Medical Ethics: Current Controversies

Like nearly all professions, the medical industry has unscrupulous practitioners. However, most doctors, whether in Western or Eastern nations, adhere to basic codes of ethics. For doctors who have been trained in the Western tradition, the two most important codes are the Hippocratic Oath---including its modern version---and Thomas Percival's Code of Medical Ethics. The Greek doctor Hippocrates developed the first code in the fifth century b.c. The traditional text asks doctors to make this vow:
I will prescribe regimens for the good of my patients according to my ability and my judgement and never do harm to anyone. To please no one will I prescribe a deadly drug nor give advice which may cause his death. Nor will I give a woman a pessary [suppository] to procure abortion. But I will preserve the purity of my life and my art. I will not cut for stone, even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art. In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or with men, be they free or slaves.
This oath has of course changed somewhat in modern times. An updated version of the oath was written in 1964 by the academic dean of the school of medicine at Tufts University and is used in many medical schools.
The Western interpretation of medical ethics is not the only kind in use today. Chinese medical ethics has developed over several thousand years and many feel that its teachings, which emphasize care and respect for patients, are worth incorporating into Western ethics.
Chinese medical professionals must follow six basic rules: use all means available to help the dying and wounded; practice medicine with honesty; constantly work on improving medical skills; behave politely; treat all patients equally; and do not be arrogant or disrespectful of other people's achievements.
Chinese medical ethics actually predate the Confucian era. Still, it was the Chinese philosopher Confucius (c. 551--479 b.c.) whose teachings, which emphasized ethics, helped form the underpinnings for medical ethics in that nation.
At their core Confucian medical ethics are about love and benevolence---doctors show love for their patients by healing them. Doctors further exhibit these noble feelings by neither disrespecting nor causing harm to their patients and by treating patients equally regardless of wealth or social status.
In more recent years, however, Chinese medical ethics have moved away from a strict Confucian interpretation. Chinese doctors are now influenced by Western medical practices. So too are Western doctors learning from the teachings of Confucius. In many ways these two versions of medical ethics are not so different; the well-being of the patients is of primary concern. The growing popularity of "alternative" treatments common to China---notably, acupuncture and herbal remedies---in Western nations shows the intertwining of Western and Eastern medicine.

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

Background

Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.

Methods/Design

Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:

Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.

Ethics - beneficence, non-maleficence, autonomy, justice.

Economics - scarcity of resources, choices, opportunity costs.

For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.

Discussion

The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.

Background

A US Food and Drug Administration (FDA) public health announcement, released to physicians in October 2008, highlighted concerns associated with the use of licensed mesh devices in the minimally invasive surgical repair of pelvic organ prolapse and stress urinary incontinence. The announcement reported serious complications resulting from the use of licensed devices from nine manufacturers, and pointed out that some of the complications led to significant decrease in patient quality of life with ongoing symptoms. The FDA memorandum stressed the need for surgeons to seek specialized training for each type of technique, to be vigilant about adverse events and complications, and highlighted the importance of informing patients about the potential for adverse events with possible long-term unpleasant effects on quality of life [1]. The information in the FDA announcement was reiterated in 2010 by the Health Canada Marketed Health Products Directorate [2]. These unusual announcements underline the dangers associated with the adoption of new licensed medical devices, and provide a reminder that the responsibility for patient outcome lies not only with regulators and device manufacturers, but also with policy makers and surgeons, and that patient should be active in the decision to have surgery performed.
The decisions surrounding the choice of medical device to approve (by device regulators), fund (by health care funding bodies) or adopt into clinical practice (by hospital authorities and clinicians) are affected by many different motivators and barriers, such as perceived effectiveness, safety (as highlighted by the FDA and Health Canada [1,2]), and also ethical and economic considerations. The research described in this protocol will examine specifically how ethics and economics influence stakeholders' decisions about adopting new devices, particularly when full information on effectiveness and safety may not be available.
In Canada, the licensing and use of new medical devices occurs within a health care system in which the adoption of new technologies is guided by ethics and economics as well as by clinical investigation: assuming that there is evidence that a new device is effective, the adoption of that device is subject to ethical and economic choices at all levels of the health care system. Ethics influences such decisions, seeking assurance that the device will benefit patients while not doing them disproportionate harm, that individuals are fully informed before they make decisions about adopting a new device, and that risks and benefits of a new treatment (or from withdrawing access to an older one) are fairly and reasonably distributed [3]. Economic theory offers further insights into the decision-making process, suggesting that in situations of limited resources, choices are necessary about which technologies should be adopted and which services should be sacrificed in order to free up resources [3-6]. Thus both ethics and economics are concerned with making good choices in adopting new health technologies, and may even be considered inseparable [3-6]. They are as fundamental to decisions about licensing and adopting new clinical devices, as considerations of clinical effectiveness and safety.

Licensing medical devices in Canada

The introduction of new medical devices in Canada is regulated by the Medical Devices Regulations of the Food and Drugs Act [7]. The process is governed by the Medical Device Regulatory Framework and undertaken by the Medical Device Bureau (MDB, one of the bureaux of the Health Canada Therapeutic Products Division). The mandate of MDB is specifically to evaluate and monitor the safety, efficacy and quality of diagnostic and therapeutic medical devices [8]. Manufacturers of medical devices require licenses to sell their products in Canada [9]: each new surgical device is classified according to risk, based on factors such as degree of invasiveness, duration of contact with patient, energy transmission hazard and consequences of device malfunction or failure. Risk class (Table 1) is allocated by comparing new devices to similar or competitive devices

Which medical error to disclose to patients and by whom?

Background

Disclosure of near miss medical error (ME) and who should disclose ME to patients continue to be controversial. Further, available recommendations on disclosure of ME have emerged largely in Western culture; their suitability to Islamic/Arabic culture is not known.

Methods

We surveyed 902 individuals attending the outpatient's clinics of a tertiary care hospital in Saudi Arabia. Personal preference and perceptions of norm and current practice regarding which ME to be disclosed (5 options: don't disclose; disclose if associated with major, moderate, or minor harm; disclose near miss) and by whom (6 options: any employee, any physician, at-fault-physician, manager of at-fault-physician, medical director, or chief executive director) were explored.

Results

Mean (SD) age of respondents was 33.9 (10) year, 47% were males, 90% Saudis, 37% patients, 49% employed, and 61% with college or higher education. The percentage (95% confidence interval) of respondents who preferred to be informed of harmful ME, of near miss ME, or by at-fault physician were 60.0% (56.8 to 63.2), 35.5% (32.4 to 38.6), and 59.7% (56.5 to 63.0), respectively. Respectively, 68.2% (65.2 to 71.2) and 17.3% (14.7 to 19.8) believed that as currently practiced, harmful ME and near miss ME are disclosed, and 34.0% (30.7 to 37.4) that ME are disclosed by at-fault-physician. Distributions of perception of norm and preference were similar but significantly different from the distribution of perception of current practice (P < 0.001). In a forward stepwise regression analysis, older age, female gender, and being healthy predicted preference of disclosure of near miss ME, while younger age and male gender predicted preference of no-disclosure of ME. Female gender also predicted preferring disclosure by the at-fault-physician.

Conclusions

We conclude that: 1) there is a considerable diversity in preferences and perceptions of norm and current practice among respondents regarding which ME to be disclosed and by whom, 2) Distributions of preference and perception of norm were similar but significantly different from the distribution of perception of current practice, 3) most respondents preferred to be informed of ME and by at-fault physician, and 4) one third of respondents preferred to be informed of near-miss ME, with a higher percentage among females, older, and healthy individuals.

Background

In healthcare, it is not uncommon that patients are exposed to risks of harm. Some risks are predictable, at least at statistical level, and an informed consent is obtained. Other risks, such as those occurring because of medical errors (ME) are in a sense unpredictable and an informed consent can not be obtained. An ME is defined as an act or omission that would have been judged wrong by knowledgeable peers at the time it occurred [1]. Some ME may not materialize into harm; a near miss is an event that under slightly different circumstances could have been an accident, either because the error was detected and corrected in time or because the patient was just lucky [2]. When an ME occurs, two actions should be considered: reporting it to the healthcare system (and through it to potential future patients) and disclosing it to the patient involved. Reporting ME is paramount for quality and safety improvement and should include near miss ME [1,3]; compared to reporting harmful ME, reporting near miss ME offers greater frequency and fewer barriers to data collection [3].
Full disclosure of ME includes an explicit statement that an error (rather than just a "complication") occurred, basic description of the error, who committed the error, why it did happen, how recurrences will be prevented, and an apology [4,5]. Non disclosure of harmful ME is considered a violation of ethical principles from both deontological and consequentialist perspectives [6]. A policy of open disclosure standard that demands disclosure of critical events by the provider or the institution [7] was promulgated in 2001 by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and is now reflected in similar initiatives in the UK, Canada, and Australia [8-12]. These regulations and theoretical ethical considerations are consistent with the results of empirical ethics studies in Western cultures showing that patients overwhelmingly desire full disclosure of harmful ME [5,13-17] and that full disclosure is likely to have a positive or no effect on how patients respond to ME [18].
Disclosure of near miss ME to patients is a matter of controversy [19,20] and an issue on which current guidelines are silent. Disclosure is recommended by some [21-24] but not all authors in the field [2,25]. The American Society for Reproductive Medicine states that if there is clearly no adverse effect of a ME, disclosure may not be obligatory if it may unnecessarily increase patient's stress [26]. In the few empirical studies that have specifically addressed near miss ME, 88% to 92% of patients desired disclosure [15,27]. In contrast, most physicians opposed near miss ME disclosure [5]. Determining who should disclose ME is another matter of controversy. According to Liang model [21] and the policy described by Kraman and colleagues [28], risk management committee should be responsible for disclosure. Others believe that the responsibility for disclosure belongs to the physician [10,11,22,29]. JCAHO standard requires that a responsible licensed independent practitioner or his/her designee explains the outcome [7].
Current disclosure literature contains important but unanswered questions such as how patient' preferences for disclosure vary along cultural and other dimensions [10,11]. An individual's ethical decision-making is based on his/her values and beliefs. Although major ethical values are rather universal, ethical values are subject to individual interpretation and people naturally differ in their values' hierarchy and in their beliefs. Autonomy is placed at the top of the "moral mountain" and is given a "place of honor" in Western but not other ethics [30]. Further, there are several meanings of autonomy along a spectrum from a negative or anti paternalistic model to a positive mandating model [31]. Furthermore, it has been argued that respect should be for the person rather than purely for autonomy [31,32]; trust in providers, treatment with respect, and dignity were more closely associated with patients overall evaluation of their hospitals than adequate involvement in decision-making [33]. To our knowledge, there is no study on patients' views on disclosure of ME that has been conducted in Arabic/Islamic countries or that compared preference (a statement about the person who has the preference) and perception of norm (a statement about the thing which is being judged).
The aim of this study was to obtain empirical evidence on public views on disclosure of ME in the outpatient's setting at a tertiary care hospital in Saudi Arabia. We examined preference, perception of norm, and perception of current practice on two topics, which ME to be disclosed and who to disclose ME.

Methods

This cross sectional survey was conducted in accordance with the ethical principles contained in the Declaration of Helsinki and after approval of the Research Ethics Committee of the King Faisal Specialist Hospital and Research Center (KFSH&RC) in the period from November 2007 to March 2009. All respondents gave verbal consent.
Two sets of three questionnaires addressing personal preference, perception of norm (what is appropriate in general/should be done), and perception of current practice at KFSH&RC regarding which medical error is disclosed to patients (set one) and by whom (set two) were developed by the authors in Arabic language based on literature review. After initial development, the questionnaires were presented for comments to 6 physicians and revised accordingly (minor changes in language usage to have consistency throughout the questionnaires). Face validity was assessed by interviewing 10 respondents after completing the questionnaires. The final version was pilot tested on 10 other individuals for clarity and stability (2-3 days) and found suitable. An English translation (accuracy confirmed by back translation) of the two questionnaires on personal preference is shown in Table 1. Similar statements with appropriate modifications were used for the questionnaires on perceptions of norm and current practice. For example, we used the phrase "I prefer" combined with "to be" and "my/me" to indicate personal preference and "I think" combined with "should be" and "patient/his" to indicate perception of norm. For perception of current practice questionnaires, "I prefer" was omitted and "is" was combined with "patient/his". The statements in each questionnaire were arranged from least to most demanding. Before completing the questionnaires, participants were given the following introductory information on medical errors: "Clinical practice, just like any other beneficial practice, could hardly be completely free from harm. Such harm can be divided into two types: 1) harm that can be predicted and thus can be avoided, e.g. anaphylactic shock caused by penicillin administration to a person known to have penicillin allergy, and 2) harm that can't be predicted/avoided, e.g. inflammation of the bowel after some antibiotics treatment. The first type is called medical error. A medical error is defined as failure to complete a planned medical action as intended, or the use of a wrong plan to achieve an aim. Medical errors may or may not cause harm, for example, penicillin could be wrongly prescribed by a physician but not given to the patient because the error is discovered and corrected in time by a pharmacist or nurse. Physicians may not disclose medical errors to patients for a variety of reasons that are related to patient's interests or physician's interests or because they may think it is useless to do so. Similarly, some patients wish to be informed about medical errors and some do not. Disclosing medical errors to patients is an issue separate from disclosing them to hospital administration. In this study we are interested in disclosing medical errors to patients. We would like to know your views on: 1) which medical error to be disclosed to patients, and 2) who to disclose medical errors to patients. There are three groups of statements for each of these two questions. The first is on what you personally prefer, the second is on what you think is best in general, and the last is on what you think reflect the current practice at KFSH&RC". For each questionnaire, participants were asked to choose the most representative statement. The six questionnaires are available in Additional file 1.

Patient information protection laws

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) governed by the U.S. Department of Health and Human Services' Office of Civil Rights establishes rules that ensure the privacy of Americans' individually identifiable health information. These rules protect the economically disadvantaged as well because government programs that pay for health care such as Medicare and Medicaid are covered entities under HIPAA.

Right to Request Information

American health care consumers have the right to request copies of their medical records or other related information from their health care providers. Under HIPAA, providers must give the requested information within 30 days of the request or 60 days with an adequate reason. Consumers may be charged only for the cost of copying and mailing information.

Right to Corrections

HIPAA gives health care consumers the right to request a documented change to medical records in the form of new or additional information to correct any noted discrepancies. If a medical facility disagrees, consumers still have the right to have the difference of opinion noted in their file. HIPAA requires consumer requested corrections be made within 60 days of the request. With an adequate reason, this time may be extended to 90 days.

What is a Living Will?

When you are diagnosed with a serious or terminal illness it can be overwhelming dealing with the impact of that news as well as realising that you need to put your affairs in order. Next of kin will need to be able to locate important papers to do with life insurance, valuables and assets. One thing that is being increasingly talked about is the option of making a living will.

When you become ill, you can usually discuss treatment options with your doctor and then reach a decision together about the most appropriate approach to take. However, you may be admitted to hospital when unconscious and unable to make your own decisions about your treatment. Similarly, you may be unable to communicate your wishes if you have had a stroke. To use the legal term – you would "lack mental capacity" to make an informed decision. In such situations, doctors have a duty to preserve life and a legal and ethical obligation to act in your best interests.

The Mental Capacity Act 2005 provides a legal framework to help empower people to make their own decisions and to make clear what actions carers and family can take. In other words, a living will is a document or letter written by yourself to your family, your doctors and solicitor. It is concerned with decisions that may have to be made about your treatment and hospital care if ever you yourself are unable to make those decisions.