Lecture 1 (Chapter 1)

Question 1

When a particular drug is being investigated by a company, it is identified by its _______ name.

Answer 1

Chemical; it is determined by its chemical structure.

Question 2

If the chemical structure is unknown at the time of investigation, a ______ name is assigned. It can be a combination of letters and numbers.

Answer 2

Code

Question 3

Each drug has only one _____ name, but can have many _____ names.

Answer 3

Generic; trade

Question 4

“pharmaco-“ means?

Answer 4

“drug” or “medicine”

Question 5

The ______ name is capitalized.

Answer 5

trade

Question 6

Trade names are protected under the ______ _____ law for _____ years.

Answer 6

Federal Patent; 20

Question 7

The brand name is technically the name of the company. It can be used interchangeably with ____ name.

Answer 7

trade

Question 8

The FDA requires that generic drugs (if they are to be used instead of brand names) have the same ______ ________ as the brand name drugs and….?

Answer 8

active ingredients; enter the bloodstream at the same rate

Question 9

When two formulations of a drug meet the chemical and physical standards established by the regulatory agencies, they are termed ________ equivalent.

Answer 9

chemically

Question 10

When two formulations of a drug produce similar concentrations of the drug in the blood and tissues, they are termed _______ equivalent.

Answer 10

biologically

Question 11

Before generic drugs are marketed, they must be shown to be _______ equivalent.

Answer 11

biologically

Question 12

If the generic drugs are shown to have equal therapeutic effects as the the brand name, they are deemed _______ equivalent

Answer 12

therapeutically.

Question 13

In 1914, this established regulations concerning the use of opium, opiates, and cocaine.

Answer 13

Harrison Narcotic Act

Question 14

The FDA is part of….(2)

Answer 14

The Department of Health; Human Services

Question 15

The _____ determines what drugs may be sold by Rx and OTC (in the U.S.) It regulates the labeling and advertising of Rx drugs.

Answer 15

Food and Drug Administration (FDA)

Question 16

The ________ regulates the trade practices of drug companies and prohibits the false advertising of foods, OTC drugs, and cosmetics.

Answer 16

Federal Trade Commission (FTC)

Question 17

The ________ of the Department of Justice, administers the Controlled Substances Act of 1970. It regulates the manufacture and distribution of substances that have potential for abuse.

Answer 17

Drug Enforcement Administration (DEA)

Question 18

The newest regulation concerning drugs is the _______. Beginning in 1993, pharmacists must provide patient counseling and prospective drug utilization review for Medicaid patients.

Answer 18

Omnibus Budget Reconciliation Act (OBRA)

Question 19

The Drug Amendments of 1962 caused major change. _______ to the use of drugs must be made available to the patient.

Answer 19

contraindications

Question 20

“Orphan” status drugs are used only if the diseases occur in _________ in the United States.

Answer 20

less than 200,000

Question 21

The clinical studies of drugs involve 4 phases. Phase 1 has a _____ sample group of healthy human volunteers, and primarily determines ______.

Answer 21

small; safety.

Question 22

The clinical studies of drugs involve 4 phases. Phase 2 has ______ groups of people and primarily determines ________ of the drug.

Answer 22

larger; effectiveness

Question 23

The clinical studies of drugs involve 4 phases Phase 3 has large groups of people who have the condition for which the drug is indicated. ________, ________, and ________ is determined in this stage.

Answer 23

Safety, efficacy, and dosage

Question 24

The clinical studies of drugs involve 4 phases. Phase 4 involves ___________.

Answer 24

postmarketing surveillance

Question 25

Class III controlled substances are….

Answer 25

Codeine mixtures (Ex: Tylenol #3)

Question 26

Class IV controlled substances are….

Answer 26

Diazepam, tramadol…

Question 27

Class III and class IV controls cannot have more than _____ RXs in ______ months.

Answer 27

5; 6

Question 28

Class V controls…

Answer 28

can bought OTC in some states

Question 29

What is a black box warning?

Answer 29

A warning about a drug that the FDA has required the manufacturer to prominently display in a box in a package insert. It draws attention to the specific warning and makes sure that both the patient and prescriber are aware of potentially serious/fatal adverse effects of the drugs.