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 A
Explanation
a) Phase III clinical trials involve large groups of human participants and focus on confirming the drug's effectiveness and monitoring for adverse effects. The nurse plays a key role in observing and documenting any side effects experienced by the patients.
b) Working with animals is part of preclinical trials, not phase III studies. By the time a drug reaches phase III, it has already undergone animal testing.
c) While data collected in phase III trials contribute to determining a drug’s effectiveness, the decision-making is primarily done by researchers and regulatory agencies, not individual nurses.
d) Selection of appropriate clients for a drug study is generally determined by researchers and trial coordinators based on inclusion and exclusion criteria, rather than by nurses directly.
Correct Answer is B
Explanation
a) Assessment involves gathering and analyzing data about the patient, such as their living situation, memory issues, and medication regimen, but it does not include developing a strategy to address these concerns.
b) Planning is the phase where the nurse develops interventions to help the patient manage their medications safely. By creating a medication chart and involving a family member, the nurse is ensuring adherence to the prescribed regimen.
c) Evaluation occurs after implementation to assess the effectiveness of the plan, such as checking if the patient is taking the medications correctly.
d) Implementation involves carrying out the planned interventions, such as physically setting up the pill organizer or educating the patient on medication use.
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