Release Date: April 23, 2020

Expiration Date: April 23, 2023

Amount of CME credit: 1.5 AMA PRA Category 1 Credits™

Amount of Nursing Contact Hours: 1.5 Contact Hours

Estimated Length of Time for Completion: 1.5 hours

Program Overview

This series of videos, recorded in late March and early April 2020, provides an overview of responses to the COVID-19 pandemic in the United States. It focuses on rationing and resource allocation, and on the FDA’s regulatory process for existing and investigational drugs that may be used to treat the disease.

Topics include:

  • Current rationing dilemmas and principles related to the COVID-19 outbreak.
  • Recommendations that arise from applying these principles to the COVID-19 pandemic.
  • Regulatory and ethical issues related to FDA authorization and approval of drugs to treat COVID-19.
  • Avenues through which clinicians and patients are able to access to potentially effective drugs.

Penn Med logoThis activity is co-provided by the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine Nursing.

Target Audience

Clinicians, administrators, and other stakeholders in decisions about rationing care and treating patients during the COVID-19 pandemic.

Educational Objectives

 After completing this course, you will be able to:

  • Explain dilemmas and principles relevant to rationing and resource allocation.
  • Explain distinctions in FDA drug regulation, including approval, authorization, and off-label use.
  • Explain the regulatory status of present and future drugs that could be used to treat COVID-19.
  • Outline recommendations for the rationing of medical supplies and care during the COVID-19 pandemic.

Accreditation and Designation of Credit

Physicians

The Perelman School of Medicine at the University of Pennsylvania is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Penn Medicine designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses

Penn Medicine Nursing is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.  Approval # 124-3-H-15.

Penn Medicine Nursing awards this activity 1.5 contact hours.

Physician Assistants

AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society.

PAs may receive a maximum of 1.5 Category 1 credits for completing this activity.

Meet the Faculty

Ezekiel J. Emanuel, MD, PhD

Ezekiel J. Emanuel, is the vice provost for Global Initiatives, the Diane v.S. Levy and Robert M. Levy University professor, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. He is also the special advisor to the director general of the World Health Organization. He is on leave for 2019–2021 from being the chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

From January 2009 to January 2011, Dr. Emanuel served as a special advisor on Health Policy to the Director of the Office of Management and Budget and National Economic Council. Prior to that, he was the founding chair of the Department of Bioethics at the National Institutes of Health from 1997 to August of 2011. 

Dr. Emanuel received his MD from Harvard Medical School and his PhD in political philosophy from Harvard University. He has published over 300 articles mainly on health care reform, research ethics, and end-of-life care. He has also authored or edited 13 books. His book, Prescription for the Future, identifies standout medical organizations that have achieved higher-quality, more patient-focused, and lower-cost care, and from their examples distills twelve transformational practices that could transform the entire health care sector. His new book, Which Country Has the World’s Best Health Care? was recently published by Public Affairs. Dr. Emanuel is the most widely cited bioethicist in history. 

Dr. Emanuel also serves as a venture partner at Oak HC/FT in addition to serving as a contributor for the New York Times and CNN. He is a member of the National Academy of Medicine, Association of American Physicians, the American Academy of Arts and Sciences, and the Royal College of Medicine. He turned down a Fulbright Fellowship. He is a 2018 recipient of the Dan David Prize in the category of Bioethics, an honor recognizing innovative and interdisciplinary research that cuts across traditional boundaries and paradigms. Dr. Emanuel received the 2020 Robert Wood Johnson Foundation David E. Rogers Award, given in partnership with the Association of American Medical Colleges, for his profound impact on research ethics, on bioethics training and institution-building, and on health care policy through his role in drafting the Affordable Care Act. And, he received the Lifetime Achievement Award from the American Society of Bioethics and Humanities, its highest honor.

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Holly Fernandez Lynch, JD, MBE

Holly Fernandez Lynch, JD, MBE, is an attorney-bioethicist and the John Russell Dickson, MD, Presidential Assistant Professor of Medical Ethics. She is also the assistant faculty director of Online Education in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine. Prof. Fernandez Lynch earned her BA, Master of Bioethics, and JD all from the University of Pennsylvania. Prior to returning to the university as a faculty member, she was executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She has also worked as an attorney in private practice focused on pharmaceuticals regulation, and as a bioethicist at the NIH’s Division of AIDS and President Obama's Commission for the Study of Bioethical Issues. 

Prof. Fernandez Lynch’s scholarly work focuses primarily on the ethics and regulation of human subjects research, as well as the law and ethics of conscientious refusals in health care. She is the founder and chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), established in 2018 to carry out an empirical research agenda to evaluate and improve the effectiveness of research ethics review and oversight by IRBs and Human Research Protection Programs. She has also served as a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) since 2014.  Prof. Fernandez Lynch’s work has been published in leading bioethics, medical, and law journals, including JAMA; The New England Journal of Medicine; Science; Health Affairs; The Journal of Law, Medicine, and Ethics; and The American Journal of Bioethics, in addition to popular outlets such as The New York Times, The Boston Globe, and STAT. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise (MIT Press 2008), as well as the co-editor of books covering human subjects research regulation; FDA regulation of drugs and new technologies; health law and behavioral economics; law, religion, and health; biospecimen research; big data, health law, and bioethics; and transparency in health care (forthcoming). 

Within the department’s online education initiatives, Prof. Fernandez Lynch plays a primary role in supporting the academic progress of students pursuing the Master of Health Care Innovation. She is also the curriculum director of online medical ethics education, overseeing the training of Penn medical students in clinical and research ethics. 

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Disclosures

The planning committee members have disclosed that they have no relevant financial relationships with any commercial interests related to the content of this educational activity:

  • Holly Fernandez Lynch, JD, MBe 
  • Steven Joffe, MD, MPH 
  • Connie Ulrich, PhD, MSN 
  • Adam Zolkover, MA 
  • Laura C. Hart, MFA 

The faculty involved with this activity have reported that their presentations contain no mention of investigational and/or off-label use of products.

Acknowledgment of Commercial Support

There was no commercial support used in the development of this educational activity.

Contact

If you have questions, please contact Caitlin O'Neill, Program Manager for Online Educational Initiatives, at 215-746-3971 or MEHPonline@pennmedicine.upenn.edu.

For questions related to this educational activity, contact Penn Medicine Continuing Medical and Interprofessional Education at the Perelman School of Medicine at the University of Pennsylvania at penncme@pennmedicine.upenn.edu or at 215-898-8005.