TEST BANK Applied Pharmacology for the Dental Hygienist 9/E Elena Haveles
Q Q Q Q Q Q Q Q Q Q
Chapter 01: Information Sources, Regulatory Agencies, Drug Legislation, and
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Prescription Writing
Q Q
Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition
Q Q Q Q Q Q Q Q
MULTIPLE CHOICE Q
1. Knowledge of pharmacology aids the dental professional in Q Q Q Q Q Q Q
a. obtaining a patient’s healthphistory. Q Q Q
b. administering drugs in the office. Q Q Q Q
c. handling emergency situations. Q Q
d. selection of a nonprescription medication. Q Q Q Q
e. All of the above. Q Q Q
ANS: E Q
All of the choices are true. Because many of our patients are being treatedpwith drugs, knowledg
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
epof pharmacology helps in understanding and interpreting patients’ responses to health history
Q Q Q Q Q Q Q Q Q Q Q Q
questions. Knowledge of the therapeutic and adverse effects of medications obviously helps in t
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
heir proper administration in the office. Emergency situations may be caused by drugs or treated
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
by drugs; thus, knowledge of pharmacology is of great help, especially because a rapid respons
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
epis sometimes required. A clear understanding of thepconcepts of drug action, drug handling by
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
the body, and drug interactions will allow the dental practitioner to make proper judgments and
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
grasp the concepts relevant to new drug therapies on the market.
Q Q Q Q Q Q Q Q Q Q Q
DIF: Application
REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental Hygienist
Q Q Q Q Q Q Q Q Q Q Q
(Medication Administration), Role of the Dental Hygienist (Emergency Situations), Role of thepDental
Q Q Q Q Q Q Q Q Q Q Q Q
Hygienist (NonprescriptionpMedication) | pp. 2-3 OBJ:
Q Q Q Q Q Q
1 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q
2. Which of the followingpstatements is true regarding planning appointments?
Q Q Q Q Q Q Q Q
a. Whether or not patients are taking medication for systemic diseases is of little consequence
Q Q Q Q Q Q Q Q Q Q Q Q Q
Q in the dental office.
Q Q Q
b. Asthmatic patients should have dental appointments in the morning. Q Q Q Q Q Q Q Q
c. Diabetic patients usually havepfewer problems with a morning appointment compared withp
Q Q Q Q Q Q Q Q Q Q
afternoon appointments.
Q Q
d. Both B and C are true. Q Q Q Q Q
ANS: D Q
Asthmatic patients who experiencepdental anxiety should schedule their appointments when the
Q Q Q Q Q Q Q Q Q Q
y are not rushed or under pressurepearly in the morning. Diabetic patients usually have relatively
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
fewer problems with a morning appointment. Patients taking medication for systemic diseases
Q Q Q Q Q Q Q Q Q Q Q Q
may require special handling inpthe dental office.
Q Q Q Q Q Q Q
DIF: Comprehension
REF: Rolepof the Dental Hygienist (Appointment Scheduling) | p. 3 OBJ:
Q Q Q Q Q Q Q Q Q Q
1 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q Q
3. Nutritional or herbal supplements Q Q Q
a. carry the U.S. Foodpand Drug Administration (FDA) approval for disease states.
Q Q Q Q Q Q Q Q Q Q
, b. are not drugs. Q Q
c. can causepadverse effects.
Q Q
d. will not interact with other drugs the patient may be taking.
Q Q Q Q Q Q Q Q Q Q
ANS: C Q
Nutritional or herbal supplements are quite capable of causing adversepeffects. The majority of n
Q Q Q Q Q Q Q Q Q Q Q Q Q
utritional or herbal supplements do not carry FDA approval for treating disease states. These su
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
pplements are drugs and can cause adverse effects and interact with different drugs.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Comprehension
REF: Rolepof the Dental Hygienist (Nutritional or Herbal Supplements) | p. 3 OBJ:
Q Q Q Q Q Q Q Q Q Q Q Q
1 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q Q
4. Which type of drug name usually begins with a lowercase letter?
Q Q Q Q Q Q Q Q Q Q
a. Brand name Q
b. Code name Q
c. Generic name Q
d. Trade name Q
ANS: C Q
Before any drug is marketed, it is given a generic name that becomes the “official” name of the
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
drug. Each drug is assigned only one generic name selected by the U.S. Adopted Name Council,
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
and the name is not capitalized. The brand name is equivalent to the tradepname and is capitaliz
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ed. Although thepbrand name is technically the name of the company marketing the product, this
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
term is often used interchangeably with the tradepname. The code name is thepinitial term used
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
within a pharmaceutical company to refer to a drug while it is undergoing investigation andpis of
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ten a combination of capital letters and numbers, the letters representingpan abbreviation of thepc
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ompany name.
Q Q
DIF: Comprehension REF: Drug Names | p. 4 Q Q Q Q Q
OBJ:
Q 3 TOP: NBDHE, 6.0. Pharmacology Q Q Q
5. A drug’s generic name is selected by the
Q Q Q Q Q Q Q
a. pharmaceutical company manufacturing it. Q Q Q
b. Food and Drug Administrationp(FDA). Q Q Q
c. U.S. Adopted Name Council. Q Q Q
d. Federal Patent Office. Q Q
ANS: C Q
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by thepU.S.
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
Adopted Name Council. The generic name is not selected by the FDA or the Federal Patent Offi
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ce. The pharmaceutical company manufacturing the drugpclearly has an influence on the generic
Q Q Q Q Q Q Q Q Q Q Q Q Q
name given its drug, but the final decision is not the company’s.
Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Recall REF: Drug Names | p. 4 Q Q Q Q Q OBJ:
3 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q
6. Which of the following is true concerningpgeneric and trade names of drugs?
Q Q Q Q Q Q Q Q Q Q Q
a. A drug may only have one genericpname and one trade name.
Q Q Q Q Q Q Q Q Q Q
b. A drug may only have one genericpname, but it may havepseveral trade names.
Q Q Q Q Q Q Q Q Q Q Q Q
c. A drug may have several generic names, but it may only have one trade name.
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
d. A drug may have several generic names and several tradepnames.
Q Q Q Q Q Q Q Q Q
ANS: B Q
, Each drug has only one generic name but may have several trade names. For each drug, there is
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
only one generic name. It is not capitalized, and itpbecomes the “official” name of the drug. Thep
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
Qpharmaceutical company discoveringpthe drug gives the drug a trade name. The trade name is pr
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
otected by thepFederal PatentpLaw for 20 years from the earliest claimed filing date, plus patent t
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
erm extensions. Although the brand name is technically the name of the company marketing the
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
product, it is often used interchangeably with the trade name.
Q Q Q Q Q Q Q Q Q Q
DIF: Comprehension REF: Drug Names | p. 4 Q Q Q Q Q
OBJ:
Q 3 TOP: NBDHE, 6.0. Pharmacology Q Q Q
7. Two drugs that are found to be chemically equivalent, but not biologically equivalent or thera
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
peutically equivalent are said to differ in
Q Q Q Q Q Q Q
a. potency.
b. efficacy.
c. bioavailability.
d. therapeutic index. Q
ANS: C Q
A preparationpcan be chemically equivalent yet not biologically or therapeutically equivalent. T
Q Q Q Q Q Q Q Q Q Q Q
hesepproducts arepsaid to differ in their bioavailability. The potency of a drug is a function of the
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
amount of drug required to produce an effect. Thepefficacy is the maximum intensity of effectpor
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
response that can be produced by a drug. The therapeutic index is the ratio of the lethal dose for
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
50% of the experimental animals divided by the effective dose for 50% of the experimental ani
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
mals. If the value of the therapeutic index is small, toxicity is moreplikely.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Recall REF: Drug Names (Drug Substitution) | p. 5 OBJ: 4 TOP: N
Q Q Q Q Q Q Q Q Q Q Q Q Q
BDHE, 6.0. Pharmacology
Q Q Q
8. How many years must pass after a drug patent expires before other drug companies can marke
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
tpthe same compound as a generic drug?
Q Q Q Q Q Q Q
a. 20 years Q
b. 17 years Q
c. 7 years Q
d. 0 years Q
ANS: D Q
Once a drug patent expires, competingpcompanies may immediately market the same compound
Q Q Q Q Q Q Q Q Q Q Q
in generic form. The pharmaceutical company discovering the drug gives the drug a trade name
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
. The trade name is protected by the Federal Patent Law for 20 years from the earliest claimed fil
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
Qingpdate, plus the patent term extensions. Q Q Q Q Q
DIF: Application REF: Drug Names (Drug Substitution) | p. 5 OBJ: 4 TO
Q Q Q Q Q Q Q Q Q Q Q Q
P: NBDHE, 6.0. Pharmacology
Q Q Q Q
9. Two drugpformulations that produce similar concentrations in the blood and tissues after drug
Q Q Q Q Q Q Q Q Q Q Q Q
administrationpare termed
Q equivalent. Q Q
a. chemically
b. biologically
c. therapeutically
ANS: B Q
Biologic equivalence refers to identical pharmacokinetic parameters of two drugpformulations (
Q Q Q Q Q Q Q Q Q Q
bioequivalence, for short). Chemical equivalence indicates that two formulations of a drug meet
Q Q Q Q Q Q Q Q Q Q Q Q Q
, the chemical and physical standards established by the regulatory agencies. Therapeutic equiva
Q Q Q Q Q Q Q Q Q Q Q
lencepmeans that two formulations produce the same therapeutic effects over the same duration.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Application REF: Drug Names (Drug Substitution) | p. 5 OBJ: 4 TO
Q Q Q Q Q Q Q Q Q Q Q Q
P: NBDHE, 6.0. Pharmacology
Q Q Q Q
10. The federal body that determines whether a drug is considered a controlled substance and to w
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
hich schedule itpbelongs is the
Q Q Q Q Q
a. Food and Drug Administration (FDA). Q Q Q Q
b. Federal Trade Commission (FTC). Q Q Q
c. Drug Enforcement Administration (DEA). Q Q Q
d. U.S. Pharmacopeia (USP). Q Q
ANS: C Q
The DEA regulates thepmanufacture and distribution of substances with abuse potential.
Q Q Q Q Q Q Q Q Q Q
Hence prescriber DEA numbers must appear on prescriptions for controlled substances. The FD A
Q Q Q Q Q Q Q Q Q Q Q Q Q
does not have any special powers in regard to drugs of abuse. ThepFTC regulates commerce a nd
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
advertising claims of foods, over-the-
Q Q Q Q Q
counter (OTC) products, and cosmetics. The USP regulates the uniformity and purity of drugs.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Comprehension Q Q Q
REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) | p. 5 OBJ:
Q Q Q Q Q Q Q Q Q Q Q Q Q
5 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q Q
11. Which federal regulatory agency decides whichpdrugs require a prescription and which drugs
Q Q Q Q Q Q Q Q Q Q Q
may bepsold over-the-counter (OTC)?
Q Q Q Q
a. FDA
b. OSHA
c. FTC
d. DEA
ANS: A Q
The Food and DrugpAdministration (FDA) is part of Department of Human and Health Services
Q Q Q Q Q Q Q Q Q Q Q Q Q
(DHHS), and determines what drugs may be soldpby prescription andpOTC and regulates the lab
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
eling and advertising of prescription drugs. The Occupational Safety and Health Administration
Q Q Q Q Q Q Q Q Q Q Q Q
(OSHA) ensures the safety and health of workers in thepUnited States by setting and enforcing s
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
tandards. The Federal Trade Commission (FTC) regulates theptrade practices of drug companies
Q Q Q Q Q Q Q Q Q Q Q Q
and prohibits thepfalsepadvertising of foods, nonprescription (OTC) drugs, and cosmetics. Thep
Q Q Q Q Q Q Q Q Q Q Q
QDrug Enforcement Administrationp(DEA) is a part of the Department of Justice and regulates th
Q Q Q Q Q Q Q Q Q Q Q Q Q
epmanufacture and distribution of substances that have appotential for abuse, including opioids, s
Q Q Q Q Q Q Q Q Q Q Q Q Q
timulants, and sedatives.
Q Q Q
DIF: Recall
REF: Federal Regulations and Regulatory Agencies (US Food and DrugpAdministration) | p. 5
Q Q Q Q Q Q Q Q Q Q Q
OBJ:
Q 5 TOP: NBDHE, 6.0. Pharmacology Q Q Q
12.
Whichpfederal regulatory body regulates theptrade practices of drug companies and prohibits fal
Q Q Q Q Q Q Q Q Q Q Q
se advertisingpof foods, nonprescription drugs, and cosmetics?
Q Q Q Q Q Q Q
a. FDA
b. FTC
c. DEA
d. OBRA
Q Q Q Q Q Q Q Q Q Q
Chapter 01: Information Sources, Regulatory Agencies, Drug Legislation, and
Q Q Q Q Q Q Q Q
Prescription Writing
Q Q
Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition
Q Q Q Q Q Q Q Q
MULTIPLE CHOICE Q
1. Knowledge of pharmacology aids the dental professional in Q Q Q Q Q Q Q
a. obtaining a patient’s healthphistory. Q Q Q
b. administering drugs in the office. Q Q Q Q
c. handling emergency situations. Q Q
d. selection of a nonprescription medication. Q Q Q Q
e. All of the above. Q Q Q
ANS: E Q
All of the choices are true. Because many of our patients are being treatedpwith drugs, knowledg
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
epof pharmacology helps in understanding and interpreting patients’ responses to health history
Q Q Q Q Q Q Q Q Q Q Q Q
questions. Knowledge of the therapeutic and adverse effects of medications obviously helps in t
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
heir proper administration in the office. Emergency situations may be caused by drugs or treated
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
by drugs; thus, knowledge of pharmacology is of great help, especially because a rapid respons
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
epis sometimes required. A clear understanding of thepconcepts of drug action, drug handling by
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
the body, and drug interactions will allow the dental practitioner to make proper judgments and
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
grasp the concepts relevant to new drug therapies on the market.
Q Q Q Q Q Q Q Q Q Q Q
DIF: Application
REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental Hygienist
Q Q Q Q Q Q Q Q Q Q Q
(Medication Administration), Role of the Dental Hygienist (Emergency Situations), Role of thepDental
Q Q Q Q Q Q Q Q Q Q Q Q
Hygienist (NonprescriptionpMedication) | pp. 2-3 OBJ:
Q Q Q Q Q Q
1 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q
2. Which of the followingpstatements is true regarding planning appointments?
Q Q Q Q Q Q Q Q
a. Whether or not patients are taking medication for systemic diseases is of little consequence
Q Q Q Q Q Q Q Q Q Q Q Q Q
Q in the dental office.
Q Q Q
b. Asthmatic patients should have dental appointments in the morning. Q Q Q Q Q Q Q Q
c. Diabetic patients usually havepfewer problems with a morning appointment compared withp
Q Q Q Q Q Q Q Q Q Q
afternoon appointments.
Q Q
d. Both B and C are true. Q Q Q Q Q
ANS: D Q
Asthmatic patients who experiencepdental anxiety should schedule their appointments when the
Q Q Q Q Q Q Q Q Q Q
y are not rushed or under pressurepearly in the morning. Diabetic patients usually have relatively
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
fewer problems with a morning appointment. Patients taking medication for systemic diseases
Q Q Q Q Q Q Q Q Q Q Q Q
may require special handling inpthe dental office.
Q Q Q Q Q Q Q
DIF: Comprehension
REF: Rolepof the Dental Hygienist (Appointment Scheduling) | p. 3 OBJ:
Q Q Q Q Q Q Q Q Q Q
1 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q Q
3. Nutritional or herbal supplements Q Q Q
a. carry the U.S. Foodpand Drug Administration (FDA) approval for disease states.
Q Q Q Q Q Q Q Q Q Q
, b. are not drugs. Q Q
c. can causepadverse effects.
Q Q
d. will not interact with other drugs the patient may be taking.
Q Q Q Q Q Q Q Q Q Q
ANS: C Q
Nutritional or herbal supplements are quite capable of causing adversepeffects. The majority of n
Q Q Q Q Q Q Q Q Q Q Q Q Q
utritional or herbal supplements do not carry FDA approval for treating disease states. These su
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
pplements are drugs and can cause adverse effects and interact with different drugs.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Comprehension
REF: Rolepof the Dental Hygienist (Nutritional or Herbal Supplements) | p. 3 OBJ:
Q Q Q Q Q Q Q Q Q Q Q Q
1 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q Q
4. Which type of drug name usually begins with a lowercase letter?
Q Q Q Q Q Q Q Q Q Q
a. Brand name Q
b. Code name Q
c. Generic name Q
d. Trade name Q
ANS: C Q
Before any drug is marketed, it is given a generic name that becomes the “official” name of the
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
drug. Each drug is assigned only one generic name selected by the U.S. Adopted Name Council,
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
and the name is not capitalized. The brand name is equivalent to the tradepname and is capitaliz
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ed. Although thepbrand name is technically the name of the company marketing the product, this
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
term is often used interchangeably with the tradepname. The code name is thepinitial term used
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
within a pharmaceutical company to refer to a drug while it is undergoing investigation andpis of
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ten a combination of capital letters and numbers, the letters representingpan abbreviation of thepc
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ompany name.
Q Q
DIF: Comprehension REF: Drug Names | p. 4 Q Q Q Q Q
OBJ:
Q 3 TOP: NBDHE, 6.0. Pharmacology Q Q Q
5. A drug’s generic name is selected by the
Q Q Q Q Q Q Q
a. pharmaceutical company manufacturing it. Q Q Q
b. Food and Drug Administrationp(FDA). Q Q Q
c. U.S. Adopted Name Council. Q Q Q
d. Federal Patent Office. Q Q
ANS: C Q
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by thepU.S.
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
Adopted Name Council. The generic name is not selected by the FDA or the Federal Patent Offi
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
ce. The pharmaceutical company manufacturing the drugpclearly has an influence on the generic
Q Q Q Q Q Q Q Q Q Q Q Q Q
name given its drug, but the final decision is not the company’s.
Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Recall REF: Drug Names | p. 4 Q Q Q Q Q OBJ:
3 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q
6. Which of the following is true concerningpgeneric and trade names of drugs?
Q Q Q Q Q Q Q Q Q Q Q
a. A drug may only have one genericpname and one trade name.
Q Q Q Q Q Q Q Q Q Q
b. A drug may only have one genericpname, but it may havepseveral trade names.
Q Q Q Q Q Q Q Q Q Q Q Q
c. A drug may have several generic names, but it may only have one trade name.
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
d. A drug may have several generic names and several tradepnames.
Q Q Q Q Q Q Q Q Q
ANS: B Q
, Each drug has only one generic name but may have several trade names. For each drug, there is
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
only one generic name. It is not capitalized, and itpbecomes the “official” name of the drug. Thep
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
Qpharmaceutical company discoveringpthe drug gives the drug a trade name. The trade name is pr
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
otected by thepFederal PatentpLaw for 20 years from the earliest claimed filing date, plus patent t
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
erm extensions. Although the brand name is technically the name of the company marketing the
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
product, it is often used interchangeably with the trade name.
Q Q Q Q Q Q Q Q Q Q
DIF: Comprehension REF: Drug Names | p. 4 Q Q Q Q Q
OBJ:
Q 3 TOP: NBDHE, 6.0. Pharmacology Q Q Q
7. Two drugs that are found to be chemically equivalent, but not biologically equivalent or thera
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
peutically equivalent are said to differ in
Q Q Q Q Q Q Q
a. potency.
b. efficacy.
c. bioavailability.
d. therapeutic index. Q
ANS: C Q
A preparationpcan be chemically equivalent yet not biologically or therapeutically equivalent. T
Q Q Q Q Q Q Q Q Q Q Q
hesepproducts arepsaid to differ in their bioavailability. The potency of a drug is a function of the
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
amount of drug required to produce an effect. Thepefficacy is the maximum intensity of effectpor
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
response that can be produced by a drug. The therapeutic index is the ratio of the lethal dose for
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
50% of the experimental animals divided by the effective dose for 50% of the experimental ani
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
mals. If the value of the therapeutic index is small, toxicity is moreplikely.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Recall REF: Drug Names (Drug Substitution) | p. 5 OBJ: 4 TOP: N
Q Q Q Q Q Q Q Q Q Q Q Q Q
BDHE, 6.0. Pharmacology
Q Q Q
8. How many years must pass after a drug patent expires before other drug companies can marke
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
tpthe same compound as a generic drug?
Q Q Q Q Q Q Q
a. 20 years Q
b. 17 years Q
c. 7 years Q
d. 0 years Q
ANS: D Q
Once a drug patent expires, competingpcompanies may immediately market the same compound
Q Q Q Q Q Q Q Q Q Q Q
in generic form. The pharmaceutical company discovering the drug gives the drug a trade name
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
. The trade name is protected by the Federal Patent Law for 20 years from the earliest claimed fil
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
Qingpdate, plus the patent term extensions. Q Q Q Q Q
DIF: Application REF: Drug Names (Drug Substitution) | p. 5 OBJ: 4 TO
Q Q Q Q Q Q Q Q Q Q Q Q
P: NBDHE, 6.0. Pharmacology
Q Q Q Q
9. Two drugpformulations that produce similar concentrations in the blood and tissues after drug
Q Q Q Q Q Q Q Q Q Q Q Q
administrationpare termed
Q equivalent. Q Q
a. chemically
b. biologically
c. therapeutically
ANS: B Q
Biologic equivalence refers to identical pharmacokinetic parameters of two drugpformulations (
Q Q Q Q Q Q Q Q Q Q
bioequivalence, for short). Chemical equivalence indicates that two formulations of a drug meet
Q Q Q Q Q Q Q Q Q Q Q Q Q
, the chemical and physical standards established by the regulatory agencies. Therapeutic equiva
Q Q Q Q Q Q Q Q Q Q Q
lencepmeans that two formulations produce the same therapeutic effects over the same duration.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Application REF: Drug Names (Drug Substitution) | p. 5 OBJ: 4 TO
Q Q Q Q Q Q Q Q Q Q Q Q
P: NBDHE, 6.0. Pharmacology
Q Q Q Q
10. The federal body that determines whether a drug is considered a controlled substance and to w
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
hich schedule itpbelongs is the
Q Q Q Q Q
a. Food and Drug Administration (FDA). Q Q Q Q
b. Federal Trade Commission (FTC). Q Q Q
c. Drug Enforcement Administration (DEA). Q Q Q
d. U.S. Pharmacopeia (USP). Q Q
ANS: C Q
The DEA regulates thepmanufacture and distribution of substances with abuse potential.
Q Q Q Q Q Q Q Q Q Q
Hence prescriber DEA numbers must appear on prescriptions for controlled substances. The FD A
Q Q Q Q Q Q Q Q Q Q Q Q Q
does not have any special powers in regard to drugs of abuse. ThepFTC regulates commerce a nd
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
advertising claims of foods, over-the-
Q Q Q Q Q
counter (OTC) products, and cosmetics. The USP regulates the uniformity and purity of drugs.
Q Q Q Q Q Q Q Q Q Q Q Q Q
DIF: Comprehension Q Q Q
REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) | p. 5 OBJ:
Q Q Q Q Q Q Q Q Q Q Q Q Q
5 TOP: NBDHE, 6.0. Pharmacology
Q Q Q Q Q
11. Which federal regulatory agency decides whichpdrugs require a prescription and which drugs
Q Q Q Q Q Q Q Q Q Q Q
may bepsold over-the-counter (OTC)?
Q Q Q Q
a. FDA
b. OSHA
c. FTC
d. DEA
ANS: A Q
The Food and DrugpAdministration (FDA) is part of Department of Human and Health Services
Q Q Q Q Q Q Q Q Q Q Q Q Q
(DHHS), and determines what drugs may be soldpby prescription andpOTC and regulates the lab
Q Q Q Q Q Q Q Q Q Q Q Q Q Q
eling and advertising of prescription drugs. The Occupational Safety and Health Administration
Q Q Q Q Q Q Q Q Q Q Q Q
(OSHA) ensures the safety and health of workers in thepUnited States by setting and enforcing s
Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q
tandards. The Federal Trade Commission (FTC) regulates theptrade practices of drug companies
Q Q Q Q Q Q Q Q Q Q Q Q
and prohibits thepfalsepadvertising of foods, nonprescription (OTC) drugs, and cosmetics. Thep
Q Q Q Q Q Q Q Q Q Q Q
QDrug Enforcement Administrationp(DEA) is a part of the Department of Justice and regulates th
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epmanufacture and distribution of substances that have appotential for abuse, including opioids, s
Q Q Q Q Q Q Q Q Q Q Q Q Q
timulants, and sedatives.
Q Q Q
DIF: Recall
REF: Federal Regulations and Regulatory Agencies (US Food and DrugpAdministration) | p. 5
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OBJ:
Q 5 TOP: NBDHE, 6.0. Pharmacology Q Q Q
12.
Whichpfederal regulatory body regulates theptrade practices of drug companies and prohibits fal
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se advertisingpof foods, nonprescription drugs, and cosmetics?
Q Q Q Q Q Q Q
a. FDA
b. FTC
c. DEA
d. OBRA
