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Council On Ethical And Judicial Affairs Open Forum

In conformity with Resolution 14 (I-94), which requires the Council on Ethical and Judicial Affairs (CEJA) to "conduct an Open Forum at all future meetings for the purpose of discussing pending ethical opinion issues," the 2015 Interim Meeting Open Forum will be held:

Monday, November 16, 2015
9:30 a.m. to 11 a.m.
atlanta Marriott Marquis, Marquis A
Atlanta, GA

The Open Forum is open to all AMA members, interested non-members, other guests, and the press.

New Proposed Issues

Open Forum attendees are invited to introduce emerging ethical issues that may warrant attention from CEJA and inclusion in the AMA "Code of Medical Ethics."

Responsible Prescribing

The two main ethical considerations in responsible prescribing are off-label prescribing and determining patients’ “right-to-try” unapproved drugs outside of clinical trials. Off-label prescribing is fairly common: one study looked at prescribing practices through an EHR database and found that 11% of the drugs prescribed were done so off-label. 79% of these lacked strong scientific evidence for the prescribed use. This is problematic because off-label prescribing may lead to adverse events, and challenges in documenting the indications for the off-label use make this area difficult to study. Prescribing off-label also raises concerns about adequately informed consent and patient safety.

“Right-to-try” is another critical aspect of responsible prescribing. Right-to-try laws allow terminally ill patients to request drugs and devices that have passed through Phase 1 clinical safety testing directly from pharmaceutical trials. There are several ethical issues with this accelerated way to access trial drugs. Right-to-try laws may offer a false sense of hope to terminally ill patients, and patients may claim “nothing to lose” and therefore overestimate benefits while minimizing serious risks. Use of a drug through a right to try may decrease the population available for study of the drug, resulting in less accessibility of the drug in the future. It can also be difficult to decide who can receive the drug outside of clinical trials, often benefitting patients with the most money and other resources.

Relevant Literature:
Eguale et al. Drug, Patient, and Physician Characteristics Associated with Off-Label Prescribing in
Primary Care. Arch Intern Med. 2012;172(10):781-788.

Jacob JA. Questions of safety and fairness raised as right-to-try movement gains steam. JAMA.
August 5 2015:E1-E3.

Procedural Guidelines

A member of the Council on Ethical and Judicial Affairs will briefly present each topic on the agenda. After an issue has been introduced, the audience will be invited to discuss, with the Council, the ethical and professional considerations most relevant to the development of ethical guidelines on the topic at hand. In addition, the Council will collect written testimony for consideration at the time of the Open Forum or prior to it. Advance written testimony can be submitted to the Council staff, by e-mail at danielle.hahn@ama-assn.org or by fax at (312) 464-4799. Written testimony submitted to the Council will be given the same consideration as if it had been delivered orally.

Any member of the Association is privileged to speak on agenda items. Members should be mindful to disclose any conflict of interest that may influence their testimony. All other individuals should request from the Chair the privilege to provide oral testimony, indicating their identity and affiliation. Such a request will be honored upon approval of the Chair. Due to time constraints or other considerations, however, the Chair may not approve such requests.

All commentary should directly relate to the AMA Principles of Medical Ethics:

I. A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights.

II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.

III. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements, which are contrary to the best interests of the patient.

IV. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law.

V. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.

VI. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.

VII. A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health.

VIII. A physician shall, while caring for a patient, regard responsibility to the patient as paramount.

IX. A physician shall support access to medical care for all people.

The Chair may establish rules on the presentation of testimony with respect to time constraints, repetitive statements, etc. The Chair also has the authority to prohibit photography, filming, and audio or video recording if the Chair feels that such factors would be undesirable for the orderly conduct of the meeting. Adherence to these guidelines will ensure that the forum runs smoothly and that the results are satisfactory to all.

Disclosure. The content of this activity does not relate to any product of a commercial interest as defined by the ACCME; therefore, there are no relevant financial relationships to disclose.

Learning Objectives

  • Examine their informed consent practices when it comes to off-label prescribing.
  • Describe the ethical issues that prescribing off-label raises, particularly in the absence of scientific research.
  • Recognize new and emerging “right-to-try” laws and the applicability of these laws to their own practices.
  • Describe the ethically appropriate factors to consider in determining patients’ “right-to-try” trial drugs outside of clinical trials.
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.