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Introduction To Nursing Pharmacology-Chapter 1 Questions And Answers With Verified Solutions.
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Introduction To Nursing Pharmacology-Chapter 1 Questions And Answers With Verified Solutions.
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Introduction To Nursing Pharmacology-Chapter 1Questions And Answers With Verified Solutions.
Pharmacology - ANSWER Study of the biological effects of chemicals
Pharmacotherapeutics - ANSWER Branch of pharmacology that deals with drugs (clinical
pharmacology)
Preclinical Drug Trials - ANSWER Testing of drugs on animals to determine whether they have
the presumed effects in living tissue and to evaluate adverse effects
Phase I Study - ANSWER Tightly controlled drug study using human volunteers; usually young,
healthy males; often compensated. Drugs are not tested further if they: lack therapeutic effect in
humans, cause unacceptable adverse effects, are highly teratogenic, are too toxic
Phase II Study - ANSWER Drug testing limited to patients with the condition for which the
drug was created. Drugs are not tested further if they: are less effective than anticipated, too toxic,
produce unacceptable adverse effects, have low risk to benefit ratio, are no more effective than other
drugs already available
Phase III Study - ANSWER Study of a drug in a vast clinical market; users & prescribers are
asked to report adverse effects; drug will usually be removed from study if there are reports of
unacceptable adverse effects
FDA Approval - ANSWER Experts familiar with the speciality area in which the drug will be
used evaluate the gathered data to determine approval; approval often takes 5-6 years and is
extremely expensive
Brand Drug Name - ANSWER The trade name designated by the pharmaceutical company that
developed the drug
Chemical Drug Name - ANSWER Name that reflects the chemical structure of a drug
Generic Drug Name - ANSWER Original designation the drug was given when the drug
company applied for approval
Phase IV Study - ANSWER Continual evaluation of a FDA approved drug after it goes to
market; providers are obligated to report unexpected adverse effects to the FDA
Federal Food, Drug & Cosmetic Act (1938) - ANSWER Mandated testing for drug toxicity and
provided means for recalls; established procedures for introduction of new drugs; gave the FDA
enforcement power
Controlled Substances Act (1970) - ANSWER Defined drug abuse and classified drugs as to
their potential for abuse; provided strict controls over distribution, storage & use of these drugs
Pregnancy Category A Drug - ANSWER Adequate studies in pregnant women have not
demonstrated risk to the fetus
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