Chapter 01: Information Sources, Regulatory Agencies, Drug Legislation, and
xx xx xx xx xx xx xx xx xx
Prescription Writing xx
Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition
xx xx xx xx xx xx xx xx
MULTIPLE CHOICE xx
1. Knowledge of pharmacology aids the dental professional in
xx xx xx xx xx xx xx
a. obtaining a patient’s health history. xx xx xx xx
b. administering drugs in the office. xx xx xx xx
c. handling emergency situations. xx xx
d. selection of a nonprescription medication. xx xx xx xx
e. All of the above.xx xx xx
ANS: x x E
All of the choices are true. Because many of our patients are being treated with
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
drugs, knowledge of pharmacology helps in understanding and interpreting patients’
xx xx xx xx xx xx xx xx xx xx
responses to health history questions. Knowledge of the therapeutic and adverse effects
xx xx xx xx xx xx xx xx xx xx xx
of medications obviously helps in their proper administration in the office. Emergency
xx xx xx xx xx xx xx xx xx xx xx xx
situations may be caused by drugs or treated by drugs; thus, knowledge of
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
pharmacology is of great help, especially because a rapid response is sometimes
xx xx xx xx xx xx xx xx xx xx xx xx
required. A clear understanding of the concepts of drug action, drug handling by the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
body, and drug interactions will allow the dental practitioner to make proper judgments
xx xx xx xx xx xx xx xx xx xx xx xx xx
and grasp the concepts relevant to new drug therapies on the market.
xx xx xx xx xx xx xx xx xx xx xx
DIF: Application
REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental
x x xx xx xx xx xx xx xx xx xx xx xx
Hygienist (Medication Administration), Role of the Dental Hygienist (Emergency Situations),
xx xx xx xx xx xx xx xx xx xx
Role of the Dental Hygienist (Nonprescription Medication) | pp. 2-3
xx xx xx OBJ: xx 1 xx xx xx xx xx x x
TOP: NBDHE, 6.0. Pharmacology
x x xx xx
2. Which of the following statements is true regarding planning appointments?
xx xx xx xx xx xx xx xx xx
a. Whether or not patients are taking medication for systemic diseases is of
xx xx xx xx xx xx xx xx xx xx xx
little consequence in the dental office.
xx xx xx xx xx xx
b. Asthmatic patients should have dental appointments in the morning.
xx xx xx xx xx xx xx xx
c. Diabetic patients usually have fewer problems with a morning
xx xx xx xx xx xx xx xx xx
appointment compared with afternoon appointments. xx xx xx xx
d. Both B and C are true. xx xx xx xx xx
ANS: x x D
, Asthmatic patients who experience dental anxiety should schedule their appointments
xx xx xx xx xx xx xx xx xx xx
when they are not rushed or under pressure early in the morning. Diabetic patients
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
usually have relatively fewer problems with a morning appointment. Patients taking
xx xx xx xx xx xx xx xx xx xx xx
medication for systemic diseases may require special handling in the dental office.
xx xx xx xx xx xx xx xx xx xx xx
DIF: Comprehension
REF: Role of the Dental Hygienist (Appointment
x x xx xx xx xx xx xx
Scheduling) | p. 3 OBJ: 1 TOP: NBDHE, 6.0.
xx xx xx xx x x x x xx xx
Pharmacology
3. Nutritional or herbal supplements xx xx xx
a. carry the U.S. Food and Drug Administration (FDA) approval for disease states.
xx xx xx xx xx xx xx xx xx xx xx
b. are not drugs. xx xx
c. can cause adverse effects.
xx xx xx
d. will not interact with other drugs the patient may be taking.
xx xx xx xx xx xx xx xx xx xx
ANS: x x C
Nutritional or herbal supplements are quite capable of causing adverse effects. The
xx xx xx xx xx xx xx xx xx xx xx xx
majority of nutritional or herbal supplements do not carry FDA approval for treating
xx xx xx xx xx xx xx xx xx xx xx xx xx
disease states. These supplements are drugs and can cause adverse effects and interact
xx xx xx xx xx xx xx xx xx xx xx xx xx
with different drugs.
xx xx
DIF: Comprehension
REF: Role of the Dental Hygienist (Nutritional or Herbal
x x xx xx xx xx xx xx xx xx
Supplements) | p. 3 OBJ: 1 TOP: NBDHE, 6.0. xx xx xx xx x x x x xx xx
Pharmacology
4. Which type of drug name usually begins with a lowercase letter?
xx xx xx xx xx xx xx xx xx xx
a. Brand name xx
b. Code name xx
c. Generic name xx
d. Trade name xx
ANS: x x C
Before any drug is marketed, it is given a generic name that becomes the “official”
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
name of the drug. Each drug is assigned only one generic name selected by the U.S.
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
Adopted Name Council, and the name is not capitalized. The brand name is
xx xx xx xx xx xx xx xx xx xx xx xx xx
equivalent to the trade name and is capitalized. Although the brand name is technically
xx xx xx xx xx xx xx xx xx xx xx xx xx
the name of the company marketing the product, this term is often used
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
interchangeably with the trade name. The code name is the initial term used within a
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
pharmaceutical company to refer to a drug while it is undergoing investigation and is
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
often a combination of capital letters and numbers, the letters representing an
xx xx xx xx xx xx xx xx xx xx xx xx xx
abbreviation of the company name. xx xx xx xx
DIF: Comprehension REF: Drug Names | x x xx xx
p. 4 OBJ:
xx xx3 xxTOP: x x x x NBDHE, 6.0. Pharmacology xx xx
5. A drug’s generic name is selected by the
xx xx xx xx xx xx xx
, a. pharmaceutical company manufacturing it. xx xx xx
b. Food and Drug Administration (FDA).
xx xx xx xx
c. U.S. Adopted Name Council.
xx xx xx
d. Federal Patent Office. xx xx
ANS: x x C
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
U.S. Adopted Name Council. The generic name is not selected by the FDA or the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
Federal Patent Office. The pharmaceutical company manufacturing the drug clearly has
xx xx xx xx xx xx xx xx xx xx xx
an influence on the generic name given its drug, but the final decision is not the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
company’s.
DIF: Recall REF: Drug Names | p. 4 x x xx xx xx xx OBJ:
x x3 TOP: xx x x NBDHE, 6.0. Pharmacology xx xx
6. Which of xx xx the following is true concerning generic and trade names of drugs?
xx xx xx xx xx xx xx xx xx xx
a. A drug xx xxmay only have one generic name and one trade name.
xx xx xx xx xx xx xx xx xx
b. A drug xx xxmay only have one generic name, but it may have several trade names.
xx xx xx xx xx xx xx xx xx xx xx xx
c. A drug xx xxmay have several generic names, but it may only have one trade name.
xx xx xx xx xx xx xx xx xx xx xx xx
d. A drug xx xxmay have several generic names and several trade names.
xx xx xx xx xx xx xx xx
ANS: x x B
Each drug has only one generic name but may have several trade names. For each
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
drug, there is only one generic name. It is not capitalized, and it becomes the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
“official” name of the drug. The pharmaceutical company discovering the drug gives
xx xx xx xx xx xx xx xx xx xx xx xx
the drug a trade name. The trade name is protected by the Federal Patent Law for 20
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
years from the earliest claimed filing date, plus patent term extensions. Although the
xx xx xx xx xx xx xx xx xx xx xx xx xx
brand name is technically the name of the company marketing the product, it is often
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
used interchangeably with the trade name.
xx xx xx xx xx
DIF: Comprehension REF: Drug Names | x x xx xx
p. 4 OBJ:
xx 3
xx TOP:
xx x x x x NBDHE, 6.0. Pharmacology xx xx
7. Two drugs that are found to be chemically equivalent, but not biologically
xx xx xx xx xx xx xx xx xx xx xx xx
equivalent or therapeutically equivalent are said to differ in
xx xx xx xx xx xx xx xx
a. potency.
b. efficacy.
c. bioavailability.
d. therapeutic index. xx
ANS: x x C
A preparation can be chemically equivalent yet not biologically or therapeutically
xx xx xx xx xx xx xx xx xx xx xx
equivalent. These products are said to differ in their bioavailability. The potency of a
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
drug is a function of the amount of drug required to produce an effect. The efficacy
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
is the maximum intensity of effect or response that can be produced by a drug. The
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
therapeutic index is the ratio of the lethal dose for 50% of the experimental animals
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
divided by the effective dose for 50% of the experimental animals. If the value of
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
the therapeutic index is small, toxicity is more likely.
xx xx xx xx xx xx xx xx
, DIF: Recall REF: x x Drug Names (Drug Substitution)
xx xx xx
| p. 5 OBJ:
xx xx xx xx x x 4 TOP: x x NBDHE, 6.0. Pharmacology xx xx
8. How many years must pass after a drug patent expires before other drug
xx xx xx xx xx xx xx xx xx xx xx xx xx
companies can market the same compound as a generic drug?
xx xx xx xx xx xx xx xx xx
a. 20 years xx
b. 17 years xx
c. 7 years xx
d. 0 years xx
ANS: x x D
Once a drug patent expires, competing companies may immediately market the same
xx xx xx xx xx xx xx xx xx xx xx xx
compound in generic form. The pharmaceutical company discovering the drug gives the
xx xx xx xx xx xx xx xx xx xx xx
drug a trade name. The trade name is protected by the Federal Patent Law for 20
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
years from the earliest claimed filing date, plus the patent term extensions.
xx xx xx xx xx xx xx xx xx xx xx
DIF: Application REF: x x Drug Names (Drug Substitution)
xx xx xx
| p. 5 OBJ:
xx xx xx 4 xx x x TOP: x x NBDHE, 6.0. Pharmacology xx xx
9. Two drug formulations that produce similar concentrations in the blood and tissues
xx xx xx xx xx xx xx xx xx xx xx xx
after drug administration are termed
xx xx xx xx xx equivalent.
a. chemically
b. biologically
c. therapeutically
ANS: x x B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug
xx xx xx xx xx xx xx xx xx xx
formulations (bioequivalence, for short). Chemical equivalence indicates that two
xx xx xx xx xx xx xx xx xx
formulations of a drug meet the chemical and physical standards established by the
xx xx xx xx xx xx xx xx xx xx xx xx xx
regulatory agencies. Therapeutic equivalence means that two formulations produce the
xx xx xx xx xx xx xx xx xx xx
same therapeutic effects over the same duration.
xx xx xx xx xx xx
DIF: Application REF: x x Drug Names (Drug Substitution)
xx xx xx
| p. 5 OBJ:
xx xx xx 4 xx x x TOP: x x NBDHE, 6.0. Pharmacology xx xx
10. The federal body that determines whether a drug is considered a controlled substance
xx xx xx xx xx xx xx xx xx xx xx xx xx
and to which schedule it belongs is the
xx xx xx xx xx xx xx
a. Food and Drug Administration (FDA).
xx xx xx xx
b. Federal Trade Commission (FTC). xx xx xx
c. Drug Enforcement Administration (DEA).
xx xx xx
d. U.S. Pharmacopeia (USP). xx xx
ANS: x x C
The DEA regulates the manufacture and distribution of substances with abuse
xx xx xx xx xx xx xx xx xx xx xx
potential. Hence prescriber DEA numbers must appear on prescriptions for controlled
xx xx xx xx xx xx xx xx xx xx xx
substances. The FDA does not have any special powers in regard to drugs of abuse.
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
The FTC regulates commerce and advertising claims of foods, over-the-counter (OTC)
xx xx xx xx xx xx xx xx xx xx xx
products, and cosmetics. The USP regulates the uniformity and purity of drugs.
xx xx xx xx xx xx xx xx xx xx xx
xx xx xx xx xx xx xx xx xx
Prescription Writing xx
Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition
xx xx xx xx xx xx xx xx
MULTIPLE CHOICE xx
1. Knowledge of pharmacology aids the dental professional in
xx xx xx xx xx xx xx
a. obtaining a patient’s health history. xx xx xx xx
b. administering drugs in the office. xx xx xx xx
c. handling emergency situations. xx xx
d. selection of a nonprescription medication. xx xx xx xx
e. All of the above.xx xx xx
ANS: x x E
All of the choices are true. Because many of our patients are being treated with
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
drugs, knowledge of pharmacology helps in understanding and interpreting patients’
xx xx xx xx xx xx xx xx xx xx
responses to health history questions. Knowledge of the therapeutic and adverse effects
xx xx xx xx xx xx xx xx xx xx xx
of medications obviously helps in their proper administration in the office. Emergency
xx xx xx xx xx xx xx xx xx xx xx xx
situations may be caused by drugs or treated by drugs; thus, knowledge of
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
pharmacology is of great help, especially because a rapid response is sometimes
xx xx xx xx xx xx xx xx xx xx xx xx
required. A clear understanding of the concepts of drug action, drug handling by the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
body, and drug interactions will allow the dental practitioner to make proper judgments
xx xx xx xx xx xx xx xx xx xx xx xx xx
and grasp the concepts relevant to new drug therapies on the market.
xx xx xx xx xx xx xx xx xx xx xx
DIF: Application
REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental
x x xx xx xx xx xx xx xx xx xx xx xx
Hygienist (Medication Administration), Role of the Dental Hygienist (Emergency Situations),
xx xx xx xx xx xx xx xx xx xx
Role of the Dental Hygienist (Nonprescription Medication) | pp. 2-3
xx xx xx OBJ: xx 1 xx xx xx xx xx x x
TOP: NBDHE, 6.0. Pharmacology
x x xx xx
2. Which of the following statements is true regarding planning appointments?
xx xx xx xx xx xx xx xx xx
a. Whether or not patients are taking medication for systemic diseases is of
xx xx xx xx xx xx xx xx xx xx xx
little consequence in the dental office.
xx xx xx xx xx xx
b. Asthmatic patients should have dental appointments in the morning.
xx xx xx xx xx xx xx xx
c. Diabetic patients usually have fewer problems with a morning
xx xx xx xx xx xx xx xx xx
appointment compared with afternoon appointments. xx xx xx xx
d. Both B and C are true. xx xx xx xx xx
ANS: x x D
, Asthmatic patients who experience dental anxiety should schedule their appointments
xx xx xx xx xx xx xx xx xx xx
when they are not rushed or under pressure early in the morning. Diabetic patients
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
usually have relatively fewer problems with a morning appointment. Patients taking
xx xx xx xx xx xx xx xx xx xx xx
medication for systemic diseases may require special handling in the dental office.
xx xx xx xx xx xx xx xx xx xx xx
DIF: Comprehension
REF: Role of the Dental Hygienist (Appointment
x x xx xx xx xx xx xx
Scheduling) | p. 3 OBJ: 1 TOP: NBDHE, 6.0.
xx xx xx xx x x x x xx xx
Pharmacology
3. Nutritional or herbal supplements xx xx xx
a. carry the U.S. Food and Drug Administration (FDA) approval for disease states.
xx xx xx xx xx xx xx xx xx xx xx
b. are not drugs. xx xx
c. can cause adverse effects.
xx xx xx
d. will not interact with other drugs the patient may be taking.
xx xx xx xx xx xx xx xx xx xx
ANS: x x C
Nutritional or herbal supplements are quite capable of causing adverse effects. The
xx xx xx xx xx xx xx xx xx xx xx xx
majority of nutritional or herbal supplements do not carry FDA approval for treating
xx xx xx xx xx xx xx xx xx xx xx xx xx
disease states. These supplements are drugs and can cause adverse effects and interact
xx xx xx xx xx xx xx xx xx xx xx xx xx
with different drugs.
xx xx
DIF: Comprehension
REF: Role of the Dental Hygienist (Nutritional or Herbal
x x xx xx xx xx xx xx xx xx
Supplements) | p. 3 OBJ: 1 TOP: NBDHE, 6.0. xx xx xx xx x x x x xx xx
Pharmacology
4. Which type of drug name usually begins with a lowercase letter?
xx xx xx xx xx xx xx xx xx xx
a. Brand name xx
b. Code name xx
c. Generic name xx
d. Trade name xx
ANS: x x C
Before any drug is marketed, it is given a generic name that becomes the “official”
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
name of the drug. Each drug is assigned only one generic name selected by the U.S.
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
Adopted Name Council, and the name is not capitalized. The brand name is
xx xx xx xx xx xx xx xx xx xx xx xx xx
equivalent to the trade name and is capitalized. Although the brand name is technically
xx xx xx xx xx xx xx xx xx xx xx xx xx
the name of the company marketing the product, this term is often used
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
interchangeably with the trade name. The code name is the initial term used within a
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
pharmaceutical company to refer to a drug while it is undergoing investigation and is
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
often a combination of capital letters and numbers, the letters representing an
xx xx xx xx xx xx xx xx xx xx xx xx xx
abbreviation of the company name. xx xx xx xx
DIF: Comprehension REF: Drug Names | x x xx xx
p. 4 OBJ:
xx xx3 xxTOP: x x x x NBDHE, 6.0. Pharmacology xx xx
5. A drug’s generic name is selected by the
xx xx xx xx xx xx xx
, a. pharmaceutical company manufacturing it. xx xx xx
b. Food and Drug Administration (FDA).
xx xx xx xx
c. U.S. Adopted Name Council.
xx xx xx
d. Federal Patent Office. xx xx
ANS: x x C
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
U.S. Adopted Name Council. The generic name is not selected by the FDA or the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
Federal Patent Office. The pharmaceutical company manufacturing the drug clearly has
xx xx xx xx xx xx xx xx xx xx xx
an influence on the generic name given its drug, but the final decision is not the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
company’s.
DIF: Recall REF: Drug Names | p. 4 x x xx xx xx xx OBJ:
x x3 TOP: xx x x NBDHE, 6.0. Pharmacology xx xx
6. Which of xx xx the following is true concerning generic and trade names of drugs?
xx xx xx xx xx xx xx xx xx xx
a. A drug xx xxmay only have one generic name and one trade name.
xx xx xx xx xx xx xx xx xx
b. A drug xx xxmay only have one generic name, but it may have several trade names.
xx xx xx xx xx xx xx xx xx xx xx xx
c. A drug xx xxmay have several generic names, but it may only have one trade name.
xx xx xx xx xx xx xx xx xx xx xx xx
d. A drug xx xxmay have several generic names and several trade names.
xx xx xx xx xx xx xx xx
ANS: x x B
Each drug has only one generic name but may have several trade names. For each
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
drug, there is only one generic name. It is not capitalized, and it becomes the
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
“official” name of the drug. The pharmaceutical company discovering the drug gives
xx xx xx xx xx xx xx xx xx xx xx xx
the drug a trade name. The trade name is protected by the Federal Patent Law for 20
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
years from the earliest claimed filing date, plus patent term extensions. Although the
xx xx xx xx xx xx xx xx xx xx xx xx xx
brand name is technically the name of the company marketing the product, it is often
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
used interchangeably with the trade name.
xx xx xx xx xx
DIF: Comprehension REF: Drug Names | x x xx xx
p. 4 OBJ:
xx 3
xx TOP:
xx x x x x NBDHE, 6.0. Pharmacology xx xx
7. Two drugs that are found to be chemically equivalent, but not biologically
xx xx xx xx xx xx xx xx xx xx xx xx
equivalent or therapeutically equivalent are said to differ in
xx xx xx xx xx xx xx xx
a. potency.
b. efficacy.
c. bioavailability.
d. therapeutic index. xx
ANS: x x C
A preparation can be chemically equivalent yet not biologically or therapeutically
xx xx xx xx xx xx xx xx xx xx xx
equivalent. These products are said to differ in their bioavailability. The potency of a
xx xx xx xx xx xx xx xx xx xx xx xx xx xx
drug is a function of the amount of drug required to produce an effect. The efficacy
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
is the maximum intensity of effect or response that can be produced by a drug. The
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
therapeutic index is the ratio of the lethal dose for 50% of the experimental animals
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
divided by the effective dose for 50% of the experimental animals. If the value of
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
the therapeutic index is small, toxicity is more likely.
xx xx xx xx xx xx xx xx
, DIF: Recall REF: x x Drug Names (Drug Substitution)
xx xx xx
| p. 5 OBJ:
xx xx xx xx x x 4 TOP: x x NBDHE, 6.0. Pharmacology xx xx
8. How many years must pass after a drug patent expires before other drug
xx xx xx xx xx xx xx xx xx xx xx xx xx
companies can market the same compound as a generic drug?
xx xx xx xx xx xx xx xx xx
a. 20 years xx
b. 17 years xx
c. 7 years xx
d. 0 years xx
ANS: x x D
Once a drug patent expires, competing companies may immediately market the same
xx xx xx xx xx xx xx xx xx xx xx xx
compound in generic form. The pharmaceutical company discovering the drug gives the
xx xx xx xx xx xx xx xx xx xx xx
drug a trade name. The trade name is protected by the Federal Patent Law for 20
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
years from the earliest claimed filing date, plus the patent term extensions.
xx xx xx xx xx xx xx xx xx xx xx
DIF: Application REF: x x Drug Names (Drug Substitution)
xx xx xx
| p. 5 OBJ:
xx xx xx 4 xx x x TOP: x x NBDHE, 6.0. Pharmacology xx xx
9. Two drug formulations that produce similar concentrations in the blood and tissues
xx xx xx xx xx xx xx xx xx xx xx xx
after drug administration are termed
xx xx xx xx xx equivalent.
a. chemically
b. biologically
c. therapeutically
ANS: x x B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug
xx xx xx xx xx xx xx xx xx xx
formulations (bioequivalence, for short). Chemical equivalence indicates that two
xx xx xx xx xx xx xx xx xx
formulations of a drug meet the chemical and physical standards established by the
xx xx xx xx xx xx xx xx xx xx xx xx xx
regulatory agencies. Therapeutic equivalence means that two formulations produce the
xx xx xx xx xx xx xx xx xx xx
same therapeutic effects over the same duration.
xx xx xx xx xx xx
DIF: Application REF: x x Drug Names (Drug Substitution)
xx xx xx
| p. 5 OBJ:
xx xx xx 4 xx x x TOP: x x NBDHE, 6.0. Pharmacology xx xx
10. The federal body that determines whether a drug is considered a controlled substance
xx xx xx xx xx xx xx xx xx xx xx xx xx
and to which schedule it belongs is the
xx xx xx xx xx xx xx
a. Food and Drug Administration (FDA).
xx xx xx xx
b. Federal Trade Commission (FTC). xx xx xx
c. Drug Enforcement Administration (DEA).
xx xx xx
d. U.S. Pharmacopeia (USP). xx xx
ANS: x x C
The DEA regulates the manufacture and distribution of substances with abuse
xx xx xx xx xx xx xx xx xx xx xx
potential. Hence prescriber DEA numbers must appear on prescriptions for controlled
xx xx xx xx xx xx xx xx xx xx xx
substances. The FDA does not have any special powers in regard to drugs of abuse.
xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx
The FTC regulates commerce and advertising claims of foods, over-the-counter (OTC)
xx xx xx xx xx xx xx xx xx xx xx
products, and cosmetics. The USP regulates the uniformity and purity of drugs.
xx xx xx xx xx xx xx xx xx xx xx
