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.
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Related Questions
Correct Answer is D
Explanation
a) While men and women may metabolize drugs differently, this is not the primary reason why women are often excluded from Phase I drug trials.
b) Women are not necessarily more prone to adverse effects, but concerns about fetal exposure and reproductive risks have historically limited women's participation in early trials.
c) This statement is incorrect and misleading. Drug trials are not based on strength but rather on safety, ethical concerns, and risk of reproductive harm.
d) Phase I studies test drugs on healthy volunteers, and historically, women of childbearing age were excluded due to concerns about potential teratogenic effects and unknown risks to a developing fetus. Although regulations have changed, caution is still exercised when including women in early-stage drug trials.
Correct Answer is C
Explanation
A. The statement that no drug remains is incorrect. A drug with a half-life of 8 hours will not be completely eliminated in 24 hours, as it follows a predictable pattern of reduction.
B. A reduction to 50 mg would require additional half-life intervals beyond 24 hours. The drug concentration decreases by half every 8 hours, meaning it would take more than 24 hours to reach this level.
C. The correct calculation follows the half-life principle:
- At 8 hours: 800 mg → 400 mg
- At 16 hours: 400 mg → 200 mg
- At 24 hours: 200 mg → 100 mg
Therefore, 100 mg of the drug remains after 24 hours.
D. While 200 mg is a step in the process, it represents the amount remaining after only 16 hours, not the full 24-hour period.
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