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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.
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A patient has been using sleeping pills every night for the past several months. Now admitted to the hospital, he is prescribed his usual dose of sleeping pill. After administration, the patient continues to be restless and is wide awake. The nurse notifies the health care provider, who prescribes an increased dose. After receiving the new dose, the patient falls asleep. The nurse interprets this as which of the following?
- A. Drug idiosyncrasy
- B. Cumulative drug effect
- C. Drug tolerance
- D. Toxic reactions
Correct Answer: C
Rationale: The patient has developed drug tolerance and has to be administered an increased dosage of the drug to achieve the desired effect. Cumulative drug effect occurs when the body is unable to metabolize and excrete one (normal) dose of a drug before the next dose is given. Drug idiosyncrasy is a term used to describe any unusual or abnormal reaction to a drug. Toxic reactions are caused when blood concentration levels exceed the therapeutic levels of a drug.
The nurse observes that after administration of a drug the patient has developed itching and a skin rash. The nurse interprets these findings as which of the following?
- A. Toxicity
- B. Allergic reaction
- C. Angioedema
- D. Crystalluria
Correct Answer: B
Rationale: Allergic reactions are manifested by a variety of signs and symptoms including itching, skin rashes, and hives. Swollen eyelids, lips, and mouth are some of the symptoms of angioedema, an allergic drug reaction that may block the airway, causing asphyxia. Toxicity or toxic reactions are caused when blood concentration levels exceed the therapeutic level of drugs. Reduced blood pressure is called hypotension. Crystals in the urine are symptoms of crystalluria.
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 site for the metabolism of most drugs?
- A. Liver
- B. Lungs
- C. Kidneys
- D. Intestinal mucosa
Correct Answer: A
Rationale: Although the kidneys, lungs, plasma, and intestinal mucosa may aid in the metabolism of drugs, most drugs are metabolized by the liver.
After teaching a group of nursing students about the half-life of a drug, the instructor determines the need for additional teaching when the students identify which of the following as true? Select all that apply.
- A. Half-life can be decreased in clients with renal disease.
- B. Half-life can help determine dosing frequency.
- C. Half-life does not change throughout a client's life.
- D. Layer disease can increase half-life.
- E. Half-life is the measure of the rate at which drugs are removed from the body.
Correct Answer: A,C
Rationale: Half-life is the measure of the rate at which drugs are removed from the body, and any difficulty in excreting a drug increases half-life, including liver or kidney disease or advanced age.
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.