Prescribing "Off-Label": What Should a Physician Disclose?

Katrina Furey1, Kirsten Wilkins2

  • 1Second-year resident in the Department of Psychiatry at Yale University School of Medicine in New Haven, Connecticut.

AMA Journal of Ethics
|June 21, 2016
PubMed
Summary

Physicians face dilemmas when treating rare diseases with no FDA-approved drugs, exploring off-label prescribing and shared decision-making for better patient outcomes.

Related Concept Videos

Ethical Standards II01:23

Ethical Standards II

Ethical standards are the backbone of nursing practice, guiding nurses as they interact with patients, families, and colleagues. These standards are crucial for providing safe, empathetic care centered on the patient's needs.
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
1.4K
Nursing Ethical Principles II01:27

Nursing Ethical Principles II

Ethical principles are essential in guiding nurses to fulfill their responsibilities, focusing on the quality of nursing care and decision-making. These principles, including autonomy, beneficence, non-maleficence, justice, and fidelity, shape the ethical framework within healthcare settings.
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's...
2.5K
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
1.4K
Ethics and Bioethics01:22

Ethics and Bioethics

Ethics is a philosophical study of moral actions. Ethics attempts to determine what is valuable for individuals and society. It examines the rational justification of moral judgments and analyzes what is morally just, fair, and right. Bioethics is a sub-discipline of applied ethics that analyzes the philosophical, social, and legal issues in life sciences and medicine. Ethical theories serve as a foundation for decision-making and represent the viewpoints from which people seek direction. They...
3.4K
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.9K
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
56