Lehne: Pharmacology Adn1 Test 3-Chapter-3-Drug Regulation, Development, Names, And Information

Front 1

• The Food, Drug, and Cosmetic Act of 1938 was

Back 1

the first legislation to regulate drug safety.

Front 2

• The Harris-Kefauver Amendments, passed in 1962, were

Back 2

the first legislation to demand that drugs actually be of some benefit

Front 3

• The Controlled Substances Act, passed in 1970,

Back 3

set rules for the manufacture and distribution of drugs considered to have potential for abuse.

Front 4

• The FDA Amendments Act, passed in 2007,

Back 4

expanded the mission of the FDA to include rigorous oversight of drug safety after a drug has been released for marketing.

Front 5

the FDA has the legal authority to

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require postmarketing safety surveillance studies,
order changes in a drug’s label to include new safety information, and
restrict distribution of a drug based on safety concerns

Front 6

• Some drugs have an “off-label” use, which is .

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a use that has not been evaluated by the FDA

Front 7

• Development of a new drug is

Back 7

an extremely expensive process that takes years to complete

Front 8

• The randomized controlled trial is

Back 8

the most reliable way to objectively assess drug therapy

Front 9

• The purpose of randomization is

Back 9

to prevent allocation bias

Front 10

• Phase I drug testing involves

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healthy volunteers

Front 11

• Drug testing in Phase II and Phase III clinical trials is

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limited to a relatively small number of patients, most of whom take the drug for a relatively short time

Front 12

• During Phase IV:

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the drug is released to the general public

Front 13

• Since women and children have been excluded from drug trials in the past,

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our understanding of drug effectiveness and safety in these groups is limited.

Front 14

• When a new drug is released for general use,

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it may well have adverse effects that have not yet been detected. Consequently, when working with a new drug, you should be especially watchful for previously unreported adverse events.

Front 15

• Drugs have three types of names:

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a chemical name,
a generic or nonproprietary name, and
a trade or proprietary name.

Front 16

• Each drug has only one generic name but

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can have many trade names

Front 17

• Generic names facilitate communication and therefore are good. Trade names

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confuse communication and should be outlawed. ??

Front 18

• Nurses must pay specific attention to drug names because

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many drugs have similar names and giving the incorrect drug can have significant complications for the patient.

Front 19

• Over-the-counter (OTC) drugs are

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defined as drugs that can be purchased without a prescription.

Front 20

• Since the job of the drug representative is sales and not education, this person may not be your best source of

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drug information—especially if you are trying to establish an unbiased comparison between the representative’s product and a drug from a competing manufacturer

Front 21

• the classic text/reference on pharmacology is

Back 21

Goodman & Gilman’s The Pharmacological Basis of Therapeutics (aka G & G)

Front 22

Nurses must have a source of information regarding drugs that is

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accurate and up to date and contains information relative to patient response, adverse effects, etc