Adverse Drug Reactions Flashcards

1
Q

What are adverse drug reactions?

A

Any response to a drug which is noxious, unintended and occurs at doses used in man for prophylaxis (treatment to prevent disease), diagnosis or treatment

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2
Q

What is prophylaxis?

A

Treatment to prevent disease

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3
Q

Adverse drug reactions are the what cause of death (number)?

A

4th leading cause of death

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4
Q

How much hospital admissions occur due to adverse drug reactions?

A

6.5%

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5
Q

How many inpatients suffer adverse drug reactions?

A

10-20%

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6
Q

What are the 3 classifications of the onset of adverse drug reactions?

A

Acute

Sub-acute

Latent

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7
Q

When do acute adverse drug reactions occur?

A

Within 60 seconds

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8
Q

What is an example of an acute adverse drug reaction?

A

Bronchoconstriction

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9
Q

When do sub-acute adverse drug reactions occur?

A

1 to 24 hours

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10
Q

What are examples of sub-acute adverse drug reactions?

A

Rash

Serum sickness

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11
Q

When do latent adverse drug reactions occur?

A

More than 2 days later

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12
Q

What is an example of a latent adverse drug reaction?

A

Eczematous eruptions

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13
Q

What are the 3 classifications of the severity of adverse drug reactions?

A

Mild

Moderate

Severe

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14
Q

What is a mild adverse drug reaction?

A

Bothersome but requires no change in therapy

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15
Q

What is an example of a mild adverse drug reaction?

A

Metallic taste with metronidazole

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16
Q

What is a moderate adverse drug reaction?

A

One which requires a change in therapy and some additional treatment

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17
Q

What is an example of a moderate adverse drug reaction?

A

Amphotericin induced hypokalaemia

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18
Q

What is a severe adverse drug reaction?

A

Disabling or life threatening

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19
Q

What is an example of a severe adverse drug reaction?

A

Kidney failure

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20
Q

What are the classifications of adverse drug reactions?

A

Type A (augmented)

Type B (bizarre)

Type C (chronic)

Type D (delayed)

Type E (end of treatment)

Type F (failure of treatment)

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21
Q

How can type A (augmented) drug reactions be described?

A

Dose related

Predictable

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22
Q

How can type B (bizarre) adverse drug reactions be described?

A

Idiopathic

Unpredictable

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23
Q

What are predisposing factors of adverse drug reactions?

A

Multiple drug therapy (incidents increase exponentially with the number of medicaments)

Inter-current disease (renal and hepatic impairments)

Race and genetic polymorphisms

Age (elderly and neonates)

Sex (more common in woman)

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24
Q

What does predisposing mean?

A

Make more liable

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25
Q

What are some inter-current diseases that increases the risk of adverse drug reactions?

A

Renal and hepatic impairment

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26
Q

Who are more likely to experience adverse drug reactions out of men and woman?

A

Woman

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27
Q
A
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28
Q

What are type A (augmented) adverse drug reactions due to?

A

Excess pharmacological action

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29
Q

What are examples of excess pharmacological action that causes type A (augmented) adverse drug reactions?

A

Bradycardia with beta-blockers

Hypoglycaemia with insulin

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30
Q

What is the most common adverse reaction and what percentage of total reactions does this account for?

A

80% of adverse drug reactions are type A (augmented)

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31
Q

What are the 2 types of type A (augmented) adverse drug reactions?

A

Augmentation of the primary effect

Secondary effect

32
Q

What are some common type A adverse reactions?

A

Galactorrhoea with domperidon

Dry mouth with tricylic antidepressants

Glynaecomastia with spironolactone

Bronchospasm with beta blockers

33
Q

What could some reasons for type A (augmented) adverse drug reactions be?

A

Too high a dose

Pharmaceutical variation

Pharmacokinetic variation

Pharmacodynamic variation

34
Q

What are examples of pharmacodynamic variations?

A

Variations in:

Dose
Distribution
Metabolism
Elimination

35
Q

What is pharmacogenetics?

A

The study of inherited genetic differences in drug metabolic pathways

36
Q

What are a number of drugs metabolised via, which is under genetic control?

A

Acetylation

37
Q

What are people who are slow metabolisers of drugs prone to?

A

Drug toxicity

38
Q

What diseases increase the likeliness of adverse drug reactions?

A

Renal and hepatic impairment

Cardiac failure

39
Q

Why do renal and hepatic impairments increases the risk of adverse drug reactions?

A

Not excreted or metabolised so will build up and be toxic

40
Q

Why does cardiac failure lead to increased risk of adverse drug reactions?

A

Reduced drug absorption from gut so it builds up and becomes toxic

41
Q

What are most type A adverse drug reactions in nature?

A

Pharmacokinetic

42
Q

What can you say about type B (bizarre) adverse drug reactions and dose?

A

Type B reactions are unrelated to dose

43
Q

What can you say about the reversibility of type A and type B adverse drug reactions?

A

Type A are readilly reversible whereas type B are not

44
Q

What are type B adverse drug reactions common with?

A

Macromolecules

Patients with a history of asthma

HLA status (presence of particular HLA increases risk)

45
Q

What are some macromolecules associated with type B (bizarre) adverse drug reactions?

A

Proteins

Vaccines

Polypeptides

46
Q

What are the 2 mechanisms of type B adverse drug reactions?

A

Idiosyncratic (peculiar, individual)

Drug allergy or hypersensitivity

47
Q

What are idiosyncritic type B adverse drug reactions due to?

A

Genetic abnormality such as enzyme dificiency or abnormal receptor activity

48
Q

What are the properties of hypersensitive type B adverse drug reactions?

A

No relation to the pharmacological action of the drug

Delay between exposure and adverse drug reaction

No dose response curve

49
Q

What is pharmacodynamics?

A

Branch of pharmacology concerned with the effects of drugs and the mechanisms of their actions

50
Q

What may a difference in the response to a drug, in terms of pharmogenetics, be considered as?

A

Genetic

Immunological

51
Q

What are the kinds of genetic abnormalities that lead to unpredictable responses to drugs?

A

Enzyme abnormality

Receptor abnormality

52
Q

What are type C (chronic) adverse drug reactions related to?

A

Duration of treatment as well as the dose

53
Q

What do type C (chronic) adverse reactions not occur with?

A

A single dose

54
Q

What are examples of type C adverse drug reactions?

A

Iatrogenic Cushings disease

Steroid induced osteoporosis

Opiate dependance

55
Q

What are type D adverse drug reactions?

A

Delayed, occuring a long time after treatment

56
Q

What are examples of type D (delayed) adversed drug reactions?

A

Teratogenesis

Carcinogenesis

57
Q

What is an example of teratogenesis type D adverse drug reaction?

A

Craniofacial malformations in children whose mothers were treated with isotreoin

58
Q

What is an example of carcinogenesis type D adverse drug reaction?

A

Second cancers in those treated with alkylating agens or immunosuppresive agents

59
Q

What is teratogenesis?

A

Abnormal congenital malformations in the foetus following in utero exposure due to maternal medications use during 1st trimester of pregnancy

60
Q

What are some teratogenic agents?

A

Cytotoxics

Vitamin A

Antithyroid drugs

Steroids

Oral anticoagulants

61
Q

What drugs should be avoided during pregnancy?

A

All drugs unless they are safe or the benifits outweight the potential risks

62
Q

What are type E adverse drug reactions?

A

Adverse effects that occur when a drug treatment is stopped especially suddenly following long term use

63
Q

What are examples of things that can cause type E adverse drug reactions?

A

Unstable angina and MI when beta blockers are stopped

Addisonian crises when long term steroids are suddenly stopped

Withdrawal seizures when anti-epileptics are stopped

Alcohol

64
Q

When does rebound phenomena occur?

A

When adverse drugs are suddenly withdrawn

65
Q

What are some drugs that can cause a rebound phenomena?

A

Alcohol

Benzodiazepines

Beta blockers

Corticosteroids

66
Q

What are type F adverse drug reactions?

A

A failure of therapy

67
Q

What is the frequency of type F adverse drug reactions and what are they related to?

A

They are common and are dose related

68
Q

What are type F adverse drug reactions often caused by?

A

Drug interactions

69
Q

What is the process of diagnosing adverse drug reactions?

A

1) Differential diagnosis
2) Medication history (past and present)
3) Assess time of onset and dose relationship
4) Laboratory investigations (plasma concentration measurements and allergy tests)

70
Q

What are laboratory tests used to diagnose adverse drug reactions?

A

Plasma concentration measurements

Allergy tests

71
Q

Who are some people most at risk from adverse drug reactions?

A

Age (children and elderly)

Multiple medications

Multiple co-morbid conditions

Inappropriate prescribing, use, or monitoring

End-organ dysfunction

Altered physiology

Prior history of adverse drug reactions

Extent (dose) and duration of exposure

Genetic predisposition

72
Q

What are some drugs commonly involved in adverse drug reactions?

A

Antibiotics

Antineoplastic

Anticoagulants

Cardiovascular drugs

Hypoglycaemic

Antihypertensive

NSAID/analgesics

Diagnostic agents

CNS drugs

Opiates

73
Q

What are some body systems commonly involved in adverse drug reactions?

A

Haematologic

CNS

Dermatologic/Allergic

Metabolic

Cardiovascular

Gastrointestinal

Renal/genitourinary

Respiratory

Sensory

74
Q

What can adverse drug reactions be reported to?

A

Yellow card scheme which collects information about:

Side effects
Medical device adverse incidents
Defective medicines
Counterfeit or fake medicines or medical devices

75
Q

What does the yellow card scheme collect information about?

A

Side effects

Medical device adverse incidents

Defective medicines

Counterfeit or fake medicines or medical devices