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PoD topics > Adverse Drug Reactions > Flashcards

Adverse Drug Reactions Flashcards

1
Q

what is an adverse drug reaction?

A

any response to a drug which is noxious/harmful, unintended and occurs at doses used in man for prophylaxis (preventing), diagnosis or treatment, relates to intervention of the use of the medical product

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2
Q

what is an acute onset of adverse drug reaction?

A
  • occurs within 60 minutes

- bronchoconstriction (constriction of airway)

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3
Q

what is a sub-acute onset of adverse drug reaction?

A
  • occurs from 1-24 hours

- rash, serum sickness

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4
Q

what is a latent onset of adverse drug reaction?

A
  • after >2 days

- eczematous eruptions

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5
Q

what 3 categories can an onset of adverse drug reactions be split into?

A
  1. acute
  2. sub-acute
  3. latent
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6
Q

what 3 categories can severity of adverse drug reaction be split into?

A
  1. mild
  2. moderate
  3. severe
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7
Q

what is mild severity of drug reaction?

A
  • bothersome but requires no change in therapy

e. g. metallic taste with metronidazole

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8
Q

what is moderate severity of drug reaction?

A
  • requires change in therapy and additional treatment
  • hospitalisation
    (e. g. amphotericin induced hypokalemia)
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9
Q

what is severe severity of a drug reaction?

A
  • disabling or life threatening

e. g. kidney failure

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10
Q

What is type A ADR?

A

augmented;

  • dose related
  • predictable
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11
Q

what is type B ADR?

A

bizarre;

  • idiosyncratic (distinct, individual) and unpredictable
  • also included Types C,D and E
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12
Q

what is type C ADR?

A

Chronic

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13
Q

what is type D ADR?

A

Delayed

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14
Q

what is type E ADR?

A

End of treatment

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15
Q

what is type F ADR?

A

failure of treatment

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16
Q

what are the 5 main predisposing factors to ADRs?

A
  1. multiple drug therapy
  2. age (elderly and neonates)
  3. sex (more common in women)
  4. intercurrent disease (e.g. renal or hepatic impairment)
  5. race and genetic polymorphisms
17
Q

what are properties of Type A (augmented) reactions?

A
  • normal response
  • predictable and dose dependant
  • due to excess pharmacological action
    (e. g. bradycardia with beta blockers)
  • can be due to property of drug
  • resolve when drug is reduced/stopped
  • recognised before a drug is available
18
Q

what are the reasons for Type A ADRs?

A

-pharmacokinetic variation
-pharmacodynamic variation
-too high a dose
-pharmaceutical variation
(pharmacological variation occurs as a result of disease)

19
Q

what is absorption of a drug highly dependent on in pharmacokinetic variation? (5)

A
  1. dose
  2. formulation
  3. GI motility
  4. first pass metabolism
  5. therapeutic failure
  6. distribution
  7. metabolism (hepatic; either enhanced or impaired)
  8. elimination (renal)
20
Q

what is especially important to consider if a drug has a narrow therapeutic index?

A

liver function (or disease)

21
Q

what is pharmacogenetic factor?

A
  • under genetic control; such as acetylation which is used for metabolism of many drugs
  • prone to drug toxicity
22
Q

what 3 disease especially have a huge role in ADRs and need to be monitored?

A
  1. renal impairment (build up of toxins if less excretion)
  2. hepatic impairment (toxin build up if no metabolism)
  3. cardiac failure (if oedema from circulation, then no drug reabsorption)
23
Q

what is meant by pharmacodynamic variation?

A
  • natural variability in response

- disease states can alter response significantly

24
Q

what are the properties of type B (bizarre) ADRs?

A
  • bizarre and unpredictable
  • rare
  • cause serious illness or death
  • unidentified for months or years
  • unrelated to the dose
  • can be stopped by medicine/ stopper drug
  • delay between exposure and ADR
25
Q

what is the main mechanism involved in type B ADRs?

A
  • immunological (no relation to the pharmacological action of the drug)
  • no dose response curve
26
Q

what can type B ADRs manifest as? (3)

A
  • rash
  • asthma
  • serum sickness
27
Q

which 3 factors put people at a greater risk of a Type B reaction?

A
  1. More common with macromolecules
    - proteins
    - vaccines
    - polypeptides
  2. patients with history of asthma or eczema
  3. HLA status (presence of particular human leukocyte antigens increases risk of a type B reaction)
28
Q

pharmacogenetic differences in response to a Type B ADR may be considered as what 2 things?

A
  1. genetic

2. immunological

29
Q

what are properties of a Type C ADR?

A
  • related to duration of treatment as well as the dose
  • doesn’t occur with a single dose
  • semi-predictable
30
Q

what are properties of a Type D ADR?

A
  • occur sometime after the treatment
  • occur in children of treated patients
  • occur in treated patients themselves years after treatment has stopped
  • second cancers in those treated with alkylating agents and cyclophosphamide or immunosuppressive agents
31
Q

what is a famous Type D (Delayed) effect ADR?

A

Thalidomide disaster; congenital malformations in the foetus due to maternal medication

32
Q

what are properties of Type E (end of treatment) ADR?

A
  • adverse effects occur when a drug is stopped especially suddenly
33
Q

what are common examples of Type E ADRs?

A
  • unstable angina or myocardial infarction when beta blockers are stopped
  • Addisonian crisis when long termsteroids are stopped
  • withdrawal seizures when anti-epileptics are stopped
  • alcohol withdrawal leading to seizures
34
Q

what drugs are common to have a rebound phenomena? (sudden withdrawal of a drug)

A
  1. alcohol
  2. benzodiazepines
  3. beta-blockers
  4. corticosteroids
35
Q

What are the 4 steps to an ADR diagnosis?

A
  1. differential diagnosis
  2. medication history
  3. assess time of onset and dose relationship
  4. laboratory investigations (plasma concentration measurement, allergy tests)
36
Q

what medication is commonly involved in ADRs?

A
  • antibiotics
  • antineoplastics (chemo)
  • anticoagulants
  • cardiovascular drugs
  • hypoglycemics
  • antihypersensives
  • NSAID/analgesics
  • Diagnostic agents
  • CNS drugs
37
Q

what body systems are commonly involved in ADRs?

A
  • haematologic
  • CNS
  • Dermatologic/ allergic
  • metabolic
  • cardiovascular
  • gastrointestinal
  • renal/genitourinary
  • respiratory
  • sensory
38
Q

what are the main ADR risk factors? (9)

A
  1. age (children and elderly)
  2. multiple medications
  3. multiple co-morbid conditions
  4. inappropriate medication prescribing use or monitoring
  5. altered physiology
  6. end-organ dysfunction
  7. prior history of ADRs
  8. extent (dose) and duration of exposure
  9. genetic predisposition
39
Q

what is used to report, record and monitor ADRs?

A

Yellow Card scheme
(online reports made on medicines, blood factors, immunoglobulins, herbal medicines, medical devices, homeopathic remedies)

PoD topics (34 decks)

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