Adverse Drug Reactions Flashcards Preview

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Flashcards in Adverse Drug Reactions Deck (63)
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1

What is an adverse drug reaction (ADR)

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

2

What does an ADR result in

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

3

How many people are admitted annually due to ADR's

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

4

How many inpatients suffer an ADR

10-20%

5

How many deaths a year are due to ADR

5000 - 12,000

6

What is the 4th leading cause of death

ADR

7

What type of onset can ADR show

Acute
Sub-acute
Latent

8

Describe acute ADR

Occur within 60 minutes (e.g. bronchoconstriction)

9

Describe sub-acute ADR

Occurs within 1 to 24 hours
Can present with rash and serum sickness

10

Describe latent ADR

Occurs after 2 days
May show eczematous eruptions

11

What are the three classes of severity of ADR

Mild
Moderate
Severe

12

Describe a mild ADR

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

13

Describe a moderate ADR

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

14

Describe a severe ADR

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

15

How are ADRs classified (6)

Type A - Augmented
Type B - Bizarre
Type C - Chronic
Type D - Delayed
Type E - End of treatment
Type F - Failure of treatment

16

Describe a type A ADR

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

17

Describe a type B ADR

It causes Bizarre effects
It is idiosyncratic and unpredictable

18

What are predisposing factors to ADRs

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)

19

What are type A ADRs due to

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.

20

What type of ADR is the most common

Type A (account for 80% of all ADRs)

21

How can type A be treated

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

22

What types of type A ADRs are there

Augmentation of the primary effect
Secondary effect

23

What are the reasons for a type A ADR

Too high a dose
Pharmaceutical variation
Pharmacokinetic variation
Pharmacodynamic variation

24

When do pharmacokinetic variation and pharmacodynamic variation occur

Normally due to a result of disease

25

What can pharmacokinetic variation involve

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)

26

What do ADRs that arise from absorption mainly result in

Therapeutic failure

27

When is liver disease important

When drugs have a narrow therapeutic index

28

What is the importance of pharmacogenetics

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

29

Name some pharmacogenetic factors

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

30

What will renal and hepatic impairment have on drug use

Toxic drug levels may build up