue -
- same rceep different tissue
- different receptors

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30
Q

what does it mean for an adr to be mediated by the same receptors in the same tissue

A

drug acts too much in one single tisssue

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31
Q

how does warfarin demonstrate adr effect of same receptor in same tissue

A

its an anticoag. but too much, you have too much bleeding.

32
Q

what does it mean for an adr to be mediated by same receps in different tissue

A

the drug not only carries out its effect in the intended tissue, but in another tissue that has the same receptor.

33
Q

how is digoxin an example of how an adr can be mediated by same receptor in dif tissue

A

increases force of contraction in heart by inhibiting nakatpase. but also impairs it in the kidney – electrolyte balance disrupted which leads to arrythmia

very low ti

34
Q

what does it mean for the effects of an adr to be mediated by different receptor subtypes

A

same drug can act on multiple dif receprot types, carrying out a dif effect in each.

35
Q

how does dobutamine demonstrate adr mediated by binding to different receptor subtype?

A

binds b1 and b2 to inc rate of contraction. but also binnds to breceps in periphery -> hypotension

36
Q

how does terbutaline demonstrate adr mediated by binding to different receptor subtype?

A

binds to b2 more than b1to releax bronchiole smooth muscles. but also binds in heart. lower bp, higher heart rate –> chest pain

37
Q

what are type b adrs?

A

dose unrelated

38
Q

describe the predictability and common-ness of dose unrelated adrs

A

unpredictable, and uncommon

39
Q

what causes dose unrelated adrs and how do you treat them.

A

the patient is usually more succeptible anyways due to genetics and allergies

40
Q

how does abacivir demonstrate genetic adr

A

patients with certain human leukocyte antigen genotypes are more hypersensitive

41
Q

how does primaquine demonstrate genetic adr

A

malria drug: hemolysis is more common in g6pd deficient ppl

42
Q

what are the types of type B ADRs?

A

genetic, immunological

43
Q

what is a type 1 immunologic reaction adr

A

anaphylactic

44
Q

explain how anaphylactic reactions work (how is the body treating the drug)

A

drug reacts with ide antibody on mast and basohils, histamine released, leukotrienes, prostagalndins

ex. penicillin

45
Q

what are signs and symptoms of analphylaxis

A

hives, flares, pain, airway contrsiction, anaphylaxis
runny nose, hert rate, skin itchy, loss of bladder control, respitory issues, gi problems

46
Q

what is a type 2 immunologic reaction adr

A

cytotoxic complement fixing

47
Q

explain how cytotoxic/complement fixing works

A

antibody interactis with the drug on blood cells, so complement system is activated, and cell lysis occurs

48
Q

hemolytic anemia with methyldopa is what type of immunologic rxn

A

type 2 immunologic reaction bc red blood cells get destroyed

49
Q

agranulocytosis with sulfas is what type of immunologic rxn

A

white cells destroyed, type 2 imm rxn

50
Q

thrombocytopenic purpura with ASA or phenytoin is what type of immunologic rxn

A

reducttion in platelets, type 2 imm

51
Q

what are type 3 immunologic rxns

A

toxic immune complex

52
Q

describe what happens in a toxic immune complex immunologic reaction

A

antigen antibody complexes deposit on the target tissue cell. comp activation, neutrophils, inflammatory resp, lysosomes, tissue destruction.

53
Q

what do type 3 immunologic reactions cause

A

serum sickness, glomerulonephritis, collagen disease, skin eruptions

54
Q

what are examples of drugs that cause type 3 immunologic reactions

A

allopurinol, captopril, penicillins, phenytoin, procainamide

55
Q

what are type 4 immunologic reactions

A

cell mediated/delayed.

56
Q

describe what happens in cell-mediated (delayed) immunologic reactions

A

drug meets sensitized lymphocytes, cytokin release.

57
Q

what do type four immunologic reactions cause

A

eczematous and contact derm

58
Q

what are some drugs that cause type 4 immunologic responses

A

antihistamines, paba

59
Q

what is delayed hypersensitivity reaction syndrome? what are drug examples that cause this?

A

fever, rash, and organ involvment,

phenytoin, carbamazepine, sufonamides, allopurinol, nsaids

60
Q

what are chronic effect ADRS

A

happen with long term use, and you have toxicity due to dose accumulation and dependence

61
Q

what are delayed effect ADRs

A

you have delayed onset (carcinogens, teratogens)

62
Q

what are end of treatment effect ADRs

A

seen when the drug is stopped

63
Q

what is failure of treatment ADR

A

when the expected response to treatment is not achieved

64
Q

what factors affect the discovery of ADR

A

how often drug vs non drug events occur, the mechanism of tox, the frequency of drug induced events, and the methods to assess

65
Q

what is pharmacovigilance

A

science relating to detection and prevention of adverse health events

66
Q

explain intention to treat vs as treated experimental design

A

intention: using the results of everyone that started in the trail even if they didnt complete

treated: only use results of people that made it to the end of the trial

67
Q

what are post marketing surveillance and drug monitoring methods? whats the purpose?

A

spntaneous reporting, databases, cohort studies, case control. used to anylyse where adrs occured

68
Q

what happens during each phase of the clinical trial

A

phase 1: safety and dose finding, pk
phase 2: safety and efficiacy
phase 3: efficacy, safety, optimization
phase 4: long term safety, new indications

69
Q

what are limitations of pre approval clinical trials

A

limited size, population, hard to detect adrs, and short duration

70
Q

what is the probability of an adr occurring

A

increases with the number of patients. prob tells us the prob of seeing 1 adr occur.

71
Q

what are spontaneous reports of adrs? what are the issues?

A

reported by health care professionals issues: bias, lack of info, under reporting

dependent on physician reporting, underreporting is common, bias in the system (only severe events reported, dont know if drug caused it)

spontaneous reporting lacks basic info

spontaneous reporting is underreported due to unsure cause, awareness

72
Q

how is data about adrs collected?

A
73
Q

how do databases collect info about adrs? limitations?

A

get info from studies and spont reports. limitations: cant compare drugs, assess rates, ensure causality, account for patient difs

but: prescription linked data bases can compare and have full records

74
Q

how do cohort studies collect info about adrs? limitations?

A

prospective or retrospective studies following group of ppl and collecting info

limitations: selection bias, treatement bias, expensize, large sample size.

75
Q

how do case control studies collect info about adrs? limitations?

A

retrospective, efficient only for clinically unique symtoms (ie: limb malformation with thalidomide).

limits: hard if high adr incidence, and hard to confirm drug exposure

76
Q

what drigs have been withdrawn from market due to adrs?

A

thalidomide, diethylstilbestrol, terfenadine, refocoxib

77
Q

how do we manage adrs?

A

PCL201 (19 decks)

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