PRINCIPLES OF PHARMACOLOGY
COMPREHENSIVE TEST 2026 COMPLETE
SOLUTIONS 100% CORRECT
◉ What is postmarketing surveillance? Answer: Phase 4 - which
includes all of the methods used to continue monitoring drug safety
and effectiveness after approval for public use.
- reports from health-care providers
- research about how drug is being used in clinical practice
- research comparing the drug to similar drugs on the market
◉ In what situations has the FDA made provisions to shorten the
development and review process for new drugs? Answer: For drugs
that treat life-threatening conditions (Cancer/AIDS) and if there is
not a better option.
◉ True or False: Out of thousands of compounds that enter
preclinical trials, only 1 will be released as a prescription drug for
use in humans Answer: True
◉ What is an orphan drug? Answer: A drug used to treat a rare
disease affecting fewer than 200,000 Americans
, ◉ How many orphan drugs have been approved since 1983?
Answer: over 300 (80 different diseases)
◉ Off-label prescribing Answer: The use of a drug to treat conditions
other than those that the drug was originally approved to treat
◉ gabapentin off label use Answer: chronic pain (normally
gabapentin is an anti-seizure medicine)
◉ fluoxetine (Prozac) off label use Answer: chronic pain (normally
an antidepressant)
◉ True or False: Off-label prescribing is prohibited by the FDA since
testing did not approve of a drug to be used for that purpose.
Answer: False, The FDA cannot dictate how physicians prescribe
medication
◉ Over the counter drugs (OTC) Answer: - can be purchased without
a prescription;
- In general, OTC drugs are used to treat minor problems and make
the consumer more comfortable until the condition is resolved
COMPREHENSIVE TEST 2026 COMPLETE
SOLUTIONS 100% CORRECT
◉ What is postmarketing surveillance? Answer: Phase 4 - which
includes all of the methods used to continue monitoring drug safety
and effectiveness after approval for public use.
- reports from health-care providers
- research about how drug is being used in clinical practice
- research comparing the drug to similar drugs on the market
◉ In what situations has the FDA made provisions to shorten the
development and review process for new drugs? Answer: For drugs
that treat life-threatening conditions (Cancer/AIDS) and if there is
not a better option.
◉ True or False: Out of thousands of compounds that enter
preclinical trials, only 1 will be released as a prescription drug for
use in humans Answer: True
◉ What is an orphan drug? Answer: A drug used to treat a rare
disease affecting fewer than 200,000 Americans
, ◉ How many orphan drugs have been approved since 1983?
Answer: over 300 (80 different diseases)
◉ Off-label prescribing Answer: The use of a drug to treat conditions
other than those that the drug was originally approved to treat
◉ gabapentin off label use Answer: chronic pain (normally
gabapentin is an anti-seizure medicine)
◉ fluoxetine (Prozac) off label use Answer: chronic pain (normally
an antidepressant)
◉ True or False: Off-label prescribing is prohibited by the FDA since
testing did not approve of a drug to be used for that purpose.
Answer: False, The FDA cannot dictate how physicians prescribe
medication
◉ Over the counter drugs (OTC) Answer: - can be purchased without
a prescription;
- In general, OTC drugs are used to treat minor problems and make
the consumer more comfortable until the condition is resolved
