Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment

Introduction

Advanced practice nurses have many responsibilities when treating patients. Drug prescription is one of the duties nurses can perform in several states, and this process always poses a risk of medical errors (Martyn et al., 2019). The reviewed case concerns JJ, a 7-year-old boy who experiences asthma that available medications cannot treat. The advanced practice nurse knows of a new inhaled medication containing a bronchodilator, steroid, and antihistamine, which is not yet approved for children under 12. The study will last 16 weeks.

A drug in development is not currently approved by the Food and Drug Administration (FDA), but the clinical study could ultimately help the patient deal with symptoms. Thus, the nurse encounters an ethical problem of whether to discuss this study with the patient and how to approach this information. Clinical studies on children are vital to examining their unique responses to medications, and the nurse should follow local disclosure and prescription laws when offering alternative solutions.

Ethical and Legal Implications: Impact on Stakeholders in the Selected Scenario

The selected scenario presents several ethical and legal implications for the persons involved. Firstly, the prescriber – the advanced practice nurse – has a duty to provide high-quality and safe patient care. Here, the risk of making a poor decision and exposing the child to a dangerous trial can be identified. Establishing patient or caregiver consent is vital to avoid legal problems if the trial does not deliver good results (de Araújo et al., 2019).

If the patient were enrolled in the clinical trial, the pharmacist, scholars, and the nurse would assume a degree of responsibility for treating the patient. However, as the participation is voluntary, the patient and his family have the authority to decide and cannot entirely shift the responsibility onto care providers. For all participants, the main concern is patient health, and every person has a certain degree of authority over the trial.

Disclosure and Nondisclosure Strategies: Navigating Ethical Challenges

Most states have different laws surrounding prescription, unapproved drugs, medical errors, and disclosure. For example, in Connecticut, nurses have a full range of practice, which allows them to prescribe and administer controlled substances (schedule II-V) (Legislative Commissioners Office, 2023). However, the FDA regulations allow prescribing only approved medications, as they have been tested and proven safe for patients. Some exceptions include a rare condition that cannot be treated with other drugs or a low supply of approved medicine (FDA, 2021).

The clinical trial for a new asthma medication and the patient’s unique case may fall under the first exception, thus allowing the nurse to consider this trial. The state’s laws of disclosure and nondisclosure state that medical facilities are required to disclose adverse events (Legislative Commissioners Office, 2023). However, the discussion surrounding medication errors is less transparent and based on national recommendations for openly discussing mistakes with patients. While the selected case is not concerned with medication errors, the knowledge of such laws is vital for the nurse to make an appropriate decision.

Decision-Making Strategies for Advanced Practice Nurses: Handling Errors and Disclosure

The case does not deal with a medication error, but the issue of disclosure still exists. I would rely on several strategies when choosing whether to suggest a clinical study or an experimental treatment to the patient. First, I would start reviewing the case by applying the best practice framework and reviewing all available safe and tested options. The recommendations for testing childhood asthma include a range of medications and their dosages, which one can use to create a care plan. In this case, however, it is determined that the patient’s symptoms do not subside with the help of available drugs, which indicates the need to look for additional solutions.

Prescription Writing Process: Strategies for Minimizing Medication Errors

The first approach leads me to decide to disclose experimental treatment options to the patient. The second strategy is to use the SHARE framework (seek, help, assess, reach, and evaluate), which includes the patient and family in the process (Agency for Healthcare Research and Quality, 2020). Using this approach, I would present the solutions to the patient and his family, answer their questions, and discuss the case to decide on the best option. The second strategy can help me resolve this challenging case while informing the patient’s family.

The nurse must emphasize patient safety and autonomy when writing prescriptions. Inappropriate treatment plans and medical errors can occur if one does not pay attention to patient needs or wishes or neglects available tools and other professionals’ expertise. Therefore, nurses should involve patients in prescription, examining their adherence rates and habits to ensure they take medication properly (de Araújo et al., 2019).

Furthermore, the prescribers must be attentive to patient data, such as comorbidities and drug interactions. Participation in a multidisciplinary team may also reduce medication errors, as it fosters collaboration and teamwork among various types of experts (de Araújo et al., 2019). For instance, the nurse may include a pharmacist who has in-depth knowledge of available drugs for the patient.

Conclusion

To conclude, the chosen case of a young patient being unsuccessfully treated with approved medication raises many ethical concerns for the prescriber and the patient’s family. The Advanced Practice Nurse has an opportunity to discuss a clinical trial for the patient, as the laws do not prohibit using unapproved drugs in rare situations. Nevertheless, the outcome depends on the patient and his guardians, while the nurse must inform the family about the possible options. The responsibility to disclose medical errors and adverse events is placed on the care provider if the latter had all available information and did not fully include the patient in the decision-making process. To prevent such issues, the nurse should involve the patient, collaborate with other experts, and thoroughly review all data.

References

Agency for Healthcare Research and Quality. (2020). The SHARE Approach: A model for shared decisionmaking – fact sheet. Web.

de Araújo, B. C., de Melo, R. C., de Bortoli, M. C., Bonfim, J. R. D. A., & Toma, T. S. (2019). How to prevent or reduce prescribing errors: An evidence brief for policy. Frontiers in Pharmacology, 10, 439. Web.

FDA. (2021). Unapproved drugs. Web.

Legislative Commissioners Office. (2023). Nursing. Web.

Martyn, J. A., Paliadelis, P., & Perry, C. (2019). The safe administration of medication: Nursing behaviours beyond the five-rights. Nurse Education in Practice, 37, 109-114. Web.

Cite this paper

Select style

Reference

StudyCorgi. (2024, December 11). Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment. https://studycorgi.com/ethical-considerations-in-advanced-practice-nursing-for-unapproved-drug-trials-in-pediatric-asthma-treatment/

Work Cited

"Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment." StudyCorgi, 11 Dec. 2024, studycorgi.com/ethical-considerations-in-advanced-practice-nursing-for-unapproved-drug-trials-in-pediatric-asthma-treatment/.

* Hyperlink the URL after pasting it to your document

References

StudyCorgi. (2024) 'Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment'. 11 December.

1. StudyCorgi. "Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment." December 11, 2024. https://studycorgi.com/ethical-considerations-in-advanced-practice-nursing-for-unapproved-drug-trials-in-pediatric-asthma-treatment/.


Bibliography


StudyCorgi. "Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment." December 11, 2024. https://studycorgi.com/ethical-considerations-in-advanced-practice-nursing-for-unapproved-drug-trials-in-pediatric-asthma-treatment/.

References

StudyCorgi. 2024. "Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment." December 11, 2024. https://studycorgi.com/ethical-considerations-in-advanced-practice-nursing-for-unapproved-drug-trials-in-pediatric-asthma-treatment/.

This paper, “Ethical Considerations in Advanced Practice Nursing for Unapproved Drug Trials in Pediatric Asthma Treatment”, was written and voluntary submitted to our free essay database by a straight-A student. Please ensure you properly reference the paper if you're using it to write your assignment.

Before publication, the StudyCorgi editorial team proofread and checked the paper to make sure it meets the highest standards in terms of grammar, punctuation, style, fact accuracy, copyright issues, and inclusive language. Last updated: .

If you are the author of this paper and no longer wish to have it published on StudyCorgi, request the removal. Please use the “Donate your paper” form to submit an essay.