Chapter 01: Information Sources, Regulatory Agencies, Drug Legislation, and Prescription W
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
riting
Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition
7% 7% 7% 7% 7% 7% 7% 7%
MULTIPLE CHOICE 7%
1. Knowledge of pharmacology aids the dental professional in 7% 7% 7% 7% 7% 7% 7%
a. obtaining a patient’s health history. 7% 7% 7% 7%
b. administering drugs in the office. 7% 7% 7% 7%
c. handling emergency situations. 7% 7%
d. selection of a nonprescription medication. 7% 7% 7% 7%
e. All of the above. 7% 7% 7%
ANS: 7 % E
All of the choices are true. Because many of our patients are being treated with drugs, knowledge
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
of pharmacology helps in understanding and interpreting patients’ responses to health history questi
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ons. Knowledge of the therapeutic and adverse effects of medications obviously helps in their prop
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
er administration in the office. Emergency situations may be caused by drugs or treated by drugs; t
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
hus, knowledge of pharmacology is of great help, especially because a rapid response is sometimes
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
required. A clear understanding of the concepts of drug action, drug handling by the body, and dr
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ug interactions will allow the dental practitioner to make proper judgments and grasp the concepts
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
relevant to new drug therapies on the market.
7% 7% 7% 7% 7% 7% 7%
DIF: Application
REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental Hygienist (Medica
7 % 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
tion Administration), Role of the Dental Hygienist (Emergency Situations), Role of the Dental Hygienis
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
t (Nonprescription Medication) | pp. 2-3
7% OBJ: 1 7% 7% 7% 7%
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
2. Which of the following statements is true regarding planning appointments?
7% 7% 7% 7% 7% 7% 7% 7% 7%
a. Whether or not patients are taking medication for systemic diseases is of litt
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
le
consequence in the dental office. 7% 7% 7% 7%
b. Asthmatic patients should have dental appointments in the morning. 7% 7% 7% 7% 7% 7% 7% 7%
c. Diabetic patients usually have fewer problems with a morning appointment
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
compared with afternoon appointments. 7% 7% 7%
d. Both B and C are true. 7% 7% 7% 7% 7%
ANS: 7 % D
Asthmatic patients who experience dental anxiety should schedule their appointments when they ar
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e not rushed or under pressure early in the morning. Diabetic patients usually have relatively fewer
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
problems with a morning appointment. Patients taking medication for systemic diseases may requir
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e special handling in the dental office.
7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Role of the Dental Hygienist (Appointment Scheduling) |
7 % 7% 7% 7% 7% 7% 7% 7% 7%
p. 3 OBJ: 1
7% 7%TOP: NBDHE, 6.0. Pharmacology
7 % 7 % 7% 7%
,3. Nutritional or herbal supplements 7% 7% 7%
a. carry the U.S. Food and Drug Administration (FDA) approval for disease state
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
s.
b. are not drugs. 7% 7%
c. can cause adverse effects. 7% 7% 7%
d. will not interact with other drugs the patient may be taking.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ANS: 7 % C
Nutritional or herbal supplements are quite capable of causing adverse effects. The majority of nutriti
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
onal or herbal supplements do not carry FDA approval for treating disease states. These supplements
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
are drugs and can cause adverse effects and interact with different drugs.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Role of the Dental Hygienist (Nutritional or Herbal Supplements) |
7 % 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
p. 3 OBJ: 1
7% 7% TOP: NBDHE, 6.0. Pharmacology
7 % 7 % 7% 7%
4. Which type of drug name usually begins with a lowercase letter?
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
a. Brand name 7%
b. Code name 7%
c. Generic name 7%
d. Trade name 7%
ANS: 7 % C
Before any drug is marketed, it is given a generic name that becomes the “official” name of the dr
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ug. Each drug is assigned only one generic name selected by the U.S. Adopted Name Council, and
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
the name is not capitalized. The brand name is equivalent to the trade name and is capitalized. Alt
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
hough the brand name is technically the name of the company marketing the product, this term is o
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ften used interchangeably with the trade name. The code name is the initial term used within a pha
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
rmaceutical company to refer to a drug while it is undergoing investigation and is often a combinat
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ion of capital letters and numbers, the letters representing an abbreviation of the company name.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Drug Names | p. 4 OBJ: 3
7 % 7% 7% 7% 7% 7% 7 %
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
5. A 7% drug’s generic name is selected by the
7% 7% 7% 7% 7% 7%
a. pharmaceutical company manufacturing it. 7% 7% 7%
b. Food and Drug Administration (FDA).
7% 7% 7% 7%
c. U.S. Adopted Name Council.
7% 7% 7%
d. Federal Patent Office. 7% 7%
ANS: 7 % C
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by the U.S. Adopted
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
Name Council. The generic name is not selected by the FDA or the Federal Patent Office. The pha
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
rmaceutical company manufacturing the drug clearly has an influence on the generic name given its
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
drug, but the final decision is not the company’s.
7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Recall REF: Drug Names | p. 4 7 % 7% 7% 7% 7%
OBJ: 3 TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7 % 7% 7%
6. Which of the following is true concerning generic and trade names of drugs?
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
a. A drug may only have one generic name and one trade nam
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e.
, b. A drug may only have one generic name, but it may have several trade nam
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
es.
c. A drug may have several generic names, but it may only have one trade na
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
me.
d. A drug may have several generic names and several trade names.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ANS: 7 % B
Each drug has only one generic name but may have several trade names. For each drug, there is on
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ly one generic name. It is not capitalized, and it becomes the “official” name of the drug. The phar
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
maceutical company discovering the drug gives the drug a trade name. The trade name is protected
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%by the Federal Patent Law for 20 years from the earliest claimed filing date, plus patent term exten
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
sions. Although the brand name is technically the name of the company marketing the product, it is
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%often used interchangeably with the trade name.
7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Drug Names | p. 4 OBJ: 3
7 % 7% 7% 7% 7% 7% 7 %
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
7. Two drugs that are found to be chemically equivalent, but not biologically equivalent
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
or therapeutically equivalent are said to differ in
7% 7% 7% 7% 7% 7% 7%
a. potency.
b. efficacy.
c. bioavailability.
d. therapeutic index. 7%
ANS: 7 % C
A preparation can be chemically equivalent yet not biologically or therapeutically equivalent. Thes
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e products are said to differ in their bioavailability. The potency of a drug is a function of the amou
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
nt of drug required to produce an effect. The efficacy is the maximum intensity of effect or respon
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
se that can be produced by a drug. The therapeutic index is the ratio of the lethal dose for 50% of
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
the experimental animals divided by the effective dose for 50% of the experimental animals. If the
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%value of the therapeutic index is small, toxicity is more likely.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Recall
REF: Drug Names (Drug Substitution) | p. 5 OBJ:
7 % 7% 7% 7% 7% 7% 7% 7% 7 % 4
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
8. How many years must pass after a drug patent expires before other drug companies can market t
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
he same compound as a generic drug?
7% 7% 7% 7% 7% 7%
a. 20 years 7%
b. 17 years 7%
c. 7 years 7%
d. 0 years 7%
ANS: 7 % D
Once a drug patent expires, competing companies may immediately market the same compound in
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%generic form. The pharmaceutical company discovering the drug gives the drug a trade name. The
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%trade name is protected by the Federal Patent Law for 20 years from the earliest claimed filing date
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
, plus the patent term extensions.
7% 7% 7% 7% 7%
DIF: Application
REF: Drug Names (Drug Substitution) | p. 5 OBJ:
7 % 7% 7% 7% 7% 7% 7% 7% 7 % 4
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
, 9. Two drug formulations that produce similar concentrations in the blood and tissues after dr
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ug administration are termed
7% 7% 7% 7% equivalent.
a. chemically
b. biologically
c. therapeutically
ANS: 7 % B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug formulations (bioe
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
quivalence, for short). Chemical equivalence indicates that two formulations of a drug meet the che
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
mical and physical standards established by the regulatory agencies. Therapeutic equivalence mean
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
s that two formulations produce the same therapeutic effects over the same duration.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Application
REF: Drug Names (Drug Substitution) | p. 5 OBJ:
7 % 7% 7% 7% 7% 7% 7% 7% 7 % 4
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
10. The federal body that determines whether a drug is considered a controlled substance and to whi
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ch schedule it belongs is the
7% 7% 7% 7% 7%
a. Food and Drug Administration (FDA). 7% 7% 7% 7%
b. Federal Trade Commission (FTC). 7% 7% 7%
c. Drug Enforcement Administration (DEA). 7% 7% 7%
d. U.S. Pharmacopeia (USP). 7% 7%
ANS: 7 % C
The DEA regulates the manufacture and distribution of substances with abuse potential. Hence pre
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
scriber DEA numbers must appear on prescriptions for controlled substances. The FDA does not h
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ave any special powers in regard to drugs of abuse. The FTC regulates commerce and advertising
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
claims of foods, over-the- 7% 7% 7%
counter (OTC) products, and cosmetics. The USP regulates the uniformity and purity of drugs.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) |
7 % 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
p. 5 OBJ: 5
7% TOP: NBDHE, 6.0. Pharmacology
7% 7 % 7 % 7% 7%
11. Which federal regulatory agency decides which drugs require a prescription and which drugs may
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
be sold over-the-counter (OTC)?
7% 7% 7%
a. FDA
b. OSHA
c. FTC
d. DEA
ANS: 7 % A
The Food and Drug Administration (FDA) is part of Department of Human and Health Services (
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DHHS), and determines what drugs may be sold by prescription and OTC and regulates the labelin
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
g and advertising of prescription drugs. The Occupational Safety and Health Administration (OSH
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
A) ensures the safety and health of workers in the United States by setting and enforcing standards
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
. The Federal Trade Commission (FTC) regulates the trade practices of drug companies and prohib
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
its the false advertising of foods, nonprescription (OTC) drugs, and cosmetics. The Drug Enforcem
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ent Administration (DEA) is a part of the Department of Justice and regulates the manufacture and
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%distribution of substances that have a potential for abuse, including opioids, stimulants, and sedativ
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
es.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
riting
Haveles: Applied Pharmacology for the Dental Hygienist, 9th Edition
7% 7% 7% 7% 7% 7% 7% 7%
MULTIPLE CHOICE 7%
1. Knowledge of pharmacology aids the dental professional in 7% 7% 7% 7% 7% 7% 7%
a. obtaining a patient’s health history. 7% 7% 7% 7%
b. administering drugs in the office. 7% 7% 7% 7%
c. handling emergency situations. 7% 7%
d. selection of a nonprescription medication. 7% 7% 7% 7%
e. All of the above. 7% 7% 7%
ANS: 7 % E
All of the choices are true. Because many of our patients are being treated with drugs, knowledge
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
of pharmacology helps in understanding and interpreting patients’ responses to health history questi
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ons. Knowledge of the therapeutic and adverse effects of medications obviously helps in their prop
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
er administration in the office. Emergency situations may be caused by drugs or treated by drugs; t
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
hus, knowledge of pharmacology is of great help, especially because a rapid response is sometimes
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
required. A clear understanding of the concepts of drug action, drug handling by the body, and dr
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ug interactions will allow the dental practitioner to make proper judgments and grasp the concepts
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
relevant to new drug therapies on the market.
7% 7% 7% 7% 7% 7% 7%
DIF: Application
REF: Role of the Dental Hygienist (Medication/Health History), Role of the Dental Hygienist (Medica
7 % 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
tion Administration), Role of the Dental Hygienist (Emergency Situations), Role of the Dental Hygienis
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
t (Nonprescription Medication) | pp. 2-3
7% OBJ: 1 7% 7% 7% 7%
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
2. Which of the following statements is true regarding planning appointments?
7% 7% 7% 7% 7% 7% 7% 7% 7%
a. Whether or not patients are taking medication for systemic diseases is of litt
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
le
consequence in the dental office. 7% 7% 7% 7%
b. Asthmatic patients should have dental appointments in the morning. 7% 7% 7% 7% 7% 7% 7% 7%
c. Diabetic patients usually have fewer problems with a morning appointment
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
compared with afternoon appointments. 7% 7% 7%
d. Both B and C are true. 7% 7% 7% 7% 7%
ANS: 7 % D
Asthmatic patients who experience dental anxiety should schedule their appointments when they ar
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e not rushed or under pressure early in the morning. Diabetic patients usually have relatively fewer
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
problems with a morning appointment. Patients taking medication for systemic diseases may requir
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e special handling in the dental office.
7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Role of the Dental Hygienist (Appointment Scheduling) |
7 % 7% 7% 7% 7% 7% 7% 7% 7%
p. 3 OBJ: 1
7% 7%TOP: NBDHE, 6.0. Pharmacology
7 % 7 % 7% 7%
,3. Nutritional or herbal supplements 7% 7% 7%
a. carry the U.S. Food and Drug Administration (FDA) approval for disease state
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
s.
b. are not drugs. 7% 7%
c. can cause adverse effects. 7% 7% 7%
d. will not interact with other drugs the patient may be taking.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ANS: 7 % C
Nutritional or herbal supplements are quite capable of causing adverse effects. The majority of nutriti
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
onal or herbal supplements do not carry FDA approval for treating disease states. These supplements
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
are drugs and can cause adverse effects and interact with different drugs.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Role of the Dental Hygienist (Nutritional or Herbal Supplements) |
7 % 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
p. 3 OBJ: 1
7% 7% TOP: NBDHE, 6.0. Pharmacology
7 % 7 % 7% 7%
4. Which type of drug name usually begins with a lowercase letter?
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
a. Brand name 7%
b. Code name 7%
c. Generic name 7%
d. Trade name 7%
ANS: 7 % C
Before any drug is marketed, it is given a generic name that becomes the “official” name of the dr
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ug. Each drug is assigned only one generic name selected by the U.S. Adopted Name Council, and
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
the name is not capitalized. The brand name is equivalent to the trade name and is capitalized. Alt
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
hough the brand name is technically the name of the company marketing the product, this term is o
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ften used interchangeably with the trade name. The code name is the initial term used within a pha
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
rmaceutical company to refer to a drug while it is undergoing investigation and is often a combinat
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ion of capital letters and numbers, the letters representing an abbreviation of the company name.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Drug Names | p. 4 OBJ: 3
7 % 7% 7% 7% 7% 7% 7 %
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
5. A 7% drug’s generic name is selected by the
7% 7% 7% 7% 7% 7%
a. pharmaceutical company manufacturing it. 7% 7% 7%
b. Food and Drug Administration (FDA).
7% 7% 7% 7%
c. U.S. Adopted Name Council.
7% 7% 7%
d. Federal Patent Office. 7% 7%
ANS: 7 % C
Each drug is assigned only one generic name (e.g., ibuprofen). It is selected by the U.S. Adopted
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
Name Council. The generic name is not selected by the FDA or the Federal Patent Office. The pha
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
rmaceutical company manufacturing the drug clearly has an influence on the generic name given its
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
drug, but the final decision is not the company’s.
7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Recall REF: Drug Names | p. 4 7 % 7% 7% 7% 7%
OBJ: 3 TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7 % 7% 7%
6. Which of the following is true concerning generic and trade names of drugs?
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
a. A drug may only have one generic name and one trade nam
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e.
, b. A drug may only have one generic name, but it may have several trade nam
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
es.
c. A drug may have several generic names, but it may only have one trade na
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
me.
d. A drug may have several generic names and several trade names.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ANS: 7 % B
Each drug has only one generic name but may have several trade names. For each drug, there is on
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ly one generic name. It is not capitalized, and it becomes the “official” name of the drug. The phar
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
maceutical company discovering the drug gives the drug a trade name. The trade name is protected
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%by the Federal Patent Law for 20 years from the earliest claimed filing date, plus patent term exten
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
sions. Although the brand name is technically the name of the company marketing the product, it is
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%often used interchangeably with the trade name.
7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Drug Names | p. 4 OBJ: 3
7 % 7% 7% 7% 7% 7% 7 %
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
7. Two drugs that are found to be chemically equivalent, but not biologically equivalent
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
or therapeutically equivalent are said to differ in
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a. potency.
b. efficacy.
c. bioavailability.
d. therapeutic index. 7%
ANS: 7 % C
A preparation can be chemically equivalent yet not biologically or therapeutically equivalent. Thes
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
e products are said to differ in their bioavailability. The potency of a drug is a function of the amou
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
nt of drug required to produce an effect. The efficacy is the maximum intensity of effect or respon
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
se that can be produced by a drug. The therapeutic index is the ratio of the lethal dose for 50% of
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
the experimental animals divided by the effective dose for 50% of the experimental animals. If the
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%value of the therapeutic index is small, toxicity is more likely.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Recall
REF: Drug Names (Drug Substitution) | p. 5 OBJ:
7 % 7% 7% 7% 7% 7% 7% 7% 7 % 4
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
8. How many years must pass after a drug patent expires before other drug companies can market t
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
he same compound as a generic drug?
7% 7% 7% 7% 7% 7%
a. 20 years 7%
b. 17 years 7%
c. 7 years 7%
d. 0 years 7%
ANS: 7 % D
Once a drug patent expires, competing companies may immediately market the same compound in
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%generic form. The pharmaceutical company discovering the drug gives the drug a trade name. The
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%trade name is protected by the Federal Patent Law for 20 years from the earliest claimed filing date
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
, plus the patent term extensions.
7% 7% 7% 7% 7%
DIF: Application
REF: Drug Names (Drug Substitution) | p. 5 OBJ:
7 % 7% 7% 7% 7% 7% 7% 7% 7 % 4
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
, 9. Two drug formulations that produce similar concentrations in the blood and tissues after dr
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ug administration are termed
7% 7% 7% 7% equivalent.
a. chemically
b. biologically
c. therapeutically
ANS: 7 % B
Biologic equivalence refers to identical pharmacokinetic parameters of two drug formulations (bioe
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
quivalence, for short). Chemical equivalence indicates that two formulations of a drug meet the che
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
mical and physical standards established by the regulatory agencies. Therapeutic equivalence mean
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
s that two formulations produce the same therapeutic effects over the same duration.
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DIF: Application
REF: Drug Names (Drug Substitution) | p. 5 OBJ:
7 % 7% 7% 7% 7% 7% 7% 7% 7 % 4
TOP: NBDHE, 6.0. Pharmacology
7 % 7% 7%
10. The federal body that determines whether a drug is considered a controlled substance and to whi
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ch schedule it belongs is the
7% 7% 7% 7% 7%
a. Food and Drug Administration (FDA). 7% 7% 7% 7%
b. Federal Trade Commission (FTC). 7% 7% 7%
c. Drug Enforcement Administration (DEA). 7% 7% 7%
d. U.S. Pharmacopeia (USP). 7% 7%
ANS: 7 % C
The DEA regulates the manufacture and distribution of substances with abuse potential. Hence pre
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
scriber DEA numbers must appear on prescriptions for controlled substances. The FDA does not h
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ave any special powers in regard to drugs of abuse. The FTC regulates commerce and advertising
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
claims of foods, over-the- 7% 7% 7%
counter (OTC) products, and cosmetics. The USP regulates the uniformity and purity of drugs.
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DIF: Comprehension
REF: Federal Regulations and Regulatory Agencies (US Drug Enforcement Administration) |
7 % 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
p. 5 OBJ: 5
7% TOP: NBDHE, 6.0. Pharmacology
7% 7 % 7 % 7% 7%
11. Which federal regulatory agency decides which drugs require a prescription and which drugs may
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be sold over-the-counter (OTC)?
7% 7% 7%
a. FDA
b. OSHA
c. FTC
d. DEA
ANS: 7 % A
The Food and Drug Administration (FDA) is part of Department of Human and Health Services (
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
DHHS), and determines what drugs may be sold by prescription and OTC and regulates the labelin
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
g and advertising of prescription drugs. The Occupational Safety and Health Administration (OSH
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
A) ensures the safety and health of workers in the United States by setting and enforcing standards
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
. The Federal Trade Commission (FTC) regulates the trade practices of drug companies and prohib
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its the false advertising of foods, nonprescription (OTC) drugs, and cosmetics. The Drug Enforcem
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
ent Administration (DEA) is a part of the Department of Justice and regulates the manufacture and
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7
%distribution of substances that have a potential for abuse, including opioids, stimulants, and sedativ
7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7% 7%
es.
