S14.4 Pharmacovigilance

Question 1

What is Pharmacovigilance?

Answer 1

The process of identifying and responding to safety issues of drugs.

Question 2

How are Premarketing clinical studies limited in identifying drug safety issues?

Answer 2

Only a small number of patients are treated.
Limited duration of treatment.
Restricted doses.

Question 3

How does spontaneous reporting identify ADRs?

Answer 3

Recognising ADRs, establishing causal relationship, then report observations (to regulatory authority via yellow card, or pharmaceutical companies)

Question 4

What are the advantages and disadvantages of spontaneous reporting?

Answer 4

Adv: involves Dr’s, cheap
Disadv: delays, no control group

Question 5

How do cohort studies identify ADRs?

Answer 5

Identify group exposed to drug, observe occurrence of ADRs

Question 6

What are the advantages and disadvantages of cohort studies?

Answer 6

Adv: Has a control group and tests hypothesis
Disadv: expensive

Question 7

How do case-control studies identify ADRs?

Answer 7

Select cases with ADRs and match controls to them, compare exposure to risk factor, calculate odds ratio

Question 8

What are the advantages and disadvantages of case-control studies?

Answer 8

Adv: good for rare ADRs, quick, cheap
Disadv: many biases

Question 9

Why might some ADRs not be reported?

Answer 9

Patient may not know how to report.
Lack of time.
ADR may seem like a drug presentation.