Session 14

Question 1

What is pharmacovigilance?

Answer 1

Identifying and responding to safety issues about marketing drugs.

Question 2

What are the 4 main aims of pharmacovigilance?

Answer 2

1) Find unrecognised drug safety hazards
2) Remove factors predisposing to toxicity
3) Get evidence of safety so new drugs uses can be widened
4) ‘False positive’ ADRs

Question 3

Give two limitations of pre-marketing studies.

Answer 3

Small number of patients, restricted type of patients, limited duration of treatment, high level of patient monitoring, specialist doctors.

Question 4

Give two limitations of routine clinical experience.

Answer 4

Large number of patients, type of patients guided by indication, usually any type of doctor.

Question 5

What are type A ADRs?

Answer 5

Exaggerated pharmacological response, predictable, dose-dependent, common, high morbidity, low mortality.

Question 6

What are type B ADRs?

Answer 6

Not expected, unpredictable, independent of dose, rare and high mortality.

Question 7

Give three ways that ADRs can be identified.

Answer 7

Spontaneous recording, cohort studies, case-control studies.

Question 8

Give three advantages of spontaneous reporting of ADRs.

Answer 8

As soon as the drug is marketed, entire population, all doctors, all drugs, detects common and rare reactions, inexpensive, continues indefinitely.

Question 9

Give three advantages of case-control studies to identify ADRs.

Answer 9

Good for rare ADRs, can give a quick answer if suitable database available, relatively low cost, indicates degree of increased risk.

Question 10

When should the yellow card ADR scheme be used?

Answer 10

• Recently introduced products
• All reactions to vaccines
• Reactions to established products

Question 11

What is pharmacogenetics?

Answer 11

Understanding how different individual genotypes relate to different drugs. Hence knowing which drug will be safe and effective for an individual patient.

Question 12

Give three risk factors for drug inefficiency or toxicity

Answer 12

DDIs, age, renal and liver function, concurrent illness, smoking and alcohol, genetic variation.

Question 13

How can absent or reduced CYP 2D6 activity lead to ADRs?

Answer 13

• Decreased 1st pass metabolism and drug elimination
• Accumulation of the drug as a result of reduced metabolism
• Re-routing of metabolism.

Question 14

Name the three types of corticosteroids.

Answer 14

Glucocorticoids (cortisol), mineralocorticoids (aldosterone), sex steroids.

Question 15

Give three metabolic actions of glucocorticoids.

Answer 15

Stimulates glycogenolysis and gluconeogenesis. 
Hyperglycaemia. 
Proteinolysis. 
Lipolysis. 
Lipid deposition.

Question 16

Give three signs of excess mineralocorticoids.

Answer 16

Hypernatraemia, hypertension, hypokalaemia.

Question 17

Give three signs of glucocorticoid deficiency.

Answer 17

Hypoglycaemia, weight loss, nausea, hypotension, underweight.

Question 18

Give four uses of steroid drugs.

Answer 18

Inflammatory diseases, immunosuppression, malignancy, adrenal insifficiency, cushing’s disease, preterm birth.

Question 19

Give three ADRs of glucocorticoids.

Answer 19

Osteoporosis, avascular necrosis, peptic ulcers, hypertension, diabetes, cataracts, corneal damage.

Question 20

Describe a hypo-adrenal crisis.

Answer 20

Hypotension, hypoglycaemia, hyponatraemia, hypokalaemia, severe dehydration, death if untreated.

Question 21

Give three effects of glucocorticoids on the immune system.

Answer 21

• Inhibit T and B cell responses
• Reduced transcription of cytokines
• Reduced phagocytic function
• Immunosuppression
• Reduced inflammation.