Side Effects & Adverse Drug Reactions

Question 1

Describe who is responsible for pharmacovigilance.

Answer 1

-world health organization
-detection, assessment, understanding, prevention
-adverse effects or other drug related issues

Question 2

Describe side effect VS adverse drug reactions.

Answer 2

1. Side effects
   -unintended effect of drug occurring at doses normally used which is related to the pharmacological properties of the drug
2. Adverse drug reactions
   -response to drug that is noxious & unintended at doses normally used
   -not related to pharmacological properties
   -adverse effect at higher doses

Question 3

Describe type A VS type B in adverse drug reactions.

Answer 3

1. Type A
   -predictable
   -one or more species
   -correlated w plasma drug conc
2. Type B
   -idiosyncratic (unpredictable)
   -hypersensitivity reactions
   -dont always involve adaptive IR
   -NOT dose dependent
   -individual reaction (genetic)
   -serious or life threatening
   >fever, face swelling, skin eruptions, organ dysfunction, arthropathy, blood dyscrasia, collapse
   *some reported in label

Question 4

Describe management.

Answer 4

-discontinue administration
-symptomatic treatment