Activity ID



August 7, 2022

Format Type


CME Credit



CME Provider

Louisiana Medical Mutual Insurance Company (LAMMICO)


“Off-label use” is not a phrase that many patients have heard from prescribing practitioners but, when there has been an untoward effect, it has led to claims of malpractice. Many drugs and devices commonly prescribed are used off-label (as defined by the FDA) but this fact is not often disclosed to patients. Legal and ethical considerations for disclosure of FDA status and patient consent are examined in this education to help guide the practitioner.

Diplomate Engagement

Correct answers to the post-test; Comparative performance to peers; Recommended literature or other resources (presentations, audio/video, checklists, etc.); Post-activity follow up

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NOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.

Educational Objectives

Prior to prescribing drugs or devices for purposes that are considered "off-label use," both legal and ethical considerations will be used to determine the extent of disclosure and patient consent necessary


Consent, Off-Label, Prescribing, Drugs, Devices, FDA, Disclosure, Medical Ethics, Ethics, Informed Consent, Off-Label Use, Materiality, FDA Approval


Interpersonal & Communication Skills, Patient Care & Procedural Skills, Professionalism

CME Credit Type

AMA PRA Category 1 Credit

Practice Setting

Academic Medicine, Inpatient, Outpatient, Rural, Urban, VA/Military

National Quality Strategies and/or Quadruple Aim Care Processes

Physician-Patient Relationship, Medical Ethics

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