During the development of a new drug, which would be included in the study by the researcher to prevent any bias or unrealistic expectations of the new drug's usefulness?
- A. A placebo
- B. FDA approval
- C. Informed consent
- D. Safety information
Correct Answer: A
Rationale: To prevent bias that may occur as a result of unrealistic expectations of an investigational new drug, a placebo is incorporated into the study. The other options are incorrect. FDA approval, if given, does not occur until after phase III. Informed consent is required in all drug studies. Safety information is not determined until the study is under way.
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A patient is undergoing major surgery and asks the nurse about a living will. He states, -I don't want anybody else making decisions for me. And I don't want to prolong my life. I The patient is demonstrating which ethical term?
- A. Autonomy
- B. Beneficeence
- C. Justice
- D. Veracity
Correct Answer: A
Rationale: Autonomy includes self-determination, or the ability to act on one's own, including making one's own decisions about health care. Veracity is defined as the duty to tell the truth. Justice is the ethical principle of being fair or equal in one's actions. Beneficeence is the ethical principle of doing or actively promoting good.
When reviewing the various schedules of controlled drugs, the nurse knows that which description correctly planting describes Schedule II drugs?
- A. Drugs with high potential for abuse that have accepted medical use
- B. Drugs with high potential for abuse that do not have accepted medical use
- C. Medically accepted drugs that may cause moderate physical or psychologic dependence
- D. Medically accepted drugs with limited potential for causing physical or psychologic dependence
Correct Answer: A
Rationale: Schedule II drugs are those with high potential for abuse but that have accepted medical use. Drugs that have high potential for abuse but do not have accepted medical use are Schedule I drugs. Medically accepted drugs that have moderate physical or high psychologic dependence potential are Schedule III drugs. Medically accepted drugs with limited potential for causing physical or psychologic dependence are Schedule IV and V drugs.
A member of an investigational drug study team is working with healthy volunteers whose participation will help to determine the optimal dosage range and pharmacokinetics of the drug. The team member is participating in what type of study?
- A. Phase I
- B. Phase II
- C. Phase III
- D. Phase IV
Correct Answer: A
Rationale: Phase I studies involve small numbers of healthy volunteers to determine optimal dosage range and the pharmacokinetics of the drug. The other phases progressively involve volunteers who have the disease or ailment that the drug is designed to diagnose or treat.
During discharge patient teaching, the nurse reviews prescriptions with a patient. Which statement is correct about refills for an analgesic that is classified as Schedule C-III?
- A. No prescription refills are permitted.
- B. Refills are allowed only by written prescription.
- C. The patient may have no more than five refills in a 6-month period.
- D. Written prescriptions expire in 12 months.
Correct Answer: C
Rationale: Schedule C-III medications may be refilled no more than five times in a 6-month period. The patient should be informed of this regulation. No prescription refills are permitted for Schedule C-II drugs. Requiring refills by written prescription only applies to Schedule C-II drugs. Schedule C-III prescriptions (written or oral) expire in 6 months.
During a busy night shift, a new nurse administered an unfamiliar medication without checking it in a drug handbook. Later that day, the patient had a severe reaction because he has renal problems, which was a contraindindation to that drug. The nurse may be liable for which of these?
- A. Medical negligence
- B. Nursing negligence
- C. Nonmaleficeence
- D. Autonomy
Correct Answer: B
Rationale: Negligence is the failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances. Nurses are expected to assess patients thoroughly before medications are given, and to be familiar with medications they are administering. In this case, nursing negligence applies to nurses, not medical negligence. Nonmaleficence is defined as the duty to do no harm, autonomy is defined as the right to make one's own decisions, or self-determination.
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