restricted access 2. Epidemiology and Public Health Aspects and Implications of Iatrogenicity: Regulatory, Legal and Ethical Dimensions
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INTRODUCTION The pro­ cess by which a condition or be­ hav­ ior is defined as a medical prob­ lem requiring a medical solution is known as medicalization. For medicalization to occur, one or more or­ ga­ nized social groups must have both a vested interest in the condition and sufficient power to convince ­ others to accept the newly proposed need for a medical solution. Not surprisingly, the 1999 report released by the Institute of Medicine To Err Is ­ Human: Building a Safety Health System (1), exposed treatment-­ related adverse conditions as the medicalization of harm (2–7). The report was a call to action, prompting regulators, physicians, payers, and providers including health care facilities and systems to focus on harm as a medical prob­ lem requiring a medical solution. This focus led to the patient safety movement resulting in regulations and legislative initiatives to protect patients from medical harm. The medicalization of harm is influenced as much by ethics as regulatory and­ legal reform. For medicalization to occur it is impor­ tant for one or more or­ ga­ nized social groups to have a vested interest and sufficient power to convince ­ others. The release of the Institute of Medicine’s report was a compelling and shocking revelation about the ­ human, social and eco­ nom­ ical cost of medical errors. Although patients­ were likely to hear about this report in the popu­ lar media, the report was widely examined in the permeations of professional meetings, conferences, and regulatory framework of providers, payers, and regulators. A collective social awareness of the prob­ lem and sympathy ­ toward sufferers and deceased victims gave rise to a proliferation of models to improve patient safety. At the heart of the models, the discussions , and the framework for improved responsibility was ethics. ­ There arose a heightened sense that physicians and their extended providers must own the errors both morally and professionally, and provide disclosure to the patient and ­ family as a first step ­ towards that end. See Chapter 3 for information on the importance of disclosure and apology in healing the doctor-­ patient relationship and mitigating the harm ­ after an iatrogenic event. CHAPTER 2 Epidemiology and Public Health Aspects and Implications of Iatrogenicity Regulatory, ­ Legal, and Ethical Dimensions Miriam A. Gonzalez-­ Siegel and Stephen K. Jones Key Organ­ izations in the Patient Safety Movement / 17 Institute for Healthcare Improvement (IHI) began its work in the late 1980s as part of the National Demonstration Proj­ ect on Quality Improvement in Health Care. IHI initially focused on identifying and promulgating best practices and reductions in defects and errors in microsystems such as the emergency department or the intensive care unit. As the organ­ ization entered its third de­ cade, it recognized the need for a new health care model and created the IHI ­ Triple Aim Initiative, a framework for optimizing health system per­ for­ mance by si­ mul­ ta­ neously focusing on the health of a population, the experience of care by individuals in the population, and the per capita cost of providing that care. IHI’s Innovation Series white paper published in 2011 (15) reported that ­ every day clinical adverse events occur in the health care system, causing physical and psychological harm to patients and their families, staff, physicians and allied health professionals, the community, and the health care organ­ ization. In the crisis that often emerges, what differentiates organ­ izations, positively or negatively, is their culture of safety; the role of the board of trustees and executive leadership; advanced planning for adverse events; the balanced prioritization of the needs of patients and their families, staff, and organ­ ization; and the way in which actions immediately and over time bring empathy, support, resolution, learning , and improvement. The risks of not responding to adverse events in a timely and effective manner are significant and include erosion in the delivery of competent and compassionate care, mixed messages about what is impor­ tant to the organ­ ization, increased likelihood of regulatory action and lawsuits, and challenges from the media. Patient Safety Organ­ izations The federal government’s contributions to the patient safety movement are evident in the enactment of the Patient Safety and Quality Improvement Act of 2005 (Act), which came in response to the Institute of Medicine report. The final Patient Safety Rule became effective in January 2009. The Agency for Healthcare Research and Quality (AHRQ), a division of the Department of Health and ­ Human Ser­ vices, oversees the Patient Safety Rule. The intent of the Act is to Saving...