Adverse Drug Reactions

Question 1

What is a graded dose-response curve?

Answer 1

A # of increasing doses of a drug are given to the same subject —> increase in response for each dose is measured (graded in increments)

Determines Emax of the drug

Question 2

What is a population dose-response curve (quantal)?

Answer 2

Characterize pharmacologic responses that are all-or-nothing events (not graded) in a population of subjects

Will a dose yield a response or not?

Question 3

How are quantal curves used?

Answer 3

Compare dose-response curves for desirable and toxic effects **

Question 4

How do you use the therapeutic index to compare dosage?

Answer 4

Compares the midpoint in pop’n at ED50 and LD50

TI = LD50/ED50

Higher TI = safer the drug (ideally >10-20)

Question 5

How do you use the standard safety margin to compare dosage?

Answer 5

looks at the extremes in the population (ED99 and LD1)

SSM = [(LD1/ED99)-1] x 100

Question 6

What are the general FDA categories for drug use during pregnancy?

Answer 6

A, B, C, D, X

Question 7

Describe category A for drug use during pregnancy. Give an example.

Answer 7

Controlled studies show no risk — possibility of harm to fetus is unlikely

Ex: KCl

Question 8

Describe category B for drug use during pregnancy. Give examples.

Answer 8

No evidence of risk in humans

Ex: opioids, acetaminophen

Question 9

Describe category C for drug use during pregnancy. Give examples.

Answer 9

Risk cannot be ruled out

Ex: pseudoephedrine, antidepressants

Question 10

Describe category D for drug use during pregnancy. Give examples.

Answer 10

Positive evidence of fetal risk, but potential benefits may outweigh risks (in life threatening situations or serious diseases)

Ex: ACE inhibitors, oral anticoags, diazepam

Question 11

Describe category X for drug use during pregnancy. Give examples.

Answer 11

Contraindicated in pregnancy — risks involved in the drug’s use clearly outweigh the benefits

Ex: HMG CoA reductase inhibitor statins, isotretinoin