ADR

Question 1

Any untoward medical occurrence during treatment with a pharmaceutical product but which does not have causal relationship with such treatment.

Answer 1

Adverse drug event/Experience (ADE)

Question 2

A response to a drug which is noxious, unintended, and which occur at doses normally used in man for prophylaxis, diagnosis, or therapy, of disease, or for modification of physiological function

Answer 2

Adverse Drug Reaction (ADR)

Question 3

Unintended effect occurring at a normal dose related to pharmacological properties of the drug

Answer 3

Side effect (SE)

Question 4

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine related problem

Answer 4

Pharmacovigilance

Question 5

Narrow therapeutic index drugs examples

Answer 5

Digoxin, theophylline, warfarin, heparin, aminoglycosides, anticoagulants, lithium

Question 6

Fast acetylators

Answer 6

Asians
Eskimos
Orientals (eastern)

Question 7

Slow acetylators

Answer 7

Caucasians
African-American
Egyptians

Question 8

Expected, extension, of drug’s pharmacological action (SE)

Answer 8

Type A - Augmented

Question 9

Common, reproducible, dose dependent, predictable, and majority of ADR’s

Answer 9

Type A- Augmented

Question 10

Abnormal and unusual; unrelated to pcol action

Answer 10

Type B- Bizarre

Question 11

Rare, unpredictable, not reproducible, not dose-dependent

Answer 11

Type B- Bizarre

Question 12

Chronic use in supraphysiological doses (toxicity)

Answer 12

Type C- Continuous

Question 13

Decrease responsiveness to drug to repeated use

Answer 13

Tolerance

Question 14

Rapid tolerance
Down regulation of receptors

Answer 14

Tachyphylaxis

Question 15

Reaction occurs long after exposure
Delayed onset
Dose dependent

Answer 15

Type D- Delayed