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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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Thirty-two units of Humulin insulin is ordered for the patient. The insulin is supplied in a multidose vial that is labeled 100 units/mL. How much insulin would be needed to treat this patient?
- A. 0.032 cc
- B. 0.32 cc
- C. 3.2 cc
- D. 32 cc
Correct Answer: B
Rationale: A cc is equivalent to an mL. There are 100 units in each cc. Divide that amount by 32 units for the answer (0.32 cc).
The nurse, assisting with Phase I drug studies, is talking with a woman who asks, Why cant I participate in this study? What would be the nurses best response?
- A. Drugs pose a greater risk to women of reproductive age.
- B. Drugs are only tested on men because they are stronger.
- C. Women are more prone to adverse effects from medications.
- D. Drugs affect women differently than they affect women.
Correct Answer: A
Rationale: Phase I drug trials usually involve healthy male volunteers because chemicals may exert an unknown and harmful effect on ova in women which could result in fetal damage when the woman becomes pregnant. Drugs are tested on both men and women, but women must be fully informed of risks and sign a consent stating they understand the potential for birth defects. Women are not more prone to adverse effects of medications. Although some drugs may affect women differently than men, this is a rationale for why drugs need to be tested on women, not an explanation of why women are not included in a Phase I study.
Hepatitis B immune globulin is administered to provide passive immunity to:
- A. Infants born to HBsAg-positive mothers
- B. Household contacts of hepatitis-B virus infected people
- C. Persons exposed to blood containing hepatitis B virus
- D. All of the above
Correct Answer: D
Rationale: Hepatitis B immune globulin provides passive immunity in all listed exposure scenarios .
Which of the following diagnostic studies would NOT indicate a problem related to a reductase inhibitor?
- A. Elevated serum transaminase
- B. Increased serum creatinine
- C. Elevated creatinine kinase
- D. Increased white blood cell counts
Correct Answer: D
Rationale: WBC elevation is unrelated to reductase inhibitors; others indicate liver, kidney, or muscle issues.
The client with squamous cell carcinoma of the larynx is receiving bleomycin intravenously. The nurse caring for the client anticipates that which diagnostic study will be prescribed?
- A. Echocardiography
- B. Electrocardiography
- C. Cervical radiography
- D. Pulmonary function studies
Correct Answer: D
Rationale: Bleomycin is an antineoplastic medication (Chemotherapeutic Agents) that can cause interstitial pneumonitis, which can progress to pulmonary fibrosis. Pulmonary function studies along with hematological, hepatic, and renal function tests need to be monitored. The nurse needs to monitor lung sounds for dyspnea and crackles, which indicate pulmonary toxicity. The medication needs to be discontinued immediately if pulmonary toxicity occurs. Options 1, 2, and 3 are unrelated to the specific use of this medication.