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 D

Explanation

a) Phase I studies focus on assessing the safety, dosing, and side effects of a drug in healthy volunteers, not its clinical effectiveness or potential new uses.

b) Phase II studies evaluate the drug's effectiveness and safety in a small group of patients with the targeted condition but do not focus on potential new uses.

c) Phase III studies are large-scale trials conducted to confirm the drug's effectiveness and safety before approval but do not typically involve studying new uses of the drug.

d) Phase IV studies occur after a drug has been approved and marketed. These studies, often called post-marketing surveillance, evaluate the drug's effectiveness and safety in the general population and investigate new potential uses or long-term effects.

A. "I should insert the needle and inject the medication without aspirating for blood." B. "I should put firm pressure on the injection site to decrease the risk for bleeding." C. "I will insert the needle at a 10-degree angle when injecting." D. "The subcutaneous route is used because absorption is faster this way."

Correct Answer is A

Explanation

A. When administering subcutaneous heparin, aspiration should be avoided because it can cause tissue damage and increase the risk of hematoma formation. This statement correctly reflects safe administration technique.

B. Firm pressure on the injection site is not recommended after heparin administration because it can increase the risk of bruising and bleeding. Instead, gentle pressure should be applied if necessary.

C. Subcutaneous injections should be given at a 45- to 90-degree angle, depending on the patient’s body mass. A 10-degree angle is too shallow and may result in improper medication delivery.

D. The subcutaneous route does not provide faster absorption than other routes such as intravenous or intramuscular. Instead, it allows for slow, steady absorption, which is desirable for anticoagulants like heparin.

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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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Correct Answer is A

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