NU 553
Comprehensive Resource To Help You Ace 2026-2027
Exams Includes Frequently Tested Questions With
ELABORATED 100% Correct COMPLETE SOLUTIONS
Guaranteed Pass First Attempt!! Current Update!!
1. Which reading level should medication education be in? - Correct
Answer: 5th-6th grade
2. Define active medication monitoring - Correct Answer: Provider
schedules follow-up exams to determine effectiveness of drug
3. Define passive medication monitoring - Correct Answer: Pt receives
med info and is told to contact provider if adverse effects or ineffective
treatment occurs
4. Define pharmacodynamics - Correct Answer: Study of what drugs do to
the body and how they do it
5. Define pharmacokinetics - Correct Answer: What the body does to the
drug (absorption, distribution, metabolism, excretion)
6. Define therapeutic index - Correct Answer: The ratio between the toxic
dose and the therapeutic dose of a drug, used as a measure of the relative
safety of the drug for a particular treatment.
,7. What does the FDA's medwatch program do? - Correct Answer: Collects
info on the safety of drugs
8. What do black box warnings do? - Correct Answer: Warn of drugs that
may cause serious injury or death
9. Why are infants at increased risk for adverse drug reactions? - Correct
Answer: Immature renal and liver function puts them at risk for toxicity
10.Why does the elderly population experience more drug ADRs? - Correct
Answer: Decreased liver and kidney function
11.Food and Drug Cosmetic Act of 1906 - Correct Answer: First federal law
to protect public by requiring drugs to meet official standards (labeling,
branding)
12.Food, Drug, and Cosmetic Act of 1938 - Correct Answer: Restrict drug
adulteration, mis-branding, and interstate commerce of unapproved drugs
13.Kefauver-Harris Amendment of 1962 - Correct Answer: Came about as a
result of thalidomide (100s of deformed babies in Europe); requires drug
manufacturers to ensure that the drug is SAFE in addition to effective
before marketing
14.Orphan Drug Act of 1983 - Correct Answer: Provided incentives for the
development of orphan drugs for treatment of rare diseases
,15.Drug Price Competition and Patent Term Restoration Act of 1984 -
Correct Answer: Allowed generic drug companies to market generics by
proving equivalence to brand
16.Pediatric Research Equity Act of 2003 - Correct Answer: Authorizes the
FDA to require research of pediatric uses for new drugs
17.What does the FDA control? - Correct Answer: Standardization of
nomenclature, approval process of new drugs/indications, official labeling,
surveillance of ADRs, methods of manufacturing/distribution, also medical
devices and equipment
18.What does an investigational new drug application do? - Correct
Answer: Must be completed prior to human testing/trials. Info on drug,
research plan. Testing can be done 30 days after submission to FDA.
19.Define the 3 phases of investigational new drug testing? - Correct
Answer: 1) First test in humans. Establishes tolerance/dose, therapeutic
level/effects, studies absorption, distribution, metabolism, excretion
2) Controlled studies on pts (<100) with target disease to determine
effectiveness and short-term risks
3) Controlled and uncontrolled trials in hospitals and outpt settings. See
effects/ADRs in larger group. How to administer best. If approved, this info
creates product label.
, 20.How do labels of OTC or Rx drugs differ? - Correct Answer: OTC:
directions can easily be written
Rx: directions or insert are intended for medical professional
21.Controlled Substances Act of 1970 - Correct Answer: a federal statute
that regulates the manufacture and distribution of controlled drugs by
providing a closed system for providers
22.National Provider Identifier (NPI) - Correct Answer: Unique 10-digit
code for providers which is used for prescriptions that are billed through
insurance and other services
23.What must a provider who regularly dispenses or administers controlled
substances maintain? - Correct Answer: At least 2 years of detailed
records of controlled drugs that are purchased, administered, distributed,
and dispensed
24.Define class I controlled substances - Correct Answer: No accepted
medical use. Illegal. Only for research.
25.Examples of class 1 controlled substances? - Correct Answer: Heroin,
LSD, mescaline, marijuana, peyote
26.Define class II controlled substances - Correct Answer: Electronic rx
permitted. No refills or telephone orders unless emergency. If tele order,
must follow up with written rx in 7 days
Comprehensive Resource To Help You Ace 2026-2027
Exams Includes Frequently Tested Questions With
ELABORATED 100% Correct COMPLETE SOLUTIONS
Guaranteed Pass First Attempt!! Current Update!!
1. Which reading level should medication education be in? - Correct
Answer: 5th-6th grade
2. Define active medication monitoring - Correct Answer: Provider
schedules follow-up exams to determine effectiveness of drug
3. Define passive medication monitoring - Correct Answer: Pt receives
med info and is told to contact provider if adverse effects or ineffective
treatment occurs
4. Define pharmacodynamics - Correct Answer: Study of what drugs do to
the body and how they do it
5. Define pharmacokinetics - Correct Answer: What the body does to the
drug (absorption, distribution, metabolism, excretion)
6. Define therapeutic index - Correct Answer: The ratio between the toxic
dose and the therapeutic dose of a drug, used as a measure of the relative
safety of the drug for a particular treatment.
,7. What does the FDA's medwatch program do? - Correct Answer: Collects
info on the safety of drugs
8. What do black box warnings do? - Correct Answer: Warn of drugs that
may cause serious injury or death
9. Why are infants at increased risk for adverse drug reactions? - Correct
Answer: Immature renal and liver function puts them at risk for toxicity
10.Why does the elderly population experience more drug ADRs? - Correct
Answer: Decreased liver and kidney function
11.Food and Drug Cosmetic Act of 1906 - Correct Answer: First federal law
to protect public by requiring drugs to meet official standards (labeling,
branding)
12.Food, Drug, and Cosmetic Act of 1938 - Correct Answer: Restrict drug
adulteration, mis-branding, and interstate commerce of unapproved drugs
13.Kefauver-Harris Amendment of 1962 - Correct Answer: Came about as a
result of thalidomide (100s of deformed babies in Europe); requires drug
manufacturers to ensure that the drug is SAFE in addition to effective
before marketing
14.Orphan Drug Act of 1983 - Correct Answer: Provided incentives for the
development of orphan drugs for treatment of rare diseases
,15.Drug Price Competition and Patent Term Restoration Act of 1984 -
Correct Answer: Allowed generic drug companies to market generics by
proving equivalence to brand
16.Pediatric Research Equity Act of 2003 - Correct Answer: Authorizes the
FDA to require research of pediatric uses for new drugs
17.What does the FDA control? - Correct Answer: Standardization of
nomenclature, approval process of new drugs/indications, official labeling,
surveillance of ADRs, methods of manufacturing/distribution, also medical
devices and equipment
18.What does an investigational new drug application do? - Correct
Answer: Must be completed prior to human testing/trials. Info on drug,
research plan. Testing can be done 30 days after submission to FDA.
19.Define the 3 phases of investigational new drug testing? - Correct
Answer: 1) First test in humans. Establishes tolerance/dose, therapeutic
level/effects, studies absorption, distribution, metabolism, excretion
2) Controlled studies on pts (<100) with target disease to determine
effectiveness and short-term risks
3) Controlled and uncontrolled trials in hospitals and outpt settings. See
effects/ADRs in larger group. How to administer best. If approved, this info
creates product label.
, 20.How do labels of OTC or Rx drugs differ? - Correct Answer: OTC:
directions can easily be written
Rx: directions or insert are intended for medical professional
21.Controlled Substances Act of 1970 - Correct Answer: a federal statute
that regulates the manufacture and distribution of controlled drugs by
providing a closed system for providers
22.National Provider Identifier (NPI) - Correct Answer: Unique 10-digit
code for providers which is used for prescriptions that are billed through
insurance and other services
23.What must a provider who regularly dispenses or administers controlled
substances maintain? - Correct Answer: At least 2 years of detailed
records of controlled drugs that are purchased, administered, distributed,
and dispensed
24.Define class I controlled substances - Correct Answer: No accepted
medical use. Illegal. Only for research.
25.Examples of class 1 controlled substances? - Correct Answer: Heroin,
LSD, mescaline, marijuana, peyote
26.Define class II controlled substances - Correct Answer: Electronic rx
permitted. No refills or telephone orders unless emergency. If tele order,
must follow up with written rx in 7 days
