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