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LMCC Review 2008 Communication, Legal, Ethical Issues Lilian Thorpe MD PhD FRCP MCC Considerations for Cultural- Communication, Legal, Ethical and Organizational Aspects of Medicine • CLEO developed in 1999 http://www.mcc.ca/pdf/cleo.pdf • Incorporated into the qualifying examinations Part I and Part II in 2000 to 2001 • C2LEO integrated into the CanMeds medical practitioner proficiency competencies, now include cultural and communication issues and are being incorporated into the Medical Council of Canada examination starting in 2008 http://www.mcc.ca/Objectives_online/objectives.pl?lan g=english&loc=c2leo Cultural-communication issues Candidates participating in the MCC examinations from 2008 and later must demonstrate the ability to: • Work in diverse cultures and circumstances. • Integrate the family’s role in home- care/continuity of care, mindful of cultural issues. • See the patient as the focus of culturally sensitive communication in the care of chronic illness and health care in general. • Interact with those of a differing spiritual belief in end-of life situations. Cultural-communication issues • Manage cross-cultural issues around mental health problems. • Acknowledge and resolve issues dealing with gender (e.g. male/female urogenital and rectal examination) and societal values. • Tactfully deal with specific issues unique to adolescents and the elderly. • Manage legal issues surrounding patient/human rights in social contexts such as abortion, sexual orientation/function, and life-threatening illnesses. • Emergency/intensive care (pediatric and adult), low-risk obstetrics/pre-natal care. Legal Issues • Definitions • Consent • Confidentiality • Negligence and liability • Physician professional behavior • Autonomy – The moral right to choose and follow one’s own plan of life and action. • Beneficence – The moral duty to help persons in need • Capacity – The patient’s ability to understand information relevant to making a decision. Capacity determinations are made by physicians in general, sometimes using the help of specialists physicians such as psychiatrists and other members of the health care team. • Competence – This term is frequently used interchangeably with capacity. Strictly speaking it is a legal term denoting the right to make a decision. The legal presumption is that all adults are competent, and only a judge can rule a person incompetent • Conflict of interest – A set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain). • Consent – The autonomous authorization of a medical intervention by individual patients. Consent has three components: disclosure, capacity, and voluntariness • Disclosure – The provision of relevant and material information regarding a decision by a doctor to a patient (and its comprehension by the patient). • Discrimination – An act, practice or policy that differentiates between, or otherwise treats persons in a different way, on the basis of such status as gender, age, nationality, religion, race, financial means, sexual orientation, etc. • Ethics – The discipline dealing with principles and values defining what is good and bad, and with duties and obligations for various groups. • Euthanasia – A deliberate act undertaken to end the life of another person in order to end suffering; the act is the cause of death. • Fiduciary – Person to whom property or power is entrusted for the benefit of another. • Fiduciary obligation – The obligation to promote the best interests of persons who have entrusted themselves to the fiduciary (e.g., the physician); an obligation of the highest loyalty, fidelity and trust. • Justice – The fair distribution of benefits and burdens within a community • Material risks – Those that are common, and those that are serious, even if uncommon. • Morals – The practice of ethics in everyday life. • Non-maleficence – The duty to refrain from doing harm. • Physician-assisted suicide – The act of intentionally killing oneself with the assistance of a physician • Resource allocation (and rationing) – The distribution of goods and services to programs and people; rationing is the systematic distribution of goods to specific individuals in conditions of scarcity • Security of the person/inviolability – The fundamental right of all persons to respect for and non-violation of their body and person, be it through physical, psychological or other means • Voluntariness – The patient’s right to come to a decision freely, without undue pressure including force, coercion, or manipulation Canadian Law (varies by province) Based On: • Common law (in Quebec, the Civil Code of Quebec)\ – tort law allows for patients to recover damages; negligence, battery – doctors are expected to act in the best interest of the patient (fiduciary duty). • Specific Statutes (federal and provincial) – Canadian Charter of Rights and Freedoms – The Personal Information Protection and Electronic Documents Act (PIPEDA: http://laws.justice.gc.ca/en/P- 8.6/text.html) • The constitution (supreme law of Canada: all other laws must be consistent) Saskatchewan Health Legislation http://www.health.gov.sk.ca/legislation The Ambulance Act Regulates the provision of emergency medical services. The Emergency Provides protection from liability for Medical Aid Act physicians, nurses and others when they are providing, in good faith, emergency care outside a hospital or place with adequate facilities or equipment. The Health Protects personal health information in the Information health system in Saskatchewan and Protection Act establishes a common set of rules that emphasize the protection of privacy, while ensuring that information is available to provide efficient health services. Saskatchewan Health Legislation http://www.health.gov.sk.ca/legislation Hospital Provides the standards to be met for services delivered Standards Act in hospitals. Medical Regulates physicians and surgeons. Profession Act Mental Health Regulates the provision of mental health services in the Services Act province and the protection of persons with mental disorders. Public Health Provides authority for the establishment of public health Act 1994 standards, such as public health inspection of food services. Regional Addresses the governance and accountability of the Health regional health authorities, establishes standards for the operation of various programs. Services Act Saskatchewan Health Legislation http://www.health.gov.sk.ca/legislation The Vital Administers the registration of births, deaths, Statistics Act marriages, adoptions and divorces in the 1995 province. The Youth Provides authority for the detention of youth Drug who are suffering from severe drug addiction Detoxification and abuse. and Stabilization Act Consent for Health Care • May be formal, expressed verbally or implied • Written is best • Consent must be informed, specific to the particular situation, made by a capable individual, and be voluntary (free of coercion or pressure). • Consent may be withdrawn or changed at any point before or during an intervention Consent • It is mandatory that the patient’s consent be obtained for any medical investigation, treatment, or research • Full information must be given, in language that the patient or involved person(s) can understand. This must include information regarding the nature of the proposed treatment or investigation, anticipated effects, material or significant risks, alternatives available, and any information regarding delegation of care, and will be given according to the circumstances of each particular case. Consent • The obligation of disclosure rests with the physician who is to carry out the treatment. It may be delegated in appropriate circumstances to another qualified physician, but responsibility lies with the delegating physician. • If the patient is not competent or lacks capacity to consent, then consent may be obtained (according to the law applicable in each province and the specific circumstances) from a court, parent or substitute decision-maker. The law regarding delegation of care is specific to each province and the physician should be fully aware of local requirements in this regard. Consent • Treatment is limited to the scope of consent given, including to the identity of the treating physician. Exceptions to Consent • Emergency treatment can be provided if the patient is experiencing severe suffering, where a delay in treatment could lead to serious harm and when consent cannot be obtained (cannot violate previously expressed wishes, such as advance care directives). • Patients with mental illnesses can be treated involuntarily in certain circumstances. • Public health legislation may allow for treatment without consent when there are issues of public safety. • Legal situations (warrants) may provide for the release of patient information. Capacity • Definition of capacity varies over time and from jurisdiction to jurisdiction • Definition of capacity is influenced by societal values and by assessors • Elements: – The ability to communicate a choice – The ability to understand the specific choice – The ability to appreciate fully the broad ramifications (to him/her-self and others) of a specific choice Factors influencing capacity • Communication • Cognitive skills (MR, dementia, mild cognitive impairment) • Education • Mental illness – Delirium – Medications – Depression – Psychosis Health Decisions: Main Sources Of Substituted Consent • Parent/guardian for incompetent minors • Advance directive • Appointed proxy for health-care decisions • Power of Attorney (health-care) • Guardianship/co-decision maker order • Nearest relative • Two health care providers • Emergency treatment Makes own treatment decision No Two treatment providers: Other substitute exceptions decision maker available? yes Yes Individual No Follow directions Competent? Legal guardian Yes with power to make decision? Decision No No Yes Follow Advance directive, POA directions or proxy available? Confidentiality • Physicians are legally required to maintain the confidentiality of a patient's medical information (Personal Information Protection and Electronic Documents Act, Canadian Charter of Rights and Freedoms) • Confidentiality is necessary to preserve trust in the doctor-patient relationship and to provide optimal care • Physicians must only access information of patients under their care Confidentiality • Physicians are also required to store, handle and dispose of health information appropriately, informing patients of their mechanisms of doing so. • Patients have the right to access their own health information, with a few limitations, such as when there is a potential for harm to either the patient or another person. Confidentiality • It is considered appropriate to share information with other members of the health care team (circle of care), as it is necessary to care for the patient • Disclosure of patient information may also occur: – with the consent of the patient (or legally designated decision maker) – in various circumstances dictated by law (child abuse or neglect, fitness to drive or fly, certain communicable diseases, improper conduct of physicians or other health professionals, vital statistics and reporting to coroners). – In situations posing material risks to others or themselves (Duty to warn) Negligence • Breach of a legal duty of care which results in damage to a patient. • Courts normally expect physicians to adhere to a standard of care which would reasonably be expected under similar circumstances of a physician with a roughly equivalent training and experience. • Physicians may also be held liable for the actions of staff acting under their direction, such as nurses or junior physicians. Physician professional behavior • This is mostly under the auspices of the provincial College of Physicians and Surgeons in each province, which is the designated licensing authority. • Physicians are required to maintain a legal license to practice. • Appropriate clinical coverage must be maintained. • Sexual relationships with patients are generally considered to be inappropriate. Physician professional behavior • Appropriate records must be maintained for the appropriate length of time, as designated by provincial legislation. • In Saskatchewan, physicians should keep their records for 15 years after the last clinical contact with adults (mostly CMPA related), and longer in the case of minors. Ethics: Key Principles • Autonomy • Beneficence • Non-maleficence • Justice Ethics: Particular Issues • Confidentiality • Consent • Truth-telling • Resource allocation – Fair access to health care resources – Obligations to seek best interest of patient – Prudent use of health care resources – Rank known patients above future or future patients – Consult hospital ethics committees or other bodies in cases of conflict Ethics: Particular Issues • Research Ethics – Scientific and ethical merits of research – Conflict of interest – Full disclosure to informed consent – Right of non-participation or withdrawal without prejudice – Appropriate ethics committee approvals – Acknowledgement and disclosure of any possible conflict of interest on the part of investigator. Ethics: Physicians and Industry • The primary obligation of the physician is to their patient. Relationships with industry are appropriate only if they do not impinge upon that responsibility • Any conflicts of interest arising from a relationship with industry must be resolved in favour of the patient. • Physicians in their practice must preserve their professional autonomy. Any potential conflict of interest must be disclosed to the patient. CMA Code of Ethics and CMA Guidelines for physicians in interactions with industry, 2007 Ethics: Doctor Patient Relationship • Obligations and restrictions • Conflict of interest, disclosure of personal or moral limitations • Professional boundaries • Physician’s and patient’s rights • Care of friends and family Ethics: Controversial and Evolving Ethical Issues in Practice • Euthanasia • Physician assisted suicide • Maternal-fetal conflict of rights • Advanced reproductive technology • Fetal tissue • Abortion • Genetic testing Which of the following are in the CMA Code of Ethics? 1. Consider first the well-being of the patient. 2. Practise the profession of medicine in a manner that treats the patient with dignity and as a person worthy of respect. 3. Provide for appropriate care for your patient, even when cure is no longer possible, including physical comfort and spiritual and psychosocial support. 4. Consider the well-being of society in matters affecting health. All True Which of the following is not in the CMA Code of Ethics? 1. Recognize and disclose conflicts of interest that arise in the course of your professional duties and activities, and resolve them in the best interest of patients. 2. Decline to provide service to patients when this might be seen as a conflict of interest 3. Limit treatment of yourself or members of your immediate family to minor or emergency services and only when another physician is not readily available 2 is incorrect. In providing medical service, you may not discriminate against a patient the grounds of: • Age • Political affiliation • Gender • Race • Marital status • Religion • Medical condition • Sexual orientation • National or ethnic • Socioeconomic status origin • Physical or mental disability All true Which of the following is true: 1. Because of the previous principle, a physician may not refuse to accept any patient as long as there is still available time in the practice. 2. The “meet and greet” session for new patients is unethical 3. Physicians may decline to accept patients whose needs they are not able to meet 3. is true Ethical principles for Previous Questions (CMA Code of Ethics) • Inform your patient when your personal values would influence the recommendation or practice of any medical procedure that the patient needs or wants. • Recognize your limitations and, when indicated, recommend or seek additional opinions and services • Promote and maintain your own health and well-being. Which is True: Having accepted professional responsibility for a patient: 1. Services must continue to be provided until the patient no longer requires or wants them 2. Services cannot be discontinued until another suitable physician has assumed responsibility for the patient. 3. Services may be discontinued if the patient has been given reasonable notice that you intend to terminate the relationship 3. is true Ethical principles for the preceding question (CMA Code of Ethics) • “This does not abrogate your physician’s right to refuse to accept a patient for legitimate reasons.” You have had a few drinks at a party when a person collapses. What do you do? • You clear space around the person and immediately proceed to follow your best resuscitation practices • You quickly leave the room as you are mildly impaired and may not make the best decisions • You announce that you have had a few drinks, and ask if anyone else has appropriate expertise to take over. If not, proceed if medically necessary while asking someone else to call emergency services. 3 is the best choice Ethical principles relating to Previous Question. (CMA Code of Ethics) • Practise the art and science of medicine competently, with integrity and without impairment • Take all reasonable steps to prevent harm to patients; should harm occur, disclose it to the patient. • Recognize your limitations and, when indicated, recommend or seek additional opinions and services • Provide whatever appropriate assistance you can to any person with an urgent need for medical care. • Provide your patience with the information they need to make informed decisions about their medical care, and answer their questions to the best of your ability. A patient demands a treatment that does not usually help in his situation and has significant potential for serious side effects 1. You explain the potentially serious side effects and poor treatment efficacy, but give him the treatment anyway since autonomy is one of the most important ethical principles 2. You explain the potentially serious side effects and poor treatment efficacy and deny his request 3. You explain the potentially serious side effects and poor treatment efficacy and decline to provide this treatment yourself. You provide him with the name of a physician in town who does administer this treatment, and express your support in him pursuing a second opinion from the physician 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • Consider first the well-being of the patient • Recommend only those diagnostic and therapeutic services that you consider to be beneficial to your patient or to others. • Practise the art and science of medicine competently, with integrity and without impairment. • Take all reasonable steps to prevent harm to patients; should harm occur, disclose it to the patient. • Respect the right of a competent patient to accept or reject any medical care recommended Your patient has had a catastrophic stroke, and can no longer swallow. Her advance care directives clearly state that she does not want any feeding tubes in this situation. Her daughter says that you can’t let her starve. 1. You call the surgeon to put the feeding tube in and have the daughter sign the consent 2. You tell the daughter that she has no say in the matter. 3. You tell the daughter you are legally bound to respect the directive, but spend time with the daughter explaining feeding tubes, legal status of directives, and control of discomfort. 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • Ascertain wherever possible and recognize your patient's wishes about the initiation, continuation or cessation of life-sustaining treatment. • Respect the intentions of an incompetent patient as they were expressed (for example through valid advance directive or proxy designation) before the patient became incompetent. • Be considered of the patient's family and significant others and cooperate with them in the patient's interest. Your patient has had a catastrophic stroke, and can no longer swallow. She has no advance care directives and no family. 1. You call the surgeon to put in a feeding tube 2. You decide she won’t benefit from a feeding tube, so you call palliative care to keep her comfortable 3. You or the social worker find a friend and get some information about her previous wishes. You make your best decision about her likely wishes, and ask a second treatment provider to write a progress not stating he/she is in agreement with the treatment 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • When the intentions of an incompetent patient are unknown and when no formal mechanism for making treatment decisions is in place, render such treatment as you believe to be in accordance with the patient's values or, if these are unknown, the patient's best interests. Legal principle: Saskatchewan • Health care Directives and Substitute Decision Makers Act http://www.qp.gov.sk.ca/documents/English/Statutes/Statutes/H 0-001.pdf • Where there is no relative or when a reasonable attempt to find a relative has been made but the nearest relative cannot be found, …. A treatment provider may provide treatment (to an incompetent patient) if another treatment provider agrees in writing that the treatment is needed. You get a fax from an unknown doctor’s office telling you to fax them your notes on a patient you saw two years ago. 1. You fax them all you can find dating back to that time 2. You throw the fax in the garbage 3. You ask them to have the patient send a release of information form 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • Consider first the well-being of the patient • Protect the personal health information of your patients • Disclose your patient's personal health information to third parties only with their consent, or as provided for by law Your patient discloses plans to shoot his wife as he believes she has been unfaithful 1. You encourage him not to do so, but respect his right to confidentiality and don’t tell anyone else. 2. You notify the police and hope he doesn’t find out 3. You tell him that you are required to breach confidentiality, and then notify the police 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • Disclose your patient's personal health information to third parties only with their consent, or as provided for by law: – such as when the maintenance of confidentiality would result in a significant risk of substantial harm to others or, in the case of incompetent patients, to the patients themselves. In such cases take all reasonable steps to inform the patients that the usual requirements for confidentiality will be breached The daughter of your elderly patient wants to go on holidays and insists you admit her to hospital for the duration, as she cannot stay alone. 1. You admit her to hospital: other patients having surgeries cancelled because of bed shortages is not your problem 2. You tell her absolutely not….. And move on to your next patient! 3. You explain the bed shortages and connect her with respite resources 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • Recognize the responsibility of physicians to promote equitable access to health care resources. • Use health-care resources prudently You are part of a prestigious and very well reimbursed drug trial, which was approved by ethics. You have discovered new information that this treatment helps the condition you are studying, but increases overall mortality 1. You keep quiet, as you can’t afford to antagonize the sponsor who is giving you a large, “unrestricted” grant for your other research. 2. You notify the sponsor, but keep entering patients 3. You put your concerns in writing, make sure the other investigators and your patients are aware of your information and withdraw your patients from the study if they wish. 3 is the best choice Ethical principles for the preceding question (CMA Code of Ethics) • The practising physician’s primary responsibility is to the patient (CMA Guidelines for physicians in interactions with industry, 2007) • Do not exploit patients for personal advantage • Take all reasonable steps to prevent harm to patients; should harm occur, disclose it to the patient Pharmaceutical company X gives you samples of their latest, very expensive product, and tells you they are conducting post-marketing research, so will pay you for every patient you put on the drug while filling out a brief outcome sheet. 1. This is just research, so you participate 2. You ask how the study was designed, how they will analyze it, and then decide you will decline 2 is the best choice Ethical principles for the preceding question (CMA Code of Ethics and CMA Guidelines for physicians in interactions with industry, 2007) • The distribution of samples should not involve any form of material gain for the physician • Ensure that any research in which you participate is evaluated both scientifically and ethically and is approved by a research ethics board that meets current standards of practice • Inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of your participation including any compensation A company invites you and 12 of your colleagues to a fancy spa to give them feedback about their new drug (after extensive presentations about the benefit of their drug by the company research physician). The company tells you that you are considered faculty (as you are helping them fine- tune use of the drug), so they will pay everything, including the massages. 1. You ask if you can bring your spouse and kids 2. You decline politely, referring to the CMA Guidelines for physicians in interactions with industry (well…. Duhhhhhhhh) Ethical principles for the preceding question (CMA Code of Ethics and CMA Guidelines for physicians in interactions with industry, 2007) • Faculty indicates a presenter who prepares and presents a substantive educational session in an area in which they are a recognized expert or authority. • All attendees at an event cannot be designated faculty.
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