,
,
,
,A 5-star review⭐⭐⭐⭐⭐would
mean the world to us!
It helps more students find our
resources and keeps our study
support going strong
Thanks in advance 😁😁
, 9. Two drug formulations that produce similar concentrations in the blood and tissues after drug
administration are termed _____ equivalent.
a. chemically
b. biologically
c. therapeutically
ANS: B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug formulations
(bioequivalence, for short). Chemical equivalence indicates that two formulations of a drug meet the
chemical and physical standards established by the regulatory agencies. Therapeutic equivalence
means that two formulations produce the same therapeutic effects over the same duration.
DIF: Application REF: Drug Names (Drug Substitution) | p. 5
OBJ: 4 TOP: NBDHE, 6.0. Pharmacology
10. The federal body that determines whether a drug is considered a controlled substance and to which
schedule it belongs is the
a. Food and Drug Administration (FDA).
b. Federal Trade Commission (FTC).
c. Drug Enforcement Administration (DEA).
d. U.S. Pharmacopeia (USP).
ANS: C
The DEA regulates the manufacture and distribution of substances with abuse potential. Hence
prescriber DEA numbers must appear on prescriptions for controlled substances. The FDA does not
have any special powers in regard to drugs of abuse. The FTC regulates commerce and advertising
claims of foods, over-the-counter (OTC) products, and cosmetics. The USP regulates the uniformity
and purity of drugs.
DIF: Comprehension
REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) | p. 5
OBJ: 5 TOP: NBDHE, 6.0. Pharmacology
11. Which federal regulatory agency decides which drugs require a prescription and which drugs may be
sold over-the-counter (OTC)?
a. FDA
b. OSHA
c. FTC
d. DEA
ANS: A
The Food and Drug Administration (FDA) is part of Department of Human and Health Services
(DHHS), and determines what drugs may be sold by prescription and OTC and regulates the labeling
and advertising of prescription drugs. The Occupational Safety and Health Administration (OSHA)
ensures the safety and health of workers in the United States by setting and enforcing standards. The
Federal Trade Commission (FTC) regulates the trade practices of drug companies and prohibits the
false advertising of foods, nonprescription (OTC) drugs, and cosmetics. The Drug Enforcement
Administration (DEA) is a part of the Department of Justice and regulates the manufacture and
distribution of substances that have a potential for abuse, including opioids, stimulants, and sedatives.
, DIF: Recall
REF: Federal Regulations and Regulatory Agencies (US Food and Drug Administration) | p. 5
OBJ: 5 TOP: NBDHE, 6.0. Pharmacology
12. Which federal regulatory body regulates the trade practices of drug companies and prohibits false
advertising of foods, nonprescription drugs, and cosmetics?
a. FDA
b. FTC
c. DEA
d. OBRA
ANS: B
Consumers who refer to care labels on their clothes, product warranties, or stickers showing the energy
costs of home appliances are using information required by the FTC. Businesses must be familiar with
the laws requiring truthful advertising and prohibiting price fixing. These laws are also administered
by the FTC. When the FTC was created in 1914, its purpose was to prevent unfair methods of
competition in commerce. Over the years, the U.S. Congress has passed additional laws giving the
agency greater authority to police anticompetitive practices. The FDA grants approval so that drugs
can be marketed in the United States. Before the FDA can approve a drug, the drug must be
determined to be both safe and effective. The DEA regulates the manufacture and distribution of
substances that have a potential for abuse. OBRA (Omnibus Budget Reconciliation Act) is not a
regulatory body; it is an act that mandates that pharmacists must provide patient counseling.
DIF: Recall
REF: Federal Regulations and Regulatory Agencies (Federal Trade Commission) | p. 5
OBJ: 5 TOP: NBDHE, 6.0. Pharmacology
13. An investigational new drug application (INDA) is submitted _____.
a. before preclinical trials
b. before phase 1 clinical trials
c. after phase 2 clinical trials
d. before phase 3 clinical trials
ANS: B
Preclinical testing usually lasts about 3 years. After the preclinical trials have been completed, an
INDA must be filed with the FDA before a drug company can commence phase 1 clinical trials.
Animal testing data must be accumulated from preclinical trials before filing an INDA. Phase 1 is the
first trial using patients, and phases 2 and 3 follow phase 1. An INDA must be filed before any testing
in humans can commence.
DIF: Recall REF: Clinical Evaluation of a New Drug | p. 5
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
14. Phase 1 clinical trials involve all of the following except which one?
a. Safe dose range
b. Toxic effects of the drug
c. Metabolism
d. Effectiveness
ANS: D
, In phase 1 clinical trials, small and then increasing doses are administered to a limited number of
healthy human volunteers, primarily to determine safety. This phase determines the biologic effects,
metabolism, safe dose range in humans, and toxic effects of the drug. The main purpose of phase 2 is
to test effectiveness. Biologic effects, metabolism, safe dose range in humans, and toxic effects of the
drug are, in fact, goals of phase 1 clinical trials.
DIF: Comprehension REF: Clinical Evaluation of a New Drug | p. 5
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
15. Which of the following is determined during a phase 3 clinical evaluation of a new drug?
a. Effectiveness
b. Safety and efficacy
c. Dosage
d. Both A and B
e. Both B and C
ANS: E
Both safety and efficacy must be demonstrated during phase 3 of the clinical evaluation of a new drug.
Dosage is also determined during this phase. During phase 3, clinical evaluation takes place involving
a large number of patients who have the condition for which the drug is indicated. The main purpose
of phase 2 clinical evaluation is to test a drug’s effectiveness.
DIF: Recall REF: Clinical Evaluation of a New Drug | p. 6
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
16. Which of the following is a Schedule II controlled substance?
a. Heroin
b. Propranolol
c. Amphetamine
d. Dextropropoxyphene (Darvon)
ANS: C
Amphetamine, oxycodone, morphine, and secobarbital are all schedule II controlled substances.
Heroin is a schedule I substance. Propranolol is a nonscheduled prescription drug.
Dextropropoxyphene is a schedule IV substance.
DIF: Recall
REF: Drug Legislation (Scheduled Drugs [Table 1.2: Schedules of Controlled Substances]) | p. 6
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
17. Controlled substances in schedule _____ require a written prescription with the provider’s signature
and do not permit refills.
a. II, III, and IV
b. II and III
c. III and IV
d. II only
e. III only
ANS: D
, Controlled substances in schedule II require a written prescription with the provider’s signature and do
not permit refills. Any prescription for schedule II drugs must be written in pen or indelible ink or
typed. A designee of the dentist, such as the dental hygienist, may write the prescription, but the
prescriber must personally sign the prescription in ink and is responsible for what any designee has
written. Prescriptions for controlled substances in both schedule III and schedule IV may be
telephoned, and no more than five prescriptions in 6 months are permitted.
DIF: Comprehension REF: Drug Legislation (Scheduled Drugs) | p. 6
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
18. Schedule III controlled substances may be telephoned to the pharmacist and may be refilled no more
than five times in 6 months.
a. Both parts of the statement are true.
b. Both parts of the statement are false.
c. The first part of the statement is true; the second part is false.
d. The first part of the statement is false; the second part is true.
ANS: A
Both parts of the statement are true. Schedule III controlled substances may be telephoned to the
pharmacist and may be refilled as many as five times in 6 months. Both parts of the statement are true
for schedule III and schedule IV controlled substances. Schedule I controlled substances have no
accepted medical use. Schedule II controlled substances require a written prescription with the
provider’s signature, and no refills are permitted. Schedule V controlled substances can be bought
OTC in some states.
DIF: Recall REF: Drug Legislation (Scheduled Drugs) | p. 6
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
19. What is the purpose of a “black box warning” on a package insert?
a. It is used to reconstruct the events leading to a fatality resulting from a medication
error.
b. It is issued by the Drug Enforcement Administration (DEA) to indicate
medications that may be used to manufacture illicit drugs such as
methamphetamine.
c. It is used to draw attention to potentially fatal, life threatening, or disabling adverse
effects for different medications.
d. It means that the effects of the drug have not yet been determined.
ANS: C
A black box warning is about a drug the FDA has required a manufacturer to prominently display in a
box in the package insert. The intent of the black box is to draw attention to the specific warning and
make sure that both the prescriber and patient understand the serious safety concerns associated with
that drug. A black box on an airplane is used to reconstruct events prior to a tragedy; however, the
black box warning on a medication package insert is used to warn about safety concerns with the drug.
A black box is not used as a warning about illicit use of medications. All drugs must go through
preclinical and clinical trials prior to being marketed.
DIF: Recall REF: Drug Legislation (Black Box Warning) | pp. 6-7
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
, 20. An “orphan drug” is
a. not related to any other medication currently available.
b. developed specifically to treat a rare medical condition.
c. a drug that has been on the market for longer than 20 years and generic substitution
is permitted.
d. no longer available for use as newer, more effective medications are available.
ANS: B
Rare medical conditions with orphan status refer to diseases that occur in fewer than 200,000 people in
the United States. Orphan drugs may be related to other medications. Orphan drug status is not related
to the time the drug has been available. Many newer drugs have been assigned orphan status.
DIF: Recall REF: Drug Legislation (Orphan Drugs) | p. 7
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
21. The word stat on a prescription means
a. before meals.
b. at bedtime.
c. immediately.
d. every.
ANS: C
The word stat on a prescription means immediately (now). The abbreviation ac means before meals, hs
means at bedtime, and q means every.
DIF: Recall REF: Table 1.3: Abbreviations Commonly Used in Prescriptions | p. 8
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
22. The abbreviation used on prescriptions for four times a day is
a. bid.
b. qid.
c. qd.
d. ud.
ANS: B
qid is the abbreviation for quarter in die, or four times a day. bid stands for twice a day, qd stands for
every day, and ud stands for as directed.
DIF: Recall
REF: Prescription Writing (Prescription Label Regulations [Table 1.3: Abbreviations Commonly Used in
Prescriptions]) | pp. 8-9 OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
23. The heading of a prescription contains the following information except the
a. name and address of the prescriber.
b. name and address of the patient.
c. telephone numbers of the patient and the prescriber.
d. date of birth of the prescriber.
e. date of the prescription.
ANS: D
,
,
,A 5-star review⭐⭐⭐⭐⭐would
mean the world to us!
It helps more students find our
resources and keeps our study
support going strong
Thanks in advance 😁😁
, 9. Two drug formulations that produce similar concentrations in the blood and tissues after drug
administration are termed _____ equivalent.
a. chemically
b. biologically
c. therapeutically
ANS: B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug formulations
(bioequivalence, for short). Chemical equivalence indicates that two formulations of a drug meet the
chemical and physical standards established by the regulatory agencies. Therapeutic equivalence
means that two formulations produce the same therapeutic effects over the same duration.
DIF: Application REF: Drug Names (Drug Substitution) | p. 5
OBJ: 4 TOP: NBDHE, 6.0. Pharmacology
10. The federal body that determines whether a drug is considered a controlled substance and to which
schedule it belongs is the
a. Food and Drug Administration (FDA).
b. Federal Trade Commission (FTC).
c. Drug Enforcement Administration (DEA).
d. U.S. Pharmacopeia (USP).
ANS: C
The DEA regulates the manufacture and distribution of substances with abuse potential. Hence
prescriber DEA numbers must appear on prescriptions for controlled substances. The FDA does not
have any special powers in regard to drugs of abuse. The FTC regulates commerce and advertising
claims of foods, over-the-counter (OTC) products, and cosmetics. The USP regulates the uniformity
and purity of drugs.
DIF: Comprehension
REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) | p. 5
OBJ: 5 TOP: NBDHE, 6.0. Pharmacology
11. Which federal regulatory agency decides which drugs require a prescription and which drugs may be
sold over-the-counter (OTC)?
a. FDA
b. OSHA
c. FTC
d. DEA
ANS: A
The Food and Drug Administration (FDA) is part of Department of Human and Health Services
(DHHS), and determines what drugs may be sold by prescription and OTC and regulates the labeling
and advertising of prescription drugs. The Occupational Safety and Health Administration (OSHA)
ensures the safety and health of workers in the United States by setting and enforcing standards. The
Federal Trade Commission (FTC) regulates the trade practices of drug companies and prohibits the
false advertising of foods, nonprescription (OTC) drugs, and cosmetics. The Drug Enforcement
Administration (DEA) is a part of the Department of Justice and regulates the manufacture and
distribution of substances that have a potential for abuse, including opioids, stimulants, and sedatives.
, DIF: Recall
REF: Federal Regulations and Regulatory Agencies (US Food and Drug Administration) | p. 5
OBJ: 5 TOP: NBDHE, 6.0. Pharmacology
12. Which federal regulatory body regulates the trade practices of drug companies and prohibits false
advertising of foods, nonprescription drugs, and cosmetics?
a. FDA
b. FTC
c. DEA
d. OBRA
ANS: B
Consumers who refer to care labels on their clothes, product warranties, or stickers showing the energy
costs of home appliances are using information required by the FTC. Businesses must be familiar with
the laws requiring truthful advertising and prohibiting price fixing. These laws are also administered
by the FTC. When the FTC was created in 1914, its purpose was to prevent unfair methods of
competition in commerce. Over the years, the U.S. Congress has passed additional laws giving the
agency greater authority to police anticompetitive practices. The FDA grants approval so that drugs
can be marketed in the United States. Before the FDA can approve a drug, the drug must be
determined to be both safe and effective. The DEA regulates the manufacture and distribution of
substances that have a potential for abuse. OBRA (Omnibus Budget Reconciliation Act) is not a
regulatory body; it is an act that mandates that pharmacists must provide patient counseling.
DIF: Recall
REF: Federal Regulations and Regulatory Agencies (Federal Trade Commission) | p. 5
OBJ: 5 TOP: NBDHE, 6.0. Pharmacology
13. An investigational new drug application (INDA) is submitted _____.
a. before preclinical trials
b. before phase 1 clinical trials
c. after phase 2 clinical trials
d. before phase 3 clinical trials
ANS: B
Preclinical testing usually lasts about 3 years. After the preclinical trials have been completed, an
INDA must be filed with the FDA before a drug company can commence phase 1 clinical trials.
Animal testing data must be accumulated from preclinical trials before filing an INDA. Phase 1 is the
first trial using patients, and phases 2 and 3 follow phase 1. An INDA must be filed before any testing
in humans can commence.
DIF: Recall REF: Clinical Evaluation of a New Drug | p. 5
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
14. Phase 1 clinical trials involve all of the following except which one?
a. Safe dose range
b. Toxic effects of the drug
c. Metabolism
d. Effectiveness
ANS: D
, In phase 1 clinical trials, small and then increasing doses are administered to a limited number of
healthy human volunteers, primarily to determine safety. This phase determines the biologic effects,
metabolism, safe dose range in humans, and toxic effects of the drug. The main purpose of phase 2 is
to test effectiveness. Biologic effects, metabolism, safe dose range in humans, and toxic effects of the
drug are, in fact, goals of phase 1 clinical trials.
DIF: Comprehension REF: Clinical Evaluation of a New Drug | p. 5
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
15. Which of the following is determined during a phase 3 clinical evaluation of a new drug?
a. Effectiveness
b. Safety and efficacy
c. Dosage
d. Both A and B
e. Both B and C
ANS: E
Both safety and efficacy must be demonstrated during phase 3 of the clinical evaluation of a new drug.
Dosage is also determined during this phase. During phase 3, clinical evaluation takes place involving
a large number of patients who have the condition for which the drug is indicated. The main purpose
of phase 2 clinical evaluation is to test a drug’s effectiveness.
DIF: Recall REF: Clinical Evaluation of a New Drug | p. 6
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
16. Which of the following is a Schedule II controlled substance?
a. Heroin
b. Propranolol
c. Amphetamine
d. Dextropropoxyphene (Darvon)
ANS: C
Amphetamine, oxycodone, morphine, and secobarbital are all schedule II controlled substances.
Heroin is a schedule I substance. Propranolol is a nonscheduled prescription drug.
Dextropropoxyphene is a schedule IV substance.
DIF: Recall
REF: Drug Legislation (Scheduled Drugs [Table 1.2: Schedules of Controlled Substances]) | p. 6
OBJ: 6 TOP: NBDHE, 6.0. Pharmacology
17. Controlled substances in schedule _____ require a written prescription with the provider’s signature
and do not permit refills.
a. II, III, and IV
b. II and III
c. III and IV
d. II only
e. III only
ANS: D
, Controlled substances in schedule II require a written prescription with the provider’s signature and do
not permit refills. Any prescription for schedule II drugs must be written in pen or indelible ink or
typed. A designee of the dentist, such as the dental hygienist, may write the prescription, but the
prescriber must personally sign the prescription in ink and is responsible for what any designee has
written. Prescriptions for controlled substances in both schedule III and schedule IV may be
telephoned, and no more than five prescriptions in 6 months are permitted.
DIF: Comprehension REF: Drug Legislation (Scheduled Drugs) | p. 6
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
18. Schedule III controlled substances may be telephoned to the pharmacist and may be refilled no more
than five times in 6 months.
a. Both parts of the statement are true.
b. Both parts of the statement are false.
c. The first part of the statement is true; the second part is false.
d. The first part of the statement is false; the second part is true.
ANS: A
Both parts of the statement are true. Schedule III controlled substances may be telephoned to the
pharmacist and may be refilled as many as five times in 6 months. Both parts of the statement are true
for schedule III and schedule IV controlled substances. Schedule I controlled substances have no
accepted medical use. Schedule II controlled substances require a written prescription with the
provider’s signature, and no refills are permitted. Schedule V controlled substances can be bought
OTC in some states.
DIF: Recall REF: Drug Legislation (Scheduled Drugs) | p. 6
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
19. What is the purpose of a “black box warning” on a package insert?
a. It is used to reconstruct the events leading to a fatality resulting from a medication
error.
b. It is issued by the Drug Enforcement Administration (DEA) to indicate
medications that may be used to manufacture illicit drugs such as
methamphetamine.
c. It is used to draw attention to potentially fatal, life threatening, or disabling adverse
effects for different medications.
d. It means that the effects of the drug have not yet been determined.
ANS: C
A black box warning is about a drug the FDA has required a manufacturer to prominently display in a
box in the package insert. The intent of the black box is to draw attention to the specific warning and
make sure that both the prescriber and patient understand the serious safety concerns associated with
that drug. A black box on an airplane is used to reconstruct events prior to a tragedy; however, the
black box warning on a medication package insert is used to warn about safety concerns with the drug.
A black box is not used as a warning about illicit use of medications. All drugs must go through
preclinical and clinical trials prior to being marketed.
DIF: Recall REF: Drug Legislation (Black Box Warning) | pp. 6-7
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
, 20. An “orphan drug” is
a. not related to any other medication currently available.
b. developed specifically to treat a rare medical condition.
c. a drug that has been on the market for longer than 20 years and generic substitution
is permitted.
d. no longer available for use as newer, more effective medications are available.
ANS: B
Rare medical conditions with orphan status refer to diseases that occur in fewer than 200,000 people in
the United States. Orphan drugs may be related to other medications. Orphan drug status is not related
to the time the drug has been available. Many newer drugs have been assigned orphan status.
DIF: Recall REF: Drug Legislation (Orphan Drugs) | p. 7
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
21. The word stat on a prescription means
a. before meals.
b. at bedtime.
c. immediately.
d. every.
ANS: C
The word stat on a prescription means immediately (now). The abbreviation ac means before meals, hs
means at bedtime, and q means every.
DIF: Recall REF: Table 1.3: Abbreviations Commonly Used in Prescriptions | p. 8
OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
22. The abbreviation used on prescriptions for four times a day is
a. bid.
b. qid.
c. qd.
d. ud.
ANS: B
qid is the abbreviation for quarter in die, or four times a day. bid stands for twice a day, qd stands for
every day, and ud stands for as directed.
DIF: Recall
REF: Prescription Writing (Prescription Label Regulations [Table 1.3: Abbreviations Commonly Used in
Prescriptions]) | pp. 8-9 OBJ: 7 TOP: NBDHE, 6.0. Pharmacology
23. The heading of a prescription contains the following information except the
a. name and address of the prescriber.
b. name and address of the patient.
c. telephone numbers of the patient and the prescriber.
d. date of birth of the prescriber.
e. date of the prescription.
ANS: D
