adverse drug reactions Flashcards

1
Q

Adverse Drug Reactions =

A

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

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2
Q

Adverse Drug Reactions =

A

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

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3
Q

Onset of event (ADR)

A
Acute 
    - within 60 minutes
    - bronchoconstriction
Sub-acute 
    - 1 to 24 hours
    - Rash, serum sickness
Latent 
    - 2 days
    - Eczematous eruptions
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4
Q

Severity of reaction (ADR)

A
Mild
    - bothersome but requires no change in therapy
    - Metallic taste with metronidazole
Moderate
    - requires change in therapy, additional  treatment or 
      hospitalization 
    - Amphotericin induced hypokalemia
Severe
    - disabling or life-threatening
    - kidney failure
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5
Q

Classification of ADRs

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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6
Q

Type A ADRs

A

Augmented pharmacologic effects

  • Dose related
  • Predictable
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7
Q

Type B ADRs

A

Bizarre effects

- Idiosyncratic and unpredictable

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8
Q

Predisposing Factors to ADR

A
Multiple Drug Therapy
    - Incidence of ADRs increase exponentially with the 
      number of medicaments
Inter-current Disease
    - Renal and hepatic impairment
Race and Genetic Polymorphisms
Age
    - Elderly and neonates 
Sex
    - ADRs more common in women
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9
Q

Type A Reactions

A

They are due to excess pharmacological action

  • bradycardia with beta-blockers
  • hypoglycaemia with sulphonylureas or insulin

Easily reversible on reducing the dose or stopping the drug
They are the most common of all ADRS accounting for 80% of all ADRs
Not usually life threatening

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10
Q

Reasons for Type A ADRs due to disease

A

Pharmacokinetic variation

Pharmacodynamic variation

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11
Q

Pharmacokinetic Variation

A
  • The majority of ADRs which arise through absorption problems result in therapeutic failure
  • Liver disease is particularly important when drugs have a narrow therapeutic index
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12
Q

Pharmacogenetic

A

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

  • 10% of the population are slow metabolisers
  • prone to drug toxicity
  • peripheral neuropathy with isoniazid
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13
Q

Disease and ADRs

A

Renal and hepatic impairment
- If a drug is excreted by the kidneys toxic drug levels
may build up
Cardiac Failure
- Reduce drug absorption from the gut due to oedema
- Poor renal perfusion and decreased GFR
- Hepatic congestion

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14
Q

Most type A ADRs are

A

pharmacokinetic in nature

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15
Q

Type B ADRs

A
Bizarre
Unpredictable
Rare
Cause serious illness or death
Unidentified for months or years
Unrelated to the dose
Not readily reversed
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16
Q

Type B ADRs mechanism

A

Idiosyncratic
Drug allergy or hypersensitivity
- 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

17
Q

Type B ADRs Important Factors

A
More common with macromolecules
    - proteins
    - vaccines
    - polypeptides
Patients with history of asthma, excema, 
HLA status
    - Presence of particular HLA increases risk of a type B 
      reaction
18
Q

Idiosyncratic is the

A

Inherent abnormal response to a drug
Due to genetic abnormality such as enzyme deficiency
Or abnormal receptor activity.

19
Q

Pharmacogenetic

Differences in response to drugs may be considered as:

A

Genetic

Immunological

20
Q

Type C Chronic/Long Term Effects

A

This type of ADR is related to the duration of treatment as well as the dose and does not occur with a single dose.

Semi-predictable

  • Iatrogenic Cushings disease
  • Steroid induced osteoporosis
  • Opiate dependence
  • Tardive dyskinesia with neuroleptic drugs
  • Analgesic nephropathy due to paracetamol or NSAIDs
21
Q

Type D Delayed Effects

A

These adverse effects occur a long time after treatment

  • Teratogenesis
  • Carcinogenesis
    - The children of treated patients-teratogenesis
    - Carcinogenesis in treated patients years after treatment has stopped.
22
Q

Type D Delayed Effects

Craniofacial malformations in

A

children whose mothers were treated with isotretinoin

Due to maternal medication use during 1st trimester of pregnancy

23
Q

All drugs should be avoided during

A

pregnancy unless they are safe or the benefit outweighs potential risk

24
Q

teratogenic Agents

A
isotretinoin
Cytotoxics
Vitamin A
Antithyroid drugs
Steroids
Oral nticoagulants
25
Q

Type E End of Treatment Effects

A

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

26
Q

Type E End of Treatment Effects

Unstable angina and MI when

A

beta blockers are stopped.

27
Q

Type E End of Treatment Effects

Addisonian crisis when

A

Long term steroids are suddenly stopped

28
Q

Type E End of Treatment Effects

Withdrawal seizures when

A

anti-epileptics are stopped

29
Q

Rebound Phenomena Occur when

A

drug is suddenly withdrawn

  • Alcohol
  • Benzodiazepines
  • beta-blockers
  • corticosteroids
30
Q

Type F ADRs

A

Failure of therapy
Common
Dose related
Frequently caused by drug interactions

Failure of the OCP when administered with hepatic enzyme inducers/ antibiotics

31
Q

most at risk of ADRs?

A

Age (children and elderly)
Multiple medications
Multiple co-morbid conditions
Inappropriate medication prescribing, use, or monitoring

32
Q

60% of ADRs and ADEs are

A

preventable, although some effects cannot be avoided (e.g. nausea in chemo treatment for cancer)

33
Q

Report ADRs using

A

Yellow Card Scheme