**3. Adverse events in healthcare**

In contrast, Leape [10] refers to errors attributed to actions or omissions but overlooks the actions based on design errors, unless they lead to adverse effects. Reason's and Leape's definitions are subjected to several limitations. Although an action may be mistaken or the plan for the accomplishment of the desired effect may not be appropriate, errors or omissions must not be always blamed for adverse events in the healthcare sector, since there are other factors that contribute to them, such as an unexpected allergic response to a new medication treatment.

An equivalent definition of error, similar to the one provided by Reason [6], is the definition by

errors in the healthcare sector. Therewith, a "medical error" is defined as the failure to complete a planned action or the use of ineffective planning for the accomplishment of an objective [11]. In a report published in 2000 regarding medical errors and patients' safety, Quality Interagency Coordination Task Force (QuIC) in USA attempts a conceptual clarification of error in the healthcare sector expanding the definition that was provided by the IOM the previous year. According to this definition, "error" is defined as the failure to complete a planned action as expected or as the use of incorrect/poor planning to achieve an objective. According to the same report, "medical errors" may also refer to processes, practices, and equipment [12].

In order to understand the concept of error in the healthcare sector more accurately this time, Reason [13] defined error as the variations in the provision of healthcare that may cause harm to the patient. Other definitions concerning medical errors, which were published recently,

Zhang et al. (2002) [14] "Medical error" occurs when a healthcare provider chooses an inappropriate method to

Kyritsi (2009) [17] "Error" is any unintended event that poses a threat to patient's safety or any deviation from the rules and the established practices in the workplace Raftopoulos (2009) [18] "Error" is an action that fails to achieve the intended outcome, which may be analgesia, muscle relaxation, or any other recession of unpleasant symptoms Kapaki (2015) [19] "Medical error" refers to a healthcare professional's action or omission during the planning

to improve a patient's health status

improve a patient's health status or fails to apply the appropriate method correctly in order

"Medical error" is the unintended outcome, caused by a certain defect in healthcare provision. Moreover, errors in the healthcare sector may be divided into "errors of practice" (wrong action), "errors of omission" (lack of the correct or appropriate action), and "errors of execution" (performance of the correct action executed wrongly)

"Medical error" is an action or omission throughout the design and execution of a healthcare provision process that causes or is likely to cause adverse events

and implementation of healthcare provision, which contributes or could contribute to the further impairment of a patient's health status on the one hand and the healthcare

Institute of Medicine (IOM) has been renamed to National Academy of Medicine (NAM).

provision system on the other

**Table 1.** Additional definitions of medical errors.

in the United States in 1999, in a published report, regarding

the Institute of Medicine (IOM)<sup>1</sup>

16 Vignettes in Patient Safety - Volume 3

are presented in **Table 1**.

National Patient Safety Foundation (NPSF) (2003) [15]

Grober and Βοhnen (2005) [16]

1

A previous literature review includes research on patient safety issues that mainly focus on adverse outcomes from the practice of medicine, adopting definitions of medical errors and related terms based on the adverse outcomes of medical practice [20–24]. This could be explained by the basic medical principle of Hippocrates, which is summarized in three words: "Primum non nocere" or "First, do no harm" [10, 25]. Moreover, the definition of patient safety dictates an outcome-based approach of medical error.

"Patients' safety" is defined as avoidance, prevention, and improvement of negative effects or injuries caused to patients during healthcare provision [26]. IOM defines "patient's safety" as freedom from random harm [11].

In his study "Hazards of Hospitalization," Schimmel [27] argued that the evaluation of undesirable effects resulting from healthcare provision, as well as the registration of their frequency, is necessary regardless of the severity of the effects. It is also paramount that an overall risk assessment is realized, regarding the patients' exposure to polypharmacy and complex procedures during healthcare provision. Within this context, he introduces the term "noxious episode" for the first time.

"Noxious episodes" are all the unpleasant events, the complications, and the misfortunes caused by acceptable diagnostic and therapeutic measures executed in the healthcare unit [27].

The term "potentially compensatable event" was introduced for the first time in 1977 in the study titled "The California Medical Insurance Feasibility Study," defining it as an event that occurs during healthcare provision and leads to disability or prolonged hospitalization [28].

Four major researches regarding errors in the healthcare sector were published in the 1990s, emphasizing the term "adverse event." According to "Harvard Medical Practice Study" [20, 21], "The Utah and Colorado Medical Practice Study" [22], "The Quality in Australian Health Study" [23, 24], and the study of IOM in US "To Err is Human: Building a Safer Health System" [11], an "adverse event" is defined as a localized damage or complication caused to patients by medical care that does not result from patient's impending disease and leads to patient's disability, prolonged hospitalization, or even death.

"An adverse or undesirable event" refers to an outcome of a process, whereas an error characterizes an action itself. This means that an error may cause an adverse event or not, either because this action caused no harmful effects and the patient did not experience any symptoms or because it was detected on time and was prevented. An error constitutes a necessary but not sufficient cause of an "adverse event." This is explained by the fact that "adverse events" do not always result from errors or omissions; they may also arise from appropriate actions with "adverse effects" (complications) that were either unknown at the time the action was taken or they were known and expected but could not be prevented (e.g., adverse drug events, etc.) [29].

Leape [10] classifies "adverse events" into three categories as shown in **Figure 2**.

**ii.** events such as suicide, rape, delivery of a newborn to the wrong family, violent abduc-

Defining Adverse Events and Determinants of Medical Errors in Healthcare

http://dx.doi.org/10.5772/intechopen.75616

19

The terms "close call" or "near miss" are almost identical and refer to certain actions or situations, which could have caused an "adverse event" but were timely detected and prevented

A term that is often used when referring to "adverse drug events" is that of "side effects," which regard the known effects of a drug and are different than those for which the drugs

"Iatrogenic injury" or "illness" is another term, which refers to undesirable effects that result, partly or entirely, from the medical process or medication treatment and do not constitute a direct or an indirect complication of the patient's initial state or the disease. This term is similar (or identical) to the side effects. The difference between "iatrogenic injuries" and "side effects" is that the first are not known and therefore they are totally unexpected. Furthermore, they are not caused due to technical failures, and therefore they do not constitute a criminal

The term "incident" occurs frequently in cases relating to patient safety, and it is used as a general term until the moment the event has been classified [36]. It characterizes an event that has already led or could lead to an artless injury and patient complain, and loss or damage [37]. The National Research Council (NRC) defined "incident" as an event that could be considered an accident, if it had taken place under slightly different circumstances. A critical

The concept of "error" is often confused with the concept of "injury". WHO defines "injury" as tissue damage caused due to a factor or under certain circumstances? "Errors" become noticeable when they cause a certain "adverse event" or "injury" to the patient and influence health outcomes in a negative way [34]. Leape [10] argues that most "errors" do not

The term "harm," which is typical of the body's structural or functional impairment and the

The term "hazard" has the meaning of risk factor and refers to anything that causes damage. A "hazard" is also defined as a factor, a situation, or an action, which may lead to or increase risk. In his article titled "The hazards of hospitalization" published in 1964, Schimmel refers to the terms "hazard," "adverse reaction," "adverse episodes," "incidence," and "risk" and categorizes reactions into those caused by diagnostic or therapeutic interventions that occurred in the hospital and those resulting from physicians' or nurses' errors of negligence [27].

The first study regarding "errors" in the healthcare sector was conducted in 1960 at a New York City hospital and indicated that 60% of the "errors" are caused by healthcare professionals'

tion of a patient, surgery on the wrong body part of a patient, etc.

offense. This term is not also different from an "adverse event" [35].

event regards an event that leads to serious damage or even death [38].

resulting negative effects, is also frequently used in the study [34].

**5. Determinants of medical errors**

or randomly prevented [33].

were originally designed [34].

lead to "injury".

negligence [39].

**Figure 2.** Adverse events classification by Leape. Source: Leape [10].

Literature also makes frequent reference to "adverse events," the severity, and criticality of which could have been significantly limited, provided that different actions had been followed (ameliorable adverse event) [30].

In addition to the conceptual clarification of the term "adverse event," studies, such as the Harvard Medical Practice Study [20, 21] and the Utah and Colorado Medical Practice Study [22], introduced the term "negligent adverse event" for the first time as a subcategory of the "preventable adverse events," which, however, meet the legal criteria defining negligence.

Other than words such as "mistake," "error," and "adverse or undesirable event," literature regarding patient safety issues also makes frequent use of several relevant terms without any clear and distinct conceptual differentiation. According to Cook et al. [31], it is a fact that the approach of patient safety issues is not the same among all healthcare professionals.
