Regulatory, Ethical, and Professional Practice Issues
Decision-Making and Capacity
Decision-making capacity is task-specific and assessed clinically: the patient must understand the relevant information, appreciate the consequences, reason about options, and communicate a choice. Capacity differs from competence, which is a legal determination. When capacity is impaired and no surrogate exists, follow state law and ethics consultation. Advance directives include living wills and durable power of attorney for health care; POLST/MOLST forms translate goals into actionable orders for seriously ill patients.
Ethical Principles
Know autonomy, beneficence, nonmaleficence, and justice. Apply them to deprescribing, goals of care, and resource allocation. Informed consent requires disclosure, comprehension, voluntariness, and capacity. Confidentiality is governed by HIPAA; minimum necessary disclosure applies.
Regulatory Practice
Understand the role of the pharmacist in medication therapy management, collaborative practice agreements, and drug utilization review. Controlled substances are regulated under the Controlled Substances Act and state law; prescription drug monitoring programs should be checked. The FDA regulates labeling and postmarketing surveillance; off-label use is legal and sometimes evidence-based. Report adverse events through MedWatch. State boards of pharmacy govern licensure and scope.
Traps
Questions may conflate capacity with competence or assume a family member can automatically consent. Another trap is treating a POLST as a substitute for a discussion rather than a record of one.
Rule of Thumb
When a patient refuses a recommended treatment and capacity is intact, autonomy prevails after informed discussion; document the conversation. If capacity is questionable, assess the specific decision rather than the person globally.