Pharmacovigilance & Pharmacogenetics

Question 1

What is pharmacovigilance?

Answer 1

The identification, assessment and subsequent prevention of adverse drug reactions, this responsibility lies with prescribers, patients and carers.

Question 2

What is an adverse drug reaction?

Answer 2

An unintended, noxious reaction to a specific drug that has been given within the therapeutic range, the reaction is usually mentioned in the prescription explanation and the reaction is evidence based from clinical trials.

Question 3

What is an adverse drug event?

Answer 3

Side effect which was only revealed after usage of the drug and not evident from clinical trials, the reaction is reported from personal experience.

Question 4

What are ‘serious’ ADRs?

Answer 4

Can be fatal, life-threatening, cause prolonged hospitalisation, long term disability or congenital abnormalities.

Question 5

Name the 2 types of ADRs.

Answer 5

Type A - well known reactions that are dose-related, predictable and common and can be managed with dose adjustment.
Type B - generally unknown and reactions tend to be more serious, they are not dose-related, are uncommon and unpredictable and the drug needs to be stopped.

Question 6

Of type A and B ADRs, which are more commonly reported?

Answer 6

Type B tend to be reported more as they are more concerning and we aren’t aware of them, where as Type A are already well-known.

Question 7

Give an example of a type A ADR.

Answer 7

Warfarin - bleeding
Oral antidiabetic agent - hypoglycaemia
Nitrates - headache due to vasodilation

Question 8

Give an example of a type B ADR.

Answer 8

Penicillin anaphylaxis

Question 9

What is the difference between baseline risk and relative risk?

Answer 9

Baseline risk - risk of something happening e.g. MI, to someone within the normal range e.g. Normal weight.
Relative risk - risk of MI for someone who is overweight (5x) compared to the person within the normal range.
E.g. If baseline risk is 1/500, relative risk is 5/500.

Question 10

What is DoTS?

Answer 10

Dose relatedness, time relatedness and susceptibility - a classification scheme used for ADRs.
Describes the dose (normal or toxic), time of reaction (delayed, first dose) and who is more susceptible (age, gender, ethnicity, disease).

Question 11

What statistical measure is used to confirm an ADR?

Answer 11

95% confidence interval (p<0.05)

Question 12

Name the 4 MOAs for an ADR.

Answer 12

• exaggerated response e.g. Bleeding with warfarin
• desired pharmacological effect at an alternative sites e.g. GTN spray causes headaches
• additional pharmacological effect e.g. Affects QT length
• triggers an immune response e.g. Anaphylaxis

Question 13

What is the yellow card scheme?

Answer 13

An online reporting system for any suspected ADRs, it is available to anyone and it is the responsibility of everyone.

Question 14

Give an advantage and disadvantage of reporting ADRs.

Answer 14

A - simple, timely, inexpensive

D - inevitable and unquantifiable under-reporting.

Question 15

What is pharmacogenetics?

Answer 15

How an individual gene can affect the response to a drug or the drugs effect on the body - person variability contributes to 7% of serious ADRs.

Question 16

What is Steven’s Johnson Syndrome?

Answer 16

A rare and serious cutaneous reaction to a medication or an infection, predominantly found in Asian patients. Begins with flu-like symptoms, followed by painful rashes and blisters, can lead to sepsis and death.

Question 17

Why is angioedema more prevalent in African Caribbean populations and older people?

Answer 17

They have low renin states.

Question 18

What is a genetic polymorphism?

Answer 18

A single point mutation that can affect both the pharmacokinetics and pharmacodynamics of a drug.