Tools
Adverse Events
Introduction
Adverse events are common across healthcare systems, with some studies' results reporting that 10% to 25% of patients are affected.[1][2] Definitions vary across studies and institutions, but an adverse event is generally defined as a patient injury arising from medical intervention that necessitates additional treatment or hospitalization or results in death.[3] (Source: University of California, Davis Patient Safety Network Editorial Team, 2024.) Nearly any medical test or treatment carries the potential for harm. The consequences vary widely in severity depending on the clinical context. Although some adverse events are unavoidable, many are preventable. In recent decades, large-scale initiatives have aimed to analyze and reduce preventable errors to improve patient safety.
Etiology
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Etiology
Adverse events may result from diagnostic testing, surgical procedures, or medication administration. Some are unavoidable, as all treatments carry inherent risks that may lead to patient discomfort or harm, but human error plays a significant role in many adverse events. A preventable adverse event can be avoided through adherence to the standard of care. These incidents often involve wrong medications, incorrect procedures, or errors in procedure site selection. An ameliorable adverse event may not be preventable, but can result in less severe harm if different actions are taken. Preventable events often involve errors, defined as actions or omissions that result in an actual or potential undesired outcome. A near-miss event has the potential to cause significant harm but does not do so, typically due to chance rather than intervention. Each category mentioned above involves human error and may be preventable to varying degrees.
Medication errors are a major contributor to both preventable and unpreventable adverse events. Medication-related adverse events include adverse drug effects, drug interactions, prescription errors, and administration mistakes.[4][5][6] Such events occur in both inpatient and outpatient settings. Surgical and procedural errors also account for many adverse events. Surgery-related complications, including wrong-site operations and inadequate perioperative care, result in a substantial number of patient deaths each year.[7] Additional contributors include nosocomial infections, improper documentation, inaccurate orders or prescriptions, misdiagnosis, missed diagnosis, and premature hospital discharge.[8][9] Early discharge may lead to adverse outcomes (eg, injury) that require readmission.[10]
Epidemiology
More than 250,000 patients in the United States (US) experience an adverse event each year, and tens of thousands die as a result. Study results suggest that adverse events occur more in the US than in many other developed nations.[11][12] In contrast, countries with lower average individual incomes typically report even higher rates of adverse events.[13] Globally, roughly 10% of patients have experienced at least 1 adverse event.[14] Certain patient populations are at increased risk of adverse events, including racial minorities, individuals of lower socioeconomic status, patients with limited or poor insurance coverage, those at the extremes of age, and patients with a high burden of chronic disease.[15][16][17][18]][19]
A systematic review estimated the annual incidence of adverse events in healthcare settings to be approximately 10%, with half of these deemed preventable.[20] The mortality rate associated with adverse events was estimated at 8%. The most frequently reported events included surgical errors, medication- and fluid-related complications, and healthcare-associated infections.
History and Physical
Symptoms vary depending on the nature and severity of the adverse event. A detailed history of present illness should include recent medical interventions, current and recent medications, known allergies, and associated symptoms. A comprehensive review of the patient's medical chart is essential when an adverse event is suspected. Some adverse events may cause only mild symptoms. Severe adverse events, however, may present with encephalopathy, end-organ dysfunction, hemodynamic instability, or death.[21][22]
Evaluation
Suspected adverse events must be evaluated promptly. Evaluation should include a face-to-face patient assessment and a focused review of potential contributing factors. Diagnostic testing may be necessary to confirm an adverse event or investigate alternative diagnoses. Patients undergoing procedures or receiving new treatments should be informed of potential adverse effects and complications. Healthcare providers should then monitor for these effects and promptly address any reported symptoms. Severe adverse events, such as patient injury or death, are classified as sentinel events and require immediate reporting and comprehensive evaluation. In the US, many healthcare facilities use institutional or centralized electronic reporting systems for adverse events, although reporting rates vary widely across institutions.[23][24][25]
Addressing an adverse event typically begins with an internal review of the case and developing strategies to prevent recurrence.[26] Fostering a culture of safety encourages the reporting and systematic analysis of medical errors.[27][28] Identifying and correcting systemic flaws involves the application of various analytical tools to evaluate patterns and design appropriate interventions.[29][30] Institutional protocols may be implemented, revised, or discontinued based on findings to reduce the risk of future events.[31] The Agency for Healthcare Research and Quality has developed patient safety indicators to guide institutional responses to adverse events. Additional strategies include quality improvement frameworks such as Plan-Do-Study-Act cycles and Root Cause Analysis.[32]
Treatment / Management
Adverse events should be treated at the patient level and addressed at the system level. When a patient experiences an adverse event, the clinician must deliver timely and appropriate treatment based on the nature of the complication. For example, infections should be treated with antibiotics and supported by relevant laboratory testing. Medications causing adverse reactions should be discontinued when possible. Symptoms should be managed supportively.
Adverse events occurring within the healthcare system must be reported according to established institutional protocols.[33][34][35] Reporting databases are critical for identifying trends and implementing changes to prevent or mitigate future events.[36][37][38] However, research has shown that adverse events are frequently underreported.[39][40] Fostering a true culture of harm prevention requires clinicians to commit to consistently reporting all adverse events.[41](A1)
Differential Diagnosis
The differential diagnosis should always include adverse reactions to recent medical interventions or medications. The differential diagnosis for a suspected adverse event is broad and should be guided by the patient's presenting symptoms.
Prognosis
The prognosis of an adverse event depends on its nature and severity. Minor adverse drug effects often resolve without lasting complications. In contrast, more severe complications related to medical care may result in significant morbidity or death.[42] The expected prognosis should be clearly communicated to the patient. The median in-hospital mortality rate associated with adverse events is approximately 8%; the estimated annual secondary cost of managing these events is around $17 billion.
Complications
The complications associated with an adverse event depend on the nature and severity of the event.[43] Permanent injury and death are recognized risks of medical treatment. However, many adverse events are manageable with timely intervention. Healthcare professionals should counsel patients regarding potential complications to support informed decision-making. Shared decision-making should be encouraged when appropriate. Patients retain the right to refuse treatment at any time.[44]
Deterrence and Patient Education
Patients may receive appropriate education about their care and treatment, which may reduce the frequency of adverse events.[45][46] Healthcare professionals who fully inform patients, engage in shared decision-making, and tailor treatment plans to individual needs are more likely to prevent complications. Common or anticipated adverse events and side effects should be clearly communicated during care.
Consistent reporting can further reduce future adverse events. Timely reporting enables review of sentinel events and supports policy revision when indicated. Developing systematic response mechanisms to analyze and act on collected data from sentinel and adverse events is essential.[47] To support these efforts, healthcare systems must foster a culture of safety by allocating the resources and support necessary to facilitate event reporting.
Pearls and Other Issues
Adverse events are common in healthcare. Clinicians must remain vigilant to the risk of such events and continuously monitor for complications arising from medical care. Iatrogenic causes should always be considered in the differential diagnosis of new or unexplained symptoms. Fragmentation within healthcare systems can complicate reporting and preventing adverse events.[48] Patient education at admission and discharge may facilitate recognizing and timely communication of adverse outcomes. A comprehensive review should be conducted when an adverse event occurs to identify system vulnerabilities and revise care protocols as needed. These measures can help prevent recurrence and enhance overall patient safety.[49]
Enhancing Healthcare Team Outcomes
Every healthcare team member plays a critical role in reducing the incidence of adverse events. Prevention, timely reporting, appropriate follow-up, and thorough analysis all improve care and reduce risk. Analyzing adverse events allows teams to refine clinical processes and develop safer or alternative approaches to treatment.[50][51][52][53]
The following are commonly reportable categories of adverse events:
- Surgical events (eg, wrong patient, wrong site, wrong procedure, retained foreign object)
- Product- or device-related events (eg, use of contaminated products, air embolism from medical devices)
- Patient protection events (eg, patient elopement, suicide during care)
- Care management events (eg, medication errors, mismatched blood transfusions)
- Environmental events (eg, patient burns, electric shock, incorrect gas delivery)
- Criminal events (eg, sexual assault, impersonation of healthcare staff, physical assault) [54]
Preventing adverse events relies on cultivating an environment where safety is a shared responsibility. Sustaining a culture of safety is essential to protecting patient health and preventing harm.[55]
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