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Pharmaceutical ethics

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Pharmaceutical ethics

Medical ethics

Medical ethics is primarily a field of applied ethics, the study of oral values and judgments as they apply to edicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.



Medical ethics tends to be understood narrowly as an applied professional ethics, whereas ioethics appears to have worked more expansive concerns, touching upon the philosophy of science and the critique of biotechnology. Still, the two fields often overlap and the distinction is more a matter of style than professional consensus.

Medical ethics shares many principles with other branches of healthcare ethics, such as nursing ethics.

History

Historically, Western medical ethics may be traced to guidelines on the uty of physicians in antiquity, such as the Hippocratic Oath, and early abbinic and hristian teachings. In the medieval and early modern period, the field is indebted to Muslim physicians such as Ishaq bin Ali Rahawi (who wrote the Conduct of a Physician, the first book dedicated to medical ethics) and al-Razi (known as Rhazes in the West), Jewish thinkers such as aimonides, Roman Catholic scholastic thinkers such as Thomas Aquinas, and the case-oriented analysis (asuistry) of Catholic moral theology. These intellectual traditions continue in Catholic, Islamic and Jewish medical ethics.

By the 18th and 19th centuries, medical ethics emerged as a more self-conscious discourse. For instance, authors such as the British Doctor Thomas Percival (1740-1804) of anchester wrote about "medical jurisprudence" and reportedly coined the phrase "medical ethics." Percival's guidelines related to physician consultations have been criticized as being excessively protective of the home physician's reputation. Jeffrey Berlant is one such critic who considers Percival's codes of physician consultations as being an early example of the anti competitive, "guild", like nature of the physician community. In 1847, the American Medical Association adopted its first ode of ethics, with this being based in large part upon Percival's work [2]. While the secularized field borrowed largely from Catholic medical ethics, in the 20th century a distinctively liberal Protestant approach was articulated by thinkers such as Joseph Fletcher. In the 1960's and 1970's, building upon liberal theory and procedural justice, much of the discourse of medical ethics went through a dramatic shift and largely reconfigured itself into ioethics.

Values in medical ethics

Six of the values that commonly apply to medical ethics discussions are:

  • Beneficence - a practitioner should act in the best interest of the patient. (Salus aegroti suprema lex.)
  • Non-maleficence - "first, do no harm" (primum non nocere).
  • Autonomy - the patient has the right to refuse or choose their treatment. (Voluntas aegroti suprema lex.)
  • ustice - concerns the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality).
  • ignity - the patient (and the person treating the patient) have the right to dignity.
  • ruthfulness and onesty - the concept of informed consent has increased in importance since the historical events of the Doctors' Trial of the Nuremberg trials and Tuskegee Syphilis Study.

Values such as these do not give answers as to how to handle a particular situation, but provide a useful framework for understanding conflicts.

When moral values are in conflict, the result may be an ethical ilemma or crisis. Writers about medical ethics have suggested many methods to help resolve conflicts involving medical ethics. Sometimes, no good solution to a dilemma in medical ethics exists, and occasionally, the values of the medical community (i.e., the hospital and its staff) conflict with the values of the individual patient, family, or larger non-medical community. Conflicts can also arise between health care providers, or among family members. For example, the principles of autonomy and beneficence clash when patients refuse life-saving blood transfusion, and truth-telling was not emphasized to a large extent before the HIV era.

In the United Kingdom, General Medical Council provides clear overall modern guidance in the form of its 'ood Medical Practice' statement. Other organisations, such as the Medical Protection Society and a number of university departments, are often consulted by British doctors regarding issues relating to ethics.

How does one ensure that appropriate ethical values are being applied within hospitals? Effective hospital accreditation requires that ethical considerations are taken into account, for example with respect to physician integrity, conflicts of interest, research ethics and organ transplantation ethics.

Informed consent

Informed Consent in ethics usually refers to the idea that an uninformed agent is at risk of mistakenly making a choice not reflective of his or her values. It does not specifically mean the process of obtaining consent, nor the specific legal requirements, which vary from place to place, for decision-making capacity. Patients can elect to make their own medical decisions, or can delegate decision-making authority to another party. If the patient is incapacitated, laws around the world designate different processes for obtaining informed consent, typically by having the next-of-kin make decisions for the incapacitated patient.

The value of informed consent is closely related to the values of autonomy and truth telling. The American legal system places a high value on these principles, finding justification in the U.S. Constitution and Declaration of Independence.

Confidentiality

Confidentiality is commonly applied to conversations between doctors and patients. This concept is commonly known as patient-physician privilege. Legal protections prevent physicians from revealing their discussions with patients, even under oath in court. Confidentiality is mandated in America by HIPAA laws, specifically the Privacy Rule, and various state laws, some more rigorous than HIPAA. Confidentiality is challenged in cases such as the diagnosis of a sexually transmitted disease in a patient who refuses to reveal the diagnosis to a spouse, or in the termination of a pregnancy in an underage patient, without the knowledge of the patient's parents. Many states in the U.S. have laws governing parental notification in underage abortion3]

Beneficence

The concept of doing good to humanity in general.

This is the principle of taking actions that benefit your patient, and that is in their best interest. It is not an absolute principle in that it only applies to your patients, unlike the principle on non-maleficence.

Autonomy

The principle of Autonomy recognizes the rights of individuals to self determination. This is rooted in society�s respect for individuals� ability to make informed decisions about personal matters. Autonomy has become more important as social values have shifted to define medical quality in terms of outcomes that are important to the patient rather than medical professionals. The increasing importance of Autonomy can be seen as a social reaction to a �paternalistic� tradition within healthcare. Respect for autonomy is the basis for informed consent and advance directives. Autonomy can often come into conflict with Beneficence when patients disagree with recommendations that health care professionals believe are in the patient�s best interest. Individuals� capacity for informed decision making may come into question during resolution of conflicts between Autonomy and Beneficence. The role of surrogate medical decision makers is an extension of the principle of Autonomy.

Non-Maleficence

The concept of non-maleficence is embodied by the phrase, "first, do no harm," or the Latin, primum non nocere. Physicians are obligated under medical ethics to not prescribe medications they know to be harmful. American physicians interpret this value to exclude the practice of uthanasia, though not all concur. Probably the most extreme example in recent history of the violation of the non-maleficence dictum was Dr. Jack Kevorkian, who was convicted of second-degree homicide in Michigan in 1998 after demonstrating active euthanasia on the TV news show, 60 Minutes.

Non-maleficence is a legally definable concept. Violation of non-maleficence is the subject of medical malpractice litigation.

Double effect

Some interventions undertaken by physicians can create a positive outcome while also potentially doing harm. The combination of these two circumstances is known as the "double effect." The most applicable example of this phenomenon is the use of morphine in the dying patient. Such use of orphine can ease the pain and suffering of the patient, while simultaneously hastening the demise of the patient through suppression of the respiratory drive.

Criticisms of orthodox medical ethics

It has been argued that mainstream medical ethics is biased by the assumption of a framework in which individuals are not simply free to contract with one another to provide whatever medical treatment is demanded, subject to the ability to pay. Because a high proportion of medical care is typically provided via the welfare state, and because there are legal restrictions on what treatment may be provided and by whom, an automatic divergence may exist between the wishes of patients and the preferences of medical practitioners and other parties. Tassano has questioned the idea that Beneficence might in some cases have priority over Autonomy. He argues that violations of Autonomy more often reflect the interests of the state or of the supplier group than those of the patient.

Importance of communication

Many so-called "ethical conflicts" in medical ethics are traceable back to a lack of communication. Communication breakdowns between patients and their healthcare team, between family members, or between members of the medical community, can all lead to disagreements and strong feelings. These breakdowns should be remedied, and many apparently insurmountable "ethics" problems can be solved with open lines of communication.

Ethics committees

Many times, simple communication is not enough to resolve a conflict, and a hospital ethics committee of d hoc nature must convene to decide a complex matter. Permanent bodies, ethical boards are established to a greater extent as ethical issues tend to increase. These bodies are composed of health care professionals, philosophers, lay people, and still lergy.

The assignment of philosophers or clergy will reflect the importance attached by the ociety to the basic values involved. An example from weden with Torbj�rn T�nnsj� on a couple of such committees indicates secular trends gaining influence.

Cultural concerns

Culture differences can create difficult medical ethics problems. Some cultures have spiritual or magical theories about the origins of disease, for example, and reconciling these beliefs with the tenets of Western medicine can be difficult.

Truth-telling

Some cultures do not place a great emphasis on informing the patient of the diagnosis, especially when cancer is the diagnosis. Even American culture did not emphasize truth-telling in a cancer case, up until the 1970s. In American medicine, the principle of informed consent takes precedence over other ethical values, and patients are usually at least asked whether they want to know the diagnosis.

Conflicts of interest

Physicians should not allow a conflict of interest to influence medical judgment. In some cases, conflicts are hard to avoid, and doctors have a responsibility to avoid entering such situations. Unfortunately, research has shown that conflicts of interests are very common among both academic physicians and physicians in practice. The The Pew Charitable Trusts has announced the Prescription Project for "academic medical centers, professional medical societies and public and private payers to end conflicts of interest resulting from the $12 billion spent annually on pharmaceutical marketing".

Referral

For example, doctors who receive income from referring patients for medical tests have been shown to refer more patients for medical tests . This practice is proscribed by the American College of Physicians Ethics Manual .

Fee splitting and the payments of commissions to attact referrals of patients is considered unethical and unacceptable in most parts of the world. It is tolerated, though, in some areas of US medical care.

Vendor relationships

Studies show that doctors can be influenced by drug company inducements, including gifts and food. Industry-sponsored Continuing Medical Education (CME) programs influence prescribing patterns. Many patients surveyed in one study agreed that physician gifts from drug companies influence prescribing practices. A growing movement among physicians is attempting to diminish the influence of pharmaceutical industry marketing upon medical practice, as evidenced by Stanford University's ban on drug company-sponsored lunches and gifts. Other academic institutions that have banned pharmaceutical industry-sponsored gifts and food include the University of Pennsylvania, and Yale University.

Treatment of family members

Many doctors treat their family members. Doctors who do so must be vigilant not to create conflicts of interest or treat inappropriately..

Sexual relationships

Sexual relationships between doctors and patients can create ethical conflicts, since sexual consent may conflict with the iduciary responsibility of the physician. Doctors who enter into sexual relationships with patients face the threats of deregistration and prosecution. In the early 1990's it was estimated that 2-9% of doctors had violated this rule.

Futility

Advanced directives include living wills and durable powers of attorney for healthcare. (See also Do Not Resuscitate and cardiopulmonary resuscitation) In many cases, the "expressed wishes" of the patient are documented in these directives, and this provides a framework to guide family members and ealth care professionals in decisionmaking when the patient is incapacitated. Undocumented expressed wishes can also help guide decisionmaking, in the absence of advanced directives. "Substituted judgement" is the concept that a family member can give consent for treatment if the patient is unable (or unwilling) to give consent himself. The key question for the decisionmaking surrogate is not, "What would you like to do," but instead, "What do you think the patient would want in this situation." Courts have supported family's arbitrary definitions of futility to include simple biological survival, as in the aby K case. A more in-depth discussion of futility is available at futile medical care.

  • Baby Doe Law Establishes state protection for a disabled child's right to life, ensuring that this right is protected even over the wishes of parents or guardians in cases where they want to withhold treatment.



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