Prescribing

Question 1

Why do you prescribe differently for children?

Answer 1

Decreased body weight
Different body composition
Decreased surface area
Nutritional status
Organ maturation

Question 2

What extra steps do you take to ensure safety when giving children fluids?

Answer 2

Do U&Es every day

Question 3

What is an ADR?

Answer 3

Adverse drug reaction
An unwanted or harmful reaction which occurs after administration of a drug/drugs and is suspected or known to be due to the drug(s)

Question 4

Name the 2 types of ADR and their differences

Answer 4

Type A: pharmacological mechanism, predictable, readily reversible on stopping drug/lowering dose
Type B: Idiosynchratic/immunological, not predictable, unrelated to dose, prolonged/permanent/fatal

Question 5

Give 2 examples of a type A ADR

Answer 5

Dry cough with ACEi

Bradycardia with B-blockers

Question 6

Give 2 examples of type B ADRs

Answer 6

Penicillin anaphylaxis

Angioedema with ACEi

Question 7

What % of ADRs are type A?

Answer 7

80%

Question 8

What % of hospital admissions are due to ADRs?

Answer 8

6-7%

Question 9

In a patient information leaflet, what does a very common ADR mean?

Answer 9

> 10% patients (1/10)

Question 10

In a patient information leaflet, what does a common ADR mean?

Answer 10

1%-10% patients (1/10-1/100)

Question 11

In a patient information leaflet, what does a very rare ADR mean?

Answer 11

less than 0.01%

Question 12

What ensures all medicines are regulated?

Answer 12

The Medicines Act of 1968

Safety, quality, efficacy

Question 13

Name 3 UK organisations involved in the regulation of drugs

Answer 13

MHRA (Medical & Healthcare Products Regulatory Agency)
CHM (Commission Medicines Agency)
BP (British pharmacopoeia)

Question 14

How are ADRs identified before drug is licensed??

Answer 14

Genetic screening for carcinogens
Acute single dose studies
Rodent & dog short term studies
90 days rodent and dog doses

Question 15

How many phases are there in clinical trials?

Answer 15

4

Question 16

What is involved in stage 1 of a clinical trial?

Answer 16

Route and metabolic fate is defined in normal volunteers (n less than 50)

Question 17

What is involved in stage 2 of a clinical trial?

Answer 17

Therapeutic profile and dose regimen is defined
Dose ranging (n less than 500)

Question 18

What is involved in stage 3 of a clinical trial?

Answer 18

Clinical efficacy determined, compared to placebo/comparator
Longer duration (n less than 500)

Question 19

What is involved in stage 4 of a clinical trial?

Answer 19

Post marketing surveillance (pharmacovigilance)

Question 20

How do you assess an ADR?

Answer 20

Nature and severity of reaction
History and timings
Relationship to dose
Complete drug history
Review ADR profile of drug
Complete yellow card
Specific investigatons/further complications/drug monitoring?

Question 21

Do you break the doctor-patient confidentiality if you fill in a yellow card without their consent?

Answer 21

No, yellow cards do not violate patient confidentiality

Question 22

What needs to be included in a yellow card?

Answer 22

1 piece of patient info (age/sex/weight/initials/ID)
Name of suspected drug/drugs
Brief description of ADR
Contact details of the reporter