Preamble

This document outlines specific tenets of ethical behavior for medical toxicologists as promulgated by the American College of Medical Toxicology (the College). It is not meant to be all-inclusive and thus activities in areas not covered by these guidelines should not be considered to be deemed a priori ethical. These guidelines are meant to supplement and not to supplant the Code of Medical Ethics of the American Medical Association (referred to as the “Code of the AMA”)¹.

This Code of Ethics is meant to be specifically applicable to medical toxicologists. A medical toxicologist is defined, for the purposes of this document, as a physician who is qualified to be a member of the College.

The purpose of these guidelines is to delineate principles constituting the ethical foundations upon which the medical toxicologist should rely in fulfilling his/her responsibilities to their patients, society, and other health professionals. Except under circumstances delineated in this document, or as required by law, the medical toxicologist’s primary responsibility is to his/her patients. As a physician, a medical toxicologist should strive to exemplify the highest standards of moral character.

These guidelines apply to the practice of medical toxicology. Any medical toxicologist whose ability to practice is physically, mentally, or emotionally impaired should not continue to function in those aspects of practice which may be affected by their impairment.

It is recognized that this Code of Ethics cannot encompass the entire range of possible circumstances. These guidelines are applicable to the vast majority of foreseeable circumstances but may not apply when extenuating circumstances are present.

The College may censure, deny, or revoke membership to members who are in violation of these guidelines, in accord with established policies and procedures. Membership in the College is contingent upon compliance with this code of Ethics.

Medical Toxicologists and the Public Health

Medical toxicologists are stewards of the public health. In this role they have a responsibility to assure that appropriate public health authorities are informed of situations or occurrences that may represent an imminent and unrecognized risk to public health. If such information is privileged by a physician-patient relationship or by law, the decision to reveal it to appropriate authorities may only be made to the extent permitted by applicable law and the Code of the AMA.

If the medical toxicologist determines that a patient’s condition renders them dangerous when driving, operating heavy equipment, or taking part in other safety-sensitive activities there is an obligation to intervene, to the extent permitted by applicable law and the Code of the AMA, balancing the patient’s best interest with any danger to society. This may mean direct confrontation of the patient, or the patient’s family. For cases in which the patient’s dangerous behavior persists despite this intervention, appropriate authorities should be notified. However, the latter should be considered to be a last resort to be employed only after other measures, as described above, fail.

To the extent permitted by applicable law and the Code of the AMA, if a medical toxicologist has reasonable suspicion of domestic violence, including child or elder abuse, there is an ethical responsibility to report these concerns, or assure that other appropriate parties make such reports, to governmental or other appropriate authorities.

When a medical toxicologist determines that there is an ethical responsibility to inform authorities about a patient’s behavior or limitations, it should be done in a way that maintains as much patient confidentiality as possible, revealing only the minimal amount of information necessary. When embarking on such an activity, or considering the need to do so, the medical toxicologist should make reasonable attempts to inform the patient of their ethical and/or legal responsibilities to make such reports.

Physicians are encouraged to participate in activities aimed at enhancing the public health. They should not participate in any activity contrary to the public good.

Relationships With Other Professionals

Society confers a special level of trust, respect, and deference to physicians. Medical toxicologists should always act in a dignified and honorable way respectful of this public trust.

Relationships with physicians, nurses, and other health care professionals should live up to the faith that the public-at-large has in physicians and be characterized by fairness, honesty, respect, and integrity.

Cooperation with other health care professionals and institutions should occur to the extent necessary to serve the patient’s and society’s best interests.

To the extent permitted by applicable law and the Code of AMA, concerns about physicians or other health professionals acting in an apparently impaired, incompetent, unethical or negligent fashion are guided by the principle of non-maleficence and thus should be reported to appropriate authorities, regional medical societies, and/or hospital medical staff officials, quality assurance, or peer-review programs. Fraud or deceptive behavior is considered unethical and should be reported per these guidelines. All such reports should be done with the utmost discretion. In the event that a medical toxicologist is being investigated by any of the bodies enumerated in this paragraph they should honestly and openly cooperate with the investigation.

Where possible, medical toxicologists should constructively assist colleagues who appear to be impaired, incompetent, or acting in an unethical fashion. This may include advice for self- referral for treatment.

Sexual harassment of a staff member, or another health care professional is unethical. Sexual harassment is defined here as physical or verbal intimation of a sexual nature involving a staff member, or a colleague or subordinate when such conduct creates an unreasonable, intimidating, hostile or offensive workplace environment.

The Physician-Patient Relationship

The physician-patient relationship must be founded on mutual trust, cooperation, and respect. All patients should be treated with compassion and dignity. The welfare of the patient is central to all considerations in the patient-physician relationship. The medical toxicologist must have freedom to choose patients whom she/he will serve. However, the medical toxicologist should not refuse to accept patients because of the patient’s race, sexual orientation, creed, color, sex, gender identification, national origin, medical condition, or disability. In emergencies, if reasonable to do so, a medical toxicologist should make her/his services available to all patients. However, if the scope of the required care is outside of the competence of the medical toxicologist, it is appropriate to decline the role of being a treating physician.

A medical toxicologist is never justified in abandoning a patient. Rather they should attempt to give due notice in writing to the patient, or to those responsible for the patient’s care, when she/he withdraws from the case so that another physician may be engaged. In such cases, the medical toxicologist must continue to provide acute care for a reasonable period of time while the patient makes alternative care arrangements.

A sexual or romantic relationship between a Physician and a current or recent patient is unethical. When a patient’s parent, guardian, spouse, partner, or proxy mediates the patient-physician relationship, a sexual or romantic relationship between a Physician and such individuals in unethical.

To the extent permitted by applicable law and the Code of the AMA, the medical toxicologist shall keep confidential all individual medical information, releasing such information only: 1) when required by law or overriding public health considerations; 2) to other health care professionals according to accepted medical practice; or 3) to others at the request of the individual patient. Requests to release records by the patient, or legal surrogate, should not be denied based on outstanding unpaid bills. To the extent permitted by applicable law and the Code of the AMA, disclosure of detailed information to insurance carriers or other interested third parties must be restricted to instances where the patient provides informed consent to do so, and any significant inadvertent breaches of patient confidentiality should be revealed to the patient.

No medical toxicologist shall advertise or solicit patients directly or indirectly through the use of materials or activities that are false or misleading; nor should a medical toxicologist provide or bill for services that are not medically justifiable. Bills for services should not be based on any contingency, such as successful outcome of therapy or other positive end points. Medical

toxicologists should not engage in intentional “fee splitting” with any referral sources or health- care provider/facility to whom they refer patients; nor should they accept finders-fees for referring a patient to another practitioner, or facility. Fees charged for services should not be excessive. Fees should be commensurate with the time of service, difficulty of services involved, and the quality of service. No fees should be charged by a medical toxicologist for patient care services not performed either by them or under their direct supervision. Although it is appropriate for medical toxicologists to charge for their services, the physician should use compassion when considering the patient’s ability to pay. A medical toxicologist should not charge for billing third party payers unless this activity requires an excessive amount of time. In the latter case, charges consistent with those customary in the same community are appropriate.

Unless prior arrangements are made to the contrary, if charges for laboratory or other studies done at an external facility are included in the medical toxicologist’s bill, the actual laboratory costs and any additional add-on charges should be clearly specified.

It is generally expected that patients will provide consent before treatment is rendered. Where consent is absent because of an emergent medical situation, it is expected that the medical toxicologist will provide all necessary treatments within the scope of their expertise.

The patient has the right of self-decision. When helping a patient to make a treatment decision, the medical toxicologist should consider the patient’s ability to receive information, given the patient’s condition and time available. The medical toxicologist should inform the patients of all treatment alternatives, including non-intervention, consistent with good medical practice. The medical toxicologist’s personal belief should not prevent him or her from informing the patient of medically recognized treatment alternatives.

Obligations to Patients Who Are Medically Indigent

Medical toxicologists are free to choose whom to serve. However, the paradigm of the medical profession implies responsibility to society as a whole. This includes an obligation to provide emergent care, irrespective of the patient’s ability to pay, or their legal status.

Informed Consent and the Suicidal Patient

The medical toxicologist is likely to be called upon to evaluate and care for individuals who suffer from, or are believed to suffer from, attempted self-injury using one or more chemical substances. Under these circumstances, the medical toxicologist is unlikely to have a preexisting relationship with the patient or their family and often has a limited window of time in which to make critical decisions regarding patient care.

Because the toxic exposure may pose an ongoing threat to patient well-being, rapid assessment and immediate medical intervention (often based on limited information) may be required without a formal determination of patient competency. To the extent permitted by applicable law and the Code of the AMA, in such situations, the treating physician must determine, to the best of their ability, the present decision making capability of the patient, and act in the patient’s best interest, even if this is contradictory to the patient’s current expressed or implied wishes. Thus,

evaluation, treatment, and disposition of the patient must be such that the psychiatric and physical well-being of the patient can be reasonably assured in the face of expressed or implied self harm.

Allowing self-destruction or even serious self-injury is not in the long term best interests of the patient and should be avoided. Yet the wishes of the patient regarding treatment, confidentiality, and other medico-legal decisions must thus be respected to the maximal extent possible, consistent with appropriate medical care and psychiatric assessment.

To the extent permitted by applicable law and the Code of the AMA, physicians may investigate or treat without securing informed consent, even in the face of refusal, when immediate intervention is deemed necessary to prevent potential death or serious harm to the patient. This should only occur when treatment or evaluation cannot be delayed without serious potential harm. While it may be necessary to physically or pharmacologically restrain a patient to assure that essential medical services are provided, such restraints should be applied in a stepwise manner and only to the degree necessary to protect the patient and those around him or her, with the necessary minimum violation of patient rights. The use of restraints should comply with applicable guidelines.

Responsibilities When Conducting Independent Medical Evaluations or Occupational Examinations

Medical toxicologists may evaluate patients on behalf of a third party as part of independent medical evaluations (IMEs) or as part of occupational health examinations. In all instances the role of a medical toxicologist as a physician must be the paramount guiding principle.

Conduct During Independent Medical Examinations

When conducting IMEs Medical Toxicologists should:

1. Be honest in all communications with the examinee and client(s);
2. Respect the rights of the examinee, and treat them with dignity and respect;
3. Inform the examinee that they are being evaluated for an IME, and that the information provided will be used in the assessment and presented in a report;
4. Inform the examinee that no treating doctor-patient relationship will be established;
5. Explain the examination procedure;
6. Provide appropriate draping and privacy if the examinee needs to remove clothing for the examination;
7. Never bias conclusions in favor of any involved party;
8. Disclose any significant incidental medical conditions identified to the examinee;
9. Reach conclusions based upon sound clinical and scientific principles;
10. Never accept a fee or any consideration for services which are dependent upon offering an opinion favorable to the source of the referral; and
11. Maintain confidentiality in a manner consistent with applicable legal requirements.

Occupational Health Examinations

Despite the absence of a traditional doctor-patient relationship, the medical toxicologist still has the responsibility to divulge to the examinee any medical conditions identified during the examination and should treat the examinee with dignity.

During the course of an occupational surveillance examination the medical toxicologist may acquire information beyond that which is relevant to the occupational examination’s requirements. Such information should not be divulged to the employer unless required by statute or regulation.

Expert Testimony

It is recognized that the discipline of medical toxicology has a unique relationship with judicial matters. This is because medical toxicologists specialize in being knowledgeable about the capacity of chemical substances to do harm. Because of their unique knowledge base the provision of legal testimony is considered to be a component of the practice of medical toxicology.

It is important the medical toxicologist consistently bear in mind the purpose of an expert witness within the legal system. The expert is not present as an advocate nor are they present to adjudicate the matter at hand. Rather, he/she is present exclusively to assist the trier of fact via the presentation of factual knowledge and scientifically-based opinion and the conveyance of understanding regarding the matter under consideration. All testimony must be objective and impartial. It is unethical to give false or misleading testimony.

Compensation of the expert should be reasonable and commensurate with the time and effort invested by the expert as well as their experience, unique expertise, and ability. An expert should not, under any circumstances, link compensation of any kind to the outcome of the case.

The physician expert witness should, in general, not make such activities the sole focus of their professional practice. Consideration can, however, be given to special circumstances such as retirement from or temporary interruption of clinical practice, so long as the expert can demonstrate that these circumstances do not materially diminish the expert’s competency to address the issues at hand.

Research

Research undertaken by medical toxicologists should be conducted with the aim of advancement in the treatment of patients and for the well-being of society. Such activities should follow the guidelines outlined by the applicable versions of the Declaration of Helsinki and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Additionally, such research should comply with relevant federal, institutional, and professional regulations and guidelines. All human subjects or animal research activities should be approved by a recognized human subjects or animal review board.

Medical toxicologists must be diligently aware of real and potential sources of bias when conducting research. This is particularly relevant where the stipulations and interest of the funding agency (e.g., pharmaceutical firms, foundations, government, industry, and educational institutions) are potential sources for bias. In no circumstances should a medical toxicologist resort to research on human subjects in an alternative location with the specific intent of avoiding restrictive patient safeguards.

Analyzing and communicating the results of research must be timely, accurate and truthful. The principal investigator of a research project must take full responsibility for the design, execution, and reporting of the results of the study. The investigator must assure that all relevant investigators in the research project receive recognition for their contributions. If the medical toxicologist has any potential or real financial benefit associated with their research, this must be disclosed to the research institution and to any potential publishers of the research. If a medical toxicologist is serving in the role of a clinical investigator of a commercial product, it is unethical to buy or sell equity in the company that may financially benefit or suffer from the results of the research until the study is completed and the results are made public. Reasonable requests for access to raw data should be respected, provided doing so does not create an unduly onerous task for the investigator and that there are no contractual obligations to the contrary.

Before embarking on a clinical trial, medical toxicologists in the U.S. should pre-register applicable studies at trial with www.clinicaltrials.gov.

Educational Activities

The medical toxicologist has had the privilege of unique training and medical education and thus is encouraged to teach their knowledge to medical students, physicians in graduate medical education, other health care professionals, patients, and society. When providing such education, the medical toxicologist should strive to do so without the bias of outside influences.

Maintenance of Professional Competency

Medical toxicologists should strive to obtain and maintain certification in medical toxicology. It is recommended that medical toxicologists who are eligible to do so actively participate in the American Board of Medical Specialties Medical Toxicology Maintenance of Certification process.

Use of Non-Accepted Therapies

A medical toxicologist must never use personal gain as a motivating factor in choosing a therapy, nor should they ever use therapies that have been established to be of no benefit.

Where possible, a medical toxicologist who uses a therapy that is unlikely to be of benefit must inform the patient of the status of the therapy, give the patient the rationale leading to that choice, inform the patient of the costs, possible lack of coverage by medical insurance (if applicable), and risks, and obtain informed consent from the patient before initiating therapy.

It is unethical for a medical toxicologist to use therapies that are contrary to accepted principles of medical practice.

Conflicts of Interest

The ethical practice of medicine demands that the physician’s obligations to the patient must not be influenced by any conflicts of interest that detract from the physician’s core obligation to the patient. The medical toxicologist must assure the use of any medication, treatment or device is based solely on the potential for patient benefit and not on any direct or indirect benefit to the practitioner or other party. The practitioner must be aware that any commercial or financial relationship with third parties, such as pharmaceutical companies or other businesses, carries a potential for conflict of interest. While such relationships should not be prohibited, the practitioner must maintain awareness of such potential conflict. When questions arise in this regard, consultation with an ethics board is encouraged. The medical toxicologist must disclose conflicts of interests. The toxicologist should disclose conflicts to the medical institution where the toxicologist practices, to journals where he or she is submitting research, and to patients who may receive treatments that involve conflicts. Patients must be made aware of and have the ability to refuse service with any such potential conflict of interest. Any disputes regarding potential conflicts of interest between the physician and the patient should be resolved with the patient’s best interest as the primary motive. If a satisfactory resolution of a disclosure of conflict of interest cannot be established, the medical toxicologist should withdraw from the relationship with the patient in a manner consistent with the principles outlined in the section on the Physician-Patient relationship of these guidelines. In these instances the medical toxicologist should assist the patient in making arrangements for care by another appropriate practitioner.

Reference

1. American Medical Association. AMA’s Code of Ethics. American http://www.ama- assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page). Accessed: April 29, 2015