Pharmacovigilance

Question 1

What is pharmacovigilance

Answer 1

Process of identifying and then responding to safety issues about marketed drugs

Question 2

Outline the requirement for pharmacovigilance

Answer 2

Survey of the safety of drugs

Elucidate factors predisposing to toxicity

Devel strategies to minimise risk and optimise benefits

Question 3

Discuss the limitations of Phase I-III clinical trials

Answer 3

ADRs that have a low incidence may not be detected in small clinical trial numbers

Frequent exclusion of pts who may be at greater risk of ADRs

Limited duration, restricted dose

Question 4

Describe the general classification of Adverse Drug Reactions (ADRs)

Answer 4

Type A = common/predictable – dose dependent, high morbidity (diarrhoea from ABX)

Type B = rare/unpredictable – independent of dose, high mortality (liver disease/death from fluticasone)

Question 5

Outline the surveillance methods for ADRs

Answer 5

Pre-marketing = clinical trials

Spontaneous reporting (MHRA/yellow card) = recognition of ADR, establish causal relationship, report observations

Limitations = underreporting, delays, poor data quality, misleading reports, no control group

Question 6

Outline when and how to complete a ‘yellow card’ to report a suspected ADR

Answer 6

When any ADR is seen in a drugs first years of use

When serious/unusual ADRs are seen in established drugs

All reactions to vaccines

How = yellow card scheme on the MHRA website