Adverse Drug Reactions (ADRs)

Question 1

Define an adverse drug reaction?

Answer 1

Any Noxious or Unintended response to drug occurring at doses used for prophylaxis, diagnosis or treatment

Question 2

What are the 3 criteria of an adverse drug reactions? (definition)

Answer 2

The response must be:
Noxious
Unintended
Dose for prophylaxis, diagnosis or treatment (i.e. not known unsafe dose)

Question 3

How many inpatients suffer ADRs?

Answer 3

10-20% of inpatients suffer an ADR

Question 4

How many hospital deaths are due to ADRs?

Answer 4

0.2-3% of hospital deaths are due to ADRs
(roughly 5-10k deaths/yr)

Question 5

How many hospital admissions are ADR related?

Answer 5

6.5% of hospital admissions are related to ADRs

Question 6

What are the 3 time periods of ADRs?

Answer 6

Acute
Sub-Acute
Latent

Question 7

How quickly does an acute ADR occur?

Answer 7

Within an hour of administration

Question 8

How quickly does a sub-acute ADR occur?

Answer 8

1-24 hours after administration

Question 9

How long does a latent ADR take to occur?

Answer 9

2 or more days after administration

Question 10

What are the 3 levels of ADR?

Answer 10

Mild
Moderate
Severe

Question 11

Define a mild ADR?

Answer 11

Bothers patient
Dont need to change treatment

Question 12

Define a moderate ADR?

Answer 12

Patient either needs hospitalisation, changed treatment or additional treatment to solve it.

Question 13

How bad is a severe ADR?

Answer 13

Disabling or life-threatening

Question 14

How are ADRs categorised?

Answer 14

Types A-F

Question 15

What do the types of ADR stand for?

Answer 15

Augmented
Bizarre
Chronic
Delayed
End of Treatment
Failure of Treatment

Question 16

Why are Type A ADRs called augmented?

Answer 16

Normal response to drug but augmented (exaggerated)

Question 17

Example of Type A ADRs?

Answer 17

Beta blockers causing bradycardia
Insulin causing hypoglycaemia

Question 18

Are type A ADRs predictable?

Answer 18

Type A adrs are predictable & related to dosage

Question 19

What causes a type A ADR?

Answer 19

Excess pharmacological action.

Question 20

What causes excess pharmacological action in a Type A ADR?

Answer 20

Too high a dose
Pharmaceutical Variation
Pharmacokinetic Variation
Pharmacodynamic Variation

Question 21

What 4 aspects of a pateint make up their pharmacokinetic variation?

Answer 21

Their drug ADME
Absorption
Distribution
Metabolism
Elimination

Question 22

What 4 factors affect drug absorption?

Answer 22

Dose
Drugs formulation
GI motility
First pass metabolism

Question 23

What effects drug metabolism?

Answer 23

altered hepatic function

Question 24

In what type of drugs is liver disease a particularly important consideration?

Answer 24

Those with a narrow therapeutic range

Question 25

What effects drug elimination?

Answer 25

Altered renal function, particularly reduced Glomerular Filtration Rate (GFR)

Question 26

How does pharmacogenetics trigger Type A ADRs?

Answer 26

10% of people are slow metabolisers making them prone to drug toxicity due to their lower first pass metabolism.

Question 27

What effects pharmacodynamic variation?

Answer 27

- Natural variability between individuals - Disease states (particularly renal/hepatic disease)

Question 28

Why are Type B ADRs called bizarrre?

Answer 28

Unpredictable & rare

Question 29

How serious can type B ADRs be?

Answer 29

Severe, they can kill you

Question 30

How are some Type B ADRs immunological?

Answer 30

Some Type B ADRs are drug allergies, i.e. examples of type 1 hypersensitivity

Question 31

What are TYPE C ADRs related to?

Answer 31

Dosage & treatment duration

Question 32

example of a type C ADR?

Answer 32

Iatrogenic Cushing's disease

Question 33

When does a TYPE D ADR occur?

Answer 33

Years after treatment.

Question 34

Whats unique about a Type D ADR?

Answer 34

Type D ADRs can occur in patients children

Question 35

What sort of Type D ADRs can immunosuppresive agents cause?

Answer 35

secondary cancers

Question 36

If a mother is treated with isotretinoin, what ADR can occur?

Answer 36

Child born with craniofacial malformation

Question 37

What ADR are thalidimide babies an example of?

Answer 37

Type D ADRs

Question 38

When does a Type E ADR occur

Answer 38

When a treatment is stopped

Question 39

Alcohol withdrawel is an example of what ADR?

Answer 39

Type E

Question 40

What are some type E ADRs known as ?

Answer 40

Rebound phenomenom

Question 41

what type E ADR can occur when beta blockers are stopped?

Answer 41

Beta blockers stopped Unstable Angina & myocardial infarction can occur

Question 42

What type E ADR occurs when long term steroid are suddenyl stoppped?

Answer 42

addisonian crisis (low bp low blood sugar high blood K+)

Question 43

What frequently causes Type F ADRs?

Answer 43

Drug interaction

Question 44

Is dose related to Type F ADR?

Answer 44

Yes, dose influences type F ADRs

Question 45

What are the 4 steps for diangosing an ADR?

Answer 45

- Differential Diagnosis - Medication history - Asses time of onset & dose relationship - Lab investigations

Question 46

What lab investiations are used to diagnose an ADR?

Answer 46

Plasma conc. measurments Allergy tests

Question 47

Whats step 1 of diagnosing an ADR?

Answer 47

Differential diagnosis

Question 48

What is step 2 of ADR diagnosis?

Answer 48

Medication History

Question 49

Whats step 3 of ADR diagnosis?

Answer 49

Assessing relationship between dose & time of onset

Question 50

Whats step 4 of ADR diagnosis?

Answer 50

Lab tests

Question 51

How are ADRs reported?

Answer 51

To the yellow card scheme

Question 52

What does the yellow card scheme collect info on?

Answer 52

ADRs (side effects) Defective Meds Counterfeit meds Medical device incidents