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Abstract

Throughout the history of medicine, there has been recurrent attention to the harms associated with medical care. Moral judgment about these harms is inextricably tied to the cultural context, including political and social structures, theories of health and illness, and theories of error and accountability. This entry examines historical, conceptual, and ethical dimensions of medical error from ancient times to the emergence of the patient safety movement in the twentieth century and its spread around the world in the ﬁrst part of the twenty-ﬁrst century. This entry reviews the fundamental shift in accountability for medical error that is at the heart of the patient safety movement and the ethical challenge of using data on medical error to improve health care quality without compromising the fundamental obligation to be honest with individual patients about their care.

Introduction

Throughout the history of medicine, there has been recurrent attention to the harms associated with medical care, from the ancient Babylonian Code of Hammurabi to the Hippocratic writings to the ﬁrst codes of medical ethics in nineteenth century Britain and America. Moral judgment about these harms has been inextricably tied to the cultural context including political and social structures, theories of health and illness, and theories of error and accountability (Sharpe and Faden 1998).

In the Code of Hammurabi, the punishment for a physician who unintentionally killed a patient depended on whether the patient was a free man or a slave. The famous Hippocratic injunction “to help or at least to do no harm” was based on patient beneﬁt as the proper end of medicine regardless of who the physician was treating. In the volatile transition from prescientiﬁc to scientiﬁc medicine in the nineteenth century, those who subscribed to the healing powers of nature judged interventionist physicians harshly for their harms of commission. For those who thought that medicine’s role was precisely to intervene, it was harms of omission that were condemned. The establishment of the U.S. medical profession in the nineteenth century codiﬁed as a fundamental duty “exposing the injuries sustained by the unwary from the devices and pretensions of artful empirics and imposters” (American Medical Association (AMA) 1847).

As the AMA code established a duty to expose harmful “quackery,” it also consolidated the profession around the ideal of gentlemanly honor, which relied on personal integrity as the basis for moral and professional accountability. To be a professional was to be a gentleman, and as stated in the ﬁrst paragraph of the 1847 AMA code, for a gentleman, “there is no tribunal, other than his own conscience, to adjudge penalties for carelessness and neglect.” The norms of professionalism established by the 1847 Code not only succeeded in closing ranks against “imposters” but also established silence as the norm regarding errors committed either by oneself or one’s professional peers. Rather than advocate for candid reporting and open communication about bad outcomes, the professional consensus was that “Proper conduct among men and affairs must be left to the man, his tact, his judgment, his education and his experience” (Konold 1962, p. 69). Well into the twentieth century, silence about unintended medical harms remained the norm, with physicians believing that they were accountable only to themselves.

The counterpart to personal accountability for harmful error has been the belief, common to medical culture in western industrialized countries, that medical quality is largely a function of the integrity and competence of physicians. Consistent with this worldview, doctors in most western countries have been socialized to believe that errors are unusual, unacceptable, and indicative of ﬂawed character. In this context, concern about maintaining one’s reputation and thus social and income status has been noted as a principal reason why physicians are motivated to conceal their mistakes.

In other countries and cultures where physicians have relatively low social status and income, concerns about the loss of reputation may not play this role. Instead, silence about medical mistakes may be one element among many reﬂecting weak structures for governance, accountability, and transparency in the health care system as a whole (Healthcare Governance and Transparency Association (Egypt) 2014).

Before the end of the twentieth century, articles about medical error were rare in the world’s medical literature. That changed in 1991 with the publication of the Harvard Medical Practice Study (HMPS), which found that 70 % of adverse events are preventable and affect more than 1.3 million hospitalized patients annually in the U.S. The HMPS methodology was also used to study the Australian health care system and produced similarly disturbing results. These and other studies catalyzed the Institute of Medicine’s groundbreaking 1998 report To Err is Human: Building a Safer Health System (Kohn et al. 2000). The IOM famously reported on page 1 that “preventable medical errors in hospitals exceed attributable deaths to such feared threats as motor-vehicle wrecks, breast cancer, and AIDS.”

One of the most signiﬁcant things about the IOM report was its call for a fundamental shift in how we should understand accountability for medical mistakes. Based on ﬁndings that the complexity of health care delivery systems – rather than ﬂaws in individual performance or character – is the source of most preventable medical errors, the IOM report emphasized the need for a culture of patient safety rather than a culture of blame. In practical terms, the shift from iatrogenic, literally “physician-induced,” illness to patient safety requires that information about error – harmful error as well as “near misses” – be shared so that it can serve as the basis for quality improvement. The recommended shift away from blame and toward transparency is complex and controversial. Openness about medical mistakes promotes important values central to medicine: Candid reporting provides the raw material for root cause analysis and quality improvement; disclosure to patients promotes fundamental norms of honesty, trust, and patient centered care. In addition, the shift from retrospective blame to proactive design for safety has destigmatized the issue, making it possible for medical error to be the subject of open and public discussion around the world. The mantra that safety culture should be “blame-free” has, however, resulted in understandable concern that poor performers will not be held accountable. The corrective is the “just culture” movement that differentiates between medical harms that are blameworthy and those that are blameless.

This entry will examine recent literature on medical error around the globe and the ethical imperatives that shape responses to it. The author does not have enough space or knowledge to examine the speciﬁc and rich cultural context that shapes attitudes toward medical error in the many societies around the world and encourages others to do so in order that we can all beneﬁt from a deeper understanding of how preventable patient harm is understood and addressed.

Errors And Incidents

A review of the literature conducted over the last two decades on health services in 11 countries indicates that in the countries where it has been closely studied, “error is the rule, rather than the exception” (Schwappach 2014, p. 330).

Much of this literature has settled on a deﬁnition of error as a preventable adverse effect of health care, whether evident or harmful to the patient. That is, medical error is understood as preventable, but not all errors result in patient harm. The ones that don’t are typically called “near misses.” Following Canada, the World Health Organization’s (WHO) International Classiﬁcation for Patient Safety promotes the term “harmful patient safety incident” rather than “error;” the rationale being that patient harm may result from a combination of system factors and so attention should not focus exclusively on individual error (Wu et al. 2014). As the patient safety movement has spread around the world, research has also begun to be conducted on patient perceptions of error. This research indicates that patients conceptualize error more broadly to encompass a number of things that affect their satisfaction with care, including poor service, quality, and interpersonal skills. From the patient’s perspective, health care quality depends on a lot more than reducing harmful error as traditionally deﬁned.

The Scope Of The Problem

Global attention to harmful error followed the IOM report. In 2002, WHO passed a resolution to promote patient safety as a principle of health systems worldwide and in 2004–2006 launched the World Alliance for Patient Safety and the Global Health Challenge. The focus of the ﬁrst Global Patient Safety Challenge was health care–associated infection. Around this same time, the United Kingdom launched the National Patient Safety Agency and the Patient Safety Observatory, In 2002, the major accreditation body for health care in the U.S., the Joint Commission, established the ﬁrst Patient Safety Goals that would be used to assess all sectors of health care delivery. In 2006, the Council of Europe made recommendations to member states on patient safety and prevention of adverse events. Although there have been no large empirical studies of error in China, the Chinese Hospital Association has estimated that adverse events affect 1.6–7.6 million hospitalizations annually in Chinese hospitals. As a result, in 2010 the Ministry of Health of China established the Department of Health Quality and Patient Safety (Xuanyue et al. 2013, p. 47).

There is now a vast literature estimating the incidence and prevalence of harmful yet preventable adverse events in health care. The Ibero-american Adverse Event Study of ﬁve Latin American countries estimated in 2011 that the prevalence rate of adverse events was 10.5 % with more than two-thirds of these causing death or disability and 6 in 10 considered preventable. From 2006 to 2008, WHO Patient Safety conducted a large-scale study involving 26 hospitals in eight countries from the Eastern Mediterranean and Africa (WHO 2011). Health care–related harmful incidents affected 8 in 100 of the patients studied. Almost a third of patients impacted by harmful incidents died, and four out of ﬁve incidents were deemed preventable.

As the ﬁeld of patient safety has matured, the methodologies for identifying rates of harmful, preventable adverse events have become more sophisticated. The Institute for Health Care Improvement’s (IHI) Global Trigger Tool was developed to monitor the overall level of harm from adverse events. Based on this tool, a 2010 study from the U.S. found a rate of 25 harms per 100 hospital admissions, 63 % of which were preventable. A recent analysis of studies using this tool estimates that premature deaths associated with preventable harm to hospitalized patients in the U.S. are roughly 400,000 per year or four times the amount estimated in the original IOM report (James 2013).

Despite the extensive literature, available evidence about the scope of the problem is limited in a number of important ways. It is estimated that 50–96 % of medical errors are not reported and that the problem of under-reporting is worldwide (Kagan and Barnoy 2013). The largest empirical studies are based on hospital populations; however, the majority of care is provided outside hospitals. In addition, as patients seek and receive care from multiple providers in multiple settings, error can accumulate and exponentiate, but patient groups have not been studied longitudinally (Schwappach 2014). When over 27,000 citizens of the 28 member states of the European Union were surveyed in 2013 in a special Eurobarometer on patient safety and quality of care, 53 % reported having been harmed during hospital care, 50 % by nonhospital care. Finally, the literature on medical error does not typically consider nonclinical factors such as lack of clean water, instruments, and surfaces, unusable medical equipment, understafﬁng, and high bed occupancy, which contribute to national and international disparities in health care quality and outcomes. Because it emphasizes the way in which system breakdowns contribute to adverse outcomes, the patient safety movement is better able to account for the broader social and system determinants of patient harm.

Patient Safety As An Ethical Imperative

It is not medical error that is morally problematic. Rather, it is those medical errors that cause harm and that could and should have been prevented from happening in the ﬁrst place. The ethical imperatives against such harm go back to ancient times. As noted above, the Hippocratic injunction “to help or at least to do no harm” was based on a teleological philosophy that identiﬁed patient beneﬁt as the proper end of medicine. To harm the patient without providing a proportionate beneﬁt was to fail the patient and to fall short in your craft. Although the competing and conﬂicting interests of health care providers as well as antagonistic economic, political, and institutional forces present a constant challenge to this norm, it is generally accepted that patient beneﬁt and avoiding patient harm are primary duties of health care professionalism for allied health professionals and nurses as well as doctors. Although not typically framed as an ethical duty, it is increasingly recognized that health care executives and leadership must play a central role in creating a culture accountable for patient safety.

The patient safety movement has also been motivated by the ethical imperative of utility. Since the IOM report, national and international authorities have called for population-based improvements to address harmful medical error as a major public health problem. Although the IOM’s initial call for a 50 % reduction in errors over 5 years was not realized, there has been measurable success in error reduction all over the world by adherence to known safety standards including infection control, teamwork training, computerized order entry, and the use of surgical checklists.

Economic utility has also long factored as an ethical imperative against patient harm. One historian of medicine has argued that the ancient injunction to “do no harm” reﬂected the fact that practicing the craft of medicine depended on maintaining the goodwill of paying customers. Economic utility was also an important driver of the patient safety movement. Early studies that were the basis of the IOM report were either funded by the insurance industry or premised on the need to address a perceived “malpractice crisis” by understanding the economic consequences of injuries suffered by patients. In 2008, the United States Centers for Medicare and Medicaid

Services (CMS) established direct economic incentives for error prevention by no longer reimbursing for the extra costs of “never events” such as foreign object unintentionally retained after surgery, pressure ulcers, and administration of incompatible blood.

There can be tensions between these ethical imperatives. In early work on adverse events, it was unclear whether targeted efforts to prevent harm to patients could go forward without a clear “business case” that doing so would be ﬁnancially beneﬁcial to the institution. Today, the scope of the problem is still so signiﬁcant and the opportunities for low-cost, high-impact improvements – especially in developing countries – are so great that it is generally acknowledged that “safer care reduces costs” (WHO 2011).

Disclosure: Ethical And Legal Bases For A Culture Of Candor

Another way that the ethical imperatives for patient safety come into tension is in the conﬁdentiality protections intended to encourage providers to report error as a basis for quality improvement. For example, U.S. and Australian laws that protect health care quality improvement information from legal discovery and the U.K. National Health Service program that protects the conﬁdentiality of impaired physicians who self-report are often perceived to shield poor performers from accountability and to compromise the individual patient’s autonomy and right to information about their health care.

To ensure that overall quality improvement is not achieved at the expense of the individual patient’s right to know, national and international strategies increasingly promote pathways for combining adverse event reporting and legal accountability with strong standards for open disclosure of adverse events to individual patients (Sharpe 2003; WHO 2013). For example, the Michigan Claims Management Model of “open disclosure with offer” is premised on the principle that honesty is the basis for claim gains and patient safety. Likewise, programs promoting openness have been in place for up to a decade in Australia, New Zealand, U.K., and Canada. “Apology laws,” that is, laws that prohibit health care providers’ apologies and other evidence related to adverse event disclosure from being used against them in a lawsuit, have been passed in Canada, Sweden, Australia, parts of the U.S., and Denmark. These laws are an effort to remove legal fears that may deter health care professionals from being honest with patients about harm. New Zealand, Australia, and the U.K. have also established a legal duty of candor requiring health care providers to disclose to patients medical errors that have resulted in severe or moderate harm. Establishing a legally enforceable duty to be honest with patients is not without its critics who say that it resorts to a punitive approach that will cause a chilling effect on safety culture. However, the laws represent an afﬁrmation of the fundamental professional ethical obligation to be honest with patients as well as the patient’s right to know. The need for these laws also reﬂects the inadequacy of these long-standing ethical norms in guaranteeing honest communication with patients.

In 2011, WHO launched the rollout of its Multi-professional Patient Safety Curriculum Guide. In the guide, WHO emphasizes that disclosure is ﬁrst and foremost about integrity and being truly professional. In addition to being an inherent duty of professionalism, the literature has also shown that there are instrumental reasons to disclose: Nondisclosure is associated with lower patient satisfaction scores, less trust, and a greater likelihood that patients will seek legal advice.

Beyond informing patients about preventable adverse events, there has, in developed countries, been growing attention to the active involvement of patients in error prevention activities. Repeatedly, it has been shown that patients’ desire to know is not simply about justice for themselves but also about ensuring that similar harms can be prevented from happening to somebody else. Patient involvement takes a number of different forms. Calamitous adverse events have led some hospitals to make patients and families an integral and ongoing part of patient safety programs. In developed countries across the world, inﬂuential advocacy organizations have been started by families made bereft by medical errors. There are also initiatives aimed at empowering individual patients to take a more active role in their health care such as campaigns that invite patients to ask health care providers whether they have washed their hands. Such strategies are ethically problematic if they appear to place the burden of responsibility on patients to help ensure the safety of their own care or to make patients feel responsible if they experience a harmful error.

Safety Culture And Just Culture

Historically, medical culture has been based on the assumption that the moral motivations of individual health care providers were sufﬁcient to assure health care quality. Although this assumption persists, the patient safety movement has recognized the system dimensions of health care quality and accordingly established quality, safety, and transparency as norms of accountability for individuals at every level of health care delivery, from clinicians to nonclinical staff to managers, executives, and board members. “Just culture” reﬂects this broader concept (Marx 2001). First, it differentiates between inadvertent error (best managed by process changes, system redesign, training), risky behaviors (best managed by incentivizing healthy behaviors and increasing situational awareness), and reckless behaviors (best managed through remedial and punitive action). Second, just culture encourages health care administrators to recognize and embrace that they too are responsible for ensuring safe patient outcomes. Just culture also encourages support for health care providers as the “second victims” of harmful medical error by emphasizing the role that health care leaders must play in creating a healthy and supportive culture to enable health care professionals to fulﬁll their obligations to patients. One striking illustration of the role that the system – the health care system and beyond that the larger political system – and its actors play in accountability for medical harms is in the “malpractice mobs,” violent protests against hospitals and health care providers that are currently conducted in China as a means of medical dispute resolution (Liebman 2013).

The U.S. Agency for Healthcare Research and Quality’s (AHRQ) surveys on Patient Safety Culture assist hospitals, medical ofﬁces, nursing homes, and community pharmacies to self-assess how well they perform on a number of measures reﬂective of safety culture including error reporting, teamwork, and whether the response to error is punitive or nonpunitive. Since 2004, the hospital survey has been used in 57 countries with 26 different translations. Results have been reported from Oman, Palestine, Saudi Arabia, Lebanon, Taiwan, Belgium, Israel, among others. One deﬁciency of this important survey instrument is that it does not include any questions about disclosure to patients following medical error. This striking omission has prompted researchers to modify the AHRQ instrument by adding disclosure measures and to develop a standard measure on disclosure to ﬁll this noteworthy gap in safety culture assessment (Etchegaray et al. 2012). Valid tools to assess safety culture are expected to demonstrate that improvements in safety culture lead to a reduction in harmful errors.

Conclusion

Although attention to medical error and to patient safety more broadly has never been more prominent or widespread, there are signiﬁcant barriers to the achievement of safer and more ethically accountable health care delivery. If we accept the premise of the patient safety movement that reducing preventable patient harms depends on the culture in which care is delivered and understand culture to encompass not only the immediate culture of health care but all the values, beliefs, norms, institutions, and structures that shape and inform health care, then we understand the importance of coordinated work across all these domains. The leaders of the patient safety movement have made an impressive start in the global push for safe, high-quality, accountable health care.

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