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Informed consent has two aspects. First, we must give patients sufficient, precise information on the nature of their disease, natural history, possible choices of treatment, and risks of the treatment to help them make their own decisions. The estimated risks should be based on a database, not on personal impressions or limited experience. In choosing the type of prosthetic valve in young or middle-aged patients, unbiased information based on guidelines should be presented. The second aspect of informed consent is its role as a contract for providing medical service. Estimated in-hospital mortality and major morbidities should be clarified in percentages on the consent form as confirmation of understanding.

Pharmacists are requested to be involved in the management of pharmacotherapy in clinical scenes more extensively than they did ever. It can be said that changes in medical environments such as the collapse of doctors' paternalism, the rising recognition of patients' autonomy in the decision making on their own medical therapy, and the increased accountability of medical care givers to patients have obliged pharmacists to participate in pharmacotherapy as patient's advocates. To meet these social needs the education of students in pharmaceutical universities or colleges should be reconstructed extensively from a traditional research-oriented system to a patient-centered system. In particular the education of applied pharmacotherapy is to be strengthened and enforced. A drastic reform of pharmacist education should be brought in effect.

To be able to use unlicensed medicines for treatment of special patients, there are "Compassionate Use Mechanisms" n Europe. The general principles are defined under EC regulations,but the actual national systems differ per country. They are categorized two types, one is "Nominative" and the other is "Cohort". Nominative systems allow accessing unlicensed medicines on a patient by patient basis, which are called in various ways such as named patient supply, individual patient supply, nominative importations, etc. All of 25 EU countries have this system in some way. Cohort systems are for multiple patients in dedicated hospitals. 10 EU countries have this system. Therefore, these countries have both of nominative and cohort systems. Compassionate Use is a streamlined system for access for patients with serious, life threatening or disabling disease with no licensed alternative in the opinion of the treating physician, and it should be done under the medical responsibility of the treating physician. The company is responsible for providing fair, accurate and balance information to the physician for decision making and also for the quality of the medicinal product. The current Japanese "Private Import System" has caused some problems. I think that we need an appropriate "Compassionate Use system" in Japan.

All medical workers have a duty to protect a patient's privacy by law. Civil servants have a duty to prosecute anyone if a crime has been committed and others have the right to prosecute. When medical workers find their patient using illegal drugs, they are in a situation where any possible action they take is either a breach of one of the duties or an abandonment of the right to prosecute. Any worker in this situation should choose to do what will greater benefit society. Medical workers should avoid prosecuting a patient for illegal drug use, so that drug users can seek help. At the same time medical workers should try to put the patient in a situation where the patient's drug use in the future can be treated by the criminal justice system.

An ongoing debate is underway on whether the right to control medical information required for objective evaluations and uncertain information should belong to the physician. In this study, the opinions of practicing physicians were examined. Information appearing on medical records was divided into 10 items, and physicians were asked whether the right to control each item belonged to the patient and/or the physician. More than 60% the physicians answered that both patients and physician have the right to control information such as the diagnosis, examination findings, informed consent, and treatment. All of these items can be categorized as personal data. On the other hand, more than 70% of the physicians believed that only physicians have the right to control information such as the process to reach a diagnosis, subjective patient information, uncertain information and discussion with other physicians. Those physicians who answered that that both patients and physicians have the right to control information such as subjective patient information were more in favor of the disclosure of medical records than the physicians who were against the patient's right to control such information (p<0.05). The results of this study suggest that the right to control medical information on medical records should be considered separately for each chart item. As the network of medical information advances, the right to control medical information will become a topic of increasing importance.

A 41-year-old woman who had been given a diagnosis of aplastic anemia 14 years before was admitted because of recurrence of the disease. Despite therapy, the anemia progressed gradually. The patient refused blood product transfusions for religious reasons. Angina pectoris-like chest pain without ischemic changes on electrocardiograms appeared at a hemoglobin concentration (Hb) of 1.6 g/dl. The patient died of heart failure at Hb 1.5 g/dl. Autopsy showed enlargement of the heart, fatty changes in the myocardium and liver due to chronic hypoxia, and no changes in coronary arteries.

A total of 57 patients with hypopharyngeal cancer were given an opportunity to select their treatment options after a thorough explanation of the tumor stage, treatment modalities, complications due to treatment, and prognosis. As a result, many patients selected chemoradiotherapy as the initial treatment. Two patients requested treatment at other institutes and were immediately transferred. A 91-year-old patient with T4N3M0 tumor declined treatment. The duration from the initial visit to the start of treatment course was prolonged because of the informed consent process. Patient rejection of salvage surgery following the failure of chemoradiotherapy increased. However, both the physician-patient relationship and physician-patient's family relationship in the uncured group did not deteriorate. No change in the 3-year crude survival rate by introducing self-determined treatment was observed at this time. It is ideal that the patient choice of treatment options is the one physician recommend. Meanwhile, physicians should consider ideal treatment options, which are most desirable for the patient. In conclusion, thorough informed consent provides positive clinical impact even with ominous hypopharyngeal cancer.

The idea of informed consent asks for the right of self-determination which is very difficult to achieve. Human life does not depend on one's will, and neither does suffering. That is human being does not control one's own life, even though one must be responsible for it. The right of self-determination has long and struggling history. As a result we have acquired the concept of informed consent. And then the physician-patient relationship is no longer considered to be based on paternalism and now the new model is seeked for. All human beings are mortal and cannot inevitably escape suffering. Therefore we must consider the physician-patient relationship as the one based on equality. The problem of self-determination should arise from this understanding.

The objective of this study was to clarify the nursing care and its process for patients with intractable illness. An inductive qualitative study was conducted by using a grounded theory approach. Subjects were seven nurses who cared patients with intractable illness at two hospitals in Japan. The qualitative data was collected by participant observations and interviews to the subjects, and analyzed by the constant comparative analysis. Results revealed four categories of nursing care and its process for patient with intractable illness. Four categories were named as "to accept his/her emotion", "to respect his/her existence", "to develop his/her potentiality", and "to support his/her autonomy". Category 1: "To accept his/her emotion" is a nursing care to make the patient express his/her emotion freely, to understand him/her, and to communicate that everyone could feel so if situated as him/her. Category 2: "To respect existence" is a nursing care to communicate the patient that the existence of him/her is respectable regardless with his/her ability or evaluation. Category 3: "To develop potentiality" is a nursing care to develop the patient's potentiality for his/her life with safety and high-quality through changing or creating the way of life. Category 4: "To support autonomy" is a nursing care to support and expand the patient's life activities through the ways of life acquired by him/her. This study also revealed some definite actions of nurses who cared for patients with intractable illness.

Many uncertainties and fuzzinesses exist in the medicine itself and cultural differences greatly influence on the medical practice. The word "cancer" is still often considered to be synonymous with the word "death" and despite encouraging recent medical advances this dark image will most likely continue into the next century. Today the world is becoming increasingly estimated in terms of technical and economic effectiveness and the same holds true in the field of medicine. Such valuation will be-evaluated in the coming century for human beings. This paper will discuss the cultural and social significance of informing a cancer patient of truth as well as a patient's informed consent and living will. Such changes in the medical culture of Japan should be regarded positively since they should help to improve the overall trust between patients and doctors in the future.

Our medication team, consists doctors, nurses, pharmacists, and other staffs, made an effort to satisfy our patients with medical treatment. We especially tried to guarantee patient rights. Pharmacists visited patients in September 1995, seeking to inform every patient about effects and side effects of medicines using the "Medicine Information Sheet" with samples. As a result, in one case now under treatment by medicine, he no longer needs it. Then, our medication team had a conference and his doctor changed his prescription. In another case, we found a symptom suspected to be a side effect of a medicine. We asked his doctor about it, and he stopped the medicine in question. His medical condition then became better. This resulted in a "suitable amount" of medicine. We are confident that this is also necessary for every patient under treatment at home, when a pharmacist visits his or her home and informs them about the effects and side effects of medicines, and assists them to assure good treatment.

Voluntary admissions are classified by four factors-limitation of discharge, limitation of actions, procedures of protection of human rights, prescription of the special law concerning with mental health. The voluntary admission prescribed in the Mental Health Law in Japan (NIN'I-NYUUIN) has all of these four factors. But we are using also the informal admission (JIYUU-NYUUIN), which is not prescribed in the Mental Health Law in Japan, and does not have limitation of discharge. The government has done several acts against the informal admission, and some disputants argued against it, but either logically or practically, it is beneficial to use the informal admission as the one that is distinguished from the voluntary admission, and the government should stop those acts immediately. Although one disputant argues that the informal admission should be prescribed in the Mental Health Law and should have procedures of protection of human rights, we should pursue complete voluntary admission, that is, the one that is similar to admission of medical or surgical patients, and that has neither of the four factors of voluntary admissions. And we should consider the competency to consent to admission. Some disputants argue with Zinermon v. Burch, the decision of the U.S. Supreme Court in 1990. But this decision necessarily did not argue that the patient should be tested whether competent or not before voluntary admission, and some argued that the decision should not be read expansively. On voluntary admission, the clinician should consider not only the competency of the patient, but also the therapeutic benefit of voluntary admission.

Unlabelled: Nurses provide the psychosocial nursing care to promote the patients' empowerment. In spite of recognizing the importance of psychosocial nursing. The research reported here is part of a large study designed to explore the psychosocial nursing intervention strategies. This part of the study is focused on characteristics of psychosocial nursing care as identified by nurses. Research design was descriptive and qualitative. Subjects were a convenient sample of nurses who have more than 5 years experience and agreed to participate in this research. Data was collected through semistructured interviews. Data was recorded on a tape and transcribed, then analyzed based on Grounded Theory Approach., Subjects: The number of subjects consisted of 39 nurses. The average age and duration of clinical experience was 36.6 years old and 12.6 years., Result: Sixteen of the characteristics of psychosocial nursing to promote the empowerment among the patients were identified; 1) respect the patients' decision making, 2) clinical judgment from multiple perspectives, 3) predictability, 4) flexibility, 5) classification of the patients by comparison, 6) monitoring, 7) relief from reality, 8) relief from pain and suffering, 9) enhancement of the patients' ego strength, 10) nurture of hope, 11) support individualized daily living styles, 12) encouragement of the patients'own problem solving abilities, 13) respect of individuality, 14) self-utilization, 15) self-control based on professional identity, 16) utilization of team power., Discussion: Nurses choose from the sixteen dimensions of psychosocial nursing and organizing them in order to stabilizing the patients' conditions.

According to the survey in the spring, 1995 of the Minister of Health and Welfare, only 20% of recently died patients had been told the truth, having cancer, in Japan. This suggest that most of clinical trials on cancer in Japan involved patients without real Informed consent (IC) from patients themselves. Recent effort of the Japanese Clinical Oncology Group are breaking through this situation. In the first part, principles of IC in cancer patients and IC in trials were explained. Then the results of a questionnaire are shown. From my personal experience of over 700 patients told the truth, all that doctors should tell to patients in western countries could be told without causing troubles even in Japan. The results of the questionnaire answered by 388 patients of various cancers treated by the author, showed clearly the feasibility of telling the truth to Japanese cancer patients. This has long been regarded impossible or unacceptable. Only 2% of them regretted to be told the truth, only 7% did not desire to know the prognosis, more than 90% wanted to be told that they have recurrence when they would have recurrence. Even when they would be incurable, 66% of them required to be told so and only 16% did not. In such difficult situation, 36% would insist anticancer treatment, while 41% would prefer best supportive care. No one but patients themselves can make this choice.

I attended the 10th liaison society of ethics committees in medical schools in Japan. Three topics on the problems of the terminal patients, Jehovah's Witness needing blood transfusion and the patients suffering from AIDS were discussed by symposists consisted of 6 physicians, 2 nurses and a jurist. I picked up key phrases from the symposists' presentations with respect to professions. The physicians used the terms of terminal care, quality of life, informed consent, etc. The nurses emphasized a labor shortage, an ideal physician, cooperation of the patient's family, etc. A jurist expressed euthanasia, death with dignity, right of living and dying, etc. The common issue relating with all terms would be "patient's right of self-decision". Physicians should recognize this right and then exercise their discretion. All patients should be regarded as social beings under the medical care, which would be realized when physicians treat diseases with the relevant patients.

A questionnaire on the use of DNR-order was conducted on 427 trustee members of Japan Society of Reanimatology, Intensive Care Medicine and Anesthesiology with responses from 307 or 71.9%. The results of the questionnaire are as follows: DNR-order is unnecessary, 2.9%. Necessary depending on the situation, 96.7%. Here dying in dignity was the main reason for necessity of DNR-order and ethical, legal and technical problems were the reasons cited for objection. Patients' will is indispensable for DNR-order, 11.4%. Patients' will is not indispensable, 84.9%. Quality and quantity of treatment after the decision of DNR-order should not be limited or withdrawn, 21.2%. Should be withdrawn except for respirator, 60.6%. The percentage of those who had carried out a DNR-order was 69.1% (most of them more than once), but half of them did not describe the order on the chart. A guideline for a DNR-order by scientific societies and/or governmental policy for a DNR-order should be made and publicized not only for the benefit of the patients and their families but also for physicians themselves.