Pharmacovigilance Flashcards

1
Q

what is pharmacovigilance ?

A

identification, assessment and subsequent prevention of adverse drug reactions

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2
Q

what molecules can easily cross the plancental barrier ?

A

tetragens

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3
Q

what is the difference between Adverse drug reaction compared to adverse event

A

cause of ADR is due to the therapeutic but in event causality has not been confirmed

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4
Q

Name a few features of Type A (Augmented) reaction

A

dose related
predicted from pharmacology
common and reversible

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5
Q

name features of Type B reaction

A

Not dose related
uncommon
unpredictable
serious and irreversible

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6
Q

read slide on DoTS

A

work out the Table of ADRs again

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7
Q

what is DoTS?

A

Dose-related
time-related
Susceptibility (age, gender)
they help classify ADRs

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8
Q

what are the 4 broad MOAs fro ADRs?

A
  1. exaggerated response
  2. desired effect at wrong site
  3. secondary effect
  4. triggers immune response
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9
Q

what is in place by MHRA to report ADRs?

A

yellow card scheme

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10
Q

what is responder rates ?

A

the rate at which a particular patient population do not respond to a drug

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11
Q

What 2 things in PG can alter the Pharmacokinetics

A

Drug metabolism via CYP genes

Receptor efficacy

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