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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
what kind of effects do dose related adrs have
same as the phar, effects... just slightly more.
26
examples of type A adrs
opiates: resp depression propranolol: bracycardia
27
what does it mean to say that impaired elimination in patient facilitates type a adr
impaired elim, cant get rid of drug, more in plasma, adr
28
t/f: a drug causes a single specific response
false
29
how can drug effects be mediated in dose related adrs
it could be due to: - same receptors in the same tissue - - same rceep different tissue - different receptors
30
what does it mean for an adr to be mediated by the same receptors in the same tissue
drug acts too much in one single tisssue
31
how does warfarin demonstrate adr effect of same receptor in same tissue
its an anticoag. but too much, you have too much bleeding.
32
what does it mean for an adr to be mediated by same receps in different tissue
the drug not only carries out its effect in the intended tissue, but in another tissue that has the same receptor.
33
how is digoxin an example of how an adr can be mediated by same receptor in dif tissue
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
what does it mean for the effects of an adr to be mediated by different receptor subtypes
same drug can act on multiple dif receprot types, carrying out a dif effect in each.
35
how does dobutamine demonstrate adr mediated by binding to different receptor subtype?
binds b1 and b2 to inc rate of contraction. but also binnds to breceps in periphery -> hypotension
36
how does terbutaline demonstrate adr mediated by binding to different receptor subtype?
binds to b2 more than b1to releax bronchiole smooth muscles. but also binds in heart. lower bp, higher heart rate --> chest pain
37
what are type b adrs?
dose unrelated
38
describe the predictability and common-ness of dose unrelated adrs
unpredictable, and uncommon
39
what causes dose unrelated adrs and how do you treat them.
the patient is usually more succeptible anyways due to genetics and allergies
40
how does abacivir demonstrate genetic adr
patients with certain human leukocyte antigen genotypes are more hypersensitive
41
how does primaquine demonstrate genetic adr
malria drug: hemolysis is more common in g6pd deficient ppl
42
what are the types of type B ADRs?
genetic, immunological
43
what is a type 1 immunologic reaction adr
anaphylactic
44
explain how anaphylactic reactions work (how is the body treating the drug)
drug reacts with ide antibody on mast and basohils, histamine released, leukotrienes, prostagalndins ex. penicillin
45
what are signs and symptoms of analphylaxis
hives, flares, pain, airway contrsiction, anaphylaxis runny nose, hert rate, skin itchy, loss of bladder control, respitory issues, gi problems
46
what is a type 2 immunologic reaction adr
cytotoxic complement fixing
47
explain how cytotoxic/complement fixing works
antibody interactis with the drug on blood cells, so complement system is activated, and cell lysis occurs
48
hemolytic anemia with methyldopa is what type of immunologic rxn
type 2 immunologic reaction bc red blood cells get destroyed
49
agranulocytosis with sulfas is what type of immunologic rxn
white cells destroyed, type 2 imm rxn
50
thrombocytopenic purpura with ASA or phenytoin is what type of immunologic rxn
reducttion in platelets, type 2 imm
51
what are type 3 immunologic rxns
toxic immune complex
52
describe what happens in a toxic immune complex immunologic reaction
antigen antibody complexes deposit on the target tissue cell. comp activation, neutrophils, inflammatory resp, lysosomes, tissue destruction.
53
what do type 3 immunologic reactions cause
serum sickness, glomerulonephritis, collagen disease, skin eruptions
54
what are examples of drugs that cause type 3 immunologic reactions
allopurinol, captopril, penicillins, phenytoin, procainamide
55
what are type 4 immunologic reactions
cell mediated/delayed.
56
describe what happens in cell-mediated (delayed) immunologic reactions
drug meets sensitized lymphocytes, cytokin release.
57
what do type four immunologic reactions cause
eczematous and contact derm
58
what are some drugs that cause type 4 immunologic responses
antihistamines, paba
59
what is delayed hypersensitivity reaction syndrome? what are drug examples that cause this?
fever, rash, and organ involvment, phenytoin, carbamazepine, sufonamides, allopurinol, nsaids
60
what are chronic effect ADRS
happen with long term use, and you have toxicity due to dose accumulation and dependence
61
what are delayed effect ADRs
you have delayed onset (carcinogens, teratogens)
62
what are end of treatment effect ADRs
seen when the drug is stopped
63
what is failure of treatment ADR
when the expected response to treatment is not achieved
64
what factors affect the discovery of ADR
how often drug vs non drug events occur, the mechanism of tox, the frequency of drug induced events, and the methods to assess
65
what is pharmacovigilance
science relating to detection and prevention of adverse health events
66
explain intention to treat vs as treated experimental design
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
what are post marketing surveillance and drug monitoring methods? whats the purpose?
spntaneous reporting, databases, cohort studies, case control. used to anylyse where adrs occured
68
what happens during each phase of the clinical trial
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
what are limitations of pre approval clinical trials
limited size, population, hard to detect adrs, and short duration
70
what is the probability of an adr occurring
increases with the number of patients. prob tells us the prob of seeing 1 adr occur.
71
what are spontaneous reports of adrs? what are the issues?
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
how is data about adrs collected?
73
how do databases collect info about adrs? limitations?
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
how do cohort studies collect info about adrs? limitations?
prospective or retrospective studies following group of ppl and collecting info limitations: selection bias, treatement bias, expensize, large sample size.
75
how do case control studies collect info about adrs? limitations?
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
what drigs have been withdrawn from market due to adrs?
thalidomide, diethylstilbestrol, terfenadine, refocoxib
77
how do we manage adrs?

PCL201 (19 decks)

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