Which statement about the safety and efficacy of medications in children is accurate?

Children cannot give consent, so clinical drug trials are not performed on children.

Children can only be subjects in quasi-experimental clinical studies.

Data from adult clinical drug trials can be extrapolated to children.

Federal law requires that drugs for children be tested on children.

Answer and Explanation

The Correct Answer is D

a) Children can participate in clinical drug trials when appropriate consent is obtained from parents or guardians and when the study complies with ethical guidelines. They are not excluded from trials entirely because they cannot give consent.

b) Children can participate in various types of clinical studies, not just quasi-experimental ones, as long as the study follows ethical and legal guidelines for pediatric research.

c) Data from adult clinical trials cannot always be directly applied to children due to physiological differences. Pediatric drug testing is necessary to ensure drugs are both safe and effective for children.

d) Federal law mandates that drugs for children undergo testing in pediatric populations. This is to ensure that drugs are safe and effective for children, as they may respond differently than adults to medications.

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Correct Answer is C

Explanation

a) Complete blood counts (CBC) are useful for monitoring infection, anemia, or bone marrow suppression, but they are not the primary concern for azithromycin and acetaminophen toxicity.

b) Electrolytes are important for general health but are not directly related to the major side effects of these drugs.

c) Liver enzymes (AST, ALT) should be monitored because both azithromycin and acetaminophen can cause hepatotoxicity, especially at high doses. Acetaminophen overdose is a known cause of liver failure.

d) Urinalysis may be helpful in assessing kidney function, but it is not the primary focus when monitoring for drug-induced liver toxicity.

A. Phase I B. Phase II C. Phase III D. Phase IV

Correct Answer is D

Explanation

a) Phase I studies focus on assessing the safety, dosing, and side effects of a drug in healthy volunteers, not its clinical effectiveness or potential new uses.

b) Phase II studies evaluate the drug's effectiveness and safety in a small group of patients with the targeted condition but do not focus on potential new uses.

c) Phase III studies are large-scale trials conducted to confirm the drug's effectiveness and safety before approval but do not typically involve studying new uses of the drug.

d) Phase IV studies occur after a drug has been approved and marketed. These studies, often called post-marketing surveillance, evaluate the drug's effectiveness and safety in the general population and investigate new potential uses or long-term effects.

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Which statement about the safety and efficacy of medications in children is accurate?

Nursing Test Bank

Naxlex Comprehensive Predictor Exams

The nurse is caring for a patient who is receiving a high dose of intravenous azithromycin to treat an infection. The patient is also taking acetaminophen for pain. The nurse should expect to review which lab values when monitoring for this drug side effects?

Correct Answer is C

Explanation

Before marketing a new drug that has been approved for use based on clinical effectiveness and safety, the manufacturer wishes to study the potential new uses for the drug. This is an example of which phase of study?

Correct Answer is D

Explanation

A nurse is assessing the patient's home medication use. After listening to the patient list current medications, the nurse asks what priority question?

Which category is characterized as objective data?

When administering topical medications, which is an important nursing action?

The nurse is caring for an older adult patient who is receiving multiple medications. When monitoring this patient for potential drug toxicity, the nurse should review which lab values closely?

What is the responsibility of the nurse related to the patient's drug therapy? (Select all that apply.)

The nurse is conducting an admission assessment on a client. When collecting data related to medications, the nurse asks, "What medications are you currently taking?" After collecting this information, what other questions should the nurse ask? Select all that apply.

The nurse gives 800 mg of a drug that has a half-life of 8 hours. How much drug will be left in the body in 24 hours if no additional drug is given?

The nurse learns that a patient cannot afford a prescribed medication and enlists the assistance of the social worker and an outside agency to provide medications at a lower cost. Which QSEN competency do the nurse’s actions best demonstrate?