Medical harm refers to either physical or psychological or financial harm caused to patients by health care. It could be caused by a failure in the health care system or it could be caused by the health care professionals without any system failure or even in the absence of a system. Sometimes patients are harmed as a result of a system succeeding in protecting itself.
Medical harm is not limited to iatrogenic illness.
Medicine may be a long way from creating the cognitive tools necessary for solving this problem when authorities as respectable as The Institute for Healthcare Improvement (IHI) define medical harm as the “[u]nintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment or hospitalization, or that results in death. They consider such an injury to be harm whether or not it is considered preventable, whether or not it resulted from a medical error, and whether or not it occurred within a hospital.” With this definition, IHI estimates that “15 million instances of medical harm occur each year” in the United States. With a different definition would the number be larger? One must wonder whether having the word "unintended" define the concept means that injuries caused intentionally were not counted. Also, of concern is qualifying it as harm only if it requires additional monitoring, treatment or hospitalization. Sometimes debilitating injuries are not treatable and so do not require additional monitoring, treatment or hospitalization. A cleaner and more inclusive definition of harm may be in order.
The trend in medicine has not been for definitions to be inclusive. It has been to exclude much from the definition including the people within the system and define harm purely as a systems problem with none of the people in that system being part the problem. This disenfranchises the people in the system. Recent research shows that people often make mistakes because they are not considered part of the system.
While it is thought that some progress has been made in recent decades in determining the best ways to reduce incidents of medical harm, the number of patients unnecessarily bankrupted, disabled or killed each year has not declined. Some advocates, including Dr. Barbara Starfield and Dr. Lucian Leape, believe that additional measures are necessary to reduce preventable harm. So far proposed measures mostly involve systems management and/or the management of the people within those systems, like more systems change in hospitals and other healthcare facilities; financial incentives or disincentives; and creating a national regulatory body with mandated incident reporting. Elsewhere are proposed systems that do not require managing health care systems or trying to persuade health care professionals to report problems, but instead gather the information by other means and inform patients of where the problems are so that patients can avoid them.
The term "medical harm" was first used after a Harvard Medical study in 1991 concluded that patients incurred a substantial amount of injury from medical management, and the injuries were a result of substandard care. A 1999 report by the Institute of Medicine, “To Err is Human,” further defined the scope of the problem and outlined comprehensive recommendations for reducing harm.
One of the most infamous examples of deliberate medical harm is the Tuskegee syphilis experiment, a study initiated by the Public Health Service in 1932 to examine the effects of untreated syphilis that used a group of poor rural black men as participants. The study continued until 1972, long after treatment for syphilis became widely available, and as a result several participants died of syphilis and its complications, infected their wives, and fathered offspring born with congenital syphilis. As a result of public outcry, the study was ended and new regulations for the ethical conduct of medical research were established. However, these regulations are exclusive to research and do not apply to or protect patients undergoing routine medical treatment.
In the United States
- 10% of acute hospital admissions resulted in the incidence of an adverse event.
- In 1999, it was estimated that 44,000 - 98,000 people die in hospitals each year as a result of medical errors, making it the tenth leading cause of death.
- In 2000, it was estimated 225,000 deaths from iatrogenic causes in hospitals alone, making it the third leading cause of death.
- In 2013 - an estimated 400,000 unnecessary deaths annually in hospitals with a potentially greater number resulting from care outside of hospitals where they are not counted.
- Twenty to 30 percent of patients in the United States receive care that is contraindicated.
- Adults 65 years and older are three times more like than younger adults and 60% more likely than middle-aged adults to experience post-operative respiratory failure following elective surgery even after adjusting for co-morbidities.
- Few studies have been done to determine medical harm in the clinical or outpatient setting.
- 7.5 % of hospital admissions resulted in the incidence of an adverse event.
- In 2003, 197 deaths resulted from adverse care events, 22 from adverse drug events.
- In 2003, 5.2 million or 24% of Canadians reported they or a family member had experienced a preventable adverse event due to medical care, 52% of these reports stated the event had a serious consequence.
In the United Kingdom
- 10.3 % of acute hospital admissions resulted in the incidence of an adverse event.
- In 2002, 413 deaths resulted from adverse care events, 36 from adverse drug events.
In New Zealand
- 12.3 % of acute hospital admissions result in the incidence of an adverse event.
- Adverse events in in-hospital healthcare ranks number 11 in the 20 top risk factors that account for 75% of the deaths annually; ahead of air pollution, alcohol and drugs, violence and traffic road injuries; equal to a third of the size of tobacco-related deaths.
Types of medical harm
In a hospital setting
- nosocomial infection – an infection unrelated to the initial diagnosis that is acquired by a patient while in a health care facility (namely hospitals), could be pneumonia or blood infection
- restraint-related injury - patient in surgical or medical restraints end up with musculoskeletal injuries from poor positioning or skin breakdown
- falls – a patient who may be medicated, physically unstable, or elderly falls and sustains an injury
- burns – can occur from radiation treatment, heating pad or a medical device
- design-related injury - occurs when the long-standing design of a device or instrument inherently produces collateral damage, such as tissue damage
- pressure ulcer – occurs when a patient is unable to move or feel pain and is left in one position for a long time, compromising blood flow to an area and causing skin to break down
- mistaken patient identity – a patient is given another patient’s medication or taken for a diagnostic exam or to surgery under another patients name
- wrong-site surgery – the wrong side of the body is treated surgically –left leg rather than right leg amputation
- suicides while in the hospital
- adverse drug effect
- improper transfusions – patients receive the wrong blood type, or incorrect product
In a clinical setting or hospital
- misdiagnosis – a provider incorrectly identifies a patients condition or disease (ex. a patient is diagnosed with heart burn, a gastro-intestinal condition when he actually has a heart condition)
- under-diagnosis – a provider does not fully identify the cause (ex. a patient with Lyme disease, which is caused by a tick and starts out with vague symptoms like fatigue and joint pain is told he has fibromyalgia)
- overdiagnosis – something benign is identified as happening often with cancer where non-specific cancer marker is identified with the potential that the cancer carries no risk to the patient's health.
- unnecessary surgery – a provider performs a surgery without utilizing or ruling out less invasive options (ex. a hysterectomy for uterine bleeding before considering a uterine fibroid artery embolization)
- under treatment – lack of appropriate follow-up or treatment, often related to lack of health insurance, or inability of provider to diagnose
- over treatment – a provider provides more interventions than are required (ex. provider prescribes a multiple medications to ensure his patient with epilepsy is seizure free without considering the side effects)
Reducing and preventing medical harm
In 1999, the Institute of Medicine released the report "To Err is Human," bringing attention to the issue from both the medical community and the public at large. Emphasizing that "bad systems and not bad people" are the root cause of most harm, the report recommended that safety be a priority for administrators and for hospitals and clinics redesign their systems and create "non-punitive" environments for providers. As a result of this information and public response, Congress designated $50 million in grants to address the issue. Resulting projects included patient safety culture surveys, effective teamwork training, a patient safety checklist to reduce central line-associated bloodstream infections, reducing hospital readmissions through efficient discharge processes, and addressing resident fatigue. In 2005 President Bush signed The Patient Safety and Quality Improvement Act which created whistleblower protection for reporting errors and implemented a voluntary reporting system. Although Institutions that have created "blameless" reporting systems or the ability to report "close calls" as well as actual incidents of harm believe that they have had some success in increasing reporting, these systems have not been universally adopted and the rate of the accurate reporting of problems in medicine still only is 2% with 93% of problems never being reported at all according the Health and Human Services report "Adverse Events in Hospitals.". Currently, there is no mandatory national reporting system and no reason to believe that implementing one will result in a substantial increase in reporting. Payment incentives, or penalties for hospitals that do not conform to safety standards, have also been suggested as possible mechanisms for reducing medical harm. However, some believe that the issue of reducing medical harm has not been adequately addressed and that a national regulatory body is necessary to mandate and coordinate preventive measures. Others believe that a national regulatory body cannot do what local regulatory bodies have never managed to do and only is more of what has not worked yet.
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