This paper addresses the concept of moral luck. Moral luck is discussed in the context of medical error, especially an error of omission that occurs frequently, but only rarely has adverse consequences. As an example, a failure to compare the label on a syringe with the drug chart results in the wrong medication being administered and the patient dies. However, this error may have previously occurred many times with no tragic consequences. Discussions on moral luck can (...) highlight conflicting intuitions. Should perpetrators receive a harsher punishment because of an adverse outcome, or should they be dealt with in the same way as colleagues who have acted similarly, but with no adverse effects? An additional element to the discussion, specifically with medical errors, is that according to the evidence currently available, punishing individual practitioners does not seem to be effective in preventing future errors. The following discussion, using relevant philosophical and empirical evidence, posits a possible solution for the moral luck conundrum in the context of medical error: namely, making a distinction between the duty to make amends and assigning blame. Blame should be assigned on the basis of actual behavior, while the duty to make amends is dependent on the outcome. (shrink)

Applying and extending principles that can help prevent consumer error, worker fault, managerial mistakes, and organizational blunders, Human Error: Causes and Control provides useful information on theories, methods, and specific techniques for controlling human error. It forms a how-to manual of good practice, focusing on identifying human error, its causes, and how to control or prevent it. It presents constructs that assist in optimizing human performance and to achieve higher safety goals. Human Error: (...) Causes and Control bridges the gap and illustrates the means for achieving a comprehensive, fully integrated, process compatible, user effective, methodologically sound model. (shrink)

This essay reviews and defines avoidable medical error, malpractice and complication. The relevant ethical principles pertaining to unanticipated medical outcomes are identified. In light of these principles I critically review the moral culpability of the agents in each circumstance and the resulting obligations to patients, their families, and the health care system in general. While I touch on some legal implications, a full discussion of legal obligations and liability issues is beyond the scope of this paper.

Medical error is a leading problem of health care in the United States. Each year, more patients die as a result of medical mistakes than are killed by motor vehicle accidents, breast cancer, or AIDS. While most government and regulatory efforts are directed toward reducing and preventing errors, the actions that should follow the injury or death of a patient are still hotly debated. According to Nancy Berlinger, conversations on patient safety are missing several important components: religious voices, traditions, (...) and models. In After Harm, Berlinger draws on sources in theology, ethics, religion, and culture to create a practical and comprehensive approach to addressing the needs of patients, families, and clinicians affected by medical error. She emphasizes the importance of acknowledging fallibility, telling the truth, confronting feelings of guilt and shame, and providing just compensation. After Harm adds important human dimensions to an issue that has profound consequences for patients and health care providers. (shrink)

We examined nurses’ perceptions of the ethical climate of their workplace and the relationships among the perceptions, medical error experience and intent to leave through a cross-sectional survey of 1826 nurses in 33 Korean public hospitals. Ethical climate was measured using the Hospital Ethical Climate Survey. Although the sampled nurses perceived their workplace ethical climate positively, 19% reported making at least one medical error during the previous year, and 25% intended to leave their jobs in the near future. (...) Controlling for individual and organizational characteristics, we found that nurses with a more positive perception of the ‘patient’ dimension of ethical climate were less likely to have made medical errors. Nurses with a more positive perception of the ‘patient’, ‘manager’, ‘hospital’ and ‘physician’ dimensions of ethical climate were less likely to leave their current job. Enhancing workplace ethical climate could reduce medical errors and improve nurses’ retention in public hospitals. (shrink)

The Centers for Disease Control and Prevention has focused its obesity prevention and control efforts on improving population-level health. A recent Institute of Medicine report identified systems that affect population health, to include health care delivery systems, schools, businesses and employers, communities, and governmental public health infrastructure. CDC uses the public health model to engage these systems, and this process coordinates multiple settings, sectors, and jurisdictions to develop an integrated approach to identify, prevent, and control (...) obesity. The public health approach goes beyond medical care to prioritize policy and environmental strategies that can be implemented across jurisdictional levels, in collaboration with traditional and nontraditional partners. The process ultimately produces tools, guidelines, and interventions that can be used to prevent and control obesity. In this manuscript, we provide an overview of the public health perspective on obesity, outline the public health framework for addressing obesity, and discuss the rationale for leveraging law-based efforts as a tool to accomplish the public health mission. (shrink)

The Centers for Disease Control and Prevention has focused its obesity prevention and control efforts on improving population-level health. A recent Institute of Medicine report identified systems that affect population health, to include health care delivery systems, schools, businesses and employers, communities, and governmental public health infrastructure. CDC uses the public health model to engage these systems, and this process coordinates multiple settings, sectors, and jurisdictions to develop an integrated approach to identify, prevent, and control (...) obesity. The public health approach goes beyond medical care to prioritize policy and environmental strategies that can be implemented across jurisdictional levels, in collaboration with traditional and nontraditional partners. The process ultimately produces tools, guidelines, and interventions that can be used to prevent and control obesity. In this manuscript, we provide an overview of the public health perspective on obesity, outline the public health framework for addressing obesity, and discuss the rationale for leveraging law-based efforts as a tool to accomplish the public health mission. (shrink)

In order to cope with the changing health needs in the community, an holistic approach on AIDS prevention and control with particular reference to essential quality was introduced at an educational seminar at Hebei Medical University in China, 1996. We have identified three major points in the present study through learning and research process: 1. The importance of ‘cultural norm’ for the unification of science and technology is identified for the community approach; 2. ‘community care’ emphasising human quality (...) provides unity in diversity for educational program; and 3. ‘community control’ emphasising quality assurance demonstrates the effectiveness for program analysis from the viewpoint of human centred systems. (shrink)

Suicide is a leading cause of death in the United States and in many other parts of the world. As such, suicide is frequently framed as a medical and public health problem for which solutions are best recommended by medical and public health authorities. While, medicalized suicide prevention strategies often resonate with traditional Christian commitments to preserve life and to discourage suicide, there is little evidence to date that medical approaches to suicide risk-reduction decrease population rates of suicide. Further, (...) by treating suicide as a phenomenon that can be eliminated through technical managerial control, modern suicide prevention efforts construe suffering persons as carriers of risk best managed by standardized and often dehumanizing environments of care. This emphasis on the medical management of risk also erodes the clinician–patient relationship and inappropriately centers medical (e.g., systematic health screenings) rather than non-medical (e.g., access to housing) forms of response. Although, medicalized suicide prevention efforts should not be dismantled, those working to prevent suicide would do well to prioritize a positive commitment to human dignity and worth and to engage social and political systems beyond medicine and public health, while drawing on specific contributions that clinicians can offer. (shrink)

Background Various authorities recommend the participation of patients in promoting patient safety, but little is known about health care professionals' (HCPs') attitudes towards patients' involvement in safety-related behaviours. Objective To investigate how HCPs evaluate patients' behaviours and HCP responses to patient involvement in the behaviour, relative to different aspects of the patient, the involved HCP and the potential error. Design Cross-sectional fractional factorial survey with seven factors embedded in two error scenarios (missed hand hygiene, medication error). (...) Each survey included two randomized vignettes that described the potential error, a patient's reaction to that error and the HCP response to the patient. Setting Twelve hospitals in Switzerland. Participants A total of 1141 HCPs (response rate 45%). Measurements Approval of patients' behaviour, HCP response to the patient, anticipated effects on the patient–HCP relationship, HCPs' support for being asked the question, affective response to the vignettes. Outcomes were measured on 7-point scales. Results Approval of patients' safety-related interventions was generally high and largely affected by patients' behaviour and correct identification of error. Anticipated effects on the patient–HCP relationship were much less positive, little correlated with approval of patients' behaviour and were mainly determined by the HCP response to intervening patients. HCPs expressed more favourable attitudes towards patients intervening about a medication error than about hand sanitation. Conclusions This study provides the first insights into predictors of HCPs' attitudes towards patient engagement in safety. Future research is however required to assess the generalizability of the findings into practice before training can be designed to address critical issues. (shrink)

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health (...) principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized. (shrink)

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health (...) principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized. (shrink)

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, and (...) discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil. (shrink)

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, and (...) discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil. (shrink)

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, and (...) discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil. (shrink)

Definition of the problemHealth Apps are becoming increasingly important for a preventive and responsible orientation of the health system. Currently, most of these digital health applications (DiGA) are based on so-called self-tracking technologies which record physiological and psychological data via sensors, usually combined with personalized everyday information. In the last few years, these digital developments have launched an intense and clearly polarized debate about the opportunities and dangers of self-tracking in healthcare.ArgumentsAfter a brief overview of medical self-tracking, this essay wants (...) to systematize and check the polarized discourse on the basis of its decisive individual and social potentials. It turns out that self-measurement techniques have long been an integral part of medical practice in diagnostics and therapy.ConclusionThe area of tension between individual empowerment and potential loss of control by the users will be emphasized as being especially important for the implementation of health Apps in primary health care. Finally, possible implications for the current design of the new German Digital Care Law (Digitale-Versorgung-Gesetz) are shown and some existing “blind spots” are highlighted. (shrink)

Healthcare workers experience moral injury (MI), a violation of their moral code due to circumstances beyond their control. MI threatens the healthcare workforce in all settings and leads to medical errors, depression/anxiety, and personal and occupational dysfunction, significantly affecting job satisfaction and retention. This article aims to differentiate concepts and define causes surrounding MI in healthcare. A narrative literature review was performed using SCOPUS, CINAHL, and PubMed for peer-reviewed journal articles published in English between 2017 and 2023. Search terms (...) included “moral injury” and “moral distress,” identifying 249 records. While individual risk factors predispose healthcare workers to MI, root causes stem from healthcare systems. Accumulation of moral stressors and potentially morally injurious events (PMIEs) (from administrative burden, institutional betrayal, lack of autonomy, corporatization of healthcare, and inadequate resources) result in MI. Individuals with MI develop moral resilience or residue, leading to burnout, job abandonment, and post-traumatic stress. Healthcare institutions should focus on administrative and climate interventions to prevent and address MI. Management should ensure autonomy, provide tangible support, reduce administrative burden, advocate for diversity of clinical healthcare roles in positions of interdisciplinary leadership, and communicate effectively. Strategies also exist for individuals to increase moral resilience, reducing the impact of moral stressors and PMIEs. (shrink)

The emerging concept of systems medicine (or ‘P4 medicine’—predictive, preventive, personalized and participatory) is at the vanguard of the post-genomic movement towards ‘precision medicine’. It is the medical application of systems biology, the biological study of wholes. Of particular interest, P4 systems medicine is currently promised as a revolutionary new biomedical approach that is holistic rather than reductionist. This article analyzes its concept of holism, both with regard to methods and conceptualization of health and disease. Rather than representing a medical (...) holism associated with basic humanistic ideas, we find a technoscientific holism resulting from altered technological and theoretical circumstances in biology. We argue that this holism, which is aimed at disease prevention and health optimization, points towards an expanded form of medicalization, which we call ‘holistic medicalization’: Each person’s whole life process is defined in biomedical, technoscientific terms as quantifiable and controllable and underlain a regime of medical control that is holistic in that it is all-encompassing. It is directed at all levels of functioning, from the molecular to the social, continual throughout life and aimed at managing the whole continuum from cure of disease to optimization of health. We argue that this medicalization is a very concrete materialization of a broader trend in medicine and society, which we call ‘the medicalization of health and life itself’. We explicate this holistic medicalization, discuss potential harms and conclude by calling for preventive measures aimed at avoiding eventual harmful effects of overmedicalization in systems medicine (quaternary prevention). (shrink)

This book is a collection of original, interdisciplinary essays on the topic of medical error. Given the complexities of understanding, preventing, and responding to medical error in ethically responsible ways, the scope of the book is fairly broad. The contributors include top scholars and practitioners working in bioethics, communication, law, medicine and philosophy. Their contributions examine preventable causes of medical error, disproportionate impacts of errors on vulnerable populations, disclosure and apology after discovering medical errors, and ethical issues (...) arising in specific medical contexts, such as radiation oncology, psychopathy, and palliative care. They also offer practical recommendations for respecting autonomy, distributing burdens and benefits justly, and minimizing injury to patients and other stakeholders. Ethics and Error in Medicine will be of interest to a wide range of researchers, students, and practitioners in bioethics, philosophy, communication studies, law, and medicine who are interested in the ethics of medical error. (shrink)

Clinicians, operating within complex systems, make mistakes, as people do in every human endeavor, and when they do, patients are sometimes harmed. One important question is how we as clinicians can find resolution in the wake of an error. The published literature has divided errors into those caused by “systems” and by “individuals.” But whereas both “systems” and “individual” approaches are important in understanding the cause of an error, neither alone can fully lead to resolution once an (...) class='Hi'>error has occurred. Instead, both are necessary to understand, resolve, and prevent errors. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain (...) class='Hi'>medication and to pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain (...) class='Hi'>medication and to pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

Weight-gain in psychiatric populations is a common clinical challenge. Many patients suffering from mental disorders, when exposed to psychotropic medications, gain significant weight with or without other side-effects. In addition to reducing the patients' willingness to comply with treatment, this weight-gain may create added psychological or physiological problems that need to be addressed. Thus, it is critical that clinicians take precautions to monitor and control weight-gain and take into account and treat all problems facing an individual. In this review, (...) we examine some of the key issues surrounding weight-gain in individuals suffering from mental disorders for contemporary practitioners in community clinics. We describe some factors known to make certain patients more susceptible to treatment-induced weight-gain and mechanisms implicated in this process. We also highlight a few psychological and pharmacological interventions that have proven effective in weight management. Importantly, we provide critical steps for management and prevention of weight-gain and related issues in the clinical practice of psychopharmacology. (shrink)

Ethical challenges surrounding the implementation of male circumcision as an HIV prevention strategyResearchers have been exploring the possibility of a correlation between male circumcision and lowered risk of HIV infection almost since the beginning of the HIV/AIDS epidemic.1 Results from a randomised controlled trial in South Africa in 2005 indicate that male circumcision protects men against the acquisition of HIV through heterosexual intercourse,2 confirming the findings from 20 years of observational studies.3 Circumcised men in the South African trial were (...) 60% less likely to acquire HIV than their uncircumcised counterparts. A mathematical modelling study, based on the South African trial, estimates that the practice of male circumcision could avert two million new HIV infections and 300 000 HIV-related deaths over the next 10 years in sub-Saharan Africa.4 More recently, two randomised controlled trials in Kisumu, Kenya and Rakai, Uganda showed, respectively, 53% and 48% reductions in HIV acquisition among circumcised men than uncircumcised men in the trial.5 These results strongly suggest that male circumcision could play an important role in the struggle against the continued rise in new HIV infections. However, as observers noted at the 2006 XVI International AIDS Conference in Toronto, Canada, excitement about the potential epidemiological impact has overshadowed the debate over the difficult translation of research on male circumcision, into policy and practice.6 Similar calls for caution have been raised before and elsewhere.7,8The topic of male circumcision carries an enormous amount of ethical baggage. Male infants, worldwide, are circumcised for various medical, social and/or religious reasons. Circumcision is a cultural act and a surgical procedure; medical reasons are not the only reasons to circumcise that people have found and continue to find as compelling. Benatar and Benatar9 have argued that—when …. (shrink)

This book addresses the moral, social and political problems emerging from the practice of healing and caring, biomedical research and the provision of health care services. The primary aim of many professional bioethicists is, of late, to solve as efficiently as possible, the problems encountered by health care providers and scientists in clinical, laboratory and administrative settings. Seen from the viewpoint of applied philosophy, however, this is a dangerous tendency if the grounds for the suggested solutions are not properly examined. (...) Even choices which are harmless and seem to involve no immoralities can be indirectly hazardous if those making choices appeal to dubious ethical principles or inaccurate data. This is why this book is dedicated to the examination of the reasons that people can and should have for their health care related decisions as well as to the formulation of good solutions to difficult problems. It covers criterial in life and death decisions, voluntary euthanasia and medical paternalism, wrongful medical authoritarianism, health education, preventive medicine and the welfare of the population, AIDS, discrimination and legal restrictions, and health care policy-making. (shrink)

A central tenet of medical ethics holds that it is permissible to perform a medical intervention on a competent individual only if that individual has given informed consent to the intervention. However, in some circumstances it is tempting to say that the moral reason to obtain informed consent prior to administering a medical intervention is outweighed. For example, if an individual’s refusal to undergo a medical intervention would lead to the transmission of a dangerous infectious disease to other members of (...) the community, one might claim that it would be morally permissible to administer the intervention even in the absence of consent. Indeed, as we shall discuss below, there are a number of examples of public health authorities implementing compulsory or coercive measures for the purposes of infectious disease control (IDC). The plausibility of the thought that non-consensual medical interventions might be justified when performed for the purpose of IDC raises the question of whether such interventions might permissibly be used to realize other public goods. In this article we focus on one possibility: whether it could be permissible to non-consensually impose certain interventions that alter brain states or processes through chemical or physical means on serious criminal offenders. We shall suggest that some such interventions might be permissible if they safely and effectively serve to facilitate the offender’s rehabilitation and thereby prevent criminal recidivism. (shrink)

Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances—blockchain technologies—and argues that they can be used to share medical data in a secure and (...) auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion. (shrink)

Modern medicine has done much in the fields of infectious diseases and emergencies to aid cure. In most other fields, it is mostly control that it aims for, which is another name for palliation. Pharmacology, psychopharmacology included, is mostly directed towards such control and palliation too. The thrust, both of clinicians and research, must now turn decisively towards prevention and cure. Also, longevity with well-being is modern medicine's other big challenge. Advances in vaccines for hypertension, diabetes, cancers (...) etc, deserve attention; as also, the role of meditation, yoga, spirituality etc in preventing disease at various levels. Studies on longevity, life style changes and healthy centenarians deserve special scrutiny to find what aids longevity with wellbeing. A close look at complementary and alternative medicine is needed to find any suitable models they may have, cutting aside their big talk and/or hostility towards mainstream medical care. Medicine is a manifestation of the human eros, and should not become a means of its thanatos. It must realise its true potential, so that eros prevails, and thanatos prevails only ultimately, not prematurely. (shrink)

The Institute of Medicine has returned the problem of medical error to the top of the health-care agenda. Its report that 44,000 to 98,000 patients die each year as a result of medical errors in American hospitals has renewed scholarly interest in health system quality control. In To Err Is Human, the IOM provides a vivid picture of a health-care system riven with serious quality problems. It calls for systems-based error-reduction methods borrowed from other high-risk industries and (...) forcefully argues against the traditional tendency to assign accountability primarily to individual physicians. Most errors, the IOM argues, can be successfully addressed by engineering systemic fail-safe protections against the inevitable failings of human actors. (shrink)

The Institute of Medicine has returned the problem of medical error to the top of the health-care agenda. Its report that 44,000 to 98,000 patients die each year as a result of medical errors in American hospitals has renewed scholarly interest in health system quality control. In To Err Is Human, the IOM provides a vivid picture of a health-care system riven with serious quality problems. It calls for systems-based error-reduction methods borrowed from other high-risk industries and (...) forcefully argues against the traditional tendency to assign accountability primarily to individual physicians. Most errors, the IOM argues, can be successfully addressed by engineering systemic fail-safe protections against the inevitable failings of human actors. (shrink)

Active surveillance cultures and contact precautions is a strategy to control the transmission of methicillin-resistant Staphylococcus aureus (MRSA) within healthcare facilities. Whether to implement this strategy to routinely screen and isolate inpatients with MRSA in non-outbreak (endemic) settings, or to remove it and use standard infection control precautions only is scientifically and ethically controversial, in view of the potential adverse effects of contact precautions on patients. To support the use of standard precautions only, it has been argued that (...) active surveillance to identify patients who are asymptomatically colonised with MRSA to place them in contact precautions is unjust or unfair to these patients in various ways. This paper will unpack and examine four distinct arguments, which are advanced from a medical ethics or quality improvement ethical framework, for why this is so. Our analysis shows that while these arguments highlight the injustice of current practices, they do not provide strong ethical reasons for justifying the removal of active surveillance and contact precautions to control MRSA transmission and infection. An implication of our arguments is that the ethical frame for evaluating prevention and control strategies for MRSA, a multi-drug resistant bacteria, should shift from healthcare to primarily public health. From a public health ethics perspective, whether a strategy is unjust, or how ethically significant its lack of fairness is, depends on assessing the evidence for its public health effectiveness and necessity in a given setting, and the extent of the harms and burdens patients with MRSA bear when they are on contact precautions, which remain matters of scientific debate or uncertainty. As an ethical consideration in the debate, the chief normative implication of justice is to provide us further reasons to revise current active surveillance-contact precautions practices, and for the need for research and interventions to minimise their potential adverse effects on patients. (shrink)

Aims and background: Little is known about how participants perceive prevention trials, particularly trials designed to prevent mental illness. This study examined participants’ motives for participating in a trial and their views of randomisation and the ability to withdraw from a randomised controlled trial for prevention of depression. Methods: Participants were older adults reporting elevated depression symptoms living in urban and regional locations in Australia who had consented to participate in an RCT of interventions to prevent depression. Participants (...) rated their agreement with various statements describing motivations for enrolment in the trial and opinions regarding randomisation and withdrawal. Results: The majority of participants expressed a triad of altruistic motivation for participation, relative lack of concern about randomisation and commitment to the trial. Certain subgroups of participants, such as women and those with higher depression scores, reported higher levels of concern about specific issues. Conclusions: The findings suggest that participants enrolled in prevention trials for mental illness are likely to hold positive attitudes towards research trials. The identification of relationships between key person factors and trial-related attitudes enabled profiling of participant groups, which can inform recruitment strategies and interactions of participants and research projects in future prevention trials. (shrink)

Prevention and control of chronic conditions are global healthcare challenges. Patient self-management has been deemed essential for treating chronic conditions and improving the quality of patient life. However, the current Japanese system for supporting patient self-management of chronic conditions has received little ethical assessment. The first aim of this article is to provide an ethical analysis of current Japanese support for self-management of chronic conditions with reference to international discussions concerning self-management, developed mainly in western societies such as (...) Europe, the United States. The second aim is to clarify the challenges faced by Japanese biomedical ethics concerning selfmanagement support by focusing on the ethical concepts of quality of life and autonomy. This article identifies the following two challenges: [1] dispelling conceptual confusion concerning basic ethical concepts such as quality of life and autonomy, and [2] exploring the conceptual relationship between these ethical concepts, as they relate to providing support for chronically ill patients. By addressing these challenges and constructing a theoretical basis for radical change in support mechanisms, bioethics in Japan could contribute to efforts to construct a comprehensive support system for patients with chronic conditions, which organize variety kinds of supports, such as medical professional supports, supports from patient’s groups, local community supports, familial supports, support in patients’ workplace, and supports for patients’ family members as well. (shrink)

Although the teaching of medical ethics and law in medical education is an old story that has been told many times in medical literature, recent studies show that medical students and physicians lack confidence when faced with ethical dilemmas and medico-legal issues. The adverse events rates and medical lawsuits are on the rise whereas many medical errors are mostly due to negligence or malpractices which are preventable. While it is true that many medical schools teach their students medical law and (...) ethics, there are wide variations in what is being taught because there is no universally agreed syllabus. Yet the knowledge of medical law and ethics is closely relevant to the medical profession and that failure in abiding the law may result in serious civil or even criminal consequences. While this paper does not propose to lay detailed analysis of the relevant areas of law or ethics, it proposes to cover some legal areas so as to highlight and bring to attention the need for a medical law and ethics course. This article also considers the problems faced and recommendation as to future directions to be taken with respect to teaching medical law and ethics. It concludes with a suggested course outline for the teaching of medical law and ethics. (shrink)

Suicide is amongst the top ten causes of death for all age groups in most countries of the world. It is the second most important cause of death in the younger age group (15-19 yrs.) , second only to vehicular accidents. Attempted suicides are ten times the successful suicide figures, and 1-2% attempted suicides become successful suicides every year. Male sex, widowhood, single or divorced marital status, addiction to alcohol ordrugs, concomitant chronic physical or mental illness, past suicidal attempt, adverse (...) life events, staying in lodging homes or staying alone, or in areas with a changing population, all these conditions predispose people to suicides. The key factor probably is social isolation. An important WHO Study established that out of a total of 6003 suicides, 98% had a psychiatric disorder. Hence mental health professionals have an important role to play in the prevention and management of suicide. Moreover, social disintegration also increases suicides, as was witnessed in the Baltic States following collapse of the Soviet Union. Hence, reducing social isolation, preventing social disintegration and treating mental disorders is the three pronged attack that must be the crux of any public health programme to reduce/prevent suicide. This requires an integrated effort on the part of mental health professionals (including crisis intervention and medication/psychotherapy), governmental measures to tackle poverty and unemployment, and social attempts to reorient value systems and prevent sudden disintegration of norms and mores. Suicide prevention and control is thus a movement which involves the state, professionals, NGOs, volunteers and an enlightened public. Further, the Global Burden of Diseases Study has projected a rise of more than 50% in mental disorders by the year 2020 (from 9.7% in 1990to 15% in 2020). And one third of this rise will be due to Major Depression. One of the prominent causes of preventable mortality is suicidal attempts made by patients of Major Depression. Therefore facilities to tackle this condition need to be set up globally on a warfooting by governments, NGOs and health care delivery systems, if morbidity and mortality of the world population has to be seriously controlled . The need, first of all, is to identify suicide prevention as public health policy, just as we think in terms of Malaria or Polio eradication, or have achieved smallpox eradication. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 115-116 [Access article in PDF] The Ethics of Medical Mistakes: Historical, Legal, and Institutional Perspectives Introduction In late 1999, the Institute of Medicine (IOM) released its report on medical errors, To Err is Human: Building a Safer Health System. The report estimated almost 50,000 deaths per year nationally due to medical mistakes, making it a leading cause of death. IOM speculated that (...) more than half of the deaths related to medical error are preventable. The IOM report shocked the public and medical professionals alike, sparking a national discussion of how to make the health care system safer. This multifaceted issue has profound implications for all aspects of health care, from the very personal--e.g., the relationship of caregiver and patient--to the societal--e.g., a nation's responsibility to its citizens.On 15 May 2000, the University of Pittsburgh Medical Center hosted an ethics conference devoted to the topic of medical mistakes. The goal was to bring together experts from various disciplines, before an audience of both providers and patients, to discuss medical mistakes and their implications. In this issue of the Kennedy Institute of Ethics Journal, we present selected papers resulting from that conference. These papers reflect not only the original oral presentations, but also much of the discussion those presentations generated. Three key perspectives on the ethics of medical mistakes are offered: historical, legal, and institutional.Rosa Lynn Pinkus offers a revealing historical perspective on the ethics of medical mistakes. In analyzing the history of mistake reporting in neurosurgery, she shows how the notion of a mistake developed only as the notion of a standard of practice emerged. Although much of managed care is directed toward systematically fostering a standard of care, this pursuit is relatively new in health care. One might speculate that as more standards are created, mistakes--defined as deviations from standard practice--must increase. If deviation from standard practice is overly castigated, however, then needed innovation in practice may be stifled. Interestingly, as Pinkus discusses, medical malpractice suits quickly followed the emergence of practice standards, driving the initial open reporting of mistakes underground. [End Page 115]Taking up the issue of medical malpractice, Thomas May and Mark Aulisio consider the ramifications of the current malpractice system for mistake prevention. The current system, they argue, while failing to adequately achieve its purported goals of deterring medical mistakes and compensating victims, itself creates a climate that deters the open reporting of mistakes by engendering fear and shame in clinicians. According to May and Aulisio, this failure to report medical mistakes openly has serious ramifications. Chief among these is the inability to do root cause analysis of mistakes, and then, where possible, to implement safeguards to minimize the occurrence of future mistakes. Ultimately, both the prevention of medical mistakes and the goals of malpractice litigation itself will be better served if substantial malpractice reform is undertaken.Andy Thurman argues that even in the current climate institutions ought to have a policy (and practice) of admitting to and openly reporting medical mistakes. Thurman argues that doing so not only is the right thing to do, but is also in the interest of institutions. Interestingly, he contends that failing to admit and openly report mistakes is both at odds with the mission of health care institutions and puts them at higher risk of litigation, and liability. In light of this, Thurman then suggests an institutional process for handling medical mistakes.Michael DeVita concedes that disclosing mistakes is widely supported by the health professionals' principles of ethics, but argues that there are a number of factors that conspire to make doing so a very difficult task. In analyzing an index case, DeVita contends that platitudes about being honest are not nearly enough to foster honest behavior and that policies that offer specific guidance on handling unfavorable events are needed in health care institutions.Finally, we conclude with the policy on disclosure of unfavorable events (this terminology is chosen because it includes both iatrogenic and natural diseases and conditions) that resulted from... (shrink)

Some health leaders and researchers have launched mass prevention programs without sound biomedical groundwork. They have oversold the benefits of prevention and underestimated the secondary effects. Some have forced nonmedical concerns into the medical model. Others have blurred the distinctions between prevention and other measures such as screening or therapy. Some have transferred responsibility for disease to the victim. A few have imputed magical powers to certain symbols of prevention, in order to create an illusion of (...) control. (shrink)

Das Ideal einer vorhersagenden Medizin in Kombination mit wirkungsvollen, kausalen Strategien der Prävention auf molekularer Ebene ist noch immer weit davon entfernt, klinische Realität zu werden. Es ist jedoch schon heute festzustellen, dass zwischen Medizin und Gesellschaft verhandelte Konzepte von Gesundheit in immer stärkerem Maße auf zukünftige Gesundheit ausgerichtet sind, mithin einen immer präventiveren Charakter aufweisen. Der vorliegende Beitrag untersucht die Frage, ob neue Konzepte einer prädiktiv-präventiven Medizin – insbesondere Public Health Genetics bzw. Public Health Genomics – das Kriterium der (...) Verbesserung der sozialen Erreichbarkeit von Gesundheit erfüllen. Diese Analyse wird vor dem Hintergrund der Rolle sozialer Grundwerte, insbesondere dem der Gerechtigkeit, für Funktionen der Medizin in unserer Gesellschaft einerseits sowie der Bedeutung des Wandels der medizinischen Schlüsselkonzepte „Gesundheit“ und „Krankheit“ andererseits vorgenommen. (shrink)

The 2006 Centers for Disease Control and Prevention (CDC) revised recommendations for HIV testing in clinical settings contained seven specific changes to how health care facilities should provide HIV testing. These seven elements have been both supported and challenged in the lay and medical literature. Our first paper in BMC Medical Ethics presented an analysis of the three HIV testing procedural changes included in the recommendations. In this paper, we address the four remaining elements that concern HIV screening (...) policy changes: (1) nontargeted HIV screening, (2) making HIV screening similar to screening for other treatable conditions, (3) increasing HIV screening without assured additional funding for linkage to care, and (4) making patients bear the costs of increased HIV screening in health care settings. (shrink)

Understanding the nature of errors in a simple, rule‐based task—programming a VCR—required analyzing the interactions among human cognition, the artifact, and the task. This analysis was guided by least‐effort principles and yielded a control structure that combined a rule hierarchy task‐to‐device with display‐based difference‐reduction. A model based on this analysis was used to trace action protocols collected from participants as they programmed a simulated VCR. Trials that ended without success (the show was not correctly programmed) were interrogated to yield (...) insights regarding problems in acquiring the control structure. For successful trials (the show was correctly programmed), steps that the model would make were categorized as matches to the model; steps that the model would not make were violations of the model. The model was able to trace the vast majority of correct keystrokes and yielded a business‐as‐usual account of the detection and correction of errors. Violations of the model fell into one of two fundamental categories. The model provided insights into certain subcategories of errors; whereas, regularities within other subcategories of error suggested limitations to the model. Although errors were rare when compared to the total number of correct actions, they were important. Errors were made on 4% of the keypresses that, if not detected, would have prevented two‐thirds of the shows from being successfully recorded. A misprogrammed show is a minor annoyance to the user. However, devices with the approximate complexity of a VCR are ubiquitous and have found their way into emergency rooms, airplane cockpits, power plants, and so on. Errors of ignorance may be reduced by training; however, errors in the routine performance of skilled users can only be reduced by design. (shrink)

In this article, I argue that distinguishing ‘evolutionary’ from ‘Darwinian’ medicine will help us assess the variety of roles that evolutionary explanations can play in a number of medical contexts. Because the boundaries of evolutionary and Darwinian medicine overlap to some extent, however, they are best described as distinct ‘research traditions’ rather than as competing paradigms. But while evolu- tionary medicine does not stand out as a new scientific field of its own, Darwinian medicine is united by a number of (...) distinctive theoretical and methodological claims. For example, evolutionary medicine and Darwinian medicine can be distinguished with respect to the styles of evolutionary explanations they employ. While the former primarily involves ‘forward looking’ explanations, the latter depends mostly on ‘backward looking’ explanations. A forward looking explanation tries to predict the effects of ongoing evolutionary processes on human health and disease in contem- porary environments (e.g., hospitals). In contrast, a backward looking explanation typically applies evolutionary principles from the vantage point of humans’ distant biological past in order to assess present states of health and disease. Both approaches, however, are concerned with the prevention and control of human diseases. In con- clusion, I raise some concerns about the claim that ‘nothing in medicine makes sense except in the light of evolution’. (shrink)

Obesity is the result of people consistently consuming more calories than they expend. A complex interaction of social and environmental conditions affects both energy consumption and physical activity levels. These conditions include, but are not limited to the following factors: the availability of affordable and healthy food; price disparities between healthy and less healthy foods; access to or perceived safety of recreation facilities; and the conduciveness of the physical environment to active modes of transportation, such as walking and biking. As (...) outlined in the “Assessing Laws and Legal Authorities for Obesity Prevention and Control” paper in this supplement issue, laws and government policies in the United States influence nearly all of these social and environmental factors. (shrink)

Obesity is the result of people consistently consuming more calories than they expend. A complex interaction of social and environmental conditions affects both energy consumption and physical activity levels. These conditions include, but are not limited to the following factors: the availability of affordable and healthy food; price disparities between healthy and less healthy foods; access to or perceived safety of recreation facilities; and the conduciveness of the physical environment to active modes of transportation, such as walking and biking. As (...) outlined in the “Assessing Laws and Legal Authorities for Obesity Prevention and Control” paper in this supplement issue, laws and government policies in the United States influence nearly all of these social and environmental factors. (shrink)

Background: In 2006, the Centers for Disease Control and Prevention (CDC) recommended three changes to HIV testing methods in US healthcare settings: (1) an opt-out approach, (2) removal of separate signed consent, and (3) optional HIV prevention counseling. These recommendations led to a public debate about their moral acceptability. Methods: We interviewed 25 members from the fields of US HIV advocacy, care, policy, and research about the ethical merits and demerits of the three changes to HIV testing (...) methods. We performed a qualitative analysis of the participant responses in the interviews and summarized the major themes. Results: In general, arguments in favor of the methods were based upon their ultimate contribution to increasing HIV testing and permitting the consequent benefits of identifying those who are HIV infected and linking them to further care. Conclusions: The prevailing theme of ethical concern focused on suspicions that the methods might not be properly implemented, and that further safeguards might be needed. (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of (...) the sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

Fraud in medical publications is an increasing concern. In particular, disciplines related to perioperative medicine—including anaesthesia and critical care—currently hold the highest rankings in terms of retracted papers for research misconduct. The dominance of this dubious achievement is attributable to a limited number of researchers who have repeatedly committed scientific fraud. In the last three decades, six researchers have authored 421 of the 475 papers retracted in perioperative medicine. This narrative review reports on six cases of fabricated publication in perioperative (...) medicine that resulted in the paper’s retraction. The process that led to the unveiling of the fraud, the impact on clinical practice, and changes in regulatory mechanisms of scientific companies and governmental agencies’ policies are also presented. Fraud in medical publications is a growing concern that affects perioperative medicine requiring a substantial number of papers to be retracted. The continuous control elicited by readers, by local institutional review boards, scientific journal reviewers, scientific societies and government agencies can play an important role in preserving the ‘pact of trust’ between authors, professionals and ultimately the relationship between doctors and patients. (shrink)