Periodic and unexpected shortages of drugs, biologics, and even medical devices have become commonplace in the United States. When shortages occur, hospitals and clinics need to decide how to ration their available stock. When such situations arise, institutions can choose from several different allocation schemes, such as first-come, first-served, a lottery, or a more rational and calculated approach. While the first two approaches sound reasonable at first glance, there are a number of problems associated with them, including the inability to (...) make fine, individual patient-centered decisions. They also do not discriminate between what kinds of patients and what types of uses may be more deserving or reasonable than others. In this article I outline an ethically acceptable procedure for rationing drugs during a shortage in which demand outstrips supply. (shrink)

For many years a debate has raged over what constitutes futile medical care, if patients have a right to demand what doctors label as futile, and whether physicians should be obliged to provide treatments that they think are inappropriate. More recently, the argument has shifted away from the difficult project of definitions, to outlining institutional policies and procedures that take a measured and patient-by-patient approach to deciding if an existing or desired intervention is futile. The prototype is the Texas Advance (...) Directives Act, but similar procedures have been widely implemented both with and without the protection of the law. While this method has much to recommend it, there are inherent moral flaws that have not received as much discussion as warranted. Because these strategies adopt a semblance of procedural justice, it is assumed that the outcomes of such proceedings will be both correct and fair. In this paper, I argue that there are three main irremediable defects in the policy approach: there is the potential for arbitrary decision-making about futility in specific cases; there are structural, pre-ordained consequences for ethnic minorities who would be disproportionately affected by the use of these procedures; and the use of rationing justifications to support the use of these policies. These flaws detract so much from any benefit that could be derived that they make such strategies more harmful than helpful. (shrink)

Ethische Leitlinien für die klinische Praxis erfreuen sich zunehmender Beliebtheit. Damit klinisch-ethische Leitlinien aber überhaupt erfolgreich wirksam werden können, ist noch Pionierarbeit zu leisten. Solche Leitlinien müssen wissenschaftlich stärker fundiert und ihre praktische Anwendbarkeit muss verbessert werden. In dieser Arbeit werden die ersten Schritte des Projekts METAP zur methodischen Entwicklung und praktischen Implementierung einer Leitlinie für eine patientengerechte Versorgung am Krankenbett beschrieben und zur Diskussion gestellt. Das Projekt orientiert sich methodisch an der Entwicklung medizinischer Leitlinien und generiert damit eine forschungs- (...) und konsensgestützte Leitlinie, die systematischer Evaluation und Modifikation unterliegt und Rechenschaft über ihre wissenschaftliche Fundierung gibt. Zusätzlich zur Leitlinie bietet das Projekt in der Form eines Handbuchs ein Entscheidungsfindungsverfahren an, welches unter anderem deliberative Aspekte unterstützt. Das Handbuch konzentriert sich auf ethische Fragen der Mikroallokation und liefert darüber hinaus Informationen über empirische, ethische und rechtliche Grundlagen für Therapieentscheidungen. Anhand eines Eskalationsmodells können unterschiedliche Instrumente nach Bedarf als ethische Lösungsstrategien eingesetzt werden, von der Kurzfassung im Kitteltaschenformat („Leporello“) mit den wichtigsten Fakten, weiterführenden Texten und Empfehlungen mit normativen und prozeduralen Hinweisen, über stationsinterne Lösungsversuche bis hin zum Ethikkonsil. Klinische Partner sind von Beginn an aktiv in den Entwicklungsprozess eingebunden und verbessern so die Praxistauglichkeit und Akzeptanz sowie die Ausrichtung des Instrumentariums an den tatsächlichen Bedürfnissen. Dieses partnerschaftliche, partizipative Vorgehen scheint eine wichtige Voraussetzung dafür zu sein, dass METAP in der Klinik Fuß fassen konnte. (shrink)

Recently, ethical guidelines for clinical practice have gained increased popularity, but in order to become useful they require more pioneer’s work. Clinical-ethical guidelines need to be based on a scientific foundation and their practicability must be improved. We present and put to discussion the initial steps of the METAP Project about the development and practical implementation of a clinical-ethical guideline dedicated to a fair resource-allocation at the bedside. -/- With its methodological orientation, the project represents a guideline which is based (...) on both research and consensus-building, undergoing systematic evaluation and modification. In addition to the guideline, the project comes with a manual (a tool kit) including a procedural instrument for making decisions supporting deliberative aspects. It focuses on issues of micro-allocation; furthermore, it provides empirical, ethical and legal basics for making fair treatment decisions that should help to prevent overtreatment, undertreatment or discrimination in patient care. We propose an Escalation Model with various instruments serving as problem solving strategies that correspond to the respective needs; these instruments include a pocket-summary (“Leporello”) with the most important facts; further reading material; normative and procedural recommendations; ward-specific strategies, and also the option of clinical ethics consultation. -/- Clinical partners have been actively involved in the developmental process from the beginning and contributed to the practical applicability, acceptance and a valid need-orientation of the whole tool kit. This partnership and the participatory approach seem to have helped METAP to gain a foothold in the clinic. (shrink)

Whether practiced by ethics committees or clinical ethicists, medical ethics enjoys a solid foundation in acute care hospitals. However, medical ethics fails to have a strong presence in the primary care setting. Recently, some ethicists have argued that the reason for this disparity between ethics in the acute and primary care setting is that primary care ethics is distinct from acute care ethics: the failure to translate ethics to the primary care setting stems from the incorrect belief that acute care (...) ethics can be applied to the primary care setting. In this paper, I argue that primary care ethics and acute care ethics are species of the same ethical genus, and that the ethical differences are not ones of kind but of circumstance. I do this by appealing to the role obligations that underlie acute care and primary care clinicians’ medical ethical obligations and the shared institutions that ground those obligations. (shrink)

Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs were studied. (...) We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

Background Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Method Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Results Three hundred thirty-nine reports from 38 (...) CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. Discussion In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. Conclusions The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

Wie muss ein ethischer Beratungsdienst strukturiert sein, damit er in moralischen Konfliktsituationen im klinischen Alltag angefragt wird und die Ratsuchenden ergebnisorientiert unterstützen kann? Nach welchen Kriterien lassen sich die Beratungsgespräche auswerten und bewerten? Zur Beantwortung dieser Fragen werden theoretisch fundierte Konzepte ethischer Fallbesprechung aus Nimwegen, Leuven und Basel herangezogen; dies geschieht vor dem Hintergrund der Erfahrungen mit der über zehnjährigen Entwicklung der ethischen Arbeit im Ev. Krankenhaus Bielefeld (EvKB). Als Resultat stellen wir einen strukturierten, multidisziplinären Ansatz vor, mit dem in (...) den Beratungsgesprächen die ethischen Dimensionen unterschiedlicher Vorstellungen herausgearbeitet und möglichst einvernehmlichen Lösungen zugeführt werden. Am Beispiel des EvKB lässt sich zeigen, dass der ethische Beratungsdienst auch in Zeiten knapper Ressourcen implementiert und praktiziert werden kann und eine Gesprächskultur schafft, die zu neuen Zielvariablen führt; hier spielen der Perspektivenwechsel und die Prozessgerechtigkeit eine zentrale Rolle und liefern zugleich Ansatzpunkte für unsere eigene Evaluationsstrategie. Zum aktuellen Stand der Evaluation klinischer Ethikberatung wird die internationale Literatur kritisch gewürdigt. Erste konzeptionelle Ansätze und Ergebnisse einer eigenen Evaluationsstrategie werden vorgestellt. Durch die Offenlegung hoffen wir, die Auseinandersetzung mit diesen Themen zu intensivieren. (shrink)

Wie muss ein ethischer Beratungsdienst strukturiert sein, damit er in moralischen Konfliktsituationen im klinischen Alltag angefragt wird und die Ratsuchenden ergebnisorientiert unterstützen kann? Nach welchen Kriterien lassen sich die Beratungsgespräche auswerten und bewerten? Zur Beantwortung dieser Fragen werden theoretisch fundierte Konzepte ethischer Fallbesprechung aus Nimwegen, Leuven und Basel herangezogen; dies geschieht vor dem Hintergrund der Erfahrungen mit der über zehnjährigen Entwicklung der ethischen Arbeit im Ev. Krankenhaus Bielefeld (EvKB). Als Resultat stellen wir einen strukturierten, multidisziplinären Ansatz vor, mit dem in (...) den Beratungsgesprächen die ethischen Dimensionen unterschiedlicher Vorstellungen herausgearbeitet und möglichst einvernehmlichen Lösungen zugeführt werden. Am Beispiel des EvKB lässt sich zeigen, dass der ethische Beratungsdienst auch in Zeiten knapper Ressourcen implementiert und praktiziert werden kann und eine Gesprächskultur schafft, die zu neuen Zielvariablen führt; hier spielen der Perspektivenwechsel und die Prozessgerechtigkeit eine zentrale Rolle und liefern zugleich Ansatzpunkte für unsere eigene Evaluationsstrategie. Zum aktuellen Stand der Evaluation klinischer Ethikberatung wird die internationale Literatur kritisch gewürdigt. Erste konzeptionelle Ansätze und Ergebnisse einer eigenen Evaluationsstrategie werden vorgestellt. Durch die Offenlegung hoffen wir, die Auseinandersetzung mit diesen Themen zu intensivieren. (shrink)

Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the organizational context (...) in which CECs function in Europe focusing on five aspects. We conclude that in Europe clinical ethics committees need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization. CECs, perhaps particularly in transitional countries, must counter the charge of “alibi ethics”. CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges, but the fact that CECs continue to develop suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs. (shrink)

These CQ Sources were compiled by Bette Anton.