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.

Answer and Explanation

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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Correct Answer is A

Explanation

A. The FDA is responsible for regulating and ensuring the safety and efficacy of drugs, medical devices, and other health-related products. All medications must undergo rigorous scientific testing and approval processes overseen by the FDA before they can be marketed to the public.
B. The DEA regulates controlled substances and enforces laws related to drug abuse, but it does not control the scientific testing of medications.
C. The CDC focuses on public health and disease prevention, not the regulation or testing of medications.
D. The Joint Commission accredits healthcare organizations but does not directly oversee the scientific testing of medications.

A. Bioavailability B. Critical concentration C. Distribution D. Half-life

Correct Answer is A

Explanation

A. Bioavailability refers to the proportion of a drug that enters systemic circulation and is available for therapeutic effect. Generic drugs must demonstrate bioequivalence to brand-name drugs, meaning their bioavailability must be within an acceptable range to ensure similar efficacy.

B. Critical concentration is the minimum drug level required to produce a therapeutic effect, but it is not the primary factor in generic drug substitution.

C. Distribution refers to how a drug is transported in the body after absorption, but it is not the main concern when substituting generic drugs.

D. Half-life is the time required for the drug concentration to decrease by half in the body, but it does not determine whether a generic drug can replace a brand-name drug. Bioavailability is the key factor in ensuring therapeutic equivalence.

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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?

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Naxlex Comprehensive Predictor Exams

In response to the patient's question about how to know whether drugs are safe, the nurse explains that all medications undergo rigorous scientific testing controlled by what organization?

Correct Answer is A

Explanation

What concept is considered when generic drugs are substituted for brand-name drugs?

Correct Answer is A

Explanation

Which law(s) govern all drug administration by nurses?

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