Clinical Pharmacology - The Use of Medicines

Question 1

How are medicines licensed?

Answer 1

MHRA
Safety, quality and efficacy
Product and company level

Question 2

What is pharmacovigilance?

Answer 2

Detection/assessment/understanding of adverse drug reactions
Continuous assessment of risks and benefits of drugs
Yellow card scheme

Question 3

What information do MHRA Yellow Cards collect?

Answer 3

Side effects
Medical ADRs
Defective medicine
Counterfeit or fake drugs/devices
Safety concerns

Question 4

ADRs to what should be reported?

Answer 4

New drugs
Black triangle drugs
ADRs in children
Serious ADRs in established medicines

Question 5

What are “serious” ADRs?

Answer 5

Anaphylaxis
Significant harm
Death

Question 6

What must be included in a Yellow Card report?

Answer 6

The side effects
Information about affected person
Name of medicine
Name + address

Question 7

What are unlicensed drugs?

Answer 7

No marketing authorisation

Question 8

What are off-label drugs?

Answer 8

Licensed but prescribed outwith terms of marketing authorisation

Question 9

What are special drugs?

Answer 9

Special formulations of medicines made for clinical reasons (when licensed product is unsuitable)

Question 10

What is the GMC guidance for unlicensed medicines?

Answer 10

Carefully consider treatment

Be able to justify your decisions

Question 11

What are the requirements for prescription of controlled drugs?

Answer 11

Schedules 2, 3, 4 limit to 30 days Rx
Formulation and strength
Specify dose (no decimal pt .)
Total amount in words + figures

Question 12

What must be undertaken before prescribing anything?

Answer 12

Ensure accurate drug history taking
Discuss with seniors whether to stop/start/change meds - record change
Check BNF if unsure