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.
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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Related Questions
Correct Answer is D
Explanation
a) "Signature" and "hospital" are not part of the six rights of medication administration. The correct rights ensure patient safety by verifying essential aspects of drug administration.
b) "Solution," "doctor," and "shift" are not part of the six rights. The focus should be on ensuring the correct patient receives the right medication in the right manner.
c) "Order" and "signature" are important for verifying prescriptions, but they are not included in the six rights of administration.
d) The six rights of medication administration are right medication, right dosage, right route, right time, right client (patient), and right documentation. These ensure medication safety and prevent errors.
Correct Answer is B
Explanation
a) Herbs are not classified as medications under the Dietary Supplement Health and Education Act of 1994. The law classifies them as dietary supplements, which are not subject to the same rigorous safety and efficacy standards as medications.
b) Discussing herbal remedies with the patient's provider is essential. Herbs can interact with prescribed medications, and their safety and effectiveness can vary. It is important for providers to be aware of any herbal remedies the patient is using to avoid potential harmful interactions.
c) Herbs are not regulated by the government in the same way as pharmaceuticals. The FDA does not determine their safety before marketing, and manufacturers are not required to prove safety or efficacy before selling them.
d) Herbs are not harmless. Some herbs may be ineffective, but others can cause adverse effects, especially when taken alongside other medications. Therefore, it's important to consider their safety in the context of the patient’s overall treatment plan.
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