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Principles of Disease > Adverse Drug Reactions > Flashcards

Adverse Drug Reactions Flashcards

1
Q

What is an adverse drug reaction (ADR)

A

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

An appreciably harmful or unpleasant reaction

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2
Q

What does an ADR result in

A

An intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product

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3
Q

How many people are admitted annually due to ADR’s

A

1,000,000 (6.5% of all hospital admissions)

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4
Q

How many inpatients suffer an ADR

A

10-20%

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5
Q

How many deaths a year are due to ADR

A

5000 - 12,000

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6
Q

What is the 4th leading cause of death

A

ADR

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7
Q

What type of onset can ADR show

A

Acute
Sub-acute
Latent

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8
Q

Describe acute ADR

A

Occur within 60 minutes (e.g. bronchoconstriction)

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9
Q

Describe sub-acute ADR

A

Occurs within 1 to 24 hours

Can present with rash and serum sickness

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10
Q

Describe latent ADR

A

Occurs after 2 days

May show eczematous eruptions

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11
Q

What are the three classes of severity of ADR

A

Mild
Moderate
Severe

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12
Q

Describe a mild ADR

A

It is bothersome but requires no change in therapy (e.g. metallic taste with metronidazole)

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13
Q

Describe a moderate ADR

A

It requires change in therapy, additional treatment and hospitalization (e.g. amphotericin induced hypokalemia)

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14
Q

Describe a severe ADR

A

Causes a disabling or life-threatening condition (e.g. kidney failure)

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15
Q

How are ADRs classified (6)

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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16
Q

Describe a type A ADR

A

It causes normal but augmented response to the pharmacological actions of a drug
It is dose related and predictable

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17
Q

Describe a type B ADR

A

It causes Bizarre effects

It is idiosyncratic and unpredictable

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18
Q

What are predisposing factors to ADRs

A 
Multiple Drug Therapy
Inter-current Disease (e.g. renal and hepatic impairment)
Race and Genetic Polymorphisms
Age (e.g. elderly and neonates)
Sex (e.g. ADRs more common in women)
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19
Q

What are type A ADRs due to

A

Excess pharmacological action (e.g.
Bradycardia with beta-blockers or Hypoglycaemia with sulphonylureas or insulin)
The secondary pharmacology of a drug unrelated to the therapeutic effect.

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20
Q

What type of ADR is the most common

A

Type A (account for 80% of all ADRs)

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21
Q

How can type A be treated

A

Its easily reversible by reducing the dose or stopping the drug
Not usually life threatening

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22
Q

What types of type A ADRs are there

A

Augmentation of the primary effect

Secondary effect

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23
Q

What are the reasons for a type A ADR

A

Too high a dose
Pharmaceutical variation
Pharmacokinetic variation
Pharmacodynamic variation

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24
Q

When do pharmacokinetic variation and pharmacodynamic variation occur

A

Normally due to a result of disease

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25
Q

What can pharmacokinetic variation involve

A

Absorption (e.g. dose, formulation, GI motility, first pass metabolism)
Distribution
Metabolism (e.g. enhanced or impaired hepatic function)
Elimination (e.g. renal disease, reduced GFR)

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26
Q

What do ADRs that arise from absorption mainly result in

A

Therapeutic failure

27
Q

When is liver disease important

A

When drugs have a narrow therapeutic index

28
Q

What is the importance of pharmacogenetics

A

A number of drugs are metabolised via acetylation which is under genetic control

29
Q

Name some pharmacogenetic factors

A

10% of the population are slow metabolisers
Prone to drug toxicity
peripheral Neuropathy with isoniazid

30
Q

What will renal and hepatic impairment have on drug use

A

Toxic drug levels may build up

31
Q

What effect will cardiac failure have on drug usage

A

Drug absorption from the gut may reduce due to oedema
Poor renal perfusion and decreased GFR
Hepatic congestion

32
Q

What are type B ADRs (8)

A 
Bizarre
Unpredictable
Rare
Cause serious illness or death
Unidentified for months or years
Unrelated to the dose
Not readily reversed
33
Q

What are type B ADRs commonly associated with

A

Macromolecules (e.g. proteins, vaccines and polypeptides)

34
Q

Who can type B ADRs affect

A

Patients with a history of asthma or excema

35
Q

Why is the HLA status important in type B ADRs

A

Presence of particular HLA increases risk of a type B reaction

36
Q

What are the mechanisms for ADRs

A

Idiosyncratic

Drug allergy or hypersensitivity

37
Q

Describe how the drug allergy or hypersensitivity present (5)

A

Immunological
No relation to the pharmacological action of the drug
Delay between exposure and ADR
No dose response curve
Manifests as rash, asthma, serum sickness

38
Q

What is an idiosyncratic response

A

An inherent abnormal response to a drug due to genetic abnormalities such as enzyme deficiency or abnormal receptor activity

It involves pharmacogenetics and pharmacodynamics

39
Q

How can the responses to drugs be considered

A

Genetic

Immunological

40
Q

Describe the ADR that occurs in patients with the enzyme abnormality, Erythrocyte glucose 6-phosphate dehydrogenase (G6PD) deficiency

A

Individuals with sex linked inherited deficiency of this enzyme are susceptible to red cell haemolysis when given drugs such as primaquine or sulphonamides

41
Q

Describe the ADR that occurs in patients with the receptor abnormalities

A

Malignant hyperthermia with general anaesthetics

42
Q

Why do drug allergy hypersensitivity reactions occur

A

Due to antigen- antibody interaction

43
Q

How do drug allergy hypersensitivity reactions occur

A

The first dose acts as the antigen
Body produces the antibody
Subsequent antigen-antibody reaction

44
Q

What are type C ADRs related to

A

The duration of treatment as well as the dose and does not occur with a single dose
They are semi-predictable

45
Q

Give examples of type C ADRs (5)

A

Iatrogenic Cushings disease
Steroid induced osteoporosis
Opiate dependence
Tardive dyskinesia with neuroleptic drugs
Analgesic nephropathy due to paracetamol or NSAIDs

46
Q

What are type D ADRs

A

Averse effects which occur a long time after treatment

47
Q

What can type D ADRs cause

A

Teratogenesis

Carcinogenesis in treated patients years after treatment has stopped (or children of treated patients)

48
Q

In who can type D second cancers occur

A

In those treated with alkylating agents or immunosuppressive agents (e.g. cyclophosphamide or alkylating agents)

49
Q

What kind of malformations can occur in children whose mothers were treated with isotretinoin

A

Craniofacial

50
Q

What is teratogenesis

A

The abnormal congenital malformations in the fetus following in utero exposure due to maternal medication use during 1st trimester of pregnancy

51
Q

Name some teratogenic agents

A 
Cytotoxics
Vitamin A
Antithyroid drugs
Steroids
Oral nticoagulants

All drugs should be avoided during pregnancy unless they are safe or the benefit outweighs potential risk

52
Q

What are type E ADRs

A

Adverse effects which occur when a drug treatment is stopped especially suddenly following long-term use (e,g, alcohol)

53
Q

Give examples of what type E ADRs can cause

A

Unstable angina and MI when beta blockers are stopped.
Addisonian crisis when long term steroids are suddenly stopped
Withdrawal seizures when anti-epileptics are stopped

54
Q

When does rebound phenomena occur

A

When a drug is suddenly withdrawn (e.g. alcohol, benzodiazepines, beta-blockers, corticosteroids)

55
Q

Describe type F ADRs

A

Failure of therapy
Common
Dose related
Frequently caused by drug interactions

56
Q

Give an example of a type F ADR

A

The failure of the OCP when administered with hepatic enzyme inducers/ antibiotics

57
Q

How can ADRs be diagnosed

A

Step 1: Differential diagnosis
Step 2: Medication History (past & present)
Step 3: Assess time of onset and dose relationship
Step 4: Laboratory investigations (plasma concentration measurement, allergy tests)

58
Q

Who are most at risk of ADRs (at least 5)

A 
Children and elderly
Multiple medications
Multiple co-morbid conditions
Inappropriate medication prescribing, use, or monitoring
End-organ dysfunction
Altered physiology
Prior history of ADRs
Extent (dose) and duration of exposure
Genetic predisposition
59
Q

What drugs are commonly involved in ADRs (at least 5)

A 
Antibiotics
Antineoplastics
Anticoagulants
Cardiovascular drugs
Hypoglycemics
Antihypertensives
NSAID/Analgesics
Diagnostic agents
CNS drugs 
Opiates
60
Q

How many fatal ADRs do antineoplastics, cardiovascular drugs and CNS drugs account for

A

69%

61
Q

What body systems are commonly involved in ADRs (at least 5)

A 
Haematologic
CNS 
Dermatologic/Allergic
Metabolic
Cardiovascular
Gastrointestinal
Renal/Genitourinary
Respiratory
Sensory
62
Q

When should ADRs be reported

A

All significant or unusual adverse drug reactions as well as unanticipated or novel events that are suspected to be drug related
All ADRs affecting Black Triangle Drugs/Products

63
Q

How can ADRs be reported

A

Using ADR yellow card scheme

Principles of Disease (41 decks)

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