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) Lung function primarily affects gas exchange and respiratory function but does not significantly influence drug absorption.
b) Kidney function is important for drug excretion rather than absorption. It impacts drug elimination and toxicity risk rather than how well a drug is absorbed.
c) Liver function plays a key role in drug metabolism. Poor liver function can alter drug absorption and metabolism, particularly for orally administered drugs that undergo the first-pass effect.
d) The route of administration directly impacts drug absorption. For example, intravenous (IV) drugs bypass absorption entirely, while oral medications must go through the digestive system before entering circulation.
Correct Answer is ["C","D"]
Explanation
A. A generic drug name is not a registered trademark. It is a non-proprietary name, and a trademark is specific to a brand-name drug.
B. Generic drug names are not capitalized. Brand names are capitalized, but generic names are written in lowercase.
C. The generic name often reflects the drug’s chemical structure or its pharmacological classification, which helps identify the active ingredient.
D. Generic names are non-proprietary, meaning they are not owned by any one company and can be used by multiple manufacturers once the patent for the brand-name drug expires.
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