25. Pharmacovigilance

Question 1

What is pharmacovigilance?

Answer 1

The process of identifying and then responding to safety issues about marketed drugs.

Question 2

What is a type A adverse drug reaction (ADR)?

Answer 2

• predictable ADR
• common
• exaggerated pharmacological response
• dose dependent
• high morbidity, low mortality

Question 3

What is a type B ADR?

Answer 3

• unpredictable ADR - not expected from known pharmacology
• rare
• independent of dose
• high mortality

Question 4

What to report under the yellow card scheme?

Answer 4

• all ADRs however minor for black triangle drugs
• all reactions to vaccines
• unusual reactions to established products

Question 5

What are the 3 ways we can detect ADRs?

Answer 5

1) spontaneous reporting - all doctors report
2) case control studies - select cases with the adverse events e.g. peptic ulcer and then match controls without the adverse event and then compare the exposure to risk factor e.g. drug - NSAID
3) cohort studies - compare group who took drug to control group

Question 6

Why is there under reporting of ADRS?

Mnemonic: FAILURE

Answer 6

F- failure of patient to report/doctor to ask
A- ADR is too trivial
I- ignorance of how to report/do it
L- lack of time
U- uncertainty of relationship of drug to presentation
R- relation to duration of marketed drug
E- experience and familiarity with the ADR