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. Deficient knowledge may be a concern, but the primary focus here is on the safety risk associated with the side effects of the medication, particularly dizziness and orthostatic hypotension, which increase the risk of falls or injury.
B. Ineffective health maintenance is not specific to the medication side effects and does not directly address the patient's safety risk due to the medication.
C. Readiness for enhanced knowledge is more appropriate when the patient is already familiar with their condition and medication and is ready to learn more. This is not the case here, as the focus is on preventing harm from side effects.
D. Risk for injury is the most appropriate nursing diagnosis. Dizziness and orthostatic hypotension increase the risk of falls, which can lead to injury, making this the most relevant concern in this scenario.
Correct Answer is B
Explanation
a) The Physician's Desk Reference (PDR) is a valuable resource but is primarily designed for physicians. It contains drug manufacturer information but may lack nursing-specific details like patient education, nursing interventions, and administration guidelines.
b) A Nurse's Drug Guide/Handbook is the best resource for nurses because it includes essential nursing considerations such as patient education, side effects, contraindications, nursing interventions, and administration tips.
c) A drug package insert provides useful information but is not comprehensive and does not include nursing-specific recommendations. It primarily contains manufacturer-provided details on indications, dosing, and warnings.
d) Drug Facts and Comparisons is a resource primarily used by pharmacists for comparing medications rather than providing nursing-focused drug information.
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