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Case Report: Consent for the Use of Off-Label Drugs and Devices (1 hour Monograph)

Hours: 1.00

Best suited for: Practicing and resident physicians of all specialties prescribing drugs or devices for off-label use. Other interested healthcare practitioners are also welcome to participate.

Description: Most patients believe that all prescriptions are approved by the FDA when, in fact, many drugs and devices commonly prescribed are used off-label (not for an FDA approved use, location, condition or population). The FDA status of these drugs and devices is not often disclosed to the patient. When an off-label use causes an untoward effect, patients are commonly surprised to learn of the undisclosed FDA status. This often leads to a claim for malpractice. However, the legal cases are mixed on whether the FDA status should be part of patient consent. The prescriber should consider both the legal and the ethical requirements determining whether a patient must specifically consent to an off-label use.

Original Release Date: October 11, 2016
Review Date: 
Expiration Date: October 11, 2019

Learning Outcome: 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.

Learning Assessment: There will be a post test for this activity with a minimum performance requirement of 8 out of 10 correct answers.

Estimated time to complete activity: 1 hour

CME Information - Read

Residents will earn a certificate of completion. Physicians will earn CME credit. 

Method and Medium: To obtain CME credit, view the entire online presentation, complete the evaluation and post test and print your certificate online.

CME Credit: 1.0


MOC Approved: Through the American Board of Medical Specialties ("ABMS") and Association of American Colleges' ("AAMC") joint initiative (ABMS MOC Directory) to create a wide array of Maintenance of Certification ("MOC") Activities, ' . (NEW) Case Report: Consent for the Use of Off-Label Drugs and Devices (1 hour Monograph) . ' has met the MOC requirements as a MOC Part II CME Activity (apply toward CME requirement) by the following ABMS Member Boards:

  • American Board of Family Medicine
  • American Board of Ophthalmology
  • American Board of Psychiatry and Neurology
  • American Board of Radiology
  • American Board of Thoracic Surgery
  • American Board of Urology



State Requirements: Based on information from state licensing authorities published by the AMA, this program meets specific CME requirements for the following states:

Connecticut - This activity includes content in Risk Management
Massachusetts - This activity includes content in Risk Management
Pennsylvania - This activity includes content in Risk Management / Patient Safety
Texas - This activity includes content in Ethics and/or Professional Responsibility

CME Disclosure Policy: LAMMICO requires planners, speakers, faculty and all those who influence the content of a CME activity to disclose any financial relationships they have with commercial interests that are relevant to the CME activity. The disclosures shall be reviewed for any conflict of interest and subject to a mechanism for resolution of conflict of interest. A disclosure statement of relevant financial relationships will be made to the audience prior to the activity.

Disclosure: The author, editors and planning committee members for this activity have no relevant financial relationships to disclose.

Author: Karen Duncan, RN, Attorney at Law  - Read Bio

Editor: Karen K. Davis, MA, CPHRM - Read Bio

Managing Editors: Dawer Azizi, MHA, CPHRM, LAMMICO Director of Risk Management

Sharon Cusanza, MSN, RN, NEA-BC, LAMMICO Senior Risk Management Education Specialist

Content Advisors/Planning Committee Members - Read

Electronic Hardware and Software Requirements - Read

Web Master Contact Information: For assistance, contact Shea Ivey at 866/398-1038 or help@medicalinteractive.com

Disclaimer: This activity is presented as risk management education. It is not legal advice, nor does it establish medical standards of care. Standards of care vary depending on the unique presentation of each patient. The information contained herein is not a substitute for the reasonable discretion of skilled and informed clinicians at the point of care.

Copyright Information: Copyright © 2016

Bibliography: To view and download References & Resources for this presentation, please select the References tab/link below.

Member and Subscriber Access
Interested in a CME program like this for your team or facility? Contact us to schedule it and talk about pricing.

This course is offered through Experix, a wholly owned subsidiary of Physicians Insurance, and is based on more than 30 years' experience in providing continuing medical education. This course is complimentary for Physicians Insurance members.

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