NUR 220 Test
- What factor does the nurse understand is the key safeguard in drug therapy?
a) Checking for allergies in a patient prior to giving a medication
b) Educating patients about drug therapy
c) Making sure that the right medication is given to the right patient
d) Making sure that each facility has bar code scanning capabilities
Answer Educating patients about drug therapy
Educating patients is a key safeguard in drug therapy. Educating patients about drug therapy improves adherence to drug therapy and promotes therapeutic outcomes. Patients who understand the prescribed drug regimen have the best chance of achieving the maximum benefit from it
- One of the phases of drug development is the post-marketing surveillance phase. Which one
of the following activities is carried out during this phase?
a) Healthy volunteers are involved in the test.
b) In vitro tests are performed using human cells.
c) The drug is given to patients with the disease.
d) Health care providers report adverse effects to FDA.
Answer Health care providers report adverse effects to FDA.
The post-marketing surveillance phase of drug development encourages health care professionals to report adverse effects of drugs to the FDA using MedWatch. Phase I of clinical testing involves 20 to 100 healthy volunteers. In vitro testing of the drug on human or animal cells is done in the pre-FDA phase. In phase II of clinical testing, the drug is given to patients with the disease for which the drug is manufactured.
- The birth defects associated with thalidomide (Thalomid) resulted in legislation known as
which of the following?
a) Controlled Substances Act
b) Kefauver-Harris Act of 1962
c) Pure Food and Drug Act
d) Durham-Humphrey Amendment
Answer 1 / 4
Kefauver-Harris Act of 1962
The Kefauver-Harris Act of 1962 gave the Food and Drug Administration (FDA) regulatory control over testing and evaluating drugs and set standards for efficacy and safety. The Controlled Substances Act defined drug abuse and classified drugs according to their potential for abuse. The Pure Food and Drug Act prevented the marketing of adulterated drugs. The Durham-Humphrey Amendment tightened control of certain drugs.
- A drug has been approved by the Food and Drug Administration. Which of the following
would occur next?
a) Phase I study
b) Phase II study
c) Phase III study
d) Phase IV study
Answer Phase IV study
Once a drug is approved, a phase IV study occurs. This is a phase of continual evaluation in which prescribers are obligated to report to the Food and Drug Administration any untoward or unexpected adverse effects associated with the drugs being used. A phase III study involves the use of the drug in a vast clinical market. FDA approval occurs with completion of this phase. A phase II study allows investigators to try out the drug in patients who have the disease that the drug is designed to treat. A phase I study uses human volunteers for testing. This step follows preclinical trials, which involves drug testing on laboratory animals
- Which of the following Food and Drug Administration (FDA) pregnancy categories
indicates that animal studies on the drug have shown adverse fetal effects, but there are no adequate studies in humans?
a) Category A
b) Category C
c) Category D
d) Category B
Answer Category C
Category C drugs are those in which animal studies have shown adverse fetal effects, but there are no adequate studies in humans. With Category A drugs, adequate studies in pregnant women have not demonstrated risks to the fetus in the first trimester of pregnancy, and there is 2 / 4
no evidence of risk in later trimesters. With Category B drugs, animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women.With Category D drugs, there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks
- During drug evaluation, chemicals that may have therapeutic value are test- ed on laboratory
animals and would be considered in which of the following stages of development?
a) Phase I
b) Preclinical
c) Phase II
d) Phase III
Answer Preclinical
Preclinical trials involve testing potential drugs on laboratory animals. Phase I studies test potential drugs on healthy human subjects. Phase II studies test potential drugs on patients who have the disease the drugs are designed to treat. Phase III studies test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness
- A patient who reports joint pain is being seen in the rheumatology clinic. The nurse
understands that which of the following elements is used to treat rheumatoid arthritis?
a) Iron
b) Gold
c) Aluminum
d) Fluorine
Answer Gold
Gold has a therapeutic use in the treatment of rheumatoid arthritis. Aluminum has been used to treat gastric acidity and prevent the formation of phosphate urinary stones. Iron is effective in the treatment of iron-deficiency anemia. Fluorine (Fluoride) is used to prevent dental cavities.
- During which phase of study are human volunteers used to test drugs?
a) Phase IV
b) Phase III
c) Phase I 3 / 4
d) Phase II
Answer Phase I
A phase I study uses human volunteers to test a drug. During phase II, clinical investigators try out a drug with patients who have the disease that the drug is designed to treat. A phase III study involves the use of the drug in a vast clinical market. The Food and Drug Administration (FDA) relies on committees of experts familiar with the specialty area in which the drugs will be used to evaluate drugs that finish phase III studies. After the FDA approves the drug for marketing, the drug enters a phase of continual evaluation, or a phase IV study.
- In Phase I clinical trials, the potential uses and effects are determined by which of the
following?
a) Administering doses to people with the disease
b) Administering doses to healthy volunteers
c) Administering in placebo-controlled design
d) Calculating the risk-to-benefit ratio
Answer Administering doses to healthy volunteers
Phase I studies allow for the administration of the medication to healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. In Phase II studies, a few doses are given to a certain number of subjects with the disease or symptom for which the drug is being studied and responses are compared with those of healthy subjects.Placebo-controlled designs are used in the Phase III studies, in which half of the subjects receive the new drug and half receive the placebo. Calculating the risk-to-benefit ratio is used in Phase II studies to determine whether the potential benefits of the drug outweigh the risks.
- A nurse is reading an article about drug development. The article reports that the drug has
been tested on laboratory animals and is now ready for the next phase. The nurse identifies this next step as which of the following?
a) Phase II study
b) Phase III study
c) Phase I study
d) Preclinical trial
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