Explain The Ethical And Legal Implications Of The Scenario Y ✓ Solved

Explain the ethical and legal implications of the scenario you selected on all stakeholders involved

Jj is a 7-year-old male that has been dealing with asthma his entire life. Multiple treatments have been tried, which have helped symptoms, but nothing that works completely. You are treating him and know of a study regarding a new asthma medication being developed. This new medication contains a bronchodilator/steroid/antihistamine as an inhalation. None of the drugs being studied have previously been approved for children under the age of 12. The study would last for 16 weeks. Explain the ethical and legal implications of the scenario you selected on all stakeholders involved, such as the prescriber, pharmacist, patient, and patient’s family. Describe strategies to address disclosure and nondisclosure as identified in the scenario you selected. Be sure to reference laws specific to your state. Explain two strategies that you, as an advanced practice nurse, would use to guide your decision making in this scenario, including whether you would disclose your error. Be sure to justify your explanation. Explain the process of writing prescriptions, including strategies to minimize medication errors.

Sample Paper For Above instruction

The scenario involving JJ, a young child with persistent asthma, participating in a clinical trial for a novel medication underscores significant ethical and legal considerations that affecting all stakeholders—including the prescriber, pharmacist, JJ, and his family. These considerations revolve around patient safety, informed consent, legal compliance, and ethical duties to protect vulnerable populations, such as children, from potential harm while advancing medical research.

Ethically, the primary concern is respecting JJ’s best interests while balancing the potential benefits and risks associated with participation in the clinical trial. Informed consent is paramount; since JJ is a minor, his parents or legal guardians must provide consent based on comprehensive information about the experimental medication, including potential risks, benefits, unknowns (such as lack of approval for under-12), and alternatives. The principle of beneficence mandates that healthcare providers prioritize JJ’s safety, ensuring that the benefits justify any potential harm. Conversely, vigilance about possible adverse effects, especially in a pediatric population lacking prior approval, mandates close monitoring and the ability to withdraw from the study if necessary.

Legally, adherence to federal and state laws concerning clinical trials and pediatric research is essential. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Regulations of the Food and Drug Administration (FDA) stipulate strict guidelines for conducting pediatric trials, including obtaining appropriate informed consent and ensuring Institutional Review Board (IRB) approval. States may have additional statutes regarding minors’ participation in research, data privacy, and parental consent. For instance, some states require that research involving minors must demonstrate minimal risk or direct benefit to the child, which complicates the decision to enroll JJ in this experimental protocol.

The disclosure of information in this scenario must be transparent yet sensitive. Healthcare providers should fully disclose the experimental nature of the medication, including the lack of prior approval for children under 12, as well as the potential risks and unknowns. All stakeholders should be informed about the purpose of the research, the procedures involved, and the right to withdraw without penalty. Strategies for nondisclosure, such as withholding essential information, are ethically unacceptable and may lead to legal repercussions. The American Medical Association (AMA) Code of Medical Ethics emphasizes honesty in communication but also recognizes that disclosures should be adapted to the patient’s developmental level and family context.

As an advanced practice nurse, I would adopt several strategies to guide decision-making. First, I would advocate for thorough, age-appropriate informed consent discussions with JJ’s guardians, ensuring they understand the investigational nature of the drug, potential risks, and their right to decline participation or withdraw at any time. Second, I would remain vigilant about reporting any adverse effects or errors promptly to the relevant oversight bodies, such as the IRB and manufacturer, to ensure patient safety and compliance with legal requirements. In terms of ethical practice, transparency is crucial. If an error occurs, I would disclose it promptly to JJ’s family, explaining exactly what happened, its implications, and the measures taken to mitigate harm, thus maintaining trust and ethical integrity.

The process of writing prescriptions involves careful assessment of the patient’s medical history, current medications, allergies, and potential drug interactions. Strategies to minimize medication errors include verifying the right patient, drug, dose, route, and timing; utilizing electronic prescribing systems with decision support; double-checking prescriptions; and educating patients and caregivers about medication use. Implementing protocols such as barcode medication administration and standardizing dosing guidelines further reduce errors, especially in pediatric populations where dosing is often weight-based and more complex.

In conclusion, navigating the ethical and legal complexities of enrolling a child like JJ in an experimental drug trial requires meticulous attention to informed consent, adherence to laws, transparent communication, and diligent medication management. As healthcare providers, advanced practice nurses play a critical role in safeguarding patient rights and safety while contributing to medical advancements that could benefit future pediatric patients.

References

• American Medical Association. (2020). Code of Medical Ethics Opinion 5.3: Informed Consent. AMA Journal of Ethics.
• Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (1938).
• National Institutes of Health. (2018). Protection of Human Subjects in Research. NIH.gov.
• U.S. Food and Drug Administration. (2021). Pediatric Drug Development. FDA.gov.
• Chesney, M. A., et al. (2017). Ethical considerations in pediatric clinical trials. Journal of Pediatric Health Care, 31(4), 410-417.
• Beauchamp, T. L., & Childress, J. F. (2019). Principles of Biomedical Ethics. Oxford University Press.
• Levine, R. J. (2018). Ethics and Regulation of Clinical Research. Yale University Press.
• Sachs, C. (2019). Pediatric research ethics and regulations. Current Opinion in Pediatrics, 31(1), 132-137.
• Colby, S. M., & Lipkin, M. (2020). Legal protections for minors in research. Journal of Health Law & Policy, 23, 45-62.
• American Academy of Pediatrics. (2019). Pediatric Clinical Trials: Ethical and Regulatory Issues. Pediatrics, 143(4), e20183280.