This law was created in response to the thalidomide tragedy that occurred in Europe in the early 1960's
_____or_____, is defined as the use of drugs to diagnose, prevent, or treat disease or to prevent pregnancy.
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
Drug absorption, drug distribution, drug metabolism, drug excretion
The four major pharmacokinetic processes are
sweating, increased heart rate
Patients taking insulin therapy should be taught that early signs of hypoglycemia include
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 ______.
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:
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:
When a disease process triggers increased metabolism of a drug, the disease has altered the drug's: