Pharmacovigilance & Pharmacogenetics Flashcards Preview

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Flashcards in Pharmacovigilance & Pharmacogenetics Deck (18)
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1
Q

What is pharmacovigilance?

A

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

2
Q

What is an adverse drug reaction?

A

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.

3
Q

What is an adverse drug event?

A

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

4
Q

What are ‘serious’ ADRs?

A

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

5
Q

Name the 2 types of ADRs.

A

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.

6
Q

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

A

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.

7
Q

Give an example of a type A ADR.

A

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

8
Q

Give an example of a type B ADR.

A

Penicillin anaphylaxis

9
Q

What is the difference between baseline risk and relative risk?

A

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.

10
Q

What is DoTS?

A

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).

11
Q

What statistical measure is used to confirm an ADR?

A

95% confidence interval (p<0.05)

12
Q

Name the 4 MOAs for an ADR.

A
  • 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
13
Q

What is the yellow card scheme?

A

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

14
Q

Give an advantage and disadvantage of reporting ADRs.

A

A - simple, timely, inexpensive

D - inevitable and unquantifiable under-reporting.

15
Q

What is pharmacogenetics?

A

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.

16
Q

What is Steven’s Johnson Syndrome?

A

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.

17
Q

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

A

They have low renin states.

18
Q

What is a genetic polymorphism?

A

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