4. Pharmacovigilence

Question 1

What is pharmacovigilance?

Answer 1

Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines

Question 2

What is an adverse drug reaction?

Answer 2

Response to a drug which is noxious and unintended and which occurs at doses normally used in man - causal link

Question 3

What is an adverse drug event?

Answer 3

An injury that occurs during treatment and is not necessarily caused by the drug itself

Question 4

What are the types of ADR?

Answer 4

A - augmented
B- bizarre
C - chronic
D - delayed
E - end of treatment

Question 5

Give examples of type A adverse drug reactions

Answer 5

Bleeding after anticoagulants

Hypoglycaemia from insulin

Question 6

Give an example of a type B adverse drug reaction

Answer 6

Anaphylaxis from penicillin

Question 7

What are the 4 mechanisms of action for an adverse drug reaction?

Answer 7

Exaggerated response
Desired pharmacological effect at alternative/additional site
Additional/secondary pharmacological effect
Triggering an immunological response