The nurse, assisting with Phase I drug studies, is talking with a woman who asks, “Why can't I participate in this study”? What would be the nurse's best response?
Drugs affect women differently than they affect men.
Women are more prone to adverse effects from medications.
Drugs are only tested on men because they are stronger.
Drugs pose a greater risk to women of reproductive age.
The Correct Answer is D
a) While men and women may metabolize drugs differently, this is not the primary reason why women are often excluded from Phase I drug trials.
b) Women are not necessarily more prone to adverse effects, but concerns about fetal exposure and reproductive risks have historically limited women's participation in early trials.
c) This statement is incorrect and misleading. Drug trials are not based on strength but rather on safety, ethical concerns, and risk of reproductive harm.
d) Phase I studies test drugs on healthy volunteers, and historically, women of childbearing age were excluded due to concerns about potential teratogenic effects and unknown risks to a developing fetus. Although regulations have changed, caution is still exercised when including women in early-stage drug trials.
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Related Questions
Correct Answer is D
Explanation
a) Children can participate in clinical drug trials when appropriate consent is obtained from parents or guardians and when the study complies with ethical guidelines. They are not excluded from trials entirely because they cannot give consent.
b) Children can participate in various types of clinical studies, not just quasi-experimental ones, as long as the study follows ethical and legal guidelines for pediatric research.
c) Data from adult clinical trials cannot always be directly applied to children due to physiological differences. Pediatric drug testing is necessary to ensure drugs are both safe and effective for children.
d) Federal law mandates that drugs for children undergo testing in pediatric populations. This is to ensure that drugs are safe and effective for children, as they may respond differently than adults to medications.
Correct Answer is B
Explanation
A. Washing hands before handling medications is essential for infection control but is not the priority action in this scenario. Ensuring drug compatibility is crucial to prevent adverse interactions.
B. When administering two drugs simultaneously, the nurse’s priority is to determine if they are compatible, particularly for IV medications. Some medications can precipitate or cause harmful interactions when mixed, leading to reduced efficacy or adverse effects. Consulting a drug guide ensures safe administration.
C. Checking for drug allergies is important before giving any medication, but it is not the priority in this specific situation. Compatibility must be assessed first to ensure the drugs can be given together safely.
D. Identifying the patient is always necessary for safe medication administration, but in this case, ensuring drug compatibility is the first step before proceeding with administration. If the drugs are incompatible, the nurse must take alternative actions before giving them to the patient.
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