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After teaching a group of nursing students about nonprescription drugs, the nursing instructor determines that the teaching was successful when the students identify which of the following? Select all that apply.
- A. They require a licensed health care provider's signature.
- B. They are referred to as over-the-counter drugs.
- C. They can be taken without risk to the client.
- D. They have certain labeling requirements.
- E. They should be taken only as directed on the label.
Correct Answer: B,D,E
Rationale: Nonprescription drugs are often referred to as over-the-counter (OTC) drugs. They do not require a prescription (a licensed health care provider's signature) but do not come without risk to the client. The federal government has imposed labeling requirements of OTC drugs and they should only be taken as directed on the label unless under the supervision of a health care provider.
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When reviewing the phases of drug development, the nurse finds a discussion about the postmarketing surveillance phase. Which one of the following activities would the nurse expect to find as being carried out during this phase?
- A. Health care providers report adverse effects to FDA.
- B. Healthy volunteers are involved in the test.
- C. In vitro tests are performed using human cells.
- D. The drug is given to patients with the disease.
Correct Answer: A
Rationale: The postmarketing surveillance phase of drug development encourages health care professionals to report adverse effects of drugs to the FDA using MedWatch. Phase 1 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 2 of clinical testing, the drug is given to patients with the disease for which the drug is manufactured.
A patient is receiving digoxin as treatment for heart failure. Which of the following would be most important for the nurse to monitor to reduce the risk for toxicity?
- A. Seizure activity
- B. Drug blood level
- C. Urinary output
- D. Blood pressure
Correct Answer: B
Rationale: The nurse should monitor the patient's blood level of the drug to ensure that the level remains within the therapeutic range. Monitoring seizure activity, urination frequency, and blood pressure will not prevent toxicity. Seizure activity is unrelated to digoxin or heart failure.
After teaching a group of nursing students about pharmacokinetics, the instructor determines that the teaching was successful when the students identify which of the following as the first phase?
- A. Metabolism
- B. Absorption
- C. Distribution
- D. Excretion
Correct Answer: B
Rationale: Pharmacokinetics refers to the transportation activity of drugs in the body after administration. The first component is absorption. This is followed by distribution, metabolism, and finally excretion.
When reviewing information about the Orphan Drug Program, which of the following would the nurse expect to find? Select all that apply.
- A. The program encourages the development and marketing of products to treat rare diseases.
- B. The program grants provisional approval with a written commitment from the drug company to formally demonstrate client benefits.
- C. The program provides for incentives, such as research grants, protocol assistance, and special tax credits, to develop products to treat rare diseases.
- D. The program grants 7 years of exclusive marketing rights to the manufacturer if approved.
- E. The program accelerates approval of drugs based on preliminary evidence before formal demonstration of client benefits.
Correct Answer: A,C,D
Rationale: The Orphan Drug Program encourages the development and marketing of products used to treat rare diseases. The program provides incentives to encourage manufacturers to develop orphan drugs, and if approved, the manufacturer has 7 years of exclusive marketing rights. Accelerated programs involve provisional approval and approval based on preliminary evidence.
After teaching a group of nursing students about pharmacokinetics, the instructor determines that the teaching was successful when the students identify which of the following as a phase? Select all that apply.
- A. Absorption
- B. Distribution
- C. Administration
- D. Metabolism
- E. Excretion
Correct Answer: A,B,D,E
Rationale: The pharmacokinetic phases are absorption, distribution, metabolism, and excretion. The acronym ADME is a helpful way to remember the pharmacokinetic phases.