Deck 1: Introduction to Pharmacology, Drug Legislation, and Regulation

Question 1

A historical timeline showing major pharmacological developments in a continuum may be divided into how many distinct periods?

A) 3
B) 5
C) 6
D) 7

Answer 1

3

Question 2

In the United States, the development of new drugs and drug therapies can take anywhere from:

A) 2 to 3 years
B) 5 to 7 years
C) 7 to 15 years
D) 15 to 25 years

Answer 2

7 to 15 years

Question 3

The age of natural substances is characterized by the use of which of the following?

A) synthetic substances
B) DNA technology
C) biotechnology
D) plant derivatives

Answer 3

plant derivatives

Question 4

Which of the following is a branch of the United States Department of Health and Human Services?

A) CDC
B) FDA
C) DEA
D) HHS

Question 5

Pre-clinical investigation takes about:

A) 1 to 3 years
B) 3 to 5 years
C) 5 to 7 years
D) 7 to 15 years

Question 6

A new drug application for investigational human testing must be submitted to which of the following organizations?

A) Department of Health
B) Drug Enforcement Agency
C) Federal Board of Pharmacy
D) Food and Drug Administration

Question 7

Which of the following is the longest part of the drug approval process?

A) pre-clinical investigation (stage 1)
B) clinical investigation (stage 2)
C) investigational new drug review (stage 3)
D) postmarketing studies (stage 4)

Question 8

A controlled substance is a medicinal product that has a high potential for abuse and is regulated by which of the following?

A) FDA
B) DEA
C) CDC
D) DOH

Question 9

Which of the following was the first attempt by the government to control and regulate the manufacture, distribution, and sale of drugs?

A) The Harrison Narcotic Act
B) The Pure, Food, Drug, and Cosmetic Act
C) The Pure Food and Drug Act
D) The Comprehensive Drug Abuse Prevention and Control Act

Question 10

The Comprehensive Drug Abuse Prevention and Control Act is also called the:

A) Narcotic Substances Act
B) Non-narcotic Substances Act
C) Food, Drug, and Cosmetic Act
D) Controlled Substances Act

Question 11

Which of the following drug schedules has the least potential for abuse?

A) Schedule II
B) Schedule III
C) Schedule IV
D) Schedule V

Question 12

Which of the following drug schedules does not require a prescription?

A) Schedule IV
B) Schedule V
C) Schedule III
D) Schedule II

Question 13

Tylenol with codeine is an example of which drug schedule?

A) Schedule I
B) Schedule II
C) Schedule III
D) Schedule IV

Question 14

Cough syrups with codeine are examples of which drug schedule?

A) Schedule IV
B) Schedule V
C) Schedule III
D) Schedule I

Question 15

Methadone is an example of which drug schedule?

A) Schedule I
B) Schedule II
C) Schedule III
D) Schedule IV

Question 16

Which of the following drug schedules may permit 5 refills in 6 months?

A) Schedules I and V
B) Schedules II and V
C) Schedules I and II
D) Schedules III and IV

Question 17

One of the earliest written records of medicinal uses of plants was found in:

A) Greece
B) Egypt
C) Italy
D) England

Question 18

The use of proteins from cells and tissues of humans, animals, and plants in order to produce medicines and therapeutic treatments is called:

A) pharmacology
B) synthetic medicine
C) biochemistry
D) biotechnology

Question 19

Stage 3 of drug product development is known as:

A) investigational new drug review
B) postmarketing studies
C) pre-clinical investigation
D) clinical investigation

Question 20

Which of the following organizations or agencies is able to remove a drug from the market when the drug is found to cause serious problems?

A) DEA
B) CDC
C) FDA
D) state board of pharmacy

Question 21

A prescription drug is known as a ____________________ drug.

Question 22

The study of the sources, appearance, chemistry, actions, and indications of drugs is called ____________________.

Question 23

Antibiotics and insulin are examples of ____________________ substances.

Question 24

The Food and Drug Administration is a branch of the United States Department of _________________________.

Question 25

Clinical testing on humans takes place in three different phases, called clinical ____________________.

Question 26

Investigational New Drug (IND) Review is the ____________________ stage of drug approval.

Question 27

OTC drugs do not require a ____________________.

Question 28

__________ __________ drugs have the least potential for abuse.

Question 29

Before the Harrison Narcotic Act, any narcotic could be purchased _________________________.

Question 30

Drugs in Schedule I have the highest potential for ____________________ and ____________________.

Question 31

The period from 1350 to 1650 A.D. (the later stages of the Middle Ages) is known as the __________.

Question 32

In the United States, the development of new drugs can take anywhere from seven to __________ years.

Question 33

Most prescription drugs are designated by the __________.

Question 34

The Harrison Narcotic Act regulated the importation, manufacture, sale, and use of opium, __________, and their derivations.

Question 35

The Kefauver-Harris Amendment of 1963 required that prescription and non-prescription drug products be __________, __________, and safe.

Question 36

Under OBRA-90, pharmacists in every state must offer to __________ all patients and review medications that they are taking.

Question 37

The three sections of HIPAA include privacy and security regulations, as well as __________ standards.

Question 38

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 is also known as the __________ Modernization Act.

Question 39

OBRA-90 was designed to save patients __________, and expanded on OBRA-97.