HSC 343 Pharmacology Exam 1
Study Questions with Verified
Answers
Pure Food and Drug Act - ANSWERSthe FDA may enforce standards of drug strength
and purity; prohibits mislabeling or adulteration; still use today, first drug law
Food, Drug and Cosmetic Act - ANSWERSrequired adequate testing of a compound to
prevent marketing of a possibly toxic substance; new drugs must be safe as well as
pure in order to be introduced into interstate commerce; this law still did not require
proof of effectiveness
Best Pharmaceuticals for Children Act - ANSWERSdrug studies in children; see how
existing drugs work in children and determine safety; set up pediatric drug trials; used
for pediatric conditions; ex. asthma and leukemia; allowed with parental consent
Food and Drug Administration Modernization Act - ANSWERSallows for fast-tracking of
serious illnesses to market; drug manufacturers must give patient 6 months' notice
before they discontinue making a drug; informs of "off label" uses (drugs intended for
one thing but used for another)
FDA Amendments Act - ANSWERSdrug safety legislation designated to monitor drugs
once they are on the market; except consumers to report back side effects
Kefauver-Harris Amendments - ANSWERSrequired proof of efficacy as well as safety
before any new drug could be placed in interstate commerce
Durham-Humphrey Act - ANSWERSseparated drugs into legend (prescription) and
nonlegend (nonprescription, over-the-counter) categories; rules for dispensing legend
drugs
Controlled Substances Act - ANSWERSestablished rehabilitation programs for drug
users; established control (registration) and enforcement (DEA); regulates export and
import of controlled substances
CS2 has a higher abuse potential than a CS3 - ANSWERSWhat does it mean if a drug
is CS2 versus CS3?
, ·high abuse potential and no accepted medical use in US; no prescription allowed -
ANSWERSWhat are the rules for a Schedule I drug?
·currently accepted medical use in US w/ high abuse potential resulting in severe
physical or psychological dependence
- Written prescription required with prescriber's actual (legal) signature
- Must be dated the same day as signed
- No refills allowed; typically, must be seen by the doctor again - ANSWERSWhat are
the rules for a Schedule II drug?
abuse potential less than Schedule II
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANSWERSWhat are the rules for a Schedule III drug?
abuse potential less than Schedule III
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANSWERSWhat are the rules for a Schedule IV drug?
lowest abuse potential
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANSWERSWhat are the rules for a Schedule V drug?
parenteral (IV, IM, SubQ) - ANSWERSmedication route not in the GI tract (injectables)
- most rapid-acting, fastest route
- avoid first-pass effect b/c it's being injected directly into the bloodstream
- may control and titrate dosage
- relatively large volumes
- complete absorption - ANSWERSWhat are the advantages to IV?
- requires skill for administration; riskiest route (cannot take drug out of system without
reversing agent but not every drug has one)
- requires water-soluble (oily drugs or drugs with stuff floating in it cannot be IV - can
cause clot or embolus) - ANSWERSWhat are the disadvantages to IV?
- easy as a caregiver (easier than IV)
- relatively rapid absorption
- suitable for suspensions and depot forms (doesn't need to be water-soluble; can be
oily or viscous) - ANSWERSWhat are the advantages to IM?
- can be painful, and even for days after
- must avoid injection into vessel
- rate of absorption dependent on blood flow at injection site (second fastest after IV) -
ANSWERSWhat are the disadvantages to IM?
Study Questions with Verified
Answers
Pure Food and Drug Act - ANSWERSthe FDA may enforce standards of drug strength
and purity; prohibits mislabeling or adulteration; still use today, first drug law
Food, Drug and Cosmetic Act - ANSWERSrequired adequate testing of a compound to
prevent marketing of a possibly toxic substance; new drugs must be safe as well as
pure in order to be introduced into interstate commerce; this law still did not require
proof of effectiveness
Best Pharmaceuticals for Children Act - ANSWERSdrug studies in children; see how
existing drugs work in children and determine safety; set up pediatric drug trials; used
for pediatric conditions; ex. asthma and leukemia; allowed with parental consent
Food and Drug Administration Modernization Act - ANSWERSallows for fast-tracking of
serious illnesses to market; drug manufacturers must give patient 6 months' notice
before they discontinue making a drug; informs of "off label" uses (drugs intended for
one thing but used for another)
FDA Amendments Act - ANSWERSdrug safety legislation designated to monitor drugs
once they are on the market; except consumers to report back side effects
Kefauver-Harris Amendments - ANSWERSrequired proof of efficacy as well as safety
before any new drug could be placed in interstate commerce
Durham-Humphrey Act - ANSWERSseparated drugs into legend (prescription) and
nonlegend (nonprescription, over-the-counter) categories; rules for dispensing legend
drugs
Controlled Substances Act - ANSWERSestablished rehabilitation programs for drug
users; established control (registration) and enforcement (DEA); regulates export and
import of controlled substances
CS2 has a higher abuse potential than a CS3 - ANSWERSWhat does it mean if a drug
is CS2 versus CS3?
, ·high abuse potential and no accepted medical use in US; no prescription allowed -
ANSWERSWhat are the rules for a Schedule I drug?
·currently accepted medical use in US w/ high abuse potential resulting in severe
physical or psychological dependence
- Written prescription required with prescriber's actual (legal) signature
- Must be dated the same day as signed
- No refills allowed; typically, must be seen by the doctor again - ANSWERSWhat are
the rules for a Schedule II drug?
abuse potential less than Schedule II
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANSWERSWhat are the rules for a Schedule III drug?
abuse potential less than Schedule III
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANSWERSWhat are the rules for a Schedule IV drug?
lowest abuse potential
- Written or verbal prescription allowed; valid from 6 months from the date written
- Limit 5 refills - ANSWERSWhat are the rules for a Schedule V drug?
parenteral (IV, IM, SubQ) - ANSWERSmedication route not in the GI tract (injectables)
- most rapid-acting, fastest route
- avoid first-pass effect b/c it's being injected directly into the bloodstream
- may control and titrate dosage
- relatively large volumes
- complete absorption - ANSWERSWhat are the advantages to IV?
- requires skill for administration; riskiest route (cannot take drug out of system without
reversing agent but not every drug has one)
- requires water-soluble (oily drugs or drugs with stuff floating in it cannot be IV - can
cause clot or embolus) - ANSWERSWhat are the disadvantages to IV?
- easy as a caregiver (easier than IV)
- relatively rapid absorption
- suitable for suspensions and depot forms (doesn't need to be water-soluble; can be
oily or viscous) - ANSWERSWhat are the advantages to IM?
- can be painful, and even for days after
- must avoid injection into vessel
- rate of absorption dependent on blood flow at injection site (second fastest after IV) -
ANSWERSWhat are the disadvantages to IM?
