The nurse is preparing to give a medication to a child. The child's parent asks whether the drug is safe for children. How will the nurse respond to the parent?
Drugs are tested on adults and safe doses for children are based on weights compared to adult weights.
Drugs are deemed safe for children over time when repeated use proves effectiveness and safety.
Drugs are tested for both efficacy and safety in children in order to be marketed for pediatric use.
Drugs are tested on children in post-marketing studies and on a limited basis.
The Correct Answer is C
A. While pediatric doses are often weight-based, this does not fully account for differences in drug metabolism and effects in children. Pediatric drug safety requires specific testing beyond weight comparisons to adults.
B. Relying on repeated use over time to determine safety is not an evidence-based approach. Drug approval for pediatric use requires formal clinical trials to establish safety and efficacy.
C. The U.S. FDA and other regulatory agencies require that drugs intended for pediatric use undergo clinical trials specifically designed to assess safety, efficacy, and appropriate dosing in children. This ensures that medications are appropriately tested before being marketed for pediatric patients.
D. While some post-marketing studies may include children, initial approval for pediatric use requires pre-market clinical testing. Relying solely on post-marketing studies does not ensure comprehensive safety data before widespread pediatric use.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is C
Explanation
a) Encouraging increased fluid intake is not always appropriate for a patient on a thiazide diuretic, as these drugs promote fluid loss. Excess fluid intake may not be beneficial unless there are signs of dehydration.
b) Increasing activity and exercise can be beneficial for overall health, but the priority is ensuring safety due to the risk of orthostatic hypotension and falls.
c) Initiating a fall risk protocol is crucial because thiazide diuretics can cause hypotension, dizziness, and electrolyte imbalances, all of which increase the risk of falls, particularly in older adults.
d) Providing a low potassium diet is inappropriate, as thiazide diuretics can lead to hypokalemia (low potassium levels), so monitoring and possibly increasing potassium intake may be necessary.
Correct Answer is A
Explanation
a) Oral medications, such as oral analgesics, undergo a disintegration process in the gastrointestinal (GI) tract before they can be absorbed into the bloodstream. Tablets and capsules must break down into smaller particles to be dissolved and absorbed.
b) Subcutaneous medications bypass the GI tract and are absorbed directly into the tissue, so they do not require a disintegration process.
c) Intramuscular injections are directly absorbed into the bloodstream from muscle tissue and do not require disintegration.
d) Intravenous drugs are delivered directly into the bloodstream and are immediately available for action, eliminating the need for disintegration.
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