Pennsylvania Health Care Worker Flu Immunization Campaign A Patient Safety & Employee Health Initiative Training Resources: Ethics Module Version 1.4 June 2011

Role of Bioethics in HCW Flu Vaccination Bioethics as strategy to apply clear thinking to decision-making and implications of decisions: - Testing against ethical principles can provide guidance – not the same as “legal finding Center for Vaccine Ethics and Policy/Penn following this issue for several years - Not entirely neutral given the evidence This exercise to orient meeting participants at very high level to ethical frameworks and how they link Your programs WILL encounter ethical issues…even dilemmas!!

Vaccination Requirements and Mandates: Ethical Frameworks and Principles Harm Principle Effectiveness Proportionality Necessity Infringement Public Justification Autonomy Beneficence Nonmaleficence Justice Professional Codes of Ethics Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 3

Bioethical ‘Principles’ Applied Autonomy – Respect individual choice and freedom to decline any health intervention Beneficence – Do good that benefits others, including prevention or removal of harms (safety) (also “rescue imperative” - no cost is too great to save a human life) Nonmaleficence – “Do no harm” and, by implication, assure patient safety Justice – Fair allocation of health care resources to assure that good is done fairly across populations and other contexts Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 See Beauchamp, TL, Childress, JF Principles of Biomedical Ethics

Harm Principle John Stuart Mill, On Liberty: “The only purpose for which power can be rightly exercised over any member of a civilized community against his will is to prevent harm to others.” Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011

Harm Principle Tipping points: A known threat or harm to others can be avoided by exercise of such power (e.g. mandated vaccination) Form of exercise does not imperil or risks are known and accepted Professional duty/accepted code of ethics or conduct already address issue at some fundamental level Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011

Professional Codes of Ethics Unique status of professional codes of ethics Developed and agreed to by members of a profession Reflect standards and norms that members of a profession accept as central to their professional duties Supplement/complement general ethical norms Hippocratic Oath (5th c. BC); AMA Code of Ethics (1847); ANA Code of Ethics (1995) Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011

AMA Code of Medical Ethics American Medical Association: “A physician must recognize responsibility to patients first and foremost.” “A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health.” “To preserve the quality of their performance, physicians have a responsibility to maintain their health and wellness… When health or wellness is compromised, so may the safety and effectiveness of the medical care provided.” Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 From AMA Code of Medical Ethics From AMA Code of Medical Ethics

Code of Ethics for Nurses (ANA) American Nurses Association: -- “The nurse’s primary commitment is to the patient, whether an individual, family, group or community.” -- “The nurse promotes, advocates for, and strives to protect the health, safety, and rights of the patient.” Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 From ANA Code of Ethics for Nurses

Ethicists on Health Care Worker Influenza Vaccination Mandates “Health care workers' own code of ethics dictates that they put the interests of others — their patients — first. “Getting a flu shot is the least those who claim to be bound by professional ethics ought to do.” - Art Caplan, Penn Center for Bioethics MSNBC.com, 8 October 2009 Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 10

Professional Codes of Ethics Challenges: Translating general statements about obligations of health care personnel to patients and selves to specific applications (e.g., influenza vaccination); who decides? Extending obligation to receive vaccine based on duty to patients to other personnel working in health care facilities (including those not part of a health profession, per se) Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011

General Principles: “Tests” Effectiveness – Infringement will probably protect public health Proportionality – Probable public health benefits outweigh infringed moral consideration Necessity – Absence of other effective, proportionate strategies to attain desired public health goal Least Infringement – Designed to minimize degree of infringement Public Justification – Transparency and explanation of infringement—essential to trust and accountability Adapted from: Jason L. Schwartz, MBE, AM, Center for Bioethics; Department of History & Sociology of Science University of Pennsylvania NVAC Health Care Personnel Influenza Vaccination Subgroup 31 May 2011 Childress, et al. “Public Health Ethics: Mapping the Terrain,” Journal of Law, Medicine, and Ethics, 2002

Observations I Vaccination requirements for HCWs well-established New requirements/mandates for any vaccination should meet critical tests against bioethics and other societal principles Responsibility for patient safety empowers health care providers to take prudent action: work rules, mandates, etc. Assuring HCW flu vaccination levels appropriate to patient safety falls within this empowerment

Observations II Patient safety imperative implies that work rules, immunization requirements, etc. could and should apply to all who can compromise safety Irresponsible to allow conditions which compromise patient safety to continue where corrective action is available, safe, affordable, effective

Observations III No compelling argument encountered to date that mandated programs are “unethical” per se Does not mean that any given program (voluntary OR mandated) is free from questionable/unethical policies, practices… Each program and new element must face the same tests…patient safety imperative does not mean “no challenges allowed” Case studies in this training offer a range of options…no cookie cutter solutions but templates for effective action!

Group Exercise Share an example of an “ethical” issue or challenge you and your institution faced in your current HCW flu vaccination program… How was it addressed and who addressed it? Share an example of an ethical challenge ahead, perhaps a new program element for the 2011/12 season, or one you think might emerge if you move towards a mandated program… We will use these examples to build a collection of “ethical issues and (potential) answers” for the website