[Physician's obligations to inform about complications based on a recent warning from drug authorities]. / Ärztliche Aufklärungspflichten nach Bekanntgabe eines Warnhinweises über unerwünschte Arzneimittelwirkungen.

BACKGROUND: Based on a recent warning from the drug authorities about increased suicidality among users of hormonal contraceptives, this article discusses the legal consequences of translating novel findings from clinical trials into altered contents of gaining informed consent during the medical consultation. METHODS AND RESULTS: Comprehensive information in accordance with § 630e German Civil Code (BGB) requires that rare drug reactions be mentioned by the prescribing physician, when they are associated with serious sequelae. This act regulates the treating physician's obligations to inform about complications for both preventive and curative treatment options. In this paper, we refer to the scientific evidence level of data from clinical trials as the key feature for implementing altered medical information in the proper conduct of acquiring the consent of the patient in line with § 630e BGB. The article discusses how additions and amendments to the package leaflet and the expert information will impact on the obligations for the treating party to provide information for the patient in order to obtain informed consent. In particular, we focus on the relationship between the obligations for the physician prescribing oral contraceptives on an individual case and the generalized information conditions according to § 11 and § 11a German Medicinal Products Act. DISCUSSION: Current warnings of the drug authorities in the form of red-hand letters do not necessarily have legal consequences for gaining informed consent during the medical consultation.

[Decision-making support in Intensive Care to facilitate organ donation : Position paper of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. / Entscheidungshilfe bei erweitertem intensivmedizinischem Behandlungsbedarf auf dem Weg zur Organspende : Positionspapier der Sektion Ethik und der Sektion Organspende und -transplantation der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

BACKGROUND AND CHALLENGE: Injuries, especially traumatic brain injury, or specific illnesses and their respective sequelae can result in the demise of the patients afflicted despite all efforts of modern intensive care medicine. If in principle organ donation is an option after a patient's death, intensive therapeutic measures are regularly required in order to maintain the homeostasis of the organs. These measures, however, cannot benefit the patient afflicted anymore-which in turn might lead to an ethical conflict between dignified palliative care for him/her and expanded intensive treatment to facilitate organ donation for others, especially if the patient has opted for the limitation of life-sustaining therapies in an advance directive. METHOD: The Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) have convened several meetings and a telephone conference and have arrived at a decision-making aid as to the extent of treatment for potential organ donors. This instrument focusses first on the assessment of five individual dimensions regarding organ donation, namely the certitude of a complete and irreversible loss of all brain function, the patient's wishes as to organ donation, his or her wishes as to limiting life-sustaining therapies, the intensity of expanded intensive treatment for organ protection and the odds of its successful attainment. Then, the combination of the individual assessments, as graphically shown in a {Netzdiagramm}, will allow for a judgement as to whether a continuation or possibly an expansion of intensive care measures is ethically justified, questionable or even inappropriate. RESULT: The aid described can help mitigate ethical conflicts as to the extent of intensive care treatment for moribund patients, when organ donation is a medically sound option. NOTE: Gerald Neitzke und Annette Rogge contributed equally to this paper and should be considered co-first authors.

[Legal implications of overtreatment]. / Juristische Implikationen einer Übertherapie.

Treatment measures beyond a justifiable indication are not only dubious from a medical point of view but also risky with respect to liability law and criminal law, even if the patient wishes to do so. Thoughtless automatisms in the daily routine of health care, economic pressures and legal "sciolism" endanger the the making of appropriate decisions regarding treatment and the society's claim to an economical and equitable use of resources. It is expected that the judicial system will not only take the violation of the patient's right to self-determination into account, but in the future-more than it used to-the defiance of boundaries of the medical profession.

[Amendment to the documentation of decisions to withhold or withdraw life-sustaining therapies in consideration of wish to donate organs : Recommendation of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. / Ergänzung des Dokumentationsbogens "Therapiebegrenzung" unter Berücksichtigung eines möglichen Organspendewunsches : Empfehlung der Sektion Ethik sowie der Sektion Organspende und Organtransplantation der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

The Ethics Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) recently published a documentation for decisions to withhold or withdraw life-sustaining therapies. The wish to donate organs was not considered explicitly. Therefore the Ethics Section and the Organ Donation and Transplantation Section of the DIVI together with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine worked out a supplementary footnote for the documentation form to address the individual case of a patient's wish to donate organs.

[Quo vadis, modern intensive care medicine? Outdated considerations regarding risks and side effects]. / Quo vadis, moderne Intensivmedizin? Unzeitgemäße Betrachtungen zu ihren Risiken und Nebenwirkungen.

Modern intensive care medicine is faced with large challenges which are not solely caused by medical-technical progress, but above all by the demographic and value-related changes of society and its citizens. Thereby, three central problem areas are of particular interest: the fragile effectiveness of a patient's right to self-determination at the end of life, the uncertainties regarding the demarcation of futility, and the question of the influence of economic considerations (rationing) in view of the different levels for the allocation of duties and execution of duties. This article contains the revised version of the lecture from June 18, 2015 on the occasion of the 47th annual joint conference of DGIIN (Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin) and ÖGIAIN (Österreichischen Gesellschaft für Internistische und Allgemeine Intensivmedizin und Notfallmedizin) on the general subject: "quality and humanity".

[Change in therapy target and therapy limitations in intensive care medicine. Position paper of the Ethics Section of the German Interdisciplinary Association for Intensive Care and Emergency Medicine]. / Therapiezieländerung und therapiebegrenzung in der intensivmedizin. Positionspapier der Sektion Ethik der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin.

The task of physicians is to maintain life, to protect and re-establish health as well as to alleviate suffering and to accompany the dying until death, under consideration of the self-determination rights of patients. Increasingly more and differentiated options for this are becoming available in intensive care medicine. Within the framework of professional responsibility physicians must decide which of the available treatment options are indicated. This process of decision-making is determined by answering the following question: when and under which circumstances is induction or continuation of intensive care treatment justified? In addition to the indications, the advance directive of the patient is the deciding factor. Medical indications represent a scientifically based estimation that a therapeutic measure is suitable in order to achieve a defined therapy target with a given probability. The ascertainment of the patient directive is achieved in a graded process depending on the state of consciousness of the patient. The present article offers orientation assistance to physicians for these decisions which are an individual responsibility.

[Preventive crisis management in general outpatient palliative care - prospectively cross-sectional study of General Practitioners in Eastern Bavaria]. / Vorbeugendes Krisenmanagement in der allgemeinen ambulanten Palliativversorgung. Prospektive Querschnittstudie bei Hausärzten in Ostbayern.

BACKGROUND: General out-patient palliative care (GOPC) must be integrated into the care of patients with life-limiting diseases. Aim of the study was to evaluate experiences of general practitioners concerning advance directives and palliative emergency sheets. METHODS: A self-provided survey was mailed to all general practitioners in Regensburg (cross-sectional study). Main outcome measures included responses regarding a palliative emergency sheet (PES) and a palliative emergency plan (PEP). The investigation period was four months. The analysis was performed using defined criteria (e. g. professional experience concerning palliative care patients, patients treated in nursing homes, patients with dementia). RESULTS: Sixty-nine questionnaires from 259 were analysed (response rate 27 %). 86 % of respondents named practical experience in the care of palliative patients, 46 % named theoretical knowledge in this field. 41 % and 40 % consider creating an advance directive for their practical work as important/very important (p = 0.004 concerning the treatment of more than five palliative care patients per three months). 52 % and 49 % regard a PES or a PEP to be relevant (PES median: 6.5, SD ± 2.7; PEP median: 6.5 SD ± 2.9; inter-group analysis p < 0.05). 94 % of respondents name the general practitioner to be suitable for creating an advance directive. CONCLUSION: In Germany, GOPC in end-of-life care is very important. This study shows that advance directives were declared as an important instrument for patients? autonomy. The sense of PES and PEP to ensure patients? autonomy, especially for acute emergency medical palliative care, must be better recognized. However, the increase in acceptance in the GOPC for such instruments must be disclosed. Further studies to investigate this problem are necessary.

[End-of-life decisions in cases of vegetative state from the legal point of view]. / Therapiebegrenzende Entscheidungen in "Wachkoma"-Fällen aus rechtlicher Sicht.

The perspective of having to "vegetate" in a so-called persistent vegetative state over an indefinite period of time is regarded as unacceptable by many people. How to operationalise and enforce the patients "right of self-determination" in such cases is a subject of current medical and ethical debate. In addition, there is great uncertainty about how far and how long further treatment or supply is still indicated in such cases. The article discusses the legal framework and illustrates existing uncertainties and points out those aspects that demand clarification.

[Emergency medical treatment of palliative care patients at the end of life: regulatory emergency medical care framework--a case control investigation of medical intervention and advance directives]. / Notfallmedizinische Betreuung von Palliativpatienten am Lebensende : Juristische Beurteilung notfallmedizinischer Handlungsweisen - retrospektive Fallbetrachtung zur medizinischen Indikation und zum Patientenwillen.

BACKGROUND: The treatment of out-of-hospital palliative emergency care situations during cardiac arrest is a special situation. The prehospital emergency physician (EP) and the paramedic must be informed about the medical, legal, and ethical specifics of these situations, but this knowledge is not integrated within emergency medical curricula at all. We present a case study to discuss such legal and ethical specifics. METHODS: We retrospectively analysed six emergency cases with palliative care patients in the final stages of their illnesses. On the basis of these case studies, we present six different emergency cases with different regulatory frameworks for each EP and paramedic. In accordance with the Declaration of Helsinki, data were collected pseudonymously. RESULTS: The six case studies show therapeutic concepts concerning the emergency medical care of palliative care patients during cardiac arrest. The differences are apparent in the treatment given by EPs and by paramedics (such as whether to start or stop resuscitation). EPs and paramedics differ in their therapeutic approach to these specific situations (e.g. paramedics more often start resuscitation during cardiac arrest even though patients would refuse this according to their advance directives). These differences may be important for the patient and his or her caregivers. CONCLUSIONS: Every EP and paramedic may be involved in the care of palliative care patients who are at the end of their lives. EPs and paramedics do not always adapt their treatment to the will or supposed will of the patient (especially in accordance with the new German law concerning advance directives). The reasons for this usually concern legal uncertainties. Therefore, EPs and paramedics should know that different legal meanings could be important in emergency medical care therapy of palliative care patients. A written "do not resuscitate" order as an advance directive must be evaluated as a desired therapeutic limitation.

[Palliative care patients in an advanced state of disease. Cardiopulmonary resuscitation and determination of death]. / Palliativpatienten im weit fortgeschrittenen Krankheitsstadium. Notärztliche Reanimation und Todesfeststellung.

BACKGROUND: Prehospital emergency teams will be confronted with the specific needs of resuscitation in palliative patients in whom a return of spontaneous circulation (ROSC) could be found significantly less frequently than in other emergency situations. The present investigation aims to show medical and judicial problems related to cardiopulmonary resuscitation (CPR), external examination of the corpse and death certification. METHODS: Over a 12-month period all emergency cases involving physicians in an out-of-hospital resuscitation setting in cancer patients were retrospectively analysed for indications for emergency call, situation on-site and prehospital treatment by emergency physicians, external examination of the corpse and determination of death. RESULTS: For the period mentioned 164 (2.7% of the total) emergency calls by cancer patients or their relatives were identified. In the following study 43 patients (26.2%) could be included. In 20 cases (46.5%) the emergency physicians attempted to resuscitate the patient by performing CPR. In the majority of cases (36; 83.7%) death certification and external examination of the corpse were necessary at the scene. CONCLUSIONS: Due to a reduced rate of ROSC in palliative patients, death certification and external examination of the corpse are more often necessary than in other emergency situations. Therefore every emergency physician should be familiar with the ethics of resuscitation of patients in palliative care and with external examination of the corpse to do justice to patients and their caregivers.

[The Göttingen palliative emergency card: improvement of emergency medical care for ambulatory palliative care patients. The "yellow card for rescue services"]. / Göttinger Palliativkrisenbogen: Verbesserung der notfallmedizinischen Versorgung von ambulanten Palliativpatienten. Die "Gelbe Karte für den Rettungsdienst."

Currently more and more patients with cancer will be treated at home, especially at the final stage of their disease. Relatives and nursing services will therefore be confronted with acute emergency situations concerning these patients. The handling of these acute situations may be beyond the relatives' coping capacity. For that reason the pre-hospital emergency system (2.5% of all emergency calls) will be confronted with very specific needs of these patients. Emergency situations of palliative patients at home are more predictable than other circumstances. It is thus possible to achieve a practicable preparation for such emergency situations. An individual "emergency plan" should be created for these cases.. The plan may be processed in an emergency situation. It may then be possible to avoid emergency calls and make it possible for the patient to remain at home. This promotes the patient's quality of life and his/her predominant desire to stay at home after the emergency. An advance directive should be made which records the patient's wishes. Because of the complexity of an advance directive it is essential to indicated the patient's wishes in a short and quickly read form in case an emergency arises. This is one of the reasons for producing a short version like the "Göttingen palliative emergency card". In acute situations it is then possible quickly to make known the patient's wishes The patient may be given the possibility of remaining at home after an emergency situation has been dealt with successfully.