Ethical and Legal Implications of Prescribing Drugs
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.Write a 2- to 3-page paper that addresses the following:
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.
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Introduction
The significance of ethical, legal, and medical considerations that clinicians give to the use of off-label drugs and drugs with known adverse effects is “above all, do no harm.” Also known as the principle of non-maleficence, in practice, it encourages nurses to prioritize the safety of patients while preventing damage or injury (Arcangelo et al., 2017). As a result, over the years, patient safety has been the most emphasized component of healthcare quality across the globe. In this paper, the author analyzes the ethical and legal implications of prescribing drugs not yet approved for clinical use in the pediatric population. The author also discusses the strategies nurses can employ to address disclosure and non-disclosure and guide decision-making. Nurses should recognize clinical dilemmas related to prescribing drugs in clinical practice, and make appropriate decisions based on their values and laws that govern nursing practice.
Case Overview
The case study involves a 7-year-old male J.J who has been dealing with asthma for the entire of his life. Although he has received multiple treatments that have helped immensely for symptomatic relief, no treatment has proven to work. During routine care as the author manages him, I recall of study about the development of a new drug for asthma, which comprises of both a bronchodilator/steroid/antihistamine, administered through inhalation, and yet to be approved for use in children aged less than 12 years. On the other hand, the study would last for 16 weeks.
Ethical and Legal Implications of Selected Scenario
Prescriber
Nurses have an ethical and legal obligation to safeguard patients from preventable harm. In the context of the selected case scenario, nurses have a legal and ethical responsibility to educate patients about their condition, available management options approved by the FDA, and those not yet approved by the FDA. To safeguard patients from possible harm, the prescriber should due their due diligence to evaluate the benefits versus the risks of a drug not yet approved for use, using the most recent and best available evidence. For patients with chronic or long-term illnesses such as asthma, the prescriber should evaluate the patient for potential factors that could be influencing poor outcomes such as exposure to triggers and non-adherence (Mitchell & Oliphant, 2016). Failure to safeguard a patient from possible harm that may result from intake of a drug not approved by the FDA for asthma can result in legal charges for the prescriber. Ultimately, the state in which the prescriber practices can revoke his/her practices license.
Pharmacist
Pharmacists have a broad scope of knowledge on the drugs currently approved by the FDA to manage different conditions including the five rights of medication administration. In practice, pharmacists are legally obligated to ensure that the clinician prescribes the right drug for the right diagnosis and patient (Mitchell & Oliphant, 2016). For off-label drugs, pharmacists have a professional role to evaluate their risks versus benefits and advice otherwise, before dispensing. Going against the aforementioned responsibilities can result in loss of a practice license authority.
Patient and Patient’s Family
Patients have a right to information. When seeking care, the nurse should discuss and evaluate patients’ physical, emotional, social, and psychological needs, and address them appropriately using a holistic approach (Clark, 2018). The nurse must share the information obtained from the evaluation such as the diagnosis, the available and alternate management options, with respective side effects with the patient. Although this patient is a minor, the nurse should share the same information with both the child and caregiver to enhance self-care efforts in the management of asthma. If the nurse proceeds to prescribe the new drug without sharing this information, it not only violates patient’s right to informed consent, but also the principle of justice. Ultimately, any associated adverse outcome can result in additional health-related costs for the patient and the family. From a legal perspective, the family can take legal action against the hospital and the prescriber.
Strategies to Address Disclosure and Non-Disclosure
The author’s state NPA (Nursing Practice Act) requires that nurses should comprehensively discuss the indication, risks, benefits, mode of action, and method of administration of every drug that a nurse prescribes. For drugs under clinical investigation, the act further requires that all nurses practice ethical prescribing by; obtaining informed consent from the patient (legal caregiver), confirming the diagnosis, demonstrating that current management methods are not satisfactory, obtaining concrete information from credible sources on the drug’s safety and usefulness.
Strategies to Guide Decision Making
To decide whether to prescribe the new drug in the selected scenario, the author would share with the patient all the relevant details of the new drug, and request the need to consult a more experienced specialist. During the consultation, the nurse would share the details of the new drug as well as the study as this approach aligns with the State’s NPA. If upon completion of the consultation it emerges that the benefits of the new drug outweigh the risks with the consent of the legal caregiver, the author would proceed to prescribe it. If vice versa, the author would reconsider evaluating the patient for other factors could be influencing a poor prognosis.
Process of Writing Prescriptions
When writing a prescription, Arcangelo et al., (2017) recommend that clinicians should follow the following six steps;
- Determine the issues that a patient has
- Evaluate the therapeutic objectives
- Select the right drug
- Start therapy using the right information
- Share/educate the patient on possible risks, adverse effects, benefits, and warnings
- Conduct regular follow-up
References
Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins.
Clark, J. (2018). Rational prescribing in primary health care. In Releasing Resources to Achieve Health Gain (pp. 31-36). CRC Press.
Mitchell, A., & Oliphant, C. M. (2016). Responsibility for Ethical Prescribing. The Journal for Nurse Practitioners, 12(3), A20.
