Ethical and Legal Implications of a New Asthma Medication Study on Stakeholders

  The Ethical and Legal Implications of a New Asthma Medication Study on Stakeholders Introduction The scenario presented involves a 7-year-old male named JJ who has been suffering from asthma since birth. Despite multiple treatments, none have provided complete relief. As the healthcare provider treating JJ, you are aware of a new asthma medication study that includes a combination of bronchodilator, steroid, and antihistamine in an inhalation form. However, none of these drugs have been approved for children under the age of 12 before. This essay will explore the ethical and legal implications of this scenario on various stakeholders, including the prescriber, pharmacist, patient, and patient’s family. Ethical and Legal Implications Prescriber Ethical Implications: The prescriber faces the ethical dilemma of whether to enroll JJ in the study considering the potential risks involved. The prescriber must consider the best interests of the patient, balancing potential benefits with potential harm. Legal Implications: Prescribing a medication that is not yet approved for children under 12 may raise legal concerns. The prescriber must ensure that they adhere to state and federal laws regarding the use of investigational drugs in pediatric patients. Pharmacist Ethical Implications: The pharmacist has the responsibility to ensure the safety and efficacy of medications dispensed to patients. If the new asthma medication is not yet approved for children under 12, the pharmacist may face ethical concerns regarding dispensing it to JJ. Legal Implications: Dispensing a medication that is not approved for JJ’s age group may violate state and federal laws related to pharmacy practice. The pharmacist must ensure compliance with regulations to avoid legal repercussions. Patient and Patient’s Family Ethical Implications: The patient and their family must make an informed decision about participating in the study. They should be provided with all relevant information regarding potential risks, benefits, and alternative treatment options. Legal Implications: The patient’s family should be informed about the investigational nature of the medication and provide informed consent for participation in the study. The healthcare provider must ensure compliance with state and federal laws regarding informed consent in research involving minors. Strategies for Disclosure and Nondisclosure In this scenario, disclosure and nondisclosure play significant roles in ensuring the ethical and legal aspects are addressed appropriately. Here are some strategies to address them: Disclosure: Clearly communicate all relevant information to the patient’s family, including the investigational nature of the medication, potential risks, benefits, and alternative treatment options. Provide written materials or access to educational resources for the family to review and understand the study. Ensure that the family has ample time to ask questions and seek further clarification before making a decision. Document all discussions and decisions made with the patient’s family regarding participation in the study. Nondisclosure: Respect the confidentiality of patient information by adhering to HIPAA regulations. Only disclose patient information to individuals directly involved in the patient’s care or as required by law. Obtain informed consent from the patient’s family before sharing any personal information with external parties. Strategies to Guide Decision Making as an Advanced Practice Nurse As an advanced practice nurse, several strategies can guide decision-making in this scenario: Ethical Frameworks: Utilize ethical frameworks such as utilitarianism or deontology to evaluate the potential benefits and risks associated with enrolling JJ in the study. Consider the principles of autonomy, beneficence, non-maleficence, and justice when making decisions. Ensure that decisions are based on evidence-based practice, professional guidelines, and ethical standards. Consultation and Collaboration: Seek input from other healthcare professionals, such as pediatric pulmonologists or pharmacologists, to gain their expertise on the investigational medication and its potential suitability for JJ’s condition. Collaborate with JJ’s family in decision-making to ensure their values, preferences, and concerns are considered. Regarding disclosure of an error: If an error occurs during the study or treatment process, it is crucial to disclose it to both JJ’s family and relevant authorities, as required by state laws and professional standards. Disclosing errors promotes transparency, trust, and accountability in healthcare delivery. By acknowledging errors promptly, appropriate measures can be taken to rectify any harm caused and prevent future occurrences. Process of Writing Prescriptions and Strategies to Minimize Medication Errors The process of writing prescriptions involves several steps: Assessment: Conduct a comprehensive assessment of the patient’s medical history, current medications, allergies, and any other relevant clinical information. Diagnosis: Establish a clear diagnosis based on clinical findings and diagnostic tests. Selection: Select an appropriate medication based on the diagnosis, taking into account factors such as efficacy, safety profile, dosage regimen, route of administration, and potential interactions. Prescription Writing: Write a clear prescription using standardized formats, including essential information such as patient name, date of birth, medication name, dosage form/strength, dosage instructions, duration of treatment, and any necessary precautions. Strategies to minimize medication errors include: Double-checking prescriptions for accuracy and completeness before issuing them. Using computerized physician order entry (CPOE) systems to reduce transcription errors. Implementing effective communication channels between healthcare providers, pharmacists, and patients to clarify any uncertainties or concerns regarding prescriptions. Educating patients and their families about medication administration instructions and potential side effects. Regularly reviewing medication lists for potential drug interactions or duplications. In conclusion, the scenario involving a new asthma medication study for a 7-year-old patient presents ethical and legal implications for various stakeholders. Strategies such as disclosure, nondisclosure, ethical frameworks, collaboration, and consultation can guide decision-making as an advanced practice nurse. Additionally, minimizing medication errors through accurate prescription writing and effective communication channels is essential for patient safety.  

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