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Harris-Kafauver Amendments

This law was created in response to the thalidomide tragedy that occurred in Europe in the early 1960's

Federal Pure Food and Drug Act

The first American law to regulate drugs was the ________of 1906.

Therapeutics, pharmacotherapeutics

_____or_____, is defined as the use of drugs to diagnose, prevent, or treat disease or to prevent pregnancy.

$800 million

In the U.S., the cost of developing a new drug is estimated to be

Food, Drug and Cosmetic Act

The first legislation to regulate drug safety passed in 1938 was the

over the counter drugs

Drugs that can be purchased without a prescription

maximum benifit, minimum harm

The objective of drug therapy is to provide ________ with ________.


A chemical that can affect living processes is a ____________.


the study of drugs and their interactions with living systems is the definition of


Thousands of women in the 1960's who took thalidomide, gave birth to babies with ________, a rare birth defect characterized by gross malformation or complete absence of arms or legs.

effectiveness, safety, selectivity

The three most important characteristics that any drug can have are

Randomized controlled trials

This is the most reliable way to objectively assess drug therapies

Drug absorption, drug distribution, drug metabolism, drug excretion

The four major pharmacokinetic processes are


The impact of drugs on the body

clinical pharmacology

The study of drugs in humans

sweating, increased heart rate

Patients taking insulin therapy should be taught that early signs of hypoglycemia include


The Greek word for pharmakon is translated as


A pre-existing condition that significantly increases the risk of an adverse reaction to a particular drug, but not to a degree that it is life threatening.

normal volunteers, patients

Phase I drug trials are usually conducted in _______ whereas Phase II and Phase III trials are tested in ____________.

iron, calcium

The antibacterial effects of tetracycline can be greatly reduced by taking _______ or __________.

baseline, high-risk, self-care

The three basic goals of preadministration assessment of medications are collecting _________data, identifying _______ patients, and assessing the patient's capacity for ________.

relieve pain, suppress inflammation

aspirin is given in low doses to ______ and in high doses to ______.

red-orange color

A harmless side affect of rifamprin is a __________________in urine.

to ensure that the unknown risks associated with early approval are balanced by the need for effective drugs.

The rationale for the 1992 changes in the Food and Drug Administration regulations to permit accelerated approval of drugs for the treatment of life-threatening or severely debilitating disease was:

is FDA approved for one use but being prescribed for another purpose.

"Off-label" means that a drug:

Prescriber's Letter.

When a nurse needs the most up-to-date and accurate information about a drug, the best source is:

be devoid of side effects.

A drug that is selective should theoretically:

The drug has passed the FDA approval process.

A new medication becomes available for the treatment of a debilitating neurologic disease. Which would be a nurse's expectation about the safety of the drug?

an absolute contraindication.

A nurse assesses a patient who has preexisting hepatic failure. Acetaminophen is prescribed, although the nurse knows this drug should not be used in patients with impaired liver function. This is an example of:

The patient's blood pressure before administration

Which aspect of the baseline assessment would be the most important before an antihypertensive agent is administered to a patient?

tailor the drug to the individual.

The best method to use in prescribing medications to patients is to:

Phase I.

Normal, healthy volunteers are used for clinical trials of new drugs during which Phase


After which phase of a clinical trial may a manufacturer apply for FDA approval?

be simple and easy to recall.

Generic names for drugs should ideally:

Food, Drug, and Cosmetic Act.

The first legislation to regulate drug safety was the:


When a disease process triggers increased metabolism of a drug, the disease has altered the drug's:


The greatest potential for abuse exists with drugs from Schedule:

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