Ethical and Legal Implications of Prescribing Drugs
What type of drug should you prescribe based on your patient’s diagnosis? How much of the drug should the patient receive? How often should the drug be administered? When should the drug not be prescribed? Are there individual patient factors that could create complications when taking the drug? Should you be prescribing drugs to this patient? How might different state regulations affect the prescribing of this drug to this patient?These are some of the questions you might consider when selecting a treatment plan for a patient.Photo Credit: Getty Images/CaiaimageAs an advanced practice nurse prescribing drugs, you are held accountable for people’s lives every day. Patients and their families will often place trust in you because of your position. With this trust comes power and responsibility, as well as an ethical and legal obligation to “do no harm.” It is important that you are aware of current professional, legal, and ethical standards for advanced practice nurses with prescriptive authority. Additionally, it is important to ensure that the treatment plans and administration/prescribing of drugs is in accordance with the regulations of the state in which you practice. Understanding how these regulations may affect the prescribing of certain drugs in different states may have a significant impact on your patient’s treatment plan. In this Assignment, you explore ethical and legal implications of scenarios and consider how to appropriately respond.To PrepareReview the Resources for this module and consider the legal and ethical implications of prescribing prescription drugs, disclosure, and nondisclosure.Review the scenario assigned by your Instructor for this Assignment.Search specific laws and standards for prescribing prescription drugs and for addressing medication errors for your state or region, and reflect on these as you review the scenario assigned by your Instructor.Consider the ethical and legal implications of the scenario for all stakeholders involved, such as the prescriber, pharmacist, patient, and patient’s family.Think about two strategies that you, as an advanced practice nurse, would use to guide your ethically and legally responsible decision-making in this scenario, including whether you would disclose any medication errors.BELOW IS THE QUESTION————–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.BELOW IS THE REQUIRED READING————————–Learning ResourcesRequired Readings (click to expand/reduce)Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.Chapter 1, “Prescriptive Authority” (pp. 1-3)Chapter 2, “Rational Drug Selection and Prescription Writing” (pp. 4-7)Chapter 3, “Promoting Positive Outcomes of Drug Therapy” (pp. 8-12)Chapter 4, “Pharmacokinetics, Pharmacodynamics, and Drug Interactions” (pp. 13-33)Chapter 5, “Adverse Drug Reactions and Medication Errors” (pp. 34-42)Chapter 6, “Individual Variation in Drug Response” (pp. 43-45)American Geriatrics Society 2019 Beers Criteria Update Expert Panel. (2019). American Geriatrics Society 2019 updated AGS Beers criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society, 67(4), 674-694. doi:10.1111/jgs.15767American Geriatrics Society 2019 updated AGS Beers criteria for potentially inappropriate medication use in older adults by American Geriatrics Society, in Journal of the American Geriatrics Society, Vol. 67/Issue 4. Copyright 2019 by Blackwell Publishing. Reprinted by permission of Blackwell Publishing via the Copyright Clearance Center.This article is an update to the Beers Criteria, which includes lists of potentially inappropriate medications to be avoided in older adults as well as newly added criteria that lists select drugs that should be avoided or have their dose adjusted based on the individual’s kidney function and select drug-drug interactions documented to be associated with harms in older adults.Drug Enforcement Administration. (2021). CFR – Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1300This website outlines the code of federal regulations for prescription drugs.Drug Enforcement Administration. (n.d.-a). Mid-level practitioners authorization by state. Retrieved May 13, 2019 from http://www.deadiversion.usdoj.gov/drugreg/practioners/index.htmlThis website outlines the schedules for controlled substances, including prescriptive authority for each schedule.Drug Enforcement Administration. (2006). Practitioner’s manual. Retrieved from http://www.legalsideofpain.com/uploads/pract_manual090506.pdfThis manual is a resource for practitioners who prescribe, dispense, and administer controlled substances. It provides information on general requirements, security issues, recordkeeping, prescription requirements, and addiction treatment programs.Drug Enforcement Administration. (n.d.-b). Registration. Retrieved February 1, 2019, from https://www.deadiversion.usdoj.gov/drugreg/index.htmlThis website details key aspects of drug registration.Fowler, M. D. M., & American Nurses Association. (2015). Guide to the code of ethics for nurses with interpretive statements: Development, interpretation, and application (2nd ed.). American Nurses Association.This resource introduces the code of ethics for nurses and highlights critical aspects for ethical guideline development, interpretation, and application in practice.Institute for Safe Medication Practices. (2017). List of error-prone abbreviations, symbols, and dose designations. Retrieved from https://www.ismp.org/recommendations/error-prone-abbreviations-listThis website provides a list of prescription-writing abbreviations that might lead to misinterpretation, as well as suggestions for preventing resulting errors.Ladd, E., & Hoyt, A. (2016). Shedding light on nurse practitioner prescribing. The Journal for Nurse Practitioners, 12(3), 166-173. doi:10.1016/j.nurpra.2015.09.17This article provides NPs with information regarding state-based laws for NP prescribing.Sabatino, J. A., Pruchnicki, M. C., Sevin, A. M., Barker, E., Green, C. G., & Porter, K. (2017). Improving prescribing practices: A pharmacist‐led educational intervention for nurse practitioner students. Journal of the American Association ofNursePractitioners, 29(5), 248-254. doi:10.1002/2327-6924.12446The authors of this article assess the impact of a pharmacist‐led educational intervention on family nurse practitioner (FNP) students’ prescribing skills, perception of preparedness to prescribe, and perception of pharmacist as collaborator.BELOW IS THE SCENARIO FOR THE ASSIGNMENT———— CORE SKILL: locating the specific ETHICAL PRINCIPLE and the specific LEGAL RULE at stake — not gesturing at “ethics” in general.
THE SCENARIO TYPES this assignment uses and what each raises: prescribing errors; disclosure of an error to a patient; prescribing for a family member or oneself; a colleague’s impairment; a patient requesting a drug that isn’t indicated; off-label prescribing; controlled-substance diversion; pharmaceutical industry gifts and conflict of interest; prescribing across state lines / telehealth licensure.
ETHICAL FRAMEWORK: the four principles (autonomy, beneficence, nonmaleficence, justice) plus VERACITY (truthfulness) and FIDELITY. The ANA Code of Ethics — cite the actual provision, not the document generically (Provision 3 covers advocacy and patient protection; Provision 4 covers accountability and responsibility for practice).
THE ERROR-DISCLOSURE QUESTION, since it’s the most common scenario: the ethical answer is DISCLOSURE, grounded in veracity and autonomy — and the evidence supports it pragmatically too. “Apology laws” exist in most states (rendering expressions of sympathy inadmissible), and communication-and-resolution programs (the University of Michigan model is the standard citation) show that HONEST DISCLOSURE PLUS APOLOGY REDUCES litigation and cost rather than increasing it. Clinicians’ intuition here is backwards, and saying so with evidence is a strong move. Distinguish DISCLOSURE (to the patient — a duty) from REPORTING (to the institution/incident system — also a duty, but a different one), and connect to JUST CULTURE: distinguishing human error (console and support), at-risk behavior (coach), and reckless behavior (discipline). Punishing honest error destroys reporting and therefore destroys safety.
LEGAL LAYER — be specific: state Nurse Practice Act and the SCOPE OF PRACTICE it defines; prescriptive authority (full, reduced, or restricted practice authority — VARIES BY STATE, and naming your state’s actual status is what the rubric wants); collaborative practice agreements; DEA registration and controlled-substance schedules I–V; PRESCRIPTION DRUG MONITORING PROGRAMS (mandatory query in most states); the Controlled Substances Act; HIPAA; and malpractice elements — DUTY, BREACH, CAUSATION, DAMAGES (all four required; a breach without causation is not malpractice, and students routinely omit causation).
OFF-LABEL PRESCRIBING: legal and common; not FDA-approved for that indication but not prohibited. The obligations are (1) an evidence basis, (2) DISCLOSURE to the patient that use is off-label, and (3) documentation of the rationale.
STRATEGIES TO PREVENT ERRORS — go beyond “be careful”: avoid dangerous abbreviations (the ISMP “do not use” list — U for units, QD, trailing zeros); use TALL-MAN LETTERING for look-alike/sound-alike drugs; independent double-checks for high-alert medications; CPOE with clinical decision support; MEDICATION RECONCILIATION at every transition of care (the single highest-yield intervention); teach-back with the patient; and awareness of ALERT FATIGUE, which undermines the very decision support meant to protect you.
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