Which are responsibilities of the FDA? (Select all that apply.)

To ensure a drug is tested for harmful effects.

To ensure a drug has accurate labeling.

To ensure a drug is free from adverse reactions.

To ensure a drug is affordable.

To ensure a drug is effective.

Answer and Explanation

Correct Answer : A,B,E

a) The FDA is responsible for overseeing the testing of drugs for harmful effects, including preclinical trials and clinical trials, to ensure that drugs do not cause unsafe side effects.

b) The FDA ensures that drugs have accurate labeling, including correct dosage, potential side effects, contraindications, and proper use.

c) The FDA does not guarantee that a drug will be free from adverse reactions. While they regulate and monitor drugs, adverse reactions can still occur after approval, and it is the responsibility of healthcare professionals and the manufacturer to monitor for these post-marketing.

d) The FDA does not ensure drug affordability; the pricing of drugs is influenced by many factors, including market forces, healthcare policies, and manufacturer decisions.

e) The FDA ensures that drugs are effective by overseeing clinical trials to demonstrate that the drug has the intended therapeutic effects for its indicated use.

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Correct Answer is B

Explanation

a) Pharmacoeconomics focuses on the cost-effectiveness of drugs and their impact on healthcare systems, not the administration of drugs for specific treatments.

b) Pharmacotherapeutics is the study of how drugs are used to treat, prevent, and diagnose diseases. Since all three nurses are administering medications for diagnostic, therapeutic, and preventive purposes, their actions fall under pharmacotherapeutics.

c) Pharmacodynamics refers to the mechanism of action of drugs, including how they interact with receptors and produce physiological effects, but it does not describe drug administration.

d) Pharmacokinetics deals with the absorption, distribution, metabolism, and excretion of drugs, but this question is focused on the purpose of drug administration rather than its movement through the body.

A. Children cannot give consent, so clinical drug trials are not performed on children. B. Children can only be subjects in quasi-experimental clinical studies. C. Data from adult clinical drug trials can be extrapolated to children. D. Federal law requires that drugs for children be tested on children.

Correct Answer is D

Explanation

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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Which are responsibilities of the FDA? (Select all that apply.)

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Naxlex Comprehensive Predictor Exams

Correct Answer is B

Explanation

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

Correct Answer is D

Explanation

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